Dor Biophar. baldige Zulassung - 500 Beiträge pro Seite

[taipan11]

nun wird es vermutlich nicht mehr lange dauern, bis wir endlich wissen, ob orBec nun die zulassung von der fda erhalten wird.
der zulassungsantrag wurde am 22.09.2006 eingereicht.
die marktzulassung könnte dann vermutlich noch ende 2007 oder anfang 2008 erfolgen und würde dann endlich geld in die kassa spühlen.
was meint ihr dazu?

taipan11

[taipan11]

Antwort auf Beitrag Nr.: 26.196.616 von taipan11 am 15.12.06 09:08:24

ich meinte natürlich, wenn es die zulassung gibt (wird vermutlich im frühjahr entschieden), kann das produkt schon ende 2007/anfang 2008 produziert und einnahmen generiert werden.

gruß

taipan11

[havedone]

http://biz.yahoo.com/iw/070104/0199725.html

Vertriebsrechte für Europa werden schon von "www.sigma-tau.it" gesichert, einem der größten Pharmakonzerne Italiens.

[benji10]

das Volumen war gestern ja ganz beachtlich

bei der news war der Kurssprung jedoch nicht so berauschend

[havedone]

Antwort auf Beitrag Nr.: 26.683.783 von benji10 am 05.01.07 08:02:42

2007 wird ( wieder) das Jahr von URAN - GOLD - Biotech - Aktien

Die wahrscheinl. bevorstehende Zulassung von Orbec(TM) ist das eine,
RiVax (TM) aus der Biodefensedivision ist redhot. Nicht umsonst gibt das DoD/ Department of Defense der US-Regierung unserem kleinen Biotechunternehmen Millionen Dollar an Steuergeldern.
Einfach mal RICIN googeln..

Hier können über Nacht 1.000 % und mehr möglich sein.
Beispiel: VXGN.PK in 2006.

meine pers. Meinung: DORB.OB ist möglicherweise die unterbewerteste Biotech-Aktie überhaupt, ein no-brainer.

[benji10]

http://www.stockta.com/cgi-bin/analysis.pl?symb=DORB&num1=15…

An der 200 Tagelinie haben wir am Freitag ja schon mal gekratzt
und die Bollinger machen auch Anzeichen als ob

Wenn man sich mal die Jahre zu vor betrachtet, war im Jan. meistens
http://www.rallymonkey.com/oldvideo.php

schau wer mal wie es kommt. Wenn wir die $,29 reißen, kommt ein schöner
Schub, dessen bin ich mir sicher

so long

[benji10]

Warum will Makler in Ffm plötzlich statt 5 000 nun 35 000?
München ebenfalls erhöht

[benji10]

Macd hat ins bullische gedreht

http://www.smallcapcenter.com/snapshot_techanalysis.asp?comp…

[benji10]

SIGMA TAU FILED THEIR SEC 13-G'S IN DORB (3 Ratings) 15-Jan-07 09:40 am
This past week on Friday night. Hey--at least things are moving in the right direction. Rght now.. thats what I care about in the immediate future.

http://edgar.brand.edgar-online.com/fetc...

http://edgar.brand.edgar-online.com/fetc...

http://edgar.brand.edgar-online.com/fetc...

http://edgar.brand.edgar-online.com/fetc...

http://edgar.brand.edgar-online.com/fetc...

http://edgar.brand.edgar-online.com/fetc...

http://edgar.brand.edgar-online.com/fetc...

[benji10]

and moving

[URANI]

[benji10]

Antwort auf Beitrag Nr.: 26.960.424 von benji10 am 16.01.07 16:57:38

und Volumen wieder überm Durchschnitt

[benji10]

http://quote.barchart.com/texpert.asp?sym=DORB

pivot point ist eingehalten
support hat gehalten

und letzter Verkauf von 1000 shares war nur Makulatur

http://stockcharts.com/charts/gallery.html?DORB

[benji10]

hier we go

n January 17, 2007, DOR BioPharma, Inc. (“DOR” or the “Company”) received an unsolicited proposal from Cell Therapeutics, Inc. (Cell Therapeutics”, NASDAQ “CTIC”) to acquire DOR. The proposal from Cell Therapeutics is subject to, among other things, the completion of satisfactory due diligence regarding clinical, regulatory, manufacturing and proprietary positioning for orBec®. Under the proposed terms, Cell Therapeutics would issue the Company’s shareholders 29,000,000 shares of Cell Therapeutics’ common stock, representing 19.9% of Cell Therapeutics outstanding shares of common stock. Warrant and option holders would receive shares of Cell Therapeutics common stock in an amount determined using the Black Scholes pricing model. Cell Therapeutics has reserved the right to offer cash as consideration for the warrants instead of Cell Therapeutics common stock. In addition, Cell Therapeutics is also offering the potential for an additional $15 million payment (in stock or cash at the Company’s option) upon receipt of the approval of the U.S. Food & Drug Administration of the Company’s new drug application for orBec®.

[havedone]

Antwort auf Beitrag Nr.: 26.699.972 von havedone am 05.01.07 20:30:32

http://us.rd.yahoo.com/finance/external/reuters/SIG=11vg3000…

unser kleines Biotech fliegt: heute plus 85% in USA

[benji10]

http://www.thelion.com/bin/la.cgi?cmd=open&url=http%3A%2F%2F…



Hier mal ein Amiboard, das sich ausgiebiger mit DORB beschäftigt

[havedone]

http://ragingbull.quote.com/mboard/boards.cgi?board=DOR&read…

CTI hat selbst 2 phase-III - products in der pipeline und ist in partnership mit NOVARTIS !

[benji10]

an 19 (Reuters) - DOR BioPharma Inc. (DORB.OB: Quote, Profile , Research) said on Friday that it received an unsolicited buyout offer from Cell Therapeutics Inc. (CTIC.O: Quote, Profile , Research) (CTIC.MI: Quote, Profile , Research).

However, DOR said it cannot consider the offer at this time as the company had signed a letter of intent which grants Sigma-Tau Pharmaceuticals Inc., a unit of Italy-based Sigma-Tau Group, exclusive right to negotiate for its lead product.

Cell Therapeutics, a biotechnology company, would issue 29 million shares to DOR shareholders, representing 19.9 percent of its outstanding stock, DOR said in a statement.

In addition, it would offer $15 million in stock or cash if the U.S. Food & Drug Administration approves DOR's new drug application for orBec, its treatment for complications of bone marrow transplantation.

Sigma-Tau had agreed to purchase $1 million of DOR shares for about 25 cents a share, and paid an additional $2 million in cash. (Reporting by Rakesh Sharma in Bangalore)

© Reuters 2007. All Rights Reserved.

[benji10]

Antwort auf Beitrag Nr.: 27.053.809 von havedone am 20.01.07 15:58:05

BM

[benji10]

The annual shareholder meeting is tomorrow in Miami

[benji10]

http://www.stockhouse.com/news/news.asp?newsid=4897310&tick=…

[benji10]

http://www.thelion.com/bin/la.cgi?cmd=open&url=http%3A%2F%2F…

[benji10]

Antwort auf Beitrag Nr.: 27.155.624 von benji10 am 24.01.07 17:28:54

sorry

http://www.marketwatch.com/news/story/dor-biopharma-host-con…

[luto9]

buy now and stay long

http://www.stockta.com/cgi-bin/analysis.pl?symb=DORB&num1=2&…

[luto9]

IAMI, FL, Jan 31, 2007 (MARKET WIRE via COMTEX News Network) --

DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or "the Company") announced that it has received notification from the U.S. Food and Drug Administration ("FDA") that the Oncology Drug Advisory Committee ("ODAC") will review the New Drug Application (NDA) for orBec(R) (oral beclomethasone dipropionate) for the treatment of gastrointestinal Graft-versus-Host disease ("GI GVHD") on May 9, 2007. The FDA has previously said it will respond to DOR's NDA by July 21, 2007 in accordance with the Prescription Drug User Fee Act (PDUFA).

"The setting of an advisory committee meeting date marks an important next step in the orBec(R) NDA review process," stated Christopher J. Schaber, Ph.D., President and Chief Executive Officer of DOR BioPharma. "We are very pleased to have this opportunity to present the orBec(R) data in GI GVHD to the ODAC panel and we look forward to reviewing our application with the FDA advisors."

The data provided in the NDA submission demonstrate that orBec(R) may provide a higher rate of survival when compared with the current standard of care, and a lowered exposure to systemic corticosteroids following allogeneic transplantation. Currently there are no approved products to treat GI GVHD. Thus an approval of orBec(R) would represent the first directed therapy for GI GVHD.

The NDA filing is supported by data from two randomized, double-blinded, placebo-controlled clinical trials. The first trial was a 129-patient pivotal Phase 3 multi-center clinical trial of orBec(R) conducted at 16 leading bone marrow/stem cell transplant centers in the U.S. and France. The second trial was a 60-patient Phase 2 single-center clinical trial conducted at the Fred Hutchinson Cancer Institute. Although orBec(R) did not achieve statistical significance in the primary endpoint of its pivotal trial, namely time to treatment failure through Day 50 (p-value 0.1177), orBec(R) did achieve statistical significance in other key outcomes such as median time to treatment failure through Day 80 (p-value 0.0226) and, most importantly, demonstrated a statistically significant long-term survival advantage compared with placebo.

In the pivotal Phase 3 trial, analysis of patient survival at the pre-specified endpoint of 200 days post-transplant showed a clinically meaningful and statistically significant 66% reduction (p-value 0.0139) in mortality among patients randomized to orBec(R). In the pivotal Phase 3 trial, a subgroup analysis also revealed that patients dosed with orBec(R) who had received stem cells from unrelated donors had a 94% reduction in the risk of mortality 200 days post-transplant.

orBec(R) further showed continued survival benefit when compared to placebo one year after randomization in the pivotal Phase 3 trial. Overall, 18 patients (29%) in the orBec(R) group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test). Results from the Phase 2 trial also demonstrated enhanced long-term survival benefit with orBec(R) versus placebo. In that study, at one year after randomization, 6 of 31 patients (19%) in the orBec(R) group while 9 of 29 patients (31%) in the placebo group had died (45% reduction in mortality, p=0.26). Pooling the survival data from both trials demonstrated that the survival benefit of orBec(R) treatment was sustained long after orBec(R) was discontinued and extended well beyond 3 years after the transplant. The risk of mortality was 37% lower for patients randomized to orBec(R) compared with placebo (hazard ratio 0.63, p=0.03, stratified log-rank test).

About FDA Advisory Committees

To keep up with the challenges that the FDA's full-time experts face when reviewing innovative and rapidly evolving technologies, the agency hires "special government employees" whose opinions complement its goals to provide safe and effective products.

These outside advisers make up the FDA's technical and scientific advisory committees. The primary role of an advisory committee is to provide independent advice that will contribute to the quality of the agency's regulatory decision-making and lend credibility to the product review process. In this way, the FDA can make sound decisions about new medical products and other public health issues. And although advisory committees have a prominent role in the product approval stage, they are sometimes included earlier in the product development cycle and are asked to consider issues relating to products already on the market.

Committees typically are asked to comment on whether adequate data supports approval, clearance, or licensing of a medical product for marketing. Advisory committees also may recommend that the FDA request additional studies or suggest changes to a product's labeling. Their recommendations are just that -- advice -- and do not bind the agency to any decision. While committee discussions and final votes are very important to the FDA, the final regulatory decision rests with the agency.

Membership in advisory committees must be "fairly balanced" -- that is, as open and inclusive as possible -- according to the law. Committee membership is expected to include ethnic, gender, and geographic diversity, as well as people with recognized expertise and judgment in a specific field, such as clinicians and researchers. Most members of the FDA's drug advisory committees, for example, are physician-scientists whose specialties or research involve the kinds of products being reviewed. Other members might include statisticians, epidemiologists, nutritionists, and toxicologists -- experts in preclinical (animal) studies. The FDA also insists on getting industry and public perspectives, and nearly all committees include industry and consumer representation.

About GI GVHD

GVHD is a debilitating and painful disease. It is a common disorder among immunocompromised cancer patients after receiving allogeneic stem cell or bone marrow transplants. Unlike organ transplants where the patient's body may reject the organ, in GVHD it is the donor cells that begin to attack the patient's body -- most frequently the gut, liver and skin. Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea. If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.

orBec(R) is a two-tablet system containing the highly potent, topically active corticosteroid beclomethasone dipropionate, and is designed to specifically target and treat upper and lower GI GVHD with reduced systemic immunosuppressive side effects. Systemic immunosuppressive agents such as prednisone, which are the current standard treatments for GI GVHD, are associated with high mortality rates due to infection and debility. Further, these drugs have not been approved for treating GI GVHD in the European Union or in the U.S., but rather are used off-label as investigational therapies for this indication.

About Allogeneic Bone Marrow/Stem Stem Cell Transplantation (HSCT)

Allogeneic hematopoietic stem cell transplantation ("HSCT") is considered a potentially curative option for many leukemias as well as other forms of blood cancer. In an allogeneic HSCT procedure, hematopoietic stem cells are harvested from a closely matched relative or unrelated person, and are transplanted into the patient following either high-dose chemotherapy or intense immunosuppressive conditioning therapy. The curative potential of allogeneic HSCT is now partly attributed to the so-called graft-versus-leukemia ("GVL") or graft-versus-tumor ("GVT") effects of the newly transplanted donor cells to recognize and destroy malignant cells in the recipient patient.

The use of allogeneic HSCT has grown substantially over the last decade due to advances in human immunogenetics, the establishment of unrelated donor programs, the use of cord blood as a source of hematopoietic stem cells and the advent of non-myeloablative conditioning regimens ("mini-transplants") that avoid the side effects of high-dose chemotherapy. Based on the latest statistics available, it is estimated that there are more than 10,000 HSCT procedures annually in the U.S. and a comparable number in Europe. Estimates as to the current annual rate of increase in these procedures are as high as 20%. High rates of morbidity and mortality occur in this patient population. Clinical trials are also underway testing allogeneic HSCT for treatment of some metastatic solid tumors such as breast cancer, renal cell carcinoma, melanoma and ovarian cancer. Allogeneic transplants have also been used as curative therapy for several genetic disorders, including immunodeficiency syndromes, inborn errors of metabolism, thalassemia and sickle cell disease. The primary toxicity of allogeneic HSCT, however, is GVHD in which the newly transplanted donor cells damage cells in the recipient's gastrointestinal tract, liver and skin.

About orBec(R)

orBec(R) represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec(R), if approved by the EMEA and the FDA, would be the first oral formulation of beclomethasone dipropionate ("BDP") available in the European Union and the United States, respectively. orBec(R) is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD. BDP is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the U.S. and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered dose inhaler for the treatment of patients with

allergic rhinitis and asthma. orBec(R) is formulated for oral administration as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the more distal portions of the GI tract.

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to DOR, orBec(R) also benefits from orphan drug designations in the U.S. and in Europe for the treatment of GI GVHD, which provide for 7 and 10 years of post-approval market exclusivity, respectively.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec(R) (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR has filed an NDA with the FDA for the treatment of GI GVHD, and has received an FDA PDUFA date of July 21, 2007. An MAA with the EMEA for orBec(R) has also been filed and validated. orBec(R) may also have application in treating other gastrointestinal disorders characterized by severe inflammation.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the recently enacted Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. The ricin toxin vaccine, RiVax(TM), has been evaluated successfully in a Phase 1 clinical trial in normal volunteers.

For further information regarding DOR BioPharma, please visit the Company's website located at www.dorbiopharma.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec(R) for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec(R). Where possible, DOR has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec(R), particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the U.S. Government or other countries, that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec(R) for gastrointestinal GVHD include the risks that: because orBec(R) did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may not consider orBec(R) approvable based upon existing studies, orBec(R) may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR expects or may never gain approval; DOR is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; or orBec(R) may not gain market acceptance; and others may develop technologies or products superior to orBec(R). These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.

Company Contact

[havedone]

Antwort auf Beitrag Nr.: 27.320.064 von luto9 am 31.01.07 14:26:33

hab' heute mal wieder nachgekauft, zwar teurer, aber immer noch billig

[luto9]

Antwort auf Beitrag Nr.: 27.326.784 von havedone am 31.01.07 18:03:30

hi

bin mal gespannt, ob in den nächsten Tagen noch mal ein Kaufangebot
kommt. Amis spekulieren ja drauf (Novartis, Amgen, Astra Zeneca)

[luto9]

wenn man mal bedenkt, daß Dor Mitte 92 schon mal bei $ 175 war, dann
haben wir ja noch ein bischen Luft nach oben

[luto9]

von rechtswegen sollte das Teil diese Woche ausbrechen.

Ich meine, daß genug Zittrige rausgeschüttelt sind und uptrend
(short term) ist generiert.

[luto9]

DOR BioPharma Sponsors GVHD Working Committee at 2007 Tandem BMT Conference
DOR BioPharma, Inc. (OTCBB: DORB) (DOR or the Company) announced that the company will sponsor a Graft versus Host Disease (GVHD) Working Committee at the 2007 Tandem Bone Marrow Transplant (BMT) Meeting to be held February 8-12, 2007 in Keystone, Co. The purpose of the Working Committee is to educate transplant practitioners and patient advocacy groups by reviewing the past year's research accomplishments as well as discuss current studies and the scientific activities for the coming year.

The 2007 Tandem Meetings are joint meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood and Marrow Transplant Research (CIBMTR), and is the largest annual meeting of blood and marrow transplant specialists. The meeting is attended by practicing transplant physicians from around the world as well as transplant patients and patient advocacy groups. During this meeting leading authorities will present and discuss the latest developments in the broad field of blood and marrow transplantation in plenary sessions, concurrent scientific sessions, workshops, poster sessions and symposia.

About Allogeneic Bone Marrow/Stem Stem Cell Transplantation (HSCT)

Allogeneic hematopoietic stem cell transplantation ("HSCT") is considered a potentially curative option for many leukemias as well as other forms of blood cancer. In an allogeneic HSCT procedure, hematopoietic stem cells are harvested from a closely matched relative or unrelated person, and are transplanted into the patient following either high-dose chemotherapy or intense immunosuppressive conditioning therapy. The curative potential of allogeneic HSCT is now partly attributed to the so-called graft-versus-leukemia ("GVL") or graft-versus-tumor ("GVT") effects of the newly transplanted donor cells to recognize and destroy malignant cells in the recipient patient.

The use of allogeneic HSCT has grown substantially over the last decade due to advances in human immunogenetics, the establishment of unrelated donor programs, the use of cord blood as a source of hematopoietic stem cells and the advent of non-myeloablative conditioning regimens ("mini-transplants") that avoid the side effects of high-dose chemotherapy. Based on the latest statistics available, it is estimated that there are more than 10,000 HSCT procedures annually in the U.S. and a comparable number in Europe. Estimates as to the current annual rate of increase in these procedures are as high as 20%. High rates of morbidity and mortality occur in this patient population. Clinical trials are also underway testing allogeneic HSCT for treatment of some metastatic solid tumors such as breast cancer, renal cell carcinoma, melanoma and ovarian cancer. Allogeneic transplants have also been used as curative therapy for several genetic disorders, including immunodeficiency syndromes, inborn errors of metabolism, thalassemia and sickle cell disease. The primary toxicity of allogeneic HSCT, however, is GVHD in which the newly transplanted donor cells damage cells in the recipient's gastrointestinal tract, liver and skin.

About orBec®

orBec® represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec®, if approved by the EMEA and the FDA, would be the first oral formulation of beclomethasone dipropionate ("BDP") available in the European Union and the United States, respectively. orBec® is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD. BDP is a highly-potent, topically-active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the U.S. and worldwide since the early 1970's as the active pharmaceutical ingredient in a nasal spray and in a metered dose inhaler for the treatment of patients with allergic rhinitis and asthma. orBec® is formulated for oral administration as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the more distal portions of the GI tract.

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to DOR, orBec® also benefits from orphan drug designations in the U.S. and in Europe for the treatment of GI GVHD, which provide for 7 and 10 years of post-approval market exclusivity, respectively.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR has filed an NDA with the FDA for the treatment of GI GVHD, and has received an FDA PDUFA date of July 21, 2007. In addition, the FDA's Oncology Drug Advisory Committee ("ODAC") will review the NDA for orBec® on May 9, 2007. An MAA with the EMEA for orBec® has also been filed and validated. orBec® may also have application in treating other gastrointestinal disorders characterized by severe inflammation.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the recently enacted Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. The ricin toxin vaccine, RiVax™, has been evaluated successfully in a Phase 1 clinical trial in normal volunteers.

For further information regarding DOR BioPharma, please visit the Company's website located at www.dorbiopharma.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec®. Where possible, DOR has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the U.S. Government or other countries, that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: because orBec® did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may not consider orBec® approvable based upon existing studies, orBec® may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR expects or may never gain approval; DOR is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; or orBec® may not gain market acceptance; and others may develop technologies or products superior to orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.

Source: Market Wire (February 7, 2007 - 8:01 AM EST)

News by QuoteMedia
www.quotemedia.com

[luto9]

by Stockguru.com

DOR BioPharma, Inc. (OTCBB DORB) Wednesday's market went up 2.04% to $0.50 per share, with a total of 780,965 shares traded. The company announced that the company will sponsor a Graft versus Host Disease (GVHD) Working Committee at the 2007 Tandem Bone Marrow Transplant (BMT) Meeting to be held February 8-12, 2007 in Keystone, Co. The purpose of the Working Committee is to educate transplant practitioners and patient advocacy groups by reviewing the past year's research accomplishments as well as discuss current studies and the scientific activities for the coming year. The 2007 Tandem Meetings are joint meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood and Marrow Transplant Research (CIBMTR), and is the largest annual meeting of blood and marrow transplant specialists. The meeting is attended by practicing transplant physicians from around the world as well as transplant patients and patient advocacy groups. During this meeting leading authorities will present and discuss the latest developments in the broad field of blood and marrow transplantation in plenary sessions, concurrent scientific sessions, workshops, poster sessions and symposia.

DOR BioPharma, Inc., a biopharmaceutical company, develops products for side effects of cancer treatments, serious gastrointestinal diseases, and bioterrorism in the United States and internationally. It is developing a lead product, orBec, a potent, locally-acting corticosteroid for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a life-threatening complication of bone marrow transplantation. The company has recently filed a New Drug Application with the FDA for orBec for the treatment of GI GVHD, which also has applications in treating other gastrointestinal disorders characterized by severe inflammation. It also develops various other biotherapeutics products, including Oraprine, LPM-Leuprolide, and LPE and PLP systems for delivery of water-insoluble drugs. In addition, the company is developing biomedical countermeasures, through its biodefense division. Its biodefense products in development include recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. DOR BioPharma?s ricin toxin vaccine, RiVax, has completed a Phase I clinical trial. The company was incorporated in 1987 and is based in Miami, Florida.

[yeter]

CTIC bietet ca.43 Mio$ für DORB und zudem 15 Mio$ bei erfolgreichem Fed-Entscheid zu orBec, damit insgesamt 58 Mio$

Glaubt ihr sigma-tau steigt als weißer Ritter ein?

Ich bin seit heute dabei und hoffe auf Kurse von mind. 90c$, das würde dem CTIC-Angebot entsprechen.

Dann mal sehen

[yeter]

Sigma-Tau had agreed to purchase $1 million of DOR shares for about 25 cents a share, and paid an additional $2 million in cash.

Weiß jemand unter welchen Voaraussetzungen die 2 Mio`s bezahlt wurden? Ist es ein Kredit oder Unterstützungsgeschenk?

[yeter]

Ich habe die Antwort beim reherchieren gefunden:

orBec(R) Strategic Alliance
Thursday January 4, 8:30 am ET


MIAMI, FL--(MARKET WIRE)--Jan 4, 2007 -- DOR BioPharma, Inc. (OTC BBORB.OB - News) ("DOR" or the "Company") announced today that it has received $3 million under a non-binding letter of intent with Sigma-Tau Pharmaceuticals, Inc. ("Sigma-Tau"), which grants Sigma-Tau an exclusive right to negotiate terms and conditions for a possible business transaction or strategic alliance regarding orBec® (oral beclomethasone dipropionate) and potentially other DOR pipeline compounds until March 1, 2007.

Under the terms of the agreement, Sigma-Tau has purchased $1 million of DOR's common stock at the market price of $0.246 per share, representing approximately four million shares. An additional $2 million was paid in cash, and will be considered an advance payment to be deducted from upfront monies due to DOR by Sigma-Tau pursuant to any future orBec commercialization arrangement reached between the two parties. If no agreement is reached by March 1, 2007, DOR will return the $2 million to Sigma-Tau within 60 days. If DOR does not pay Sigma Tau back in cash by May 31, 2007, interest will accrue at a rate of 6% compounded annually and Sigma Tau will have the option in its sole discretion of converting the accrued amount into common stock at a price per share equal to 80% of the market price at the time the payment is made.

"We are exceptionally pleased with Sigma-Tau's interest in orBec® and in DOR's pipeline products," said Christopher J. Schaber, Ph.D., President and CEO of DOR. "We view Sigma-Tau as an excellent potential partner for orBec® especially with regard to the EU territory. We look forward to productive discussions with Sigma-Tau to reach a mutually beneficial arrangement."

The common stock sold to Sigma-Tau has not been registered under the Securities Act or any state securities laws, and the securities may not be offered or sold absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws

[yeter]

Hier ein informativer Artikel:

Analysis: An unlikely use for asthma drug
By ED SUSMAN
WASHINGTON, Jan. 25 (UPI) -- A drug used to treat patients with asthma also appears to combat often deadly graft-versus-host-disease, a frequent serious complication of bone-marrow transplants undertaken to cure people with leukemia and other diseases, researchers said Thursday.

Doctors at the Fred Hutchinson Cancer Research Center in Seattle said that treating patients with beclomethasone dipropionate in an experimental two-capsule formulation reduced the mortality of patients with graft-versus-host-disease by 67 percent in a phase 3 clinical trial.

"People with graft-versus-host-disease are caught between a rock and a hard place," said David Hockenbery, professor of medicine at the University of Washington and a member of the Hutchinson medical faculty.

The disease itself indicates the new donor blood transplant is working to eradicate remaining cancer cells in the blood, but at the same time the disease is destroying healthy tissues in the stomach and small intestine, Hockenbery told United Press International.

Doctors treat graft-versus-host-disease with high doses of the systemic steroid prednisone, but that has its own galaxy of dangerous side effects, including a tendency to weaken the immune system and make patients with already compromised immune systems even further at risk from serious opportunistic bacterial and fungal infections that can also be lethal.

Writing in the current online issue of Blood, the journal of the Washington -based American Society of Hematology, Hockenbery and colleagues described use of the investigative formulation of beclomethasone. One tablet dissolves in the stomach, while the second tablet is enteric-coated, so it survives the stomach and dissolves in the small intestine.

"Although graft-versus-host disease can affect the skin and the liver and other parts of the body, most of the time it attacks the gut," Hockenbery explained. The experimental formulation -- called Orbec and being developed by DOR BioPharma in Miami, acts as a topical steroid, he said. It coats the stomach and the small intestine and protects those organs from graft-versus-host-disease.

In the clinical trial, researchers from across the United States recruited 129 patients with graft-versus-host-disease following bone marrow transplant procedures and first gave them prednisone for 10 days to acutely control the disease, and then were rapidly tapered off the drug.

Then, 62 patients were given oral beclomethasone, while another 67 patients were given placebo in a 50-day treatment course.

After six months following the start of the trial, five of the patients on beclomethasone had died, compared with 16 patients taking placebo -- a 67-percent reduction in mortality, Hockenbery said. Even more encouraging was that survival benefit continued for at least a year, he reported.

Hockenbery said that Orbec is under review by the Food and Drug Administration.

"This treatment looks pretty exciting," Susan Stewart, executive director of the Blood & Marrow Transplant Information Network, a patient advocacy and information group, told UPI.

"When it comes to graft-versus-host-disease, patients are faced with, 'Which devil do you want to choose?' -- the destruction of your tissues by the disease or the side effects of prednisone, which is the 'moon-faced' effect that occurs very rapidly when taking the drug and the high risk of serious infections," she said.

"This drug offers a better choice, and will likely change clinical practice if it receives FDA approval," Stewart said.

About 20,000 people a year in the United States undergo bone-marrow transplantation for curative treatment of blood cancers such as leukemia, lymphoma and multiple myeloma, said Stewart, who is a long-term survivor of leukemia and a bone-marrow transplant.

Bone-marrow transplantation is also used to treat patients with hereditary immune disorders such as severe combined immunodeficiency disorder -- the so-called "Bubble Boy" disease -- sickle cell anemia, severe aplastic anemia and other rare disorders.

Stewart said about half the patients who undergo bone-marrow transplant receive their own blood cells and only rarely suffer graft-versus-host-disease, but the risk of the disease is about 60 percent in patients who receive blood marrow transplants from other people, usually closely related relatives.


http://www.upi.com/HealthBusiness/view.php?StoryID=20070125-…

[yeter]

Und hier noch ein aktueller Artikel vom Miami Herald:

Despite losses, Miami biopharma firm pins hopes on FDA approvalBY JOHN DORSCHNER

In a tale that's emblematic of the risk and rewards of small pharmaceutical and biotech companies, tiny DOR BioPharma of Miami now finds itself with competing suitors and perhaps even a viable product after nearly two decades of steady losses.

''It's a true development stage company,'' says Christopher J. Schaber, 40, DOR's eighth chief executive in the past five years. But among the many long-suffering biopharma and biotech companies, he maintains, ``I think we're in the minority. There are very few companies that have been able to get to the cusp of an NDA [new drug application] approval.''

The drug is orBec, a generic steroidal compound that DOR is seeking approval for a new use, fighting deadly side effects of bone marrow and stem cell transplants.

Schaber acknowledges that the ''cusp'' of an approval from the Food and Drug Administration means DOR still has a very large hurdle to clear, but Schaber is brimming with optimism. ``It's my job to make sure [the application] crosses the finish line.''

A University of Miami transplant expert, Gary Kleiner, is not so enthusiastic. ''The data is not that strong'' in orBec studies, and he points out DOR failed to meet the study's main objective.

Still, there are no alternatives for treating the deadly conditions it is aimed at, and James Bianco, chief executive of Cell Therapeutics in Seattle, a physician and former director of a bone-marrow transplant center, thinks orBec is so promising that he has made an unsolicited offer to buy DOR.

``RISKY BET''

Bianco said he's willing to make ''obviously a risky bet'' that the FDA will approve orBec, because it's able to help some patients when nothing else can.

Bianco says he made a similar bet in 2000, buying PolaRx, a company as small as DOR, and the stock of the smaller company went up 5,000 percent and Cell Therapeutic's up 1,500 percent, because PolaRx had a new cancer drug with huge hopes. (CT's stock slid back, and it sold the cancer drug in 2005.)

Another company, the Italian-owned Sigma-Tau, meanwhile paid $3 million to be the first to talk to DOR about making a deal on orBec or possibly purchasing the company. The deadline for talks is March 1. On Friday afternoon, Sigma-Tau said it was interested in continuing discussions but only about the European marketing of orBec.

Like many such companies, DOR has at times had great hopes -- and crushing losses. The company now has eight employees, four of which are in its office on Brickell Avenue in Miami. It was delisted from the American Stock Exchange last year and trades as an over-the-counter penny stock. Over the years, the company has amassed an accumulated deficit in shareholder equity of $91 million, according to its latest filings with the Security and Exchange Commission.

Still, the company has kept going, frequently changing focus in an attempt to find a winner, and in that, too, it is like many others. Arthur D. Levinson, chief executive of Genentech, one of the few successful biotech companies, estimates that the industry has lost about $100 billion over the past quarter century.

Occasionally, DOR has made headlines. Alexander M. Haig, the four-star general and former secretary of state, was once chairman. He was replaced by his son, Alexander P. Haig. In August 2006, P. Haig was replaced by James Kuo, a physician, while Schaber became chief executive.

The previous CEO, Michael Sember, is now suing the company, complaining that he is owed a $100,000 bonus. DOR says Sember's claims are without merit.

Founded in 1987 in Fargo, N.D., as a biotech company developing drugs to improve the immune system in cancer patients, it moved to suburban Chicago in the 1990s and then in 2003 to Miami, to be closer to the home of a CEO who has long since departed.

After 9/11 and the anthrax-envelope deaths, DOR achieved considerable buzz -- and a major bump in its stock price -- for partnering with university researchers to develop vaccines to protect against biowarfare threats like the deadly poison ricin and the botulinum toxin.

The company has received almost $15 million in federal grants to develop the vaccines, says DOR spokesman Keith Thornton, and the company boasts in SEC filings that it has ``one customer, the U.S. Federal Government.''

CLINICAL TRIALS

Both vaccines are still in the early stages of development, and it might be years before they come to market, if they ever do. In a phone interview, Schaber prefers to discuss orBec, which consists of beclomethasone dipropionate, long used as an inhaled drug for asthma.

In its new form, orBec consists of two tablets aimed at treating gastrointestinal graft-versus-host disease, which can lead to anorexia, vomiting and diarrhea as transplanted cells attack the body's tissue.

In a 60-patient clinical trial at a cancer institute in Seattle, three of 31 patients who took orBec died within 200 days of the transplant, compared with six of 29 who didn't get the drug. In a broader, 129-patient study at transplant centers in France and the United States, 16 of 67 given a placebo died in the first 200 days compared with five of 62 who received orBec.

These results were published last month in Blood, the journal of the American Society of Hematology. Putting the two studies together, DOR stated in a news release, randomized patients receiving orBec had a 37 percent less chance of dying within three and a half years after transplant than those given a placebo.

FAILED OBJECTIVE

That's a significant number. The problem, which DOR acknowledges, is that in the pivotal larger trial, it had set out to prove a difference at 50 days after transplant -- and at that benchmark, orBec showed no statistical significance.

''It looks like it might be beneficial,'' says Kleiner at UM, ''but the positive results weren't in the acute phase,'' immediately after the transfer.

Bianco, at Cell Therapeutics, says failing to achieve the primary endpoint and then claiming better results at a different endpoint makes FDA investigators suspicious. ``The company may be pointing to something that occured by pure chance that they weren't expecting. In science, if you say you're going to roll a seven and you roll a seven, that proves your theory. If you say you're going to roll a seven and roll a two, that might be random chance.''

Even so, Bianco and DOR BioPharma believe that the overall mortality figures -- and the fact that there is no alternative -- will work in the drug's favor. In January, the FDA told DOR that the Oncology Drug Advisory Committee will review the new drug application on May 10 and will announce by July 21 whether the drug will be approved or is at least approvable.

Before the committee, DOR's challenge will be to explain why it failed at its original endpoint but still achieved better mortality figures.

Even with this challenge, other companies are now interested in the lonely path that DOR has been following for two decades.

INTERESTED BIDDERS

In early January, Sigma-Tau Pharmaceuticals, a company focused on developing drugs to treat rare diseases, purchased $1 million in DOR stock at the market price of 24.6 cents a share and paid the company $2 million in cash to negotiate ``a possible business transaction.''

Two weeks after the Sigma-Tau offer, Cell Therapeutics made an unsolicited proposal to buy DOR for 29 million shares of the Seattle company's stock and an additional cash payment of $15 million if orBec is approved.

At the time of the Cell Therapeutics offer, the company was trading at $1.72 -- making the deal worth at least $50 million. DOR then had a market cap of about $21 million.

After that, investors' interest perked up considerably, and Tuesday DOR hit a 52-week high of 67.5 cents, making the company worth about $46 million. On Friday, after Sigma-Tau said it had no plans to buy DOR, investors soured. For the day, DOR fell 19 percent, closing at 52 cents.

CEO Schaber remained upbeat. He said Cell Therapeutics is not alone in bidding on DOR and plans to listen to all offers. ``There's other interest out there, and we need to maximize shareholder value.''

In a presentation for industrial conferences, DOR estimates orBec could have a $200 million annual market worldwide and, because it is serving a severe, unmet need, the FDA is likely to declare it an orphan drug, extending its exclusivity. The firm says that it can continue to develop and market orBec on its own -- assuming it gets approval.

''This is a very interesting time,'' says Schaber. ``There's always a risk.''

[yeter]

Hier der Grund für den Absturz vom Freitag:

As previously reported, DOR BioPharma, Inc. (the "Company") entered into a non-binding letter of intent (the "Letter of Intent") with Sigma-Tau Pharmaceuticals, Inc. ("Sigma-Tau"), which granted Sigma-Tau an exclusive right to negotiate terms and conditions for a possible business transaction or strategic alliance regarding the Company's lead product, orBec® ("oral beclomethasone dipropionate") and potentially other Company pipeline compounds until March 1, 2007. As of February 21, 2007, Sigma-Tau has relinquished its exclusive rights under the Letter of Intent with regard to acquisition discussions. However, all other terms of the Letter of Intent remain in effect, and the Company and Sigma-Tau are engaged in discussions for a European collaboration relating to orBec®.

A copy of the Letter from Sigma-Tau is entered as Exhibit 10.1 to this Current Report on Form 8-K.

[yeter]

Damit wäre ein möglicher Käufer raus, da Sigma sich nur noch für die Vertriebsrechte in Europa für Orbec interessiert.

Bleibt Ctic mit seinem offenen Angebot, aber es geht aus dem Miami Herald hervor, dass da noch andere Kaufinteressenten sein sollen laut CEO Schaper. Momentan liegt das Angebot von CTIC bei ca. 50Mio$ für Dorb.
Für Orbec wird ein jährlicher Marktumsatz von 200 Mio$ mit einem Wachstum von 10% pro Jahr erwartet.

Nach m.E. sind die 50+15 von Ctic zu wenig, mind. 100 Mio$ wären angemessen für Dorb. Das müssten 1,20$ in etwa sein.

Andere Meinungen würden mich dazu sehr interessieren

[Belu1972]

Korrektur bei Amis vorbei

haben das Teil ja auch ganz schön ausgelutscht, aber waren prima
Kurs zum Kaufen

[havedone]

könnte mir vorstellen hier eine ähnliche Entwicklung wie bei DNDN zu sehen. freefload natürlich geringer
Deadline 09.05.

[havedone]

Antwort auf Beitrag Nr.: 28.729.217 von havedone am 09.04.07 17:46:59

correction: freefload gem. yahoo Dorb.ob

[Belu1972]

http://www.thelion.com/bin/la.cgi?cmd=open&url=http%3A%2F%2F…

[Belu1972]

Antwort auf Beitrag Nr.: 28.779.902 von Belu1972 am 12.04.07 17:20:08

sorry ich probiers noch mal

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…

[Belu1972]

wow in Amiland geht ja ganz schön was über die Theke

[Belu1972]

der count down läuft
in 4 Wochen wissen wir mehr

http://quote.barchart.com/texpert.asp?sym=DORB

eventuell heute noch ein paar kleine Gewinnmitnahmen und dann
nächste Woche ab über den letzten Widerstand bei $ ,68 dann steht
dem ATH nichts mehr im Weg

[Belu1972]

Eröffnungsgap geschlossen

dann kann´s ja losgehen

[Belu1972]

http://www.smallcapcenter.com/snapshot_newsrelease.asp?compo…

[Belu1972]

http://www.smallcapcenter.com/snapshot_newsrelease.asp?compo…

[havedone]

Antwort auf Beitrag Nr.: 28.796.608 von Belu1972 am 13.04.07 16:13:59

http://biz.yahoo.com/e/070412/dorb.ob8-k.html


Am besten gefallen hat mir die Begründung für die Ablehnung des Übernahmeangebots von CTIC
in o.a. 8-K: "... in order to maximize value to shareholders..."

may 09, may 09, may 09

[Belu1972]

Antwort auf Beitrag Nr.: 28.797.169 von havedone am 13.04.07 16:41:36

Wenn ich den SK für heute bestimmen könnte, wäre mir persönlich $ ,65 oder
etwas drunter am Liebstem.

[Belu1972]

gestern war wirklich ein interessanter Tag. Habe mal die Käufe und
Verkäufe verfolgt. Sobald die MM´s die Verkäufe auf $ ,68 runter-
gesetzt haben,wurde gekauft, als ob es nächste Woche keine shares
mehr gäbe

diese Ankündigung der Investorenconferenz wird Dorb neue Flügel ver-
leihen
http://www.smallcapcenter.com/snapshot_newsrelease.asp?compo…

http://www.redchip.com/visibility/investor.asp?symbol=DORB

Das Managesment weiß was es will und uns kann es nur recht sein

-Feb-07 CLAVIJO JAMES
Officer 53,191 Direct Purchase at $0.47 per share. $24,999
9-Feb-07 KANZER STEVE H
Director 212,766 Direct Purchase at $0.47 per share. $100,000
9-Feb-07 SCHABER CHRISTOPHER J
Officer 212,766 Direct Purchase at $0.47 per share. $100,000
9-Feb-07 MYRIANTHOPOULOS EVAN
Officer 53,191 Direct Purchase at $0.47 per share. $24,999

Würde mich nicht wundern, wenn der Kurs auf´n $++ hochgezogen wird,
dann Konso auf hohem Niveau bis 9.5. und dann up, up and away

time will tell

schönes und sonniges Wochenende allen Dorbianern und die es werden
wollen

[havedone]

http://www.cnbc.com/id/15837275?q=dorb



http://quotes.barchart.com/texpert.asp?sym=DORB

[Belu1972]

Antwort auf Beitrag Nr.: 28.821.003 von havedone am 14.04.07 22:54:17

[Belu1972]

Antwort auf Beitrag Nr.: 28.729.217 von havedone am 09.04.07 17:46:59

morgen

1996 war eine ähnliche Situation in der TA, da folg Dorb von

- $ ,97 bis auf $ 37, -

innerhalb von 3 Tagen

[hedger_de]

NEUE KAUFEMPFEHLUNG FÜR DOR VON US-BÖRSENBRIEF !!!!
(keine Aufforderung zum Kauf meinerseits !!!)

Auszug aus der heutigen Ausgabe (bzw. vom 15.04.)

NOW FOR THE PENNY STOCK PICKS FOR - April 15th, 2007

TOP PICK: DORB
Buy at .70, Sell at $1 + (Aggressive Growth Play)

DOR BioPharma, Inc. is a company that has become a hot topic of interest throughout the small cap investment
community over recent weeks, and after some of our own DD, we feel that now may be an opportune time to pick up
some shares. DOR BioPharma, Inc. is a biopharmaceutical company developing products to treat life-threatening side
effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's
lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed
for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow
transplantation. DOR has filed an NDA with the FDA for the treatment of GI GVHD, and has received a PDUFA date
of July 21, 2007. In addition, the FDA's Oncology Drug Advisory Committee ("ODAC") will review the NDA for
orBec® on May 9, 2007. An MAA with the EMEA for orBec® has also been filed and validated. orBec® may also
have application in treating other gastrointestinal disorders characterized by severe inflammation. Visit their website:
http://www.dorbiopharma.com In recent news, the company announced the initiation of a clinical development
program for oral Leuprolide, and will be presenting at the RedChip Small-Cap San Francisco investor conference.
The stock has been steadily increasing in price over the past three months, volume is nearly 1 Million, and the spread
is minimal. The stock is in play and we are recommending a buy.

na dann, TOI TOI TOI.... LASST UNS UNSEREN URLAUB VERDIENEN !...und gerne noch mehr !

hedger_de

[Belu1972]

Antwort auf Beitrag Nr.: 28.850.588 von hedger_de am 17.04.07 07:15:00

aber diese Woche werden die Zweifler noch rausgeschüttelt

"long Term buy" ist generiert

habe meine erste Posi bei $ ,25 gekauft und bin recht zufrieden

hier kann man nur sagen: " buy more on dips"

[mike32]

Warum ist dieser Thread so verwaist ?

[entombed1966]

Antwort auf Beitrag Nr.: 28.955.126 von mike32 am 23.04.07 16:30:09

Ich bin ja bei Dir!

btw: RT + 4 % in den USA...

[mastermind23]

Gemütlich hier.

[havedone]

http://www.investorshub.com/boards/read_msg.asp?message_id=1…

Kurz: Der Poster geht von sehr hoher Wahrscheinlichkeit der Zulassung aus, weil dieses Steroid bereits in anderer Formulation für andere Anwendungsfälle, z.B. als Asthmaspray für Kinder seit vielen Jahren zugelassen ist...

weitere Anwendungsfälle dieser Formulierung als Tabletten sind in Sichtweite

[havedone]

http://www.cnbc.com/id/15837275?q=dorb

gem.Link soll Claudio Cavazza (Sigma-Tau) allein 5,6 Mio Aktien halten.

www.sigma-tau.it

[entombed1966]

Antwort auf Beitrag Nr.: 28.956.592 von mastermind23 am 23.04.07 17:56:57

Ja, richtig kuschelig. Ich zünde mal ein paar Kerzen an und hole 1 Flasche Rotwein aus der Küche.

btw: aktuell mehr als 11 % Plus "drüben" - und das bei extrem (?) hohen Volumen. Nett.

[Belu1972]

http://stockcharts.com/charts/gallery.html?DORB

würde mich nicht wundern, wenn die Amis das Teil über den $ ziehn und
dann auf hohem Niveau korrigieren

egal was kommt,den longs kann das nur recht sein

[havedone]

Antwort auf Beitrag Nr.: 28.964.156 von Belu1972 am 24.04.07 08:39:41

http://www.telecentro.pt/forum/ler_questao.asp?qt=2201&varid…

was ist davon zu halten????????

Achtung!!!: unbestätigtes Gerücht von einem portugiesischen Board betr. angebl. bevorstehendem Übernahmeangebot für 2,4 USD/share
( englisch)

[Belu1972]

Antwort auf Beitrag Nr.: 28.974.678 von havedone am 24.04.07 17:28:48

ähnliches hab ich bei den Amis auch gelesen

[Belu1972]

Sieht so aus, als wenn wir diese Woche schon den $ sehn

[havedone]

Antwort auf Beitrag Nr.: 28.976.484 von Belu1972 am 24.04.07 19:02:21

.......falls an dem Übernahme-Gerücht was dran sein sollte sehen wir bis 09.05.evtl. noch mehr

[Belu1972]

Antwort auf Beitrag Nr.: 28.976.688 von havedone am 24.04.07 19:15:11

nehme alles was kommt

[mike32]

[Belu1972]

sieht immer beseer aus

http://stockcharts.com/charts/gallery.html?DORB

[mike32]

DOR BIOPHARMA INC

RealPennies: Alerts: Turning Pennies into dollars: (Pink Sheets: GNNS), (OTCBB: NCSH), (OTCBB:TLBT),(OTCBB:BTEM) (OTCBB: DORB)
4/25/2007

Apr 25, 2007 (M2 PRESSWIRE via COMTEX News Network) --
RealPennies.com ALERTS: reporting on dollar volume movers.

http://www.stockhouse.com/news/news.asp?newsid=5468011&tick=…

[Belu1972]

Las grade im Amiboard, das Daytrder ins Boot gestiegen sind

[NewSpice]

Antwort auf Beitrag Nr.: 28.993.156 von Belu1972 am 25.04.07 16:37:04

und was heist das jetzt

[Belu1972]

Antwort auf Beitrag Nr.: 28.994.232 von NewSpice am 25.04.07 17:12:14

zumindest sehr volatil

Beste Möglichkeit, diese wieder zu entfernen, sind fallende Kurse.

wäre auch ganz gesund. Sieh Dir mal den RSI an, stand gestern abend bei
87,+

Konso bis $,80 oder etwas drunter, wäre ganz gut

[mike32]

Antwort auf Beitrag Nr.: 28.981.513 von Belu1972 am 25.04.07 08:07:35

und wie passt das zu Deinem Posting #70 , von heute Morgen ?

[Belu1972]

hoffe daß ich Dir mit BM ausreichende Erklärung gegeben habe

[mike32]

Welch ein herrlicher Tag , - 10 % , was will man mehr !

[mike32]

sorry , wenn ich mit meinen Bemerkungen , den Boardfrieden gestört habe , also lasst Euch nicht aufhalten , werde nur noch mitlesen .

[NewSpice]

Antwort auf Beitrag Nr.: 28.994.537 von Belu1972 am 25.04.07 17:22:23

hallo..

hat hir jemand news was den kurs beflügen könnte

[mike32]

Antwort auf Beitrag Nr.: 29.092.289 von NewSpice am 02.05.07 11:57:17

[schmacki]

Antwort auf Beitrag Nr.: 29.098.663 von mike32 am 02.05.07 17:51:05

So,bin auch mit dabei.
Auf steigende Kurse!

[mike32]

[mike32]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[mike32]

Antwort auf Beitrag Nr.: 28.996.792 von Belu1972 am 25.04.07 18:41:04

Wenn man nun wüsste was man nicht wüsste ?

Sind das nun Kaufkurse ?

Oder sollte man nicht ins fallende Messer greifen ?

Oder , oder ...


mfG , mike32

[entombed1966]

Biotechreport vom 4.5.:

"Dor Biopharma - Spannung steigt
Am 9. Mai wird das Beratergremium der US-Gesundheitsbehörde seine Empfehlung darüber abgeben, ob das von Dor entwickelte Medikament orBec zugelassen werden soll oder nicht. Bei einem positiven Votum der Kommission dürfte der Aktienkurs deutlich in die Höhe schießen. Fällen die Experten ein negatives Urteil, rückt die Zulassung in weite Ferne - und der Aktienkurs fällt vermutlich ins Bodenlose. Anlegern, denen diese „Hopp- oder Top-Entscheidung" zu heiß ist, sollten die bisher erzielten Gewinn von knapp 34 Prozent mitnehmen."

Ich gehe volles Risiko, bleibe invesitiert.

[Belu1972]

Afternoon Session

DOR BioPharma, Inc.

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.


DOR BioPharma, Inc. NDA 022-062 orBec (oral beclamethasone diproprionate, BDP) (pdf)

Errata for DOR BioPharma, Inc. NDA 022-062 orBec (htm)


FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552). These redacted portions will appear as white space on the screen or on the printed page.


FDA Briefing Material for NDA 022-062 orBec (pdf)

Errata Briefing Material for NDA 022-062 orBec (htm)

[GBRW]

hallo,
was ist denn jetzt passiert????

[mike32]

Antwort auf Beitrag Nr.: 29.190.175 von GBRW am 07.05.07 16:28:25

da musst Du Belu1972 fragen , ich sehe nur den Kursrutsch ?

[NewSpice]

nach dem gewaltigen Kurs rutsch zuurteilen wird es wohl keine zulassungs empfelung der FDA geben hab heute morgen noch für 0,54 gekauft

[mike32]

Antwort auf Beitrag Nr.: 29.190.306 von NewSpice am 07.05.07 16:33:43

das tut mir leid !

[entombed1966]

Puhh, das war ein kurzer, aber teurer Spass. Bin ausgestoppt worden... Deckel zu und vergessen.

[GBRW]

Antwort auf Beitrag Nr.: 29.190.306 von NewSpice am 07.05.07 16:33:43

ich auch

[GBRW]

ich hab noch mal die gleiche menge nachgekauft.

[NewSpice]

Antwort auf Beitrag Nr.: 29.190.617 von GBRW am 07.05.07 16:48:11

vieleicht wurde ja auch nur eine mitteilung falsch verstanden
der kurs geht ja leicht wieder nach oben

dumm nur das wir zu früh geordert haben
hätte das paket gerne für 0,30 bekommen

[GBRW]

Antwort auf Beitrag Nr.: 29.190.820 von NewSpice am 07.05.07 16:56:31

ja,
denke ich auch aus dem text werde ich nicht schlau!!!
da sin einige stopplos order ausgelöst worden.
kann auch nirgends was finden.die haben die zulassung doch gerade erst beantragt!!!!

Kupferberg (aktiencheck.de AG) - Die Experten von "Pennystockraketen.de" halten die Dor Biopharma-Aktie (ISIN US2580941019/ WKN 873539) für ein interessantes Investment. Seit ihrer damaligen Empfehlung habe sich bei der Biotechnologie-Gesellschaft einiges getan: So hätten etwa die Phase-III-Studien zum Krebsmedikament orBec erfolgreich abgeschlossen werden können. Bereits am 21. Juli 2007 werde die US-Gesundheitsbehörde FDA darüber entscheiden, ob eine Zulassung erteilt werden könne. Im Fall einer positiven Entscheidung seien bei Dor Biopharma mittelfristig stark steigende Umsatz- und Gewinnbeiträge zu erwarten. Höchst erfreulich sei auch, dass Dor Biopharma in der Geschäftseinheit Bioterrorismus von der US-Regierung erste Aufträge erhalten habe. Neben Cell Therapeutics und Sigma-Tau gebe es noch mehrere Unternehmen, die Dor Biopharma übernehmen wollen - hier zeichne sich für die nächsten Wochen und Monate ein beinharter Bieterkampf ab. Die Experten würden davon ausgehen, dass ein etwaiger Übernehmer für Dor Biopharma mehr als einen Dollar je Aktie auf den Tisch legen müsste (aktuelle Notierung: 0,825 USD). In der Ausgabe vom 20. Februar 2006 hätten die Experten empfohlen, etwaige Orders in den USA zu platzieren und mit 0,30 USD zu limitieren. Der Kurs von Dor Biopharma sei daraufhin nicht nur unter diese Marke gefallen, sondern habe im August 2006 sogar ein Tief bei 0,195 USD und im Dezember 2006 Notierungen von knapp oberhalb von 0,20 USD erreicht. Sowohl auf USD-Basis als auch auf Euro-Basis habe der Titel dabei die per Ende 2005 markierten Tiefs unterschritten. Aus dem Chart könne man gut erkennen, dass sich Dor Biopharma im Januar 2006 innerhalb kürzester Zeit mehr als verdoppelt habe. Danach sei der Wert fast ein Jahr lang im Zuge eines "Streckfolter"-Musters wieder zurückgefallen und habe dabei - wie bereits erwähnt - neue Tiefs erreicht. Mit "Streckfolter" würden die Experten eine Formation bezeichnen, in welcher sich die Kurse nach einem kurzen Hochschießen über einen längeren Zeitraum wieder zurückbewegen würden. Im Zuge dieser Bewegung werde ein Marktteilnehmer nach dem anderen aus der Aktie herausgespült - parallel hierzu würden kapitalstarke "Big Player" den Wert einsammeln. Diese geldtechnisch sehr "schweren" Investoren seien daran interessiert, den Wert so billig und so lange nur irgend möglich günstig abzufischen. Die Experten könnten an dieser Stelle ihre nächste Regel aufstellen: Bei hochinteressanten Aktien komme es oftmals zu einer "Streckfolter"-Formation. Dabei werde nach einem Hochschießen des Kurses erst viel später ein weiteres Tief ausgebildet - dieses Tief könne unter dem ersten Tief liegen. Da der Chart dann "kaputt" erscheine, schaue sich keiner mehr den Wert an. Der darauffolgende Kursauschwung führe die Aktie auf neue Hochs und noch weit darüber hinaus. Bei derartigen Formationen sollte man versuchen, in der Nähe des zweiten Standbeins einzusteigen. Die Experten von "Pennystockraketen.de" halten die Dor Biopharma-Aktie für ein interessantes Investment. Das Kursziel sehe man über 1 USD. (Ausgabe vom 27.04.2007) (30.04.2007/ac/a/a)

[Belu1972]

Antwort auf Beitrag Nr.: 29.190.302 von mike32 am 07.05.07 16:33:31

ich bin´s nicht Schuld

The FDA's briefing document is very negative. Here's its conclusion:

The pivotal study ENT 00-02 did not demonstrate efficacy based on the protocol specified primary analysis. Due to the differences in trial design, dosing regimens, methodology, the Agency cannot rely on the post-hoc pooled analyses to prove efficacy for orBec, and such analyses are considered to be exploratory/ hypothesis generating for future studies. The Agency recommends that the applicant demonstrate orBec’s efficacy through the use of prospectively designed trial(s).

Basically, the FDA is saying Dor must do another study because he results are too hypothetical - not good clinical data to prove a nexus to Orbec. Though this is just a briefing document, I personally find it highly unlikely that the panel will approve OrBec on May 9th. Here's the full document:

http://www.fda.gov/ohrms/dockets/ac/07/b...

[GBRW]

Antwort auf Beitrag Nr.: 29.191.173 von Belu1972 am 07.05.07 17:11:26

sorry, aber ich finde da nix!?

[Belu1972]

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4301b1-…


besser?

[mike32]

Antwort auf Beitrag Nr.: 29.191.173 von Belu1972 am 07.05.07 17:11:26

bist Du auch nicht !

[GBRW]

ich hab hier mal ne google übersetzung,

Das Dokument Anweisung Der FDA ist sehr negativ. Ist hier seine Zusammenfassung: Die Angelstudie HNO00-02 zeigte nicht die Wirksamkeit, die auf der Protokoll spezifizierten Primäranalyse basierte. Wegen der Unterschiede bezüglich des Probedesigns, Regierungen, Methodenlehre dosierend, kann die Agentur nicht auf den Pfosten-hoc vereinigten Analysen beruhen, um Wirksamkeit für orBec zu prüfen, und solche Analysen werden betrachtet, die forschende Hypothese zu sein, die für zukünftige Studien erzeugt. Die Agentur empfiehlt, daß der Bewerber Wirksamkeit der orBecs durch den Gebrauch von voraussichtlich entworfenen Versuchen demonstrieren. Im Allgemeinen sagt die FDA, daß Dor Muß eine andere Studie, weil er ist zu hypothetisch resultiert - die nicht guten klinischen Daten tun, zum einer Verbindung zu Orbec zu prüfen. Obwohl dieses ein Anweisung Dokument gerecht ist, finde ich es persönlich in hohem Grade unwahrscheinlich, daß die Verkleidung OrBec am 9. Mai genehmigt. Ist hier das volle Dokument:

[GBRW]

Antwort auf Beitrag Nr.: 29.191.401 von Belu1972 am 07.05.07 17:21:09

ja, danke!

[GBRW]

das gleiche zenario gab es bei paion auch schon mal, am anderen tag war der kurs wieder auf vortagesstand! vieleicht ist es hier auch so.

[mike32]

[NewSpice]

Antwort auf Beitrag Nr.: 29.191.578 von GBRW am 07.05.07 17:28:58

nach dieser Meldung gehe ich nicht davon aus
hab schon pferde kotzen gesehen
hoffen wir das beste

[Belu1972]

Will in dieser Runde kein Spielverderber sein, Dorb hat jetzt,
wenn ich das bei den Amis richtig gelesen habe, 80 Tage Zeit
neue Studien vorzulegen. Kann mir bei dem jetzigen Scenario vorstellen,
das es noch etwas runtergeht. Für mich heißt das, das ich mit meinem
Nachkauf noch etwas warte, bis die Paniker raus sind.

http://stockcharts.com/charts/gallery.html?DORB

wäre hier $ ,375 die nächste Unterstützung. Hält die nicht, sehen
wir uns bei $,26

http://www.stockta.com/cgi-bin/analysis.pl?symb=DORB&num1=56…

[NewSpice]

Antwort auf Beitrag Nr.: 29.192.048 von Belu1972 am 07.05.07 17:48:04

Was wird heute passieren
wieder rauf oder noch weiter runter

hoffen wir das beste

[GBRW]

Antwort auf Beitrag Nr.: 29.205.256 von NewSpice am 08.05.07 08:52:13

hi,
ich denke das es eine gegenbewegung heute nachmittag geben wird,
bei 14.680,28 in den usa gehandelten stücken, wird bestimmt wieder gekauft, es wollte doch vor kurzen schon einer die dor zu 0,86us cent übernehmen!!!
wer weiß warum gestern so viele gehandelt worden sind.

[Belu1972]

Antwort auf Beitrag Nr.: 29.205.256 von NewSpice am 08.05.07 08:52:13

meine Glaskugel ist weggerollt

Warte auf die $ ,25

Heute vielleicht kleine Gegenbewegung, aber ich vermute, daß jeder kleine
Gewinn genutzt wird, um die Verluste zu reduzieren

[NewSpice]

Antwort auf Beitrag Nr.: 29.205.525 von Belu1972 am 08.05.07 09:09:41

Börse
NASDAQ OTC BB

Aktuell
0,40 USD

Zeit
07.05.07 21:59

Diff. Vortag
-42,86 %

Tages-Vol.
6,61 Mio.

Gehandelte Stück
15 Mio.

warum sollte ein so hohes Handelsvolumen sein wenn keiner an eine zulassung glaubt der kurs ist nur ins rutschen gekommen weil vormitteilungen zu negative bewertet wurdenslverkäufe ausgelösst wurden..oder

[Belu1972]

Erholung sieht ja schon mal gut aus

Schade für die, die geschmissen haben

[mike32]

Antwort auf Beitrag Nr.: 29.216.025 von Belu1972 am 08.05.07 17:14:27

[GBRW]

Antwort auf Beitrag Nr.: 29.216.025 von Belu1972 am 08.05.07 17:14:27

ja, das sind die daytrader!!!

[entombed1966]

Ups. Rebound, aktuell + 18 %!

[GBRW]

Antwort auf Beitrag Nr.: 29.240.697 von entombed1966 am 09.05.07 21:44:20

hi,
hab noch mal zu 0,26 + 0,23 nachgekauft!

[Belu1972]

Price Size Exch Time
z 0.355 25000 OBB 16:10:47
z 0.355 6670 OBB 16:10:47
z 0.355 5000 OBB 16:10:47
z 0.35 7217 OBB 16:10:47
z 0.355 3690 OBB 16:10:47
z 0.355 4000 OBB 16:10:47
z 0.35 1400 OBB 16:10:47
z 0.355 1000 OBB 16:10:47
z 0.355 2000 OBB 16:10:47
t 0.43 2000 OBB 16:08:27
z 0.385 5000 OBB 16:08:04
z 0.385 7000 OBB 16:06:22
0.42 1000 OBB 16:00:01
0.42 4071 OBB 15:59:52
0.4225 1000 OBB 15:59:50
0.42 2100 OBB 15:59:46
0.42 5000 OBB 15:59:45
0.42 4850 OBB 15:59:42
0.425 4850 OBB 15:59:42
0.42 5000 OBB 15:59:40

[schmacki]

Antwort auf Beitrag Nr.: 29.244.275 von Belu1972 am 10.05.07 09:12:19

ODAC Sitzung-Abstimmung 7:2 gegen Orbec!
Blutbad!

[entombed1966]

Antwort auf Beitrag Nr.: 29.251.722 von schmacki am 10.05.07 15:17:38

Ich habe ein paar Stücke zu 0,19 bekommen, mal schauen, viell. wird's ein lukrativer Zock.

[schmacki]

Antwort auf Beitrag Nr.: 29.252.262 von entombed1966 am 10.05.07 15:40:25

Ich warte lieber!

[Belu1972]

Antwort auf Beitrag Nr.: 29.252.372 von schmacki am 10.05.07 15:44:28

sieht mir fast so aus als wäre das noch nicht alles gewesen

hoffentlich hält $,19 nächste wäre $12

[entombed1966]

Antwort auf Beitrag Nr.: 29.253.339 von Belu1972 am 10.05.07 16:21:33

Möglich. Aber da muss wenigstens ein technischer Rebound erfolgen. Wird schon, keine Bange.

[Belu1972]

Antwort auf Beitrag Nr.: 29.253.914 von entombed1966 am 10.05.07 16:46:42

aber nicht heute. Mit bischen Glück wird der Kurs gehalten

[entombed1966]

Antwort auf Beitrag Nr.: 29.254.318 von Belu1972 am 10.05.07 17:04:15

Das ist korrekt bzw. möglich. Aber ich bin überzeugt dass er kommen wird. Wegen einem Tag auf oder ab... mir egal.

[Belu1972]

Antwort auf Beitrag Nr.: 29.254.594 von entombed1966 am 10.05.07 17:18:46

glaube nicht, das sich der Kurs wesentlich nach oben bewegen wird
in allernächster Zeit. Kein Approval of a drug.

Übernahme ist somit auch nicht in Sicht.

[Belu1972]

amis sind stinksauer, daß das Management das Kaufangebot nicht angenommen hat

[Belu1972]

Käufe
t 0.215 1864 OBB 16:02:46
t 0.215 100000 OBB 16:01:37
t 0.215 3000 OBB 16:00:35
t 0.215 500 OBB 16:00:24
t 0.215 20000 OBB 16:00:19
0.215 3800 OBB 15:59:48
0.215 10000 OBB 15:59:46
0.211 10000 OBB 15:59:42
0.215 1000 OBB 15:59:41
0.215 1000 OBB 15:59:37
0.215 1000 OBB 15:59:35
0.215 5000 OBB 15:59:28
0.215 10000 OBB 15:59:25
0.215 5000 OBB 15:59:16

[GBRW]

Antwort auf Beitrag Nr.: 29.258.674 von Belu1972 am 10.05.07 20:59:18

hi,
welsches kaufangebot meinst du???

[Belu1972]

By Luke Timmerman
May 9 (Bloomberg) -- DOR Biopharma Inc. urged U.S.
regulators to approve its drug for graft versus host disease, a
lethal complication that leukemia patients get after bone marrow
transplants.
The U.S. Food and Drug Administration's panel of advisers on
cancer drugs plans to vote today whether to recommend approving
the anti-inflammatory drug, orBec. A trial in 129 patients failed
to reach its main goal of slowing the disease, although the
company said it extended lives.
Patients receive bone marrow transplants to rebuild immune
systems knocked down by high-dose radiation or chemotherapy. In
most people, the transplanted cells attack the body's healthy
cells, causing graft-versus-host disease. DOR's drug would be its
first marketable product and would be a new option for 7,000 U.S.
patients a year who get a condition with painful vomiting, nausea
and diarrhea.
``This is clinically meaningful. It means patients can get
out of the hospital, and go home,'' George McDonald, head of
gastroenterology at the Fred Hutchinson Cancer Research Center in
Seattle, told the meeting of the FDA panel in Silver Spring,
Maryland. McDonald invented orBec.
Shares of Miami-based DOR Biopharma rose 5 cents, or 14
percent, to 42 cents at 4 p.m. New York time in over-the-counter
bulletin board trading.

Patient Became `Skeleton'

A patient who endured graft versus host disease, Steve Dugan
of Radnor Pennsylvania, said he spent 33 days in the hospital,
dropped from 154 pounds to 127 pounds and endured painful nausea
and vomiting. He said he became like a ``skeleton'' and his
children became afraid of him.
``When we talk about nausea and vomiting here, it's far
beyond anything you can imagine,'' said Susan Stewart, executive
director of Blood and Marrow Transplant InfoNet. Stewart said her
travel was paid for by a grant from DOR Biopharma.
DOR combined results from two clinical trials in an effort
to show the drug slowed graft versus host disease and extended
lives. The trials had different objectives and dosing schedules.
The studies were also conducted 10 years apart, during which
standard treatments changed, making the trials difficult to
compare, the FDA said in briefing documents posted on the
agency's Web site May 7.

Studies Called Inadequate

``Due to the differences in trial design, dosing regimens,
methodology, the agency can not rely'' on the combined analysis
to support approval of orBec, the FDA staff wrote. The FDA
reviewers recommended that DOR run another clinical trial.
OrBec is designed to work mostly in the intestines, unlike
other anti-inflammatory treatments, which can suppress the entire
immune system and make patients vulnerable to lethal infections,
DOR has said. Graft versus host characterized by anorexia-like
symptoms, abdominal pain, nausea and vomiting.
The results of the two clinical trials had been disclosed
previously to investors. In the larger study of 129 patients, the
drug failed to reach the primary goal of slowing the disease in
the first 50 days of treatment. A follow-up review showed the
drug saved lives at 80 days, 200 days, and a year, the company
has said.
If approved, orBec would have no competition and a price of
about $10,000 for a 50-day course of therapy, DOR has said. It
could reach U.S. sales of $70 million to $100 million a year, and
possibly twice that worldwide.
DOR expects to hear a decision from the FDA by July 21, the
company said. The agency usually follows the recommendations of
its advisory panels, although it isn't required to do so.

The FDA usually follows the recommendations of its advisory
panels, although it isn't required to do so. DOR said it expects
to receive a ruling from the FDA by July 21.

Chief Executive

DOR's Chief Executive Officer, Christopher Schaber, told the
panel after the vote that ``it is not economically feasible for
us at this point'' to run another clinical trial to show orBec is
effective.
DOR raised $5.5 million from institutional investors in
February, according to its most recent annual report with the
Securities and Exchange Commission. It said it has enough cash to
operate into the first quarter of 2008.
Steve Kanzer, DOR's vice chairman, shouted at the committee
chairwoman, Maha Hussain of the University of Michigan, during
the public comment portion of the meeting. He was escorted out by
two security guards and was heard yelling obscenities in the
hallway outside the meeting room. Kanzer held 1.3 million DOR
shares, based on data compiled by Bloomberg.
Kanzer is a founder of Discovery Laboratories, Inc.,
according to his biography on DOR's Web site.
A patient who endured graft versus host disease, Steve Dugan
of Radnor, Pennsylvania, told the advisory panel he spent 33 days
in the hospital, dropped from 154 pounds to 127 pounds and
endured painful nausea and vomiting. He said he became like a
``skeleton'' and his children became afraid of him.

Study Findings

``When we talk about nausea and vomiting here, it's far
beyond anything you can imagine,'' said Susan Stewart, executive
director of Blood and Marrow Transplant InfoNet, based in
Highland Park, Illinois. Stewart said a grant from DOR Biopharma
covered her travel costs.
DOR combined results of two clinical trials in an effort to
show the drug slowed graft versus host disease and extended
lives. The trials had different objectives and dosing schedules.
The studies were conducted 10 years apart, during which standard
treatments changed, making the trials difficult to compare, the
FDA said in briefing documents posted May 7.
``Due to the differences in trial design, dosing regimens,
methodology, the agency cannot rely'' on the combined analysis to
support approval of orBec, the FDA staff wrote. The FDA reviewers
recommended that DOR run another clinical trial.
$10,000 Treatment
OrBec is designed to work mostly in the intestines, unlike
other anti-inflammatory treatments, which can suppress the entire
immune system and make patients vulnerable to lethal infections,
DOR has said. Graft versus host disease is characterized by
anorexia-like symptoms, abdominal pain, nausea and vomiting.
The results of the two clinical trials had been disclosed
previously to investors. In the larger study of 129 patients, the
drug failed to reach the primary goal of slowing the disease in
the first 50 days. A follow-up review showed the drug saved lives
at 80 days, 200 days and a year, the company said.
If approved, orBec would have no competition and a price of
about $10,000 for a 50-day course of therapy, DOR said. It could
reach U.S. sales of $70 million to $100 million a year, and
possibly twice that worldwide, according to the company.

warten wir also bis 21. Juli

[NewSpice]

Antwort auf Beitrag Nr.: 29.262.501 von Belu1972 am 11.05.07 08:24:52

hallo...

mein englisch ist nicht das beste
kannst du mir in einfachen worte übersetzen was du da rein gestellt hast ???

danke im vorraus

[entombed1966]

Sagte ich's doch...

[ipollit]

Antwort auf Beitrag Nr.: 29.263.004 von NewSpice am 11.05.07 08:58:20

Das ist es nicht wert zu übersetzen... es handelt sich um alten Kram von vor dem AC (9.5.)... "ODAC will heute über orBec beraten... usw..." ist ja schon gelaufen. Was Belu wohl meint, aber wohl ein gewisses Mißverständnis der FDA ist, dass spätestens am 21.7. die richtige FDA-Entscheidung kommt. Da sollte man sich allerdings nichts erhoffen, denn nach dem negativen AC die Tage wird die Ablehnung bzw. Nicht-Zulassung von orBec durch die FDA nur ein Formalie sein!

mfg ipollit

[schmacki]

Antwort auf Beitrag Nr.: 29.271.213 von ipollit am 11.05.07 16:17:54

Vielleicht ist's bei DORB umgedreht als bei DNDN!

[ipollit]

Antwort auf Beitrag Nr.: 29.271.624 von schmacki am 11.05.07 16:38:52

vielleicht ist ja auch morgen Weihnachten... und ich bin der Osterhase...

[NewSpice]

gibt es positive News ??

kurs steigt langsam wieder an..

18.05.07 15:59 Uhr

0,20 EUR

+17,65 % [+0,03]

[Belu1972]

Gap closing $,35

[NewSpice]

das heist was

[entombed1966]

Hat sich mögl.weise gelohnt, mein Alles od. Nichts...

[NewSpice]

sehen wir heute noch die $0,35

[NewSpice]

Antwort auf Beitrag Nr.: 29.375.229 von NewSpice am 18.05.07 17:08:21

18.05.07 16:51 Uhr

0,30 USD

+27,66 % [+0,065]

[Belu1972]

Antwort auf Beitrag Nr.: 29.375.229 von NewSpice am 18.05.07 17:08:21

Luft nach oben ist auf jeden Fall genug

http://www.stockta.com/cgi-bin/analysis.pl?symb=DORB&num1=56…

[Belu1972]

DOR BioPharma, Inc. (DORB) previously at $0.24 up 14% at $0.27 with 6,389,266 (DORB) was highlighted recently by Knobias Clip Report, Red Chip, HotOTC.com, Stock Hideout and Break Out Trading

DOR BioPharma, Inc. announced recently that it plans to initiate a clinical development program in humans with its Lipid Polymer Micell oral drug delivery technology. The LPM drug delivery technology allow for the oral administration of drugs that are water-soluble but poorly permeable through the gastrointestinal tract. Leuprolide is one of the most widely used anti-cancer agents for advanced prostate cancer in men. Leuprolide is currently available only in injectable, depot and subcutaneous implant routes of delivery which limits its use and utility. Knobias Clip report featured (DORB) in today's Clip Report in which they state "another name may deserve increased attention as a decision on an NDA is due by the end of the week."
DOR BioPharma, Inc. is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents.

[bombastik]

http://www.qualitystocks.net/newsletter/newsletter.html

DOR BioPharma, Inc. (DORB) previously at $0.24 up 14% at $0.27 with 6,389,266 (DORB) was highlighted recently by Knobias Clip Report, Red Chip, HotOTC.com, Stock Hideout and Break Out Trading

DOR BioPharma, Inc. announced recently that it plans to initiate a clinical development program in humans with its Lipid Polymer Micell oral drug delivery technology. The LPM drug delivery technology allow for the oral administration of drugs that are water-soluble but poorly permeable through the gastrointestinal tract. Leuprolide is one of the most widely used anti-cancer agents for advanced prostate cancer in men. Leuprolide is currently available only in injectable, depot and subcutaneous implant routes of delivery which limits its use and utility. Knobias Clip report featured (DORB) in today's Clip Report in which they state "another name may deserve increased attention as a decision on an NDA is due by the end of the week."
DOR BioPharma, Inc. is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents.

[bombastik]

Antwort auf Beitrag Nr.: 29.398.213 von bombastik am 21.05.07 01:21:10

Monday should be fun!

[Belu1972]

The treatment indication for orbec is to use it with prednisone such that the steroid can suppress the body's immune system sufficiently to prevent the immune system from rejecting the bone marrow transplant, which is standard of care treatment for leukemia and other blood cancers. However, the depressing of the immune system permits fungal and other infections, which can and have proven fatal, to invade the body and cause a relapse of leukemia. Dr. Susan Mortimer, who sat on the ODAC panel that reviewed orbec, acknowledged the drug's steroid sparing effect and orbec's clinical studies confirm statistical significance that orbec treatment allows blood cancer patients to be exposed to significantly reduced amounts of systemic steroids following a bone marrow transplant.

Dr. McDonald's entire presentation to the ODAC panel was bottomed upon the fact that the current standard treatment for GI GVHD, huge long-term doses of prednisone and other steroids, is what is wreaking far more havoc upon patients and killing them, than the actual disease it treats, GI GVHD; a classic case of where the standard treatment is more deleterious than the disease it treats.

Given this huge benefit of orbec treatment, and orbec's proven clinical trial history of safety, the benefits of orbec treatment far outweigh the risks, which are virtually non-existent. Couple that fact with the fact that orbec, in its clinical studies and pivotal P3 study, has met all of its pre-specified secondary trial endpoints, would have meant the primary pivotal trial endpoint had it not been for that trial's design flaw, which was overcome through right-censoring of 10-day treatment failure data, plus the statistically significant secondary 80-day efficacy and 200-day and one-year survival benefits orbec has demonstrated, the survival benefits never before seen in a treatment trial for orbec. The application of the Agency's own protocol to the totality of all of these proven clinical results for orbec, which, according to recent FDA Guidelines for approval of cancer drugs, recent statements made by Dr. Von Eshenbach and Dr. Pazdur's willingness to help patients confronted with life-threatening diseases and devastating illnesses for which there are no approved treatments, should result in an FDA approval of orbec, in some form, on or before July 21, 2007, such that the drug can be made immediately available to the GI GVHD population in America, not only for the treatment of their GI GVHD, with all of its havoc-wreaking effects and potential lethal effects on the body, the prophylactic effect orbec usage would provide for the tapering-down of long-term use of steroids and thirdly, the ultimate preventive and avoidance effect orbec usage would have on the relapse of leukemia, a three-fold benefit, proven treatment efficacy and long-term survival benefits.

For the Agency not to approve orbec with that benefit profile, is to deny water to a person in the desert dying from dehydration, and such action by the Agency would fly in the face of and contravene its own defined protocol bar.

This noise made at the ODAC meeting by Dr. Michael Perry about "lowering the bar" is nonsense. OrBec's clinically proven benefit profile, as pointed out in detail above, in conjunction with the drug's safety profile, clearly meets the current FDA Protocol for drug approval and as such, no bars would be lowered, to the contrary, a life-preserver would be raised. The only bar involved here, if the Agency does not grant some form of approval for orbec sufficient to immediately make it available in the US for the treatment of GI GVHD, would be the cell bars that the FDA would be putting in front of the GI GVHD patient population who would remain imprisoned and held captive by their disease, a disease that carries with it a languishing, devastating and potentially lethal sentence.


Sentiment : Strong Buy
aus Yahoo board

[neu22]

Antwort auf Beitrag Nr.: 29.405.794 von Belu1972 am 21.05.07 16:57:52

Bitte mal ne Kurzfassung in deutsch !!!
wäre klasse !! bin bei 0,58 eingestiegen !!!!!!
danke

[entombed1966]

Antwort auf Beitrag Nr.: 29.406.097 von neu22 am 21.05.07 17:16:48

Nicht von mir... geh' jetzt eine Runde Mountainbiken.

Aber "immerhin" den RT-Chart (aktuell + 11 %!):

[Belu1972]

lasst uns mal die Daumen drücken, daß wir heute
über $ ,32 schließen, dann steht bis $ ,50 nichts mehr im Weg

[GBRW]

Antwort auf Beitrag Nr.: 29.406.097 von neu22 am 21.05.07 17:16:48

hi,
ich habe hier eine google übersetzung

Die Behandlunganzeige für orbec ist, es mit Prednison zu verwenden so, daß das Steroid das immune System des Körpers genug unterdrücken kann, um das immune System am Zurückweisen des Knochenmark Transplant zu verhindern, der Standard der Obachtbehandlung für Leukämie und andere Blutkrebse ist. Jedoch ermöglicht das Niederdrücken des immunen Systems pilzartige und andere Infektion, die und tödliches geprüft zu haben, den Körper einzudringen und einen Rückfall der Leukämie zu verursachen kann. Dr. Susan Mortimer, der auf der ODAC Verkleidung saß, die orbec wiederholte, bestätigte der ersparenden effekt des Steroids Droge und klinischen die Studien der orbecs bestätigen statistische Bedeutung, daß orbec Behandlung Blutkrebspatienten erlaubt, erheblich verringerten Mengen der Körpersteroide ausgesetzt zu werden, die einem Knochenmark Transplant folgen. Gesamte Darstellung des Dr. McDonald's zur ODAC Verkleidung wurde nach der Tatsache grundiert, daß die gegenwärtige Standardbehandlung für GI GVHD, sehr große langfristige Dosen des Prednisons und andere Steroide, was weit mehr Verwüstung nach Patienten wreaking und sie tötet, als die tatsächliche Krankheit, die sie behandelt, GI GVHD ist; ein klassischer Fall von, dem die Standardbehandlung gesundheitsschädlicher ist, als die Krankheit behandelt sie. Diesen sehr großen Nutzen der orbec Behandlung und nachgewiesene klinische Probegeschichte der orbecs der Sicherheit gegeben, überwiegt der Nutzen der orbec Behandlung weit die Gefahren, die praktisch nicht vorhanden sind. Diese Tatsache mit der Tatsache verbinden, daß orbec, in seinen klinischen Studien und in Angelstudie P3, alle seine pre-specified Sekundärprobeendpunkte getroffen hat, würde bedeutet haben den Primärangelprobeendpunkt wäre es nicht für Konstruktionsfehler dieses Versuches, der durch das recht-Zensieren der 10tägigen BehandlungFehlerangaben überwunden wurde, plus die statistisch bedeutende Sekundär80 Tageswirksamkeit gewesen und Tag 200 und einjähriges überleben Nutzen orbec hat gezeigt, der überleben Nutzen nie, vor gesehen in einen Behandlungversuch für orbec. Die Anwendung eigenen Protokolls der Agentur zur Gesamtheit von allen diese nachgewiesenen klinischen Resultate für orbec, das, entsprechend neuen FDA Richtlinien für Zustimmung der Krebsdrogen, neue Aussagen durch Dr. Von Eshenbach bildeten und Bereitwilligkeit des Dr. Pazdurs, Patienten zu helfen mit lebensbedrohenden Krankheiten und verheerenden Krankheiten konfrontierte, für die es keine anerkannten Behandlungen gibt, sollte eine FDA-Zustimmung von orbec, in irgendeiner Form ergeben, an oder vor dem 21. Juli 2007, so, daß die Droge zugänglich für die Bevölkerung des GI GVHD in Amerika, nicht nur für die Behandlung ihres GI GVHD, mit allen seine Verwüstung-wreaking Effekte und mögliche lebensgefährliche Effekte auf dem Körper sofort gemacht werden kann, der prophylactike Effekt orbec Verbrauch würde für das Zuspitzen-unten des langfristigen Gebrauches der Steroide zur Verfügung stellen und drittens, würden das entscheidende Vorbeugungsmittel und der Vermeidung Effekt orbec Verbrauch auf dem Rückfall der Leukämie, des dreifachen Nutzens, der nachgewiesenen Behandlungwirksamkeit und des langfristigen überleben Nutzens haben. Für die Agentur, zum von orbec mit diesem Nutzenprofil nicht zu genehmigen, ist, Wasser zu verweigern einer Person in der Wüste sterbend an der Dehydratisierung, und solche Tätigkeit durch die Agentur würde angesichts fliegen und seinem eigenen definierten Protokollstab zuwiderhandeln. Diese Geräusche, die bei der ODAC Sitzung vom Dr. Michael Perry über „das Senken des Stabes“ gebildet werden, sind Unsinn. OrBecs trifft klinisch nachgewiesenes Nutzenprofil, wie über, in Verbindung mit dem Profil Sicherheit der Droge im Detail unterstrichen, offenbar das gegenwärtige FDA Protokoll für Drogezustimmung und wie so, keine Stäbe gegenteilig ein Lebenretter würden angehoben gesenkt würden. Der einzige Stab, der hier betroffen ist, wenn die Agentur nicht irgendeine Form der Zustimmung für das orbec bewilligt, das genügend ist, es sofort zur Verfügung zu stellen in den US für die Behandlung von GI GVHD, würde die Zelle Stäbe, die die FDA vor der geduldigen Bevölkerung des GI GVHD setzen würde, die eingesperrter und gehaltener Gefangener durch ihre Krankheit bleiben würde, eine Krankheit sein, die mit sie einem Satz Schmachtens, des Verwüstens und möglicherweise lebensgefährlichen trägt. Gefühl: Starker Kauf aus Yahoo Brett #143 von Neu22 21.05.07 17:16: 48 Beitrag Nr.: 29.406.097 Dieses-Eintragung: versenden | melden | drucken | Antwort
Arabisch nach Englisch BETAChinesisch nach Englisch BETAChinesisch (traditionell nach vereinfacht) BETAChinesisch (vereinfacht nach traditionell) BETADeutsch nach EnglischDeutsch nach FranzösischEnglisch nach Arabisch BETAEnglisch nach Chinesisch (traditionell) BETAEnglisch nach Chinesisch (vereinfacht) BETAEnglisch nach DeutschEnglisch nach FranzösischEnglisch nach ItalienischEnglisch nach Japanisch BETAEnglisch nach Koreanisch BETAEnglisch nach PortugiesischEnglisch nach Russisch BETAEnglisch nach SpanischFranzösisch nach DeutschFranzösisch nach EnglischItalienisch nach EnglischJapanisch nach Englisch BETAKoreanisch nach Englisch BETAPortugiesisch nach EnglischRussisch nach Englisch BETASpanisch nach Englisch
Eine bessere Übersetzung vorschlagen

Wir danken für Ihren Vorschlag zu Google Übersetzer.Ihren Vorschlag zur Verbesserung der Übersetzungsqualität werden wir in künftigen Aktualisierungen unseres Systems berücksichtigen. Die Behandlunganzeige für orbec ist, es mit Prednison zu verwenden so, daß das Steroid das immune System des Körpers genug unterdrücken kann, um das immune System am Zurückweisen des Knochenmark Transplant zu verhindern, der Standard der Obachtbehandlung für Leukämie und andere Blutkrebse ist. Jedoch ermöglicht das Niederdrücken des immunen Systems pilzartige und andere Infektion, die und tödliches geprüft zu haben, den Körper einzudringen und einen Rückfall der Leukämie zu verursachen kann. Dr. Susan Mortimer, der auf der ODAC Verkleidung saß, die orbec wiederholte, bestätigte der ersparenden effekt des Steroids Droge und klinischen die Studien der orbecs bestätigen statistische Bedeutung, daß orbec Behandlung Blutkrebspatienten erlaubt, erheblich verringerten Mengen der Körpersteroide ausgesetzt zu werden, die einem Knochenmark Transplant folgen. Gesamte Darstellung des Dr. McDonald's zur ODAC Verkleidung wurde nach der Tatsache grundiert, daß die gegenwärtige Standardbehandlung für GI GVHD, sehr große langfristige Dosen des Prednisons und andere Steroide, was weit mehr Verwüstung nach Patienten wreaking und sie tötet, als die tatsächliche Krankheit, die sie behandelt, GI GVHD ist; ein klassischer Fall von, dem die Standardbehandlung gesundheitsschädlicher ist, als die Krankheit behandelt sie. Diesen sehr großen Nutzen der orbec Behandlung und nachgewiesene klinische Probegeschichte der orbecs der Sicherheit gegeben, überwiegt der Nutzen der orbec Behandlung weit die Gefahren, die praktisch nicht vorhanden sind. Diese Tatsache mit der Tatsache verbinden, daß orbec, in seinen klinischen Studien und in Angelstudie P3, alle seine pre-specified Sekundärprobeendpunkte getroffen hat, würde bedeutet haben den Primärangelprobeendpunkt wäre es nicht für Konstruktionsfehler dieses Versuches, der durch das recht-Zensieren der 10tägigen BehandlungFehlerangaben überwunden wurde, plus die statistisch bedeutende Sekundär80 Tageswirksamkeit gewesen und Tag 200 und einjähriges überleben Nutzen orbec hat gezeigt, der überleben Nutzen nie, vor gesehen in einen Behandlungversuch für orbec. Die Anwendung eigenen Protokolls der Agentur zur Gesamtheit von allen diese nachgewiesenen klinischen Resultate für orbec, das, entsprechend neuen FDA Richtlinien für Zustimmung der Krebsdrogen, neue Aussagen durch Dr. Von Eshenbach bildeten und Bereitwilligkeit des Dr. Pazdurs, Patienten zu helfen mit lebensbedrohenden Krankheiten und verheerenden Krankheiten konfrontierte, für die es keine anerkannten Behandlungen gibt, sollte eine FDA-Zustimmung von orbec, in irgendeiner Form ergeben, an oder vor dem 21. Juli 2007, so, daß die Droge zugänglich für die Bevölkerung des GI GVHD in Amerika, nicht nur für die Behandlung ihres GI GVHD, mit allen seine Verwüstung-wreaking Effekte und mögliche lebensgefährliche Effekte auf dem Körper sofort gemacht werden kann, der prophylactike Effekt orbec Verbrauch würde für das Zuspitzen-unten des langfristigen Gebrauches der Steroide zur Verfügung stellen und drittens, würden das entscheidende Vorbeugungsmittel und der Vermeidung Effekt orbec Verbrauch auf dem Rückfall der Leukämie, des dreifachen Nutzens, der nachgewiesenen Behandlungwirksamkeit und des langfristigen überleben Nutzens haben. Für die Agentur, zum von orbec mit diesem Nutzenprofil nicht zu genehmigen, ist, Wasser zu verweigern einer Person in der Wüste sterbend an der Dehydratisierung, und solche Tätigkeit durch die Agentur würde angesichts fliegen und seinem eigenen definierten Protokollstab zuwiderhandeln. Diese Geräusche, die bei der ODAC Sitzung vom Dr. Michael Perry über „das Senken des Stabes“ gebildet werden, sind Unsinn. OrBecs trifft klinisch nachgewiesenes Nutzenprofil, wie über, in Verbindung mit dem Profil Sicherheit der Droge im Detail unterstrichen, offenbar das gegenwärtige FDA Protokoll für Drogezustimmung und wie so, keine Stäbe gegenteilig ein Lebenretter würden angehoben gesenkt würden. Der einzige Stab, der hier betroffen ist, wenn die Agentur nicht irgendeine Form der Zustimmung für das orbec bewilligt, das genügend ist, es sofort zur Verfügung zu stellen in den US für die Behandlung von GI GVHD, würde die Zelle Stäbe, die die FDA vor der geduldigen Bevölkerung des GI GVHD setzen würde, die eingesperrter und gehaltener Gefangener durch ihre Krankheit bleiben würde, eine Krankheit sein, die mit sie einem Satz Schmachtens, des Verwüstens und möglicherweise lebensgefährlichen trägt. Gefühl: Starker Kauf aus Yahoo Brett

[NewSpice]

hört sich nicht schlecht an ...na dann auf steigende Kurse

[GBRW]

Antwort auf Beitrag Nr.: 29.412.980 von NewSpice am 22.05.07 09:07:43

ja das denke ich auch, bei dem kurs kann eigendlich nix falsch machen!

[Belu1972]

keiner mehr da?

[entombed1966]

Antwort auf Beitrag Nr.: 29.472.375 von Belu1972 am 25.05.07 20:10:25

Doch. Ich. Immerhin. Es bleibt spannend.

[taipan11]

Antwort auf Beitrag Nr.: 29.472.375 von Belu1972 am 25.05.07 20:10:25

auch ich bin natürlich weiter investiert.meine meinung ist,
dass wir hier einen wert von mind. 0,50$ je aktie haben.(letzes übernahmeangebot von cell) ohne berücksichtigung von der zulassung von orbec, für die ja weitere 15 mio $ bezahlt worden wären.
außerdem glaube ich, dass noch mit weiteren big pharma wegen einer übernahme verhandelt wird, aber zu einem wesentlich höheren preis als die gebotenen 0,50$ von cell.wir brauchen nur geduld,bis das angebot kommt.ist meine meinung dazu.
gruß

taipan11

[Belu1972]

Kanzer hat das Handtuch geschmissen

[NewSpice]

das heist jetzt was

[GBRW]

das scheint bei dem kurs auch nix mehr zu machen, würde sagen müssen wir aus sitzen
nur meine meinung!

[Belu1972]

On May 29, 2007, Southpoint Capital Advisors Filed a 13G/A with the SEC, declaring ownership of 2.7 million shares of DORB they purchased, along with voting power therein. Please note that this now trumps shares owned by former DORB co-chairman Steven Kanzer.

SCHEDULE 13G
This Amendment No. 1 to Schedule 13G (the “Amendment”) is an amendment to the initial statement on Schedule 13G relating to shares of common stock, par value $0.001 per share (the “Common Stock”) of Dor Biopharma, Inc., a Delaware corporation (the “Issuer”), filed with the Securities and Exchange Commission (the “SEC”) on February 16, 2007 (the “Schedule 13G”).
This Amendment is being filed on behalf of Southpoint Capital Advisors LLC, a Delaware limited liability company (“Southpoint CA LLC”), Southpoint GP, LLC, a Delaware limited liability company (“Southpoint GP LLC”), Southpoint Capital Advisors LP, a Delaware limited partnership (“Southpoint Advisors”), Southpoint GP, LP, a Delaware limited partnership (“Southpoint GP”), Robert W. Butts and John S. Clark II. Southpoint CA LLC is the general partner of Southpoint Advisors. Southpoint GP LLC is the general partner of Southpoint GP. Southpoint GP is the general partner of Southpoint Fund LP, a Delaware limited partnership (the “Fund”), Southpoint Qualified Fund LP, a Delaware limited partnership (the “Qualified Fund”), and Southpoint Master Fund, LP, a Cayman Islands exempted limited partnership (the “Master Fund”). Southpoint Offshore Fund, Ltd., a Cayman Island exempted company (the “Offshore Fund”), is also a general partner of the Master Fund. This Amendment relates to shares of Common Stock of the Issuer purchased by the Fund, the Qualified Fund and the Master Fund.
Item 4 Ownership.
Item 4 is hereby amended and restated as follows:
(a) Southpoint CA LLC, Southpoint GP LLC, Southpoint GP, Southpoint Advisors, Robert W. Butts and John S. Clark II may be deemed the beneficial owners of 2,707,088 shares of Common Stock.

(b) As of May 29, 2007, Southpoint CA LLC, Southpoint GP LLC, Southpoint GP, Southpoint Advisors, Robert W. Butts and John S. Clark II may be deemed the beneficial owners of 2.92% of the outstanding shares of Common Stock. This percentage was determined by dividing 2,707,088 by 92,689,276, the total number of Common Shares, par value $0.001, issued and outstanding, as reported in the Issuer’s Form 10-QSB filed with the Securities and Exchange Commission on May 15, 2007.

(c) Southpoint CA LLC, Southpoint GP LLC, Southpoint GP, Southpoint Advisors, Robert W. Butts and John S. Clark II have the sole power to vote and dispose of the 2,707,088 shares of Common Stock beneficially owned.
Item 5 Ownership of Five Percent or Less of a Class.

[Belu1972]

Will keiner mehr verkaufen?

[Belu1972]

http://www.newstarget.com/020328.html

[entombed1966]

Antwort auf Beitrag Nr.: 29.644.748 von Belu1972 am 05.06.07 12:58:56

Nein. Ich bin zwar nicht "keiner", aber ich verkaufe nicht. Überlege eher sogar nachzukaufen.

[Belu1972]

Antwort auf Beitrag Nr.: 29.645.638 von entombed1966 am 05.06.07 13:56:07

Bin mal gespannt, was bei DOR BioPharma to Participate in 5th Annual Biodefense Vaccin… rumgekommen ist

[Belu1972]

Da sitzt man mal nicht am Rechner und dann so ein erfreuliches Bild

wenn die $ ,30 geknackt ist, sind wir schnell bei $ ,50

Irgendwas scheint da zu brodeln (21.Juli:eek

[Belu1972]

10% unter Pari ich kann es gar nicht glauben

[Belu1972]

Diese Woche könnten wir die $ ,40 wieder sehen

[ansepe63]

Antwort auf Beitrag Nr.: 29.990.014 von Belu1972 am 18.06.07 08:38:32

Woher nimmst Du Deine Weisheiten?????

[Belu1972]

Antwort auf Beitrag Nr.: 30.018.692 von ansepe63 am 19.06.07 14:34:55

[Belu1972]

aus Yahoo board

Best summary and future outlook for Dorb. (Not rated) 21-Jun-07 12:21 am
Dr Flatau I think summed it up best at the meeting . . .

http://www.fda.gov/ohrms/dockets/ac/07/t...

Orbec wasn't perfect, but it worked for some, hence it should be given the go ahead.

Part 4 Page 306

DR. FLATAU: I guess I’m troubled. I mean, I
think it’s relatively clear that the scientific evidence
is not where we would like it to be.
I think if you look at it from what is going
to benefit patients, which it seems to me is the
important criteria, and it looks like there is probably
some efficacy with this drug.
There aren’t really any major safety concerns.
I think to do another trial to have scientific evidence
is going to postpone this drug for three, four, five
years at least. I think that from a patient point of
view that is not the right thing for patients.
It is better to get this drug that probably
has some efficacy, we think it has some efficacy, we
don’t have a high degree of confidence, but it probably
has some efficacy, and use it.
I think the other thing is that some patients
will take this drug if it’s approved and they won’t be
helped or they will fail treatment. I think they won’t
be that much worse off, and they will go on to whatever
other drugs are available to try and treat GVHD, except
that they won’t be getting BP compounded in corn oil.
I think on balance, from a patient point of
view, that approving this drug makes more sense than not approving it at this time.


and with that.
a very likely senario might be approval, with phase IV study.

Part IV Page 330
Dorb CEO C.Schaber

“with Phase IV follow-on
studies, but be able to have the drug available to the
patients and out there and marketed for the current
indication while we do follow-on studies”
(this is very likely scenario, in that case, both Dorb/Patients and FDA win) Big smiles for everyone!!!

a post stated "will the PPS go up if Orbec gets approvable?" the ans. is yes and no. 1st, "Approvable" will not cause the PPS to go up (almost always goes down). 2nd, There's a price for an "approvable" response from FDA, from that price, you gauge the price at which the rally has to achieve (30-50% has always been my assumptions). from there you just watch. IMO, Dorb is slated to be around (0.40 - 0.50) before july 21st.

just remember, the market overreacts to everything, it panics too much and falls in love with things too much.
There's a really good chance for some type of conditional approval (like the one above, where Dorb does make money while still satisfying FDA demands).

barring any negative news going into FDA date, the PPS will creep upwards. But if you want to play it safe, you will bail approx. 10 days before (july 11th) and collect your guaranteed gain from rally (just play the rally - which is fine) ... those who stay on the boat well you might see double/triple ... but don't be fooled, you might also see half of it gone.

But for now, just sit back and enjoy this upward swing for another couple of weeks.

[bernie55]

ALLGEMEINE INFOS zur Zulassung neuer Arzneien


22.06.2007 - 09:28 Uhr

FTD: Das kann ja heiter werden

Die Zulassung neuer Arzneien ist für die Pharmabranche längst keine Kleinigkeit mehr. Regelmäßig lassen die Behörden Hoffnungsträger durchfallen und Börsenträume platzen. Künftig kommt es noch dicker.


Sanofi-Aventis ist fassungslos über die Ablehnung seiner Diätpille Acomplia bei der US-Behörde FDA. Begründung: psychische Nebenwirkungen.

GlaxoSmithKline fürchtet das Aus für das umsatzstarke Diabetesmittel Avandia. Risiko: Herzinfarkt.

Das neue Krebsmittel Vectibix vom weltgrößten Biotechkonzern Amgen findet nicht den Zuspruch der Kontrolleure bei der EU-Behörde Emea. Erklärung: Wirksamkeit zweifelhaft.

Drei Beispiele aus der jüngsten Vergangenheit - eine gemeinsame Wirkung: Aufruhr an der Börse. Die Aktienkurse der betreffenden Konzerne sackten nacheinander auf ein Zweijahrestief. Allen Beteiligten, den Managern, Analysten und Kontrolleuren steckt noch der Skandal um das Schmerzmittel Vioxx in den Knochen. Die Folge für den Hersteller Merck & Co. sowie die Branche waren Tausende Schadensersatzklagen, Imagekrisen und Milliardenverluste. Das mahnte zur Vorsicht. Im Jahr drei nach Vioxx zieht die Politik auf beiden Seiten des Atlantiks die Zügel nun noch fester an.

So feilten am Donnerstag in Washington US-Senatoren an letzten Details für ein Gesetz, das der FDA mehr Einfluss und Geld für zusätzliche Sicherheitskontrollen von Medikamenten gibt. Dazu zahlt die Industrie an die FDA Gebühren von rund 400 Mio. $ jährlich, weitere 225 Mio. $ bringt sie in den kommenden fünf Jahren für die FDA-Observierung von Neueinführungen auf. "Die Nation hat aus den Sicherheitsproblemen mit dem Diabetesmedikament Avandia gelernt", sagte der Vorsitzende des Kongressausschusses, John Dingell, vor wenigen Tagen. Zudem können Verstöße gegen Marketing- und Sicherheitsauflagen mit bis zu 100 Mio. $
Strafe geahndet werden.

Und auch die Emea kann nun härter durchgreifen. Die EU-Kommission hat am 15. Juni eine Verordnung in Kraft gesetzt die Verstöße gegen Emea-Regeln mit hohen Geldbußen ahndet - etwa, wenn Firmen Vorgaben ihrer Arzneimittelzulassungen nicht einhalten, Informationen zur Risikobewertung ihrer Produkte zurückhalten oder deren Nebenwirkungen gar nicht oder erst sehr spät melden.

"Sehr harte Sanktionen"

Die Höchstgrenze der Geldbußen liegt bei fünf Prozent des Jahresumsatzes des betroffenen Zulassungsinhabers. Zulassungsinhaber kann auch eine Konzerntochter sein. "Das dürfte zu ungerechten Bestrafungen führen", sagte Unternehmensanwalt Uwe Fröhlich vom Pharmakonzern Baxter. "Zufälligerweise oder sogar absichtlich kann ein besonders umsatzstarker oder umsatzschwacher Teil eines Konzerns Inhaber der Zulassung sein. Ein Schlupfloch könnten auch Vermarktungspartnerschaften unabhängiger Unternehmen bieten, von denen nur eines die Zulassung hält." Gerechter sei es, die Buße am EU-weiten Umsatz der Arznei festzumachen. "Das sind alles in allem sehr harte Sanktionen", sagt Anwalt Jörg Schickert von der Kanzlei Lovells in München. Er findet manches an der Verordnung unausgereift. "Es gibt noch Schwachstellen, darunter die Frage, wie die Abgrenzung zwischen einzelstaatlichen Strafmaßnahmen und EU-weiten Sanktionen geregelt werden soll."

Das für Zulassungen zuständige Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) habe in der jüngeren Vergangenheit einige Straf- und Bußgeldverfahren eingeleitet, mit unterschiedlichem Ausgang entsprechend der Beweislage, heißt es auf Anfrage. "Ob es in Zukunft wichtiger sein wird, derartige Instrumentarien zur Verfügung zu haben, lässt sich nur schwer einschätzen", so das BfArM. Die im Arzneimittelgesetz für Ordnungswidrigkeiten vorgesehenen Bußgelder von maximal 25.000 Euro seien vergleichsweise gering.

Die Verordnung (EG) 658/2007 zur Auferlegung von Geldbußen durch die Kommission ist ein neuartiges Sanktionsmittel, das es für von der Emea zugelassene Arzneimittel bislang noch nicht gab. "Die Industrie sollte schnellstmöglich alle Schwachstellen abklopfen und Verfahren aufsetzen, die zukünftig Verstöße vermeiden. Dies sollte auch dokumentiert werden", sagte der Anwalt Schickert.

Emea-Chef Thomas Lönngren zumindest will nie mehr einen Tag wie den 30. September 2004 erleben: Weder der Vioxx-Hersteller Merck & Co. noch die FDA-Kollegen hatten ihn frühzeitig über den geplanten Rückruf der Schmerzpille informiert. Die Börse wusste früher Bescheid als er. "Wir wollen von Konzernen so schnell wie möglich informiert werden", sagte er.



Autor/Autoren: Peter Kuchenbuch

http://www.finanztreff.de/ftreff/news.htm?sektion=topthemen&…

[Belu1972]

Antwort auf Beitrag Nr.: 30.145.143 von bernie55 am 22.06.07 11:37:25

Sollten auch gleichzeitig mal Kontrollen durchführen, ob sich nicht
der eine oder andere $ verirrt, um Entscheidungen zu erleichtern?

[Belu1972]

http://www.stockhouse.com/news/news.asp?newsid=5582791&tick=…

[taipan11]

Antwort auf Beitrag Nr.: 30.147.439 von Belu1972 am 22.06.07 13:46:32

kann mir einer von euch sagen, was die news bedeuten sollen. irgendwie blicke ich da im detail nicht durch.
besten dank im voraus.

taipan11

[schlobb]

Mehr news: Neben orBec auch eine Impfung gegen Botulinum Vergiftung in der Pipeline. Mein Tipp - strong buy!!! . Die Rakete scheint zu starten...
schlobb wuenscht einen gruenen Tag.

Press Release Source: DOR BioPharma, Inc.

DOR BioPharma Announces Publication Describing Results of Its Multivalent Botulinum Toxin Vaccine BT-VACC(TM)
Monday July 2, 6:30 am ET

MIAMI, FL--(MARKET WIRE)--Jul 2, 2007 -- DOR BioPharma, Inc. (OTC BB ORB.OB - News) ("DOR" or the "Company") announced today that the first results from testing of a multivalent form of its botulinum toxin vaccine, BT-VACC(TM), have been published in the journal Infection and Immunity (Ravichandran et al., 2007, Infection and Immunity, v. 75, p. 3043 ). These results are the first that describe the protective immunity elicited by a multivalent vaccine that is active by the mucosal route. The vaccine consists of a combination of three non-toxic subunits of botulinum toxin that induced protection against the corresponding versions of the natural toxins.
ADVERTISEMENT

The results published in Infection and Immunity show that non-toxic subunits (protein components of the natural toxin) of three of the serotypes of botulinum toxin that cause almost all instances of human disease, namely serotypes A, B, and E, can be combined and delivered via nasal administration. The combination vaccine induced antibodies in the serum of mice and protected against subsequent exposure to high doses of a combination of the natural A, B, and E serotype neurotoxins. Further, the combination vaccine can induce protection when given mucosally as a booster to animals that have been given a primary vaccine injection.

BT-VACC(TM) is composed of a component of what is known as the heavy chain of each of the A, B, and E serotypes. These components lack the region of the toxin that are responsible for blocking neurotransmitter functions. The subunits can bind avidly to receptors on the surface of mucosal cells and traverse lung and gastrointestinal tissue to stimulate immunity. Because the binding subunits lack the toxic part of the molecule, the vaccine is safe and stimulates antibodies in not only the blood but those antibodies that coat mucosal surfaces. It is thought that antibodies that are present in lung and gastrointestinal secretions will block the uptake of the toxin before entering the bloodstream and reaching peripheral nerves. BT-VACC(TM) originated from the work of Lance Simpson, PhD, and has been exclusively licensed from Jefferson Medical College.

"These results are a major step forward and represent the first demonstration of a multivalent vaccine that is active by the mucosal route," said Christopher J. Schaber, PhD, President and CEO of DOR. "We think that these results in animals demonstrate the potential of developing subunit vaccines that can be given by a mucosal route, avoiding the use of needles and injections, with greater ease of administration and convenience for the provider and the patient. Such vaccines would further have the advantage to stimulate antibodies that block absorption of toxin into the body. We expect that the successful development of a multivalent oral botulinum toxin vaccine that can be applied to rapidly deployable mass immunization programs will be a major step forward in Biodefense countermeasures."

"These results are valuable for two reasons," added Lance L. Simpson, PhD, Professor of Medicine and Director of the Center for Research on Bioterrorism and Biodefense at Jefferson Medical College. "First, they are a clear demonstration that it is feasible to create an inhalation or intranasal vaccine against the three botulinum serotypes that are of greatest concern to human health. Second, and looking toward the future, the results are a promising indicator that it should be possible to create an oral vaccine. There is a consensus among immunologists and public health officials that oral vaccination is one of the most desirable ways to protect vulnerable populations against toxic substances."

Because the toxin naturally enters lung and intestinal tissues very efficiently, it is specifically possible to engineer a botulinum vaccine that can be administered orally or via nasal administration. Unpublished results have also shown that oral administration of one of the serotype to rats results in significant levels of circulating antibodies as well as protection against toxin exposure.

[Nemesis29]

Antwort auf Beitrag Nr.: 30.448.288 von schlobb am 02.07.07 14:14:27

Hallo schlobb

Danke für den Hinweis, aber ob hier eine Rakete startet ....
Würd gern einsteigen, aber die Nachricht und die momentanen Umsätze (US) sehen eigentlich nicht so vielversprechend aus ...

Meine Bitte - versuch mit zu überzeugen - Danke

Noch schönen Tag

N29

[schlobb]

Antwort auf Beitrag Nr.: 30.450.417 von Nemesis29 am 02.07.07 16:07:13

Hi Nemesis -

ich glaub den meisten hier ist noch gar nicht klar, dass es sich hier um eine echte Rakete handelt. Ich lehn' mich mal ein bischen aus dem Fenster:

Dor's Kurs steht und faellt mit der Zulassung von orBec einem neuen Krebsmedikament (ein Steroidderivat). Leider (oder vielleicht zum Glueck) wurde es von der FDA in der ersten Runde nicht akzeptiert. Daraufhin ist der Kurs eingebrochen. Die Praesentsation von orBec vor der FAD war hauptsaechlich die Sache von Mr Kanzer. Der ist, nachdem die Sache so schlecht gelaufen ist, abgesetzt worden. Danach hat Mr. Buhrmann das Steuer uebernommen. Er hat Erfahrung mit BioTech Firmen und ist einer der groessten Shareholder bei Dor.

Heute kam nun die News dass Dor neben orBec auch auf dem Feld 'Bioterrorabwehr' mitmischt. Sie arbeiten an einer Impfung gegen eines der uebelsten biologischen Giften (Botulinum). Interessant hierbei ist dass die Gabe des Impfstopfes bereits oral getestet wurde (einfaches Schlucken genuegt) und diese Tests positiv ausgefielen. Wohlgemerkt diese Versuche wurden noch nicht am Menschen sondern erst an Ratten durchgefuehrt.

Also ich denke dass wir bald mit besserer Praesentation der Daten ein approval von der FDA und parallel von der EMEA (das europaische Aequivalent) bekommen. Das sollte den Kurs nach Norden schiessen lassen (Achtung: persoenliche Meinung!). Weiterhin kommen immer wieder News zu parallelen Projekten. Dies ist ein weiterer Punkt warum mir Dor gefaellt.

Mein Rat: Buy - auch wenn's heute ne Seitwaertsbewegung gibt.

Gruenen Gruss, schlobb

[Nemesis29]

Antwort auf Beitrag Nr.: 30.450.942 von schlobb am 02.07.07 16:33:27

Hallo schlobb

Danke sehr ....

N29

[Nemesis29]

Antwort auf Beitrag Nr.: 30.451.605 von Nemesis29 am 02.07.07 17:10:50

Hallo schlobb

Hier gehts leider down - meiner Meinung bis mindesten 0,2 ... und ob es dann wieder bergauf geht

Gibt es hier Termine für News bzw. für geplante Einreichungen, Zulassungen, usw.?

N29

[schlobb]

Antwort auf Beitrag Nr.: 30.468.307 von Nemesis29 am 03.07.07 13:12:01

Hi Nemesis -

Ich finde den Chart eigentlich sehr interessant: In den US hatten wir einen Umsatz von ca. 1 Mio shares und es geht in einem Kanal von 0,31-0,33 seitwaerts. Ich habe das Gefuehl dass der Kurs genau gehalten wird (um nicht zu sagen gedrueckt wird). Laenger kann das aber nicht gehen, und die naechsten News werden das wohl beschleunigen. DorB ist breit aufgestellt und wird seinen Weg machen.

Wenn ich was Neues weiss werde ich es posten.

So long -

s.

[Rechercheur]

News 06.07.
DOR BioPharma Announces Issuance of European Patent for Its Oral Multivalent Botulinum Toxin Vaccine BT-VACC(TM)
DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company") announced today that the European Patent Office has granted a patent, EP 1024827 B1, with claims related to oral vaccination using mutated non-toxic forms of botulinum neurotoxin as a vaccine to prevent exposure to botulinum toxin. The European patent follows the issuance of a patent in the United States, U.S. 6,051,239, which was granted in April, 2000 and contains equivalent claims for oral vaccination. DOR has exclusively licensed these issued patents and related patent applications from Thomas Jefferson University.

Both the newly issued European patent and the formerly issued United States patent stem from the work of Dr. Lance Simpson at Thomas Jefferson University demonstrating that mutated forms of botulinum toxin can be administered orally to induce protective immunity to natural toxin exposure. The claims in the granted European patent provide protection for the use of certain non-toxic mutants of botulinum toxin that are capable of translocation from the gut to the general circulation for preparation of an oral vaccine.

"The grant of the European patent describing the underlying technology is an additional milestone that reinforces our patent portfolio in botulinum vaccines," said Christopher J. Schaber, PhD, President and CEO of DOR. "We also have applications in both the US and other key jurisdictions that cover additional features of BT-VACC(TM). We believe that oral vaccination will provide advantages over injectable botulinum vaccines because of ease of administration and rapid distribution which can facilitate mass inoculations in time of need. We hope to supply the vaccine for both civilian and military use."

The Company recently announced the publication of key results with BT-VACC(TM) showing that mucosal immunization with a multivalent version of the vaccine induces a robust immune response that resulted in protection against several of the natural serotypes of botulinum toxin. BT-VACC(TM) is composed of a component of what is known as the heavy chain of each of the A, B, and E serotypes of botulinum toxin. The heavy chain component lacks the region of the toxin that is responsible for blocking neurotransmitter functions. The subunits can bind avidly to receptors on the surface of mucosal cells and traverse lung and gastrointestinal tissue to stimulate immunity. Because the binding subunits do not contain the toxic part of the molecule, the vaccine is safe and stimulates antibodies in not only the blood but those antibodies that coat mucosal surfaces. It is thought that antibodies that are present in lung and gastrointestinal secretions will block the uptake of the toxin before entering the bloodstream and reaching peripheral nerves.

About Botulinum Toxin

Botulinum toxin is an extremely potent neurotoxin of bacterial origin that inhibits peripheral nerve function, causing severe and often fatal descending flaccid muscle paralysis. Natural botulism resulting from ingestion of toxin from contaminated food is very rare, but artificially, botulism also can result from bioterrorism and biowarfare. Because extremely small amounts of the toxin can cause neurological effects, it is classified as a category A Biothreat by the CDC. The toxin can enter the body very efficiently through lung tissue and through the gastrointestinal tract, making the threat of purposeful food contamination with botulinum toxin a real possibility as a biological weapon. Because the toxin rapidly enters target neural cells, exposure is difficult to treat with any available therapeutic regimen other than supportive care. In extremely minute quantities, botulinum toxin can be used therapeutically, as for the cosmetic use of Botox®, a commercial preparation of serotype A botulinum toxin, but the effects of the neurotoxin are extremely long lasting and paralytic at higher than therapeutic doses.

About Botulinum Toxin Vaccines

Vaccination is considered the best option to prevent neurological effects of toxin exposure. Because of the rarity of the natural disease, a vaccine would not be used in mass population immunization programs unless they were actually used or a significant threat. In that event, the vaccine would have to be made available for widespread dissemination for rapid and convenient vaccination of a large population. The only vaccine available is an experimental vaccine based on inactivation of a mixture of serotypes of the natural toxins that is given by injection, is not licensed by the FDA and cannot be used for widespread immunization. New multivalent vaccines based on non-toxic subunits are being developed, including BT-VACC(TM).

About DOR BioPharma, Inc.

DOR BioPharma, Inc. is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal ("GI") diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of GI graft-versus-host disease ("GVHD"), a common and potentially life-threatening complication of bone marrow transplantation. DOR has filed an NDA with the FDA for the treatment of GI GVHD, and has received a PDUFA date of July 21, 2007. An MAA with the EMEA for orBec® has also been filed and validated. orBec® may also have application in treating other gastrointestinal disorders characterized by severe inflammation. DOR has also recently initiated a clinical development program with its Lipid Polymer Micelle ("LPMTM") oral drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the recently enacted Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. DOR's ricin toxin vaccine, RiVax(TM), has been shown to be safely tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

For further information regarding DOR BioPharma, please visit the Company's website located at www.dorbiopharma.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec®. Where possible, DOR has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the U.S. Government or other countries, that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: because orBec® did not achieve statistical significance in its primary endpoint in the pivotal Phase 3 clinical study (i.e. a p-value of less than or equal to 0.05), the Oncologic Drug Advisory Committee ("ODAC") appointed by the FDA voted that the data supporting orBec® did not show substantial evidence of efficacy by a margin of 7 to 2 for the treatment of GI GVHD, although the FDA is not bound by ODAC's decision, the FDA may not consider orBec® approvable based upon existing studies, orBec® may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR expects or may never gain approval; DOR is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; or orBec® may not gain market acceptance; and others may develop technologies or products superior to orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.

Company Contact:
Evan Myrianthopoulos
Chief Financial Officer
[phone]
www.dorbiopharma.com

[schlobb]

Antwort auf Beitrag Nr.: 30.521.720 von Rechercheur am 06.07.07 14:18:50

Und weiter ein wichtiger Schritt in die richtige Richtung. Es scheint dass die Zulassung von orBec immer mehr an Gewicht verliert. Hoffen wir aber mal trotzdem dass die FDA/EMEA die vollen Phase III - Studien in Betracht zieht und orBec die Zulassung gibt - mit den richtigen Endpunkten, sollte es ja schon klappen.
s.

[Nemesis29]

Grüß Euch

Gehts hier los .... rund 6,5% ?
Weis jemand etwas genaueres?

Bitte, wenn möglich, um einen Informationsaustausch
Vielen Dank im Voraus

N29

[schlobb]

Antwort auf Beitrag Nr.: 30.592.921 von Nemesis29 am 09.07.07 15:26:34

Hi N29 -

nein das ist nur Vorgeplaenkel. Ich denke da bringen sich ein paar in Stellung.
Die Beurteilung von OrBec durch die FDA/EMEA steht kurz vor der Tuer und da zieht der Kurs schon mal an.
Durch die letzten 2 Mitteilungen hat Dor gezeigt, dass sie parallel noch an einer Botulinum-Impfung arbeiten und sie haben sich schlauerweise die Dareichungsform - oral - gleich mal in den US und in Europa patentieren lassen. Die Patente sind jetzt durch und bestaetigt.

So jetzt kommt hoffentlich bald der big bang (ich meine die richtigen News) und dann wird's ziemlich schnell nach Norden gehen --

Sobald ich mehr weiss wird's gepostet.

Gruss -

s.

[schlobb]

Ach ja ich hab ganz vergessen das dritte Standbein von Dor zu erwaehnen: RiVax - ein Impfstoff gegen Rizinvergiftung (Sektor Bioterror). Gut dass dazu heute ne Pressemitteilung kam :

ag-IP-news
DOR BioPharma Announces Successful Completion of cGMP Production Milestone for RiVax

MIAMI, FL - DOR BioPharma Inc. announced in a press release that it has successfully completed its cGMP (current Good Manufacturing Practices) milestone for the production of RiVax, DOR's vaccine against ricin toxin. The milestone was achieved in the performance of a Challenge Grant totaling $6.4 million previously awarded to DOR in September 2004 by the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the National Institutes of Health.

The safety and immunogenicity of RiVax has recently been evaluated in a Phase I clinical trial in healthy volunteers, and the results were published earlier this year in the Proceedings of the National Academy of Sciences.

DOR and its manufacturing partner, Cambrex BioSciences Baltimore Inc., have developed a robust and reproducible manufacturing process for the large-scale production of RiVax. The completion of cGMP manufacture of RiVax forms one of the crucial milestones in the performance of the work conducted under the NIH grant. Based on the release and further toxicology testing of the cGMP batches, the Company is planning to test the vaccine in further clinical trials.

These trials will examine the influence of an immunological adjuvant formulation and vaccination regimen on the human immune response. These studies will be directed towards providing safety and immunogenicity data needed for licensure of the vaccine by the US Food and Drug Administration (FDA). Further animal testing is also planned to provide correlation of antibody levels in human serum with protection against ricin exposure in animal models. Because vaccine efficacy for exposure of humans to ricin toxin can only be tested in animals, the FDA has established a two animal rule. Under this rule, the FDA can permit human licensure of a vaccine by relying on results from animal trials when human trials cannot ethically evaluate efficacy.

"We are pleased that we have achieved this critical milestone and are encouraged that we will have a means to manufacture RiVax at the scale necessary for potential future immunization programs of civilian or military personnel,'' President and CEO of DOR BioPharma Michael T. Sember stated.

"We are well on the pathway to successful development of RiVax as we continue work on this important biodefense countermeasure. We will continue to work closely with our partners and NIAID to propel the vaccine through the next phase of clinical studies," he added.

Ricin toxin is a potential bioterror threat due to its highly lethal toxicity in small doses, ease of manufacture, and ability to be aerosolized. Exposure to small amounts, especially by inhalation, can lead to lung damage, nausea, fever, abdominal pain, and death within several days. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon. Currently there are no FDA approved vaccines or therapeutics against ricin toxin.

[Nemesis29]

Antwort auf Beitrag Nr.: 30.595.806 von schlobb am 09.07.07 17:59:29

... Ausbruch ...

Mit wieviel rechnest Du und vorallem wann?

Weis schon - Gerda Rogers und so, aber vielleicht eine Schätzung bzw. Deine Meinung

Danke

N29

[schlobb]

Antwort auf Beitrag Nr.: 30.606.818 von Nemesis29 am 10.07.07 07:55:20

Also in den US rechnen sie bei einer positiven Bewertung von orBec mit einem Kurs $1.5-2. Das war das inoffizielle Uebernahmeangebot von Sigma-Tau Anfang diesen Jahres
s.

[DerAtze]

Hallo zusammen,
Sieht doch gut aus hier, bin selbst nun auch dabei und denke hier ist noch viel potenzial. Wünsche allen die eine erfolgreiche Zeit. Der Boden ist gut gebildet und die nächste zulassung sieht ja auch gut aus

http://www.dorbiopharma.com/pipeline.htm


Auf das die Kasse klingeln mag

MfG Der Atze

[NewSpice]

Antwort auf Beitrag Nr.: 30.656.602 von DerAtze am 12.07.07 16:57:40

Heimat InvestingMarket OverviewMarket StatsStocksMutual FundsETFsBondsOptionsIndustriesCurrencyEducationNews & OpinionMarketsInvesting IdeasExpert AdviceSpecial EditionsCompany FinancesProvidersPersonal FinanceBanking & BudgetingCareer & WorkCollege & EducationFamily & HomeInsuranceLoansReal EstateRetirementTaxesHow-Zu GuidesGet QuotesSymbol LookupFinance-Suche



Drücken Sie Release Source: DOR BioPharma, Inc.


DOR BioPharma, AG verkündet Einleitung von orBec(R, führen Sie 2 GVHD-Prophylaxe stufenweise Klinischen Versuch durch
Donnerstag 12. Juli 7:00 ist ET


MIAMI, FL, MARKT-WIRE)-12. Juli 2007 DOR BioPharma, Inc. (OTC BBORB.OB (Nachrichten) (DOR) oder die Gesellschaft) verkündete heute, daß diese Patienteneintragung in einem randomized beginnt, blendete Doppelgänger, Placebo kontrollierte Phase nach allogeneic hematopoietic Zelltransplantation (HCT) mit myeloablative, der Heilprogramme konditioniert, 2 klinischen Versuch von orBec® für die Verhütung akuter Pfropfreis-gegen-Gastgeber-Krankheit (GVHD). Der Versuch wird von Paul Martin geführt, MD beim Fred Hutchinson Krebs Forschung Zentrum in Seattle, WA und wird Unterstützung, in großem Teil, von einem Nationalen Institut der Gesundheit (NIH) unterstützt.
WERBUNG


Der Phase 2 Versuch wird versuchen, sich bis zu 138, 92 orBec® und 46 Placebo, Patienten, anzumelden. Der primäre endpoint des Versuches ist das Verhältnis zu Themen, die genügend akuten GVHD mit Strenge entwickeln, systemische immunosuppressive-Behandlung darauf zu verlangen, oder vor Tag 90 nach Transplantation. Patienten in der orBec®-Gruppe werden am Anfang vom konditionierenden Heilprogramm Studiumsarzneimittel anfangen und durch Tag 75 folgende HCT fortsetzen. Versuchseintragung wird erwartet, im zweiten Viertel von 2008 zu vervollständigen.

orBec®, mündlicher beclomethasone dipropionate (mündlicher BDP), den DOR's örtlich handelnde Therapie die gastrointestinal-Manifestation von GVHD, das Organsystem, wo GVHD meisten häufig und sehr problematischsten getroffen wird, zu Vergnügen geschneidert wird. DOR hat einen NDA mit den U.S. abgelegt. Essen und Drogenverwaltung (FDA) für die Behandlung von gastrointestinal (GI) GVHD, und hat ein PDUFA-Datum vom 21. Juli 2007 erhalten. Ein MAA mit dem EMEA denn orBec® ist auch abgelegt worden und ist bestätigt worden. Mündlicher BDP hat auch vielleicht Antrag darauf, andere gastrointestinal-Unordnungen zu behandeln, der charakterisiert wird,

[Nemesis29]

Guten Morgen

Wird darauf der Markt reagieren bzw. wo wird´s hingehen?
Sehen wir bald die 0,5?

Bitte euere geschätzten Statements - Danke

N29

[DerAtze]

Servus,
Hmmm für mich persönlich ist es "noch" etwas schwer einzuschätzen wenn etwas zugelassen und dann vermarktet wird, wieviel die Firma gewinn macht und der Krus sich dadurch verändert. Meine erste Spekulation (wie ich mir es am besten vorstellen könnte) wäre bei 0,82€ dat wäre mehr als top
Aber mal schaun denke nicht das der Kurs so hoch ausbricht, wenn doch dann sag ich türlich nicht nein

MfG Der Atze

[Nemesis29]

.... Was passiert hier?

Gehts hier los - Kursziel 0,8€

Einsteigen?


Bitte um Info, falls wer etwas wissen sollte ...

Danke

N29

[Belu1972]

Antwort auf Beitrag Nr.: 30.761.794 von Nemesis29 am 19.07.07 16:10:42

http://www.marketwatch.com/news/story/dor-biopharma-inc-anno…

[Belu1972]

20-Jul-2007

Other Events


Item 8.01 Other Events

On July 18, 2007, DOR BioPharma, Inc. (the "Company") received notification from the United States Food and Drug Administration (FDA) that the action date for the FDA's review of the New Drug Application (NDA) for orBec® (oral beclomethasone dipropionate) for the treatment of gastrointestinal graft-versus-host disease (GI GVHD) has been extended to October 21, 2007. The original action date under the Prescription Drug User Fee Act (PDUFA) for the orBec® NDA was July 21, 2007.

The extension is the result of DOR's July 13, 2007 provision of supplemental information to the orBec® NDA. This information was requested by the FDA at a June 13, 2007 NDA review meeting. According to FDA policy, the submission of this supplemental information was classified as a major amendment, putting the new action date for the orBec® NDA at October 21, 2007.

On July 19, 2007 the Company issued a press release discussing this event.

Item 9.01 Financial Statements and Exhibits

(c) Exhibits:

99.1 Press release issued by DOR BioPharma, Inc. on July 19, 2007.

[schlobb]

Kommt jetzt der Anstieg Richtung Norden??? Bis Oktober???? Hoffen wir's mal.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.196.616 von taipan11 am 15.12.06 09:08:24

News!

[SharpRatio]

Antwort auf Beitrag Nr.: 26.196.616 von taipan11 am 15.12.06 09:08:24

DOR BioPharma Announces $940,000 FDA Orphan Products Grant for Clinical Development of RiVax(TM)
7/30/2007
MIAMI, FL, Jul 30, 2007 (MARKET WIRE via COMTEX News Network) --

DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company") announced today that the Office of Orphan Products Development (OOPD) of the Food and Drug Administration (FDA) has awarded a development grant for the further clinical evaluation of its vaccine for ricin toxin, RiVax(TM). The grant has been awarded to UT Southwestern Medical Center, one of the Company's academic partners in the development of RiVax(TM). The Principal Investigator for the project is Ellen S. Vitetta, PhD, Director of the Cancer Immunobiology Center at UT Southwestern. The award totals approximately $940,000 for three years and is to be used for the evaluation of an adjuvant for use with the vaccine. Typically, awards made by the OOPD are to support clinical trials for development of products that address rare diseases or medicines that would be used in numerically small populations.

RiVax(TM) was evaluated in a small dose escalating Phase 1 clinical trial in human volunteers conducted at UT Southwestern. It was shown to be well tolerated and immunogenic especially at the highest dose levels of the vaccine given three times at monthly intervals. The vaccine induced antibodies that were correlated to protection from toxin exposure, including the capacity to neutralize the toxin. Further, the functional activity of the antibodies was established by demonstrating that transfer of serum globulins from the vaccinated individuals to mice resulted in their survival subsequent to ricin toxin exposure. The results of that confirmatory trial underpin the current effort to develop an adjuvant form of the vaccine, which is intended to enhance human antibodies' responses to the vaccine and increase their durability and rapidity of onset.

RiVax(TM) is a recombinant subunit of one of the components of ricin toxin and has been genetically detoxified. The subunit is produced in recombinant bacterial hosts, purified, and formulated with an adjuvant.

"The Phase 1 clinical trial was done to establish that we had inactivated the toxin sufficiently to remove any possible local toxicity that could be associated with intramuscular injection," said Dr. Vitetta. "Having confirmed the fundamental immunogenicity in humans, we are ready to test the immunogenicity and safety of the vaccine with an adjuvant that we expect to induce long-lasting antibodies with lower doses of the vaccine."

"The award to UT Southwestern is one part of the overall development program, which includes large scale process development, stability testing, and development of animal models that demonstrate efficacy as correlates of the human immune response," said Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. "We are continuing to transition the early development of this vaccine from UT Southwestern to commercial production, and are relying on these results as the basis for broader Phase 2 studies of the vaccine in humans."

The Company has been developing RiVax(TM) in a consortium effort between academic and industrial partners under several separate NIAID grants totaling approximately $14 Million. In addition to UT Southwestern, development partners include, Stanford Research Institute (SRI International), the University of Kansas, Lonza Baltimore, and the Wadsworth Center of the New York State Department of Health in Albany. Complementing the current OOPD grant, Dr. Ellen Vitetta has also separately been awarded a grant for $2.2 million over 5 years to conduct research in fundamental areas to develop novel vaccine formulations and characterize immune responses in small animals. The outcome of that novel research will help support ongoing development of RiVax(TM).

About ricin toxin

Ricin toxin is a potent plant toxin easily produced from abundantly available castor beans. There is no vaccine to protect against exposure and no post-exposure therapeutic other than supportive care. Ricin is highly toxic to humans and other mammals and is thought to be a bioterror threat because of its environmental stability and high potency, second only to botulinum toxin as a natural toxin. Exposure to small amounts can lead to lung damage if inhaled, rapid onset of nausea, fever, and abdominal pain if ingested. General organ failure leading to death can occur within several days. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon. The successful development of an effective vaccine against ricin toxin may act as a deterrent in the actual use of ricin as a biological weapon and can be used in rapid deployment scenarios in the event of a biological attack.

[schlobb]

Antwort auf Beitrag Nr.: 30.935.664 von SharpRatio am 30.07.07 13:36:21

Ooops das sieht ja gut aus. Hoffentlich haelt das mal und die Amis steigen auch so auf die News ein ...

s.

[NewSpice]

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Press Release Source: DOR BioPharma, Inc.


DOR BioPharma Announces Publication Describing Protection Against Oral and Aerosol Ricin Exposure With Its Ricin Vaccine RiVax(TM)
Wednesday September 5, 7:00 am ET


Ricin Toxin Found to Be 2000 Fold More Lethal by Oral Route Than Previously Described


MIAMI, FL--(MARKET WIRE)--Sep 5, 2007 -- DOR BioPharma, Inc. (OTC BBORB.OB - News) ("DOR" or the "Company") announced today results from animal testing of RiVax(TM), its vaccine against ricin toxin, have been published online in the journal Vaccine, Smallshaw et al., "RiVax(TM), A Recombinant Ricin Subunit Vaccine, Protects Mice Against Ricin Given by Gavage or Aerosol" (web link to article: http://dx.doi.org/doi:10.1016/j.vaccine.2007.08.018). The publication describes the findings that RiVax(TM) can induce protection against mortality and tissue damage from both aerosol and oral toxin exposure; the most likely routes to be used in a ricin toxin biological attack. The publication was authored by investigators at the University of Texas Southwestern Medical Center at Dallas (UT Southwestern), one of the Company's academic partners in the development of RiVax(TM).
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RiVax(TM) is already known to induce antibodies that appear primarily in the blood of animals and humans. Such antibodies in the blood are correlated to protection against exposure when the toxin reaches the circulation. One of the major effects of ricin toxin exposure through the lungs is rapid and massive lung injury that leads to death. It was not known how well RiVax(TM) would protect when ricin toxin was inhaled or ingested. This recent study demonstrated that RiVax(TM) not only protects mice against the lethal effects of the aerosolized toxin, but it can also prevent damage to lung tissue. RiVax(TM) protected animals against lung injury as measured by lung function tests and histological lesions induced by the toxin in a dose-dependent manner, where the amount of antibodies circulating in the blood correlated directly to protection against lung injury. It was also confirmed that RiVax(TM) protected mice against lethal effects when they were fed the ricin toxin. These results indicate that it is possible to induce antibodies primarily in circulation that are correlated with protection when the toxin contacts lung and gastrointestinal tissue.

"It is now clear that RiVax(TM) induces excellent protection against oral and aerosol ricin toxin exposure, and protects mucosal tissue against the direct effects of the toxin," said Ellen Vitetta, PhD, Director of the Cancer Immunobiology Center at UT Southwestern and the study's corresponding author. "The current results also show that pure ricin toxin is 2000 fold more toxic by the oral route than previously described, which is very surprising, since the literature has described much larger doses to cause mortality when ricin is fed to animals."

"We have always believed the potential for a biological attack with aerosolized ricin toxin to be significant given its ease of production; therefore, it was critical to demonstrate that RiVax(TM) protected against aerosol exposure," said Robert N. Brey, PhD, DOR's Chief Scientific Officer. "The next step will be to evaluate RiVax(TM) as protection against aerosol exposure in a higher animal species. The correlation of antibodies with protection against aerosol exposure will be a critical component necessary to support the use of RiVax(TM) in humans as a licensed vaccine or under emergency use authorization. We think that these results provide strong evidence that an injected form of RiVax(TM) will prove sufficient to induce antibodies to protect mucosal tissues in the lung as well as the gastrointestinal tract."

The Company has been developing RiVax(TM) in a consortium effort between academic and industrial partners under several separate NIAID and FDA grants to DOR and UT Southwestern totaling approximately $15 Million. In addition to UT Southwestern, development partners include, Stanford Research Institute (SRI International), the University of Kansas, Lonza Baltimore, and the Wadsworth Center of the New York State Department of Health in Albany.

The development program, through UT Southwestern, has also been recently awarded a $1 million FDA Orphan Products grant to carry out additional clinical testing of RiVax(TM). Dr. Ellen Vitetta has also separately been awarded a grant for $2.2 million over 5 years to conduct research in fundamental areas to develop novel vaccine formulations and characterize immune responses in small animals. The outcome of that novel research will help support ongoing development of RiVax(TM).

RiVax(TM) is a recombinant subunit of the ricin toxin A chain and has been genetically detoxified. The subunit is produced in recombinant bacterial hosts, purified, and formulated for human and animal testing

[Belu1972]

hier tut sich was Muß irgend etwas auf CNBC gelaufen sein

[schlobb]

Antwort auf Beitrag Nr.: 31.680.864 von Belu1972 am 20.09.07 21:35:30

Die Amis erwarten News - wie immer so gegen 6 - 7 am US time - also bei uns um die Mittagszeit. Uuuuhhh- Spannend!!!
s.

[taipan11]

Dorb excerpts of ODAC transcript

I just figured it was worth posting again

Dr. Pazdur asks the panel to discuss whether another trial is feasible to run

1 large treatment, single-arm trial.
2 Here again, one of the questions that I have,
3 if that would be ongoing, would people even consider
4 doing another trial? Would another trial be feasible to
5 do? That’s another issue.
6 CHAIRPERSON HUSSAIN: Is this an issue you
7 want us to discuss now, or this is an issue that we want
8 to discuss after the vote?
9 DR. PAZDUR: Probably after the vote or it can
10 be discussed during the vote.
11 (General laughter.)
12 DR. PAZDUR: It’s really going to be part and
13 parcel of a decision here.
14 CHAIRPERSON HUSSAIN: Yes. Just a point of
15 clarification. If someone gets an IND for a specific
16 treatment, who pays for the cost of the drug?
17 DR. PAZDUR: Usually, the Sponsor would assume
18 the cost of that. Under the treatment IND mechanism,
19 however, which is a special type of expanded access
20 program, there can be some cost recovery on the part of
21 the Sponsor. We would entertain in a situation such as
22 this that type of program.

Mcdonal explains why trials using the drug for acute gvhd would be hard to run, because the doctors are formulating a drug themselves that isn't as good as Orbec but is better than placebo

1 in this group of patients for ethical and practical
2 reasons.
3 CHAIRPERSON HUSSAIN: Could you not consider
4 doing a trial, not placebo-controlled but with
5 equivalent doses of steroids to make the point that your
6 agent has a superior profile with regard to infections,
7 complications of steroids, and things of that sort? It
8 doesn’t have to be necessarily a survival-driven trial
9 but an efficacy trial?
10 DR. McDONALD: I think that is a
11 consideration, but actually there are some data that
12 bears on the question. If you look at the placebo arm
13 of 875, you will discover that 41 percent of people
14 required only 10 days of prednisone. If you look at the
15 placebo arm of the pivotal trial, 55 percent required
16 only 10 days of prednisone.
17 I think it is very difficult to argue that a
18 high-dose prednisone regiment would benefit any of those
19 patients who required only 10 days of prednisone. I
20 think the same ethical issues exist in doing a very
21 high-dose prednisone versus this approach.
22 We have already proved, I think, that the

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1 minimum prednisone approach protected by BDP has far
2 superior results to our 25-year standard of care. Again,
3 it is not the GVH that is killing people; it is the
4 treatment for GVH that’s doing the job.
5 I think we have adequately proved that BDP has
6 a steroid-sparing effect. I’m not sure I can go back 25
7 years in time and grab our old regimens. I am quite
8 convinced. I think it might well be unethical to do
9 that kind of a comparison.
10 DR. RODELL: Excuse me. Dr. Sullivan from
11 Duke was actually not involved in the trial.
12 CHAIRPERSON HUSSAIN: I just have another
13 question, though, please. If you say you don’t want to
14 go back to the past and grab old regimens, and if your
15 drug is currently not available on the market, and we
16 have heard that people use the oil-mixed product with
17 something, is that what people are currently using? Is
18 that what the alternative out there is?
19 DR. McDONALD: The alternative is what I call
20 the ad-hoc way of formulating something that is similar
21 to what we are using in these trials, that is, to use
22 the corn oil combined with budesonide.

the panel votes no



1 overwhelmingly we were against something and the FDA
2 approved it anyway.
3 (General laughter.)
4 CHAIRPERSON HUSSAIN: They don’t necessarily
5 always listen to us. Thank you.
6 If there are no other burning questions or
7 comments, I’m going to try to ask that we go ahead to
8 the vote.
9 Put the question up again, please.
10 (Staff complies.)
11 CHAIRPERSON HUSSAIN: We will begin around the
12 table. No description of why one is voting yes or no,
13 just the vote yes or no. Identify please yourself and
14 speak clearly into the microphone.
15 Dr. Link, can we begin with you, please?
16 DR. LINK: Michael Link. I vote no that it
17 has not shown substantial evidence.
18 MS. HAYLOCK: Haylock, no.
19 DR. HARRINGTON: No.
20 DR. MORTIMER: Mortimer, no.
21 CHAIRPERSON HUSSAIN: Hussain, no.
22 DR. RICHARDSON: Richardson, no.

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1 DR. PERRY: Perry, no.
2 DR. SPORTES: Sportes, yes.
3 DR. FLATAU: Flatau, yes.
4 CHAIRPERSON HUSSAIN: Two yes, seven no.
5 Dr. Pazdur, do you want us to go into the
6 second issue of design, of study design?
7 DR. PAZDUR: We’ve already started the
8 discussion.
9 CHAIRPERSON HUSSAIN: Yes, but I thought it
10 was for discussion, not for a vote.
11 DR. PAZDUR: We’ve already started the
12 discussion.
13 CHAIRPERSON HUSSAIN: In terms of what ideal
14 study design is?
15 DR. PAZDUR: Yes.
16 CHAIRPERSON HUSSAIN: Maybe I can begin and
17 ask the sponsor first, when you look at your data and
18 you look at what you started with and then what you got,
19 what do you think, like in your gut with yourself
20 looking at this, where do you think your strongest point
21 was? Because that seems to me where you should then go
22 back to look at that area because that may be where

Hussein explains that you couldn't run a trial in this population that could be stratified equally.

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1 between treatment arms, it would require, roughly, 160
2 deaths and a true hazard ratio of 0.55 would require,
3 roughly, 120 deaths. The accrual would be quite
4 substantial.
5 CHAIRPERSON HUSSAIN: Any words of wisdom from
6 committee members as far as study designs or suggestions
7 to the Sponsor or to the FDA with regard to what they
8 should advise them to do?
9 Sir?
10 DR. FLATAU: Yes. I would like to think at
11 least a secondary endpoint of overall survival at least
12 at one year, if not longer, would be interesting.
13 CHAIRPERSON HUSSAIN: I guess the only concern
14 I have about survival is unless you make the population
15 entering very uniform with the same diseases, the same
16 regimen, the same everything, you are never going to be
17 able to interpret the results, it would seem to me,
18 unless you stratify very clear where you include several
19 groups of people clearly stratified equal in each arm.
20 I can’t see how you would do it if you argue that we
21 don’t have a huge population.

Dr. Sportes the only transplant doctor on the panel and one of the positive votes explained that the 80 day endpoint which was met clinically means more than the 50 day endpoint


22 DR. SPORTES: Actually, I was wondering and I
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1 should have asked earlier why the secondary endpoint was
2 not the primary endpoint.
3 It seems to me from a transplant perspective
4 that a followup at 80 days is probably the strongest
5 endpoint, which is why I voted yes is because I think to
6 me conceptually this is much more a reflection of the
7 entire intervention. Why was that not chosen? I just
8 seek some explanation.
9 DR. RODELL: May I respond to that?
10 CHAIRPERSON HUSSAIN: Yes.
11 DR. RODELL: I think it’s important to
12 recognize the history of how this drug was developed.
13 The initial study, the initial efficacy study was Study
14 875 that was done essentially on a completely open
15 field, that is, this type of study had never been done
16 before and so the 30-day endpoint was selected in that
17 study, essentially, arbitrarily.
18 Once the results of that study were know, Dr.
19 McDonald spoke with and talked to the FDA, shared with
20 them the results of that study and began to design the
21 02 Study.
22 The two components with respect to efficacy

Dr. Link explains that the first 10 days on Orbec should be a guarantee period and is surprised that they didn't show this slide before the vote.

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1 The practicality, even without getting into
2 the economics of doing another study, is going to be a
3 significant issue in terms of the future development of
4 the drug.
5 CHAIRPERSON HUSSAIN: Thank you.
6 Any other comments?
7 (No verbal response.)
8 CHAIRPERSON HUSSAIN: Well, we will begin with
9 Dr. Link, then, and we will go around the table.
10 DR. LINK: I have two. The first is a
11 question of what if you actually -- the mistake maybe
12 was that you started the clock too soon in terms of you
13 started on the day of randomization. Either if you if
14 you had randomized after the 10 days and only randomized
15 responders -- Dave, you’re not going to shoot me here,
16 are you?
17 The second things is to actually do an
18 analysis, start the clock when they achieve remission
19 and throw out people who didn’t achieve remission, which
20 is often done in transplant studies. That would be one
21 suggestion.
22 What does it look like? Does it look better?


1 Does it look like you had achieved your goal, just out
2 of curiosity?
3 DR. RODELL: Yes, let me ask Mr. Cruickshank
4 to address that.
5 (PowerPoint presentation is in progress.)
6 MR. CRUICKSHANK: Going back to that question
7 about, what is the effect of those early failures, we
8 did do an analysis to look at the effect whereby
9 patients who failed during the 10-day high-dose
10 induction period of prednisone.
11 If you sensor the patients at the time of
12 treatment failure, you can see here that we lose the
13 effect of the crossing Kaplan-Meier curves. We have a
14 fairly clear, sustained difference between the arms at
15 day 50 as well as day 80.
16 DR. LINK: You should have presented that.
17 Second of all, I was impressed with the ability of the
18 bone marrow transplant community to do study with soft-19
tissue endpoints, a lot of patients, a “New England
20 Journal of Medicine” article, very prompt approval.
21 I’m just wondering why you’re so discouraged
22 about doing a trial like this? Admittedly, not

Page 148 Dr. Mcdonald from the Fred Hutchinson Center in Seattle again explains why it would be difficult to run the trials in acute GVHD, and explains that a prophylaxis trial would be the proper trial to run, but the FDA doesn't like mixing endpoints. Dr Pazdur chimes in, that he is open to negotiation

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1 everybody gets bowel GVH. But if you’re transplanting
2 60-year-olds, you probably will get a lot of it. I’m
3 just wondering why you’re so pessimistic about getting
4 it done? We’re going to do it in pediatrics, and we
5 don’t have that many patients.
6 DR. McDONALD: I’m pessimistic about doing a
7 placebo-controlled trial because I don’t think we can
8 get our IRB to approve one based on these data. I think
9 there are other options.
10 I mean, we have thought about a prophylaxis
11 trial, for example, but that’s a different indication,
12 though. This indication is for treatment of acute
13 graft-versus-host disease. A prophylaxis trial is for
14 prophylaxis of acute graft-versus-host disease.
15 From the FDA’s comments, you don’t like
16 merging of different kinds of trials to come to a
17 conclusion. That would take, what, two placebo-18
controlled prophylaxis trials for that --
19 DR. PAZDUR: We are always open for
20 negotiations.
21 (General laughter.)
22 DR. McDONALD: All right. That’s one thought,

Page 149 to 152 is basically the panel members all admitting that a prophlyaxis trial would be the way to go. Of course how does the drug get approved in acute GVHD if you run a prophylaxis trial.

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1 everybody gets bowel GVH. But if you’re transplanting
2 60-year-olds, you probably will get a lot of it. I’m
3 just wondering why you’re so pessimistic about getting
4 it done? We’re going to do it in pediatrics, and we
5 don’t have that many patients.
6 DR. McDONALD: I’m pessimistic about doing a
7 placebo-controlled trial because I don’t think we can
8 get our IRB to approve one based on these data. I think
9 there are other options.
10 I mean, we have thought about a prophylaxis
11 trial, for example, but that’s a different indication,
12 though. This indication is for treatment of acute
13 graft-versus-host disease. A prophylaxis trial is for
14 prophylaxis of acute graft-versus-host disease.
15 From the FDA’s comments, you don’t like
16 merging of different kinds of trials to come to a
17 conclusion. That would take, what, two placebo-18
controlled prophylaxis trials for that --
19 DR. PAZDUR: We are always open for
20 negotiations.
21 (General laughter.)
22 DR. McDONALD: All right. That’s one thought,

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1 that is, if this drug is as highly effective as a
2 topical therapy for treatment, it should be equally
3 effective and relatively nontoxic as prophylaxis. I
4 think that is one potential option.
5 CHAIRPERSON HUSSAIN: Gee, prophylaxis sounds
6 like very attractive. Why wait until an event happens?
7 I mean, that would be a clinically meaningful endpoint.
8 DR. McDONALD: I agree. Plus, it’s easier to
9 enroll patients who aren’t sick.
10 CHAIRPERSON HUSSAIN: Correct, correct.
11 DR. McDONALD: You can get a larger accrual.
12 Seven thousand patients should provide enough to enroll.
13 The hope there is that one would with effective
14 prophylaxis take what would ultimately be Stage IV and
15 turn them into Stage III, take Stage III and turn them
16 into Stage II, take Stage II and make them end up being
17 Stage I. I think that is a feasible thing. I can’t
18 speak for the company.
19 I think there are some financial issues. This
20 is a relatively small company, and I think that is a
21 consideration. In addition to the ethical and practical
22 issues, I think there are financial issues.

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1 DR. SCHABER: Dr. McDonald -- Chris Schaber,
2 president of Dor Bio Pharma -- that is in fact the
3 issue. For a company our size, we’ve put a lot of time,
4 effort, money, and resource into this study to support
5 Dr. McDonald and the rest of the investigators to go
6 after an indication that, quite honestly, big pharma
7 didn’t want to touch because it is a very small patient
8 population.
9 Although, as was outlined here and the experts
10 have spoken, we did not achieve the primary endpoint
11 without maybe the right sensoring or guarantee period.
12 With regard to the direct correlation of 80-
13 day as well as survival, which as Dr. Sullivan has
14 clearly stated in all of the trials that have been done
15 has never been seen, this is really an important trial
16 for us. To move forward from here and start over is
17 really economically not feasible for us with this
18 product.
19 CHAIRPERSON HUSSAIN: Dr. Mortimer.
20 DR. MORTIMER: Yes. My suggestion was going
21 to be a prophylactic study, but also it seems to me that
22 the biggest selling point of this drug is that it

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1 minimizes toxicity of steroids.
2 However the study is designed, a comparison of
3 this agent against steroids, if you demonstrate an
4 improved toxicity profile, I can’t but imagine that it
5 would move farther up in line for the indication
6 indicated here today.
7 CHAIRPERSON HUSSAIN: Okay. If there are no
8 other questions, I think that the FDA -- I’m sorry, Ms.
9 Haylock.
10 MS. HAYLOCK: I just wanted to suggest that
11 since some of the side-effects that were of concern to
12 people, for example, fatigue and then also some of the
13 other psychosocial issues, that some of our public
14 presenters brought up, there are quite a few
15 psychosocial tools or instrumentation available that
16 could be pretty easily incorporated into any trial. I
17 would suggest doing that. I think that would help as
18 well.
19 MR. SCHABER: May I say one more thing,
20 please?
21 CHAIRPERSON HUSSAIN: (Chairperson moving head
22 up and down.)

When has anyone ever seen Pazdur make a positive comment like this about a drug when there is a negative vote.

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1 in survival, and we’ve seen some survival advantages but
2 nothing spectacular, barring something like that, what
3 would be the point in bringing these discussions
4 forward?
5 DR. PAZDUR: I think to get public input on
6 and for discussion of points that may be missed by the
7 FDA reviewers. I am very thankful for the discussion
8 that we had today.
9 Personally, this drug because of this
10 discussion, irrespective of the vote, has a much
11 different impact in my mind. We will have discussions
12 internally on this drug and discuss the points that were
13 presented here.
14 CHAIRPERSON HUSSAIN: Thank you.

Pazdur will have the largest input on whether the drug gets approved. I think from the comments he made he likes the drug.

[wayne99]

Eben über den Ticker gekommen

Press Release Source: DOR BioPharma, Inc

DOR BioPharma Announces Issuance of Patents for Oral Graft Versus Host Disease
Tuesday September 25, 7:00 am ET


MIAMI, FL--(MARKET WIRE)--Sep 25, 2007 -- DOR BioPharma, Inc. (OTC BBORB.OB - News) ("DOR" or the "Company") announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance of patent claims based on U.S. Patent Application #09/433,418 entitled "Topical Azathioprine for the Treatment of Oral Autoimmune Diseases." Concurrently, the patent has also been issued by the European Patent Office with the serial number EP 1 212 063 B1. This patent family specifically includes claims for treatment and prevention of oral graft versus host disease (GVHD) with locally or topically applied azathioprine, a potent immunosuppressive drug. Oral GVHD can occur in up to 70% of patients who have undergone bone marrow/stem cell transplantation despite treatment with other immunosuppressive drugs such as prednisone, methotrexate, tacrolimus, and cyclosporine.
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Azathioprine is a drug that has been widely used in transplant medicine over the past three decades, and is currently clinically indicated for the treatment of kidney transplant rejection, as well as used as a third line therapy for rheumatoid arthritis. Experimentally, it has been used by a number of clinical investigators to treat inflammatory conditions of the intestine, including Crohn's disease, and other inflammatory diseases. Azathioprine is a drug that belongs to the class of purine analogues that interfere with DNA metabolism and suppress gene transcription, especially in lymphocytes. The drug is believed to act through the suppression of autoreactive T cells that can result in local inflammatory lesions.

Oral GVHD results in painful ulcerative mucosal lesions in the oral cavity and esophagus, often resulting in dental demineralization and infections. The concept behind the issued patent claims is that potent anti-inflammatory drugs, such as azathioprine, can be applied locally in the oral cavity, and suppress or reverse the ulcerative lesions caused in the host by transplanted donor T cells. Specifically, the basis for the claims stems from human studies in which a marked improvement in oral ulcerations was observed in patients with oral GVHD given periodic mouth rinses with a formulation containing azathioprine. Since systemic exposure to azathioprine is associated with significant toxicity including among others bone marrow depression, the local application of the drug to the site of lesions is expected to result in minimal side effects and increase the ability to use the treatment in addition to other systemic immunosuppressive drugs ordinarily used in transplant medicine.

Both the US and the European patents contain claims that address the methods and the use of the azathioprine in oral lesions of GVHD whether used alone or in combination with other immunosuppressive drugs. Additionally, DOR has previously received Orphan Drug Designation for azathioprine covering the treatment of oral lesions associated with GVHD.

"The issuance of these patents in both the United States and Europe continues to reinforce and broaden our development pipeline in the area of GVHD," said Christopher J. Schaber, PhD, President and CEO of DOR. "Our azathioprine program is clearly synergistic on a number of levels with our orBec® programs as we are committed to developing therapies that can benefit patients in controlling the painful and many times life-threatening side effects of allogeneic hematopoeitic cell transplantation. While shareholders have not heard much about azathioprine, we plan on advancing this program into the clinic while assessing the optimal regulatory strategy for accelerating its development."

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR has filed an NDA for orBec® with the FDA for the treatment of GI GVHD, and subsequent to supplemental information recently submitted, the FDA has extended the PDUFA (Prescription Drug User Fee Act) date to October 21, 2007. An MAA (Marketing Authorization Application) with the EMEA (European Medicines Evaluation Agency) has also been filed and validated. orBec® may also have application in treating other gastrointestinal disorders characterized by severe inflammation. DOR has recently initiated a development program with its Lipid Polymer Micelle (LPM™) oral drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis, as well as a development program with its oral azathioprine technology for the treatment of oral GVHD.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the recently enacted Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. DOR's ricin toxin vaccine, RiVax™, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

For further information regarding DOR BioPharma, please visit the Company's website located at www.dorbiopharma.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec®. Where possible, DOR has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the U.S. Government or other countries, that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: because orBec® did not achieve statistical significance in its primary endpoint in the pivotal Phase 3 clinical study (i.e. a p-value of less than or equal to 0.05), the Oncologic Drug Advisory Committee ("ODAC") appointed by the FDA voted that the data supporting orBec® did not show substantial evidence of efficacy by a margin of 7 to 2 for the treatment of GI GVHD, although the FDA is not bound by ODAC's decision, the FDA may not consider orBec® approvable based upon existing studies, orBec® may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR expects or may never gain approval; DOR is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; or orBec® may not gain market acceptance; and others may develop technologies or products superior to orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.



Contact:
Company Contact:
Evan Myrianthopoulos
Chief Financial Officer
[phone]
http://www.dorbiopharma.com



--------------------------------------------------------------------------------
Source: DOR BioPharma, Inc

[schlobb]

Na da geht doch was.... alle hoffen wohl auf die FDA/EMEA Entscheidung... und dann ist Dor wohl ein wenig unterbewertet!

Gruene Gruesse

s.

[schlobb]

Interessant so ein Artikel in einem peer-reviewed journal - da steht dem approval von orBec wohl nix mehr im Wege, oder?



s.



orBec(R) Clinical Summary Published in "Expert Opinion on Investigational Drugs"
Tuesday October 9, 9:03 am ET

EWING, NJ--(MARKET WIRE)--Oct 9, 2007 -- DOR BioPharma, Inc. (OTC BBORB.OB - News) (DOR or the Company) announced that a summary of all clinical trials to date of its drug orBec® (oral beclomethasone dipropionate, or oral BDP) in the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD) has been published in the peer-reviewed medical journal Expert Opinion on Investigational Drugs. The publication "Oral Beclomethasone Dipropionate, a Topically-Active Corticosteroid for Treatment of Gastrointestinal Graft-vs.-Host-Disease Following Allogeneic Hematopoietic Cell Transplantation," is authored by George B. McDonald, MD, inventor of orBec® and Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center, located in Seattle, Washington. The full article is available online at http://www.expertopin.com/doi/abs/10.1517/13543784.16.10.170…
ADVERTISEMENT

Expert Opinion on Investigational Drugs is a monthly peer-reviewed journal, evaluating developments in pharmaceutical research, from animal studies to the launch of a new medicine. Authors are encouraged to express their Expert Opinion of the status of the research under review, rather than simply review the available data. The audience consists of scientists, managers and decision-makers in the pharmaceutical industry, and others closely involved in R&D. Expert Opinion on Investigational Drugs adopts a systematic approach to coverage, with each issue focusing on one of the major therapeutic areas.

The Expert Opinion paper concludes that two randomized, double-blinded placebo-controlled trials have demonstrated that orBec®, formulated as gastric-release and enteric coated pills and dosed at 8 mg/day, is safe and effective in treating acute GI GVHD when used in conjunction with a 10 day induction course of prednisone. In the pivotal Phase 3 trial, among patients eligible for prednisone taper after 10 days of induction therapy, treatment with oral BDP reduces the risk of GVHD treatment failure at study days 50 and 80 by over 60%. The type of pre-transplant conditioning and donor had no impact on the frequency of GVHD treatment failure during the 80-day study period. Both randomized trials demonstrated a 45% reduction in the risk of mortality one year after randomization, due in large part to a reduction in death due to infection and recurrent hematologic malignancy, with the greatest benefit in terms of survival among patients who had received non-myeloablative conditioning therapy and among those who received a graft from other than an HLA-matched sibling. Oral BDP is the only therapy studied in the last 30 years to effectively treat acute GVHD and reduce mortality.

Dr McDonald's opinion is that the use of orBec® in treating the pan-intestinal inflammation of acute GVHD substitutes a well characterized, topically active glucocorticoid with limited systemic bioavailability, less toxicity, and an extensive safety history, for high-dose prednisone, which is a systemic immune suppressant with a multitude of side effects, particularly a predisposition to infections, both opportunistic and routine. The same strategy has been used effectively in treating other inflammatory disorders such as acute attacks of asthma, where an induction course of prednisone to control the acute process is followed by topical, inhaled corticosteroids, including BDP.

"This is the second recent publication of our data in a well regarded peer-reviewed journal," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR BioPharma. "We are pleased with the exposure orBec® has been getting in the medical community as a result of these publications. Two randomized trials have shown that orBec® prevents relapses of acute GI GVHD, with an effect that has been shown to be durable even following discontinuation of therapy. We believe that orBec®, if approved, will potentially provide transplant physicians with an effective and much needed tool to treat their GI GVHD patients and improve outcomes including survival. We will continue working with the FDA and EMEA toward potential regulatory approval".

[entombed1966]

Antwort auf Beitrag Nr.: 31.913.032 von schlobb am 09.10.07 16:40:57

Der Thread ist ja praktisch tot - keine mehr Interesse nach dem Absturz im Frühsommer?! Ich war da auch dabei... einige zig % Verluste realisiert, das war richtig nett.

Aber so wie's aussieht dürfte das Teil wieder hochkommen - gestern ein sattes Plus, aktuell wieder fast 10 % up.



Ich denke dass ich ein paar Cent riskieren werde.

[schlobb]

Antwort auf Beitrag Nr.: 31.916.483 von entombed1966 am 09.10.07 19:51:46

Hast recht. Jetzt ist wohl die beste Zeit einzusteigen. Die Amis spekulieren darauf dass am Donnerstag orbec die Zulassung bekommt und in Phase 4 geht... Wenn das stimmt dann . Die gehen von konservativen $2-$3 oder euphorischen $7-$10 aus. Aber das ist wohl reine Vermutung ...

eine gruene Woche

s.

[schlobb]

Antwort auf Beitrag Nr.: 31.919.428 von schlobb am 09.10.07 23:44:17

Wir sind nach Boersenschluss jetzt bei $0.55 (= €0.39)!!!!

s.

[schlobb]

Wow ! € 0,42!! Bin mal gespannt wenn der Markt in US aufmacht, was dann geht!

Ob die FDA Entscheidung wirklich am Don kommt ist aber immer noch ungewiss. Also Daumen druecken! Go orBec go!

s.

[Belu1972]

Antwort auf Beitrag Nr.: 31.916.483 von entombed1966 am 09.10.07 19:51:46

richtig was los war ja hier noch nie

Ist mir lieber als ständiges Gepusche

Insider haben im August auch ein Bischen eingekauft

ganz schön grün bei barchart

http://quote.barchart.com/texpert.asp?sym=DORB

[entombed1966]

Antwort auf Beitrag Nr.: 31.922.743 von schlobb am 10.10.07 11:50:37

Ist ungewiss ob die Entscheidung an sich am DO kommt? Oder ob orbec zugelassen wird?

[entombed1966]

Antwort auf Beitrag Nr.: 31.922.743 von schlobb am 10.10.07 11:50:37

Ist ungewiss ob die Entscheidung an sich am DO kommt? Oder ob orbec zugelassen wird?

[schlobb]

Antwort auf Beitrag Nr.: 31.925.467 von entombed1966 am 10.10.07 15:04:48

Wie ich schon geschrieben habe: Beides ist ungewiss!! FDA wird sich (wenn nichts dazwischen kommt) im Oktober entscheiden. Alles andere sind Geruechte ... aber da die Boerse ja immer an der Realitaet vorbeilebt ind sich alles auf Hoffnungen aufbaut, danke ich dass in diesem Teilchen noch ganz schoen Potenzial steckt.

Weiterhin sind die Parameter alle sehr gut und deuten auf eine positive Entscheidung der FDA und daraufhin auch von der EMEA.

Ich denke, wir werden einen schoenen Anstieg bis $1 sehen - ohne News und dann muss man halt mal weitersehen - $2 - $10(?).

Gruss. S.

[ymos]

Blockkäufe und keine Peanuts!

[schlobb]

Antwort auf Beitrag Nr.: 31.927.703 von ymos am 10.10.07 17:08:25

Wenn wir heute um die €0.40 in D und um die $0.60 in US schliessen wuerden waer das schon ne klasse Sache!

[trustone]

also laut dieser Pressemeldung gibts wohl am 21. Oktober eine Entscheidung der FDA


http://biz.yahoo.com/iw/070719/0280047.html


Marketcap. derzeit um die 50 Millionen Dollar bei einer Zulassung müsste die Firma doch wohl einige hundert Millionen Dollar Wert sein

[Belu1972]

gap closing?

[Belu1972]

In Amiland ist man wohl nicht sooo sicher, daß die Zulassung kommt?

Sind ja echt dicke Fische gestern verkauft worden!

[GBRW]

Antwort auf Beitrag Nr.: 32.040.922 von Belu1972 am 17.10.07 08:21:18

wieso, sieht doch gar nicht so schlecht aus, so lange genug käufer da sind!
ich denke der kurs wird jetzt zum wochenende noch ansteigen, das ist meistens so!
ist nur meine persönliche meinung!!!

[Belu1972]

Antwort auf Beitrag Nr.: 32.041.059 von GBRW am 17.10.07 08:32:20

schon richtig, aber 115.000 ins bid verkauft

mal sehn ob heute die $ ,44 hält

[trustone]

wie schon gesagt die Entscheidung der FDA muss noch diese Woche kommen


mein Tipp heut oder morgen.............



stehe noch an der Seitenlinie, da die Chancen für eine Zulassung wohl maximal 50:50 sind

aber demnächst wissen wir mehr

[trustone]

und für mich noch immer am beeindruckendesten ist die absolut niedrige

market Cap. von derzeit nur ca. 40 Millionen Dollar...........



ganz ehrlich bei Zulassung und mit dieser Pipeline, könnte die Firma durchaus ein tenbagger werden


400 Millionen Marketcap. halte ich dann durchaus für realistisch.......

[NewSpice]

Antwort auf Beitrag Nr.: 32.042.470 von trustone am 17.10.07 09:51:29

wollen wir mal das beste hoffen
wenn die FDA diese woche das OK gibt wo wird der kurs dann stehen ??? 1-2 oder sogar 3-4 :

[schlobb]

So jeder wuerfelt ueber die FDA Entscheidung, aber einige haben sich wohl schon entschieden:

'Buy confirmed' recommendation von Amercican Bulls!

http://americanbulls.com/StockPage.asp?CompanyTicker=DORB&Ma…

Jetzt geht's los !!!

Hoffentlich kommen die News auch bald... ich meine natuerlich positive News!

s.

[schlobb]

Antwort auf Beitrag Nr.: 32.049.928 von schlobb am 17.10.07 16:50:21

So ein Mist:

DOR BioPharma Receives Not Approvable Letter From FDA for orBec(R) for Treatment of Gastrointestinal Graft-vs.-Host Disease
Friday October 19, 8:50 am ET

http://biz.yahoo.com/iw/071019/0317653.html

das war's wohl fuer die naechste Zeit mit Dor

s.

[trustone]

Antwort auf Beitrag Nr.: 32.084.423 von schlobb am 19.10.07 15:01:01

genau so iss es





http://biz.yahoo.com/iw/071019/0317653.html

[Belu1972]

sieht nach Blutbad aus

[schlobb]

Antwort auf Beitrag Nr.: 32.084.659 von Belu1972 am 19.10.07 15:19:04

ohh ja ganz schlimmes Blutbad.....

[schlobb]

Antwort auf Beitrag Nr.: 32.084.659 von Belu1972 am 19.10.07 15:19:04

Schaetzungen fuer den Schlusskurs: Ich tippe auf 0.12

[Belu1972]

Antwort auf Beitrag Nr.: 32.084.910 von schlobb am 19.10.07 15:35:25

könnt sein, sehe mir aber das Spiel jetzt erst mal von der Seite an!

Vielleicht gibt es welche nächste Woche für $ ,10 oder drunter

[GBRW]

hallo leute,
mensch hab ich diesmal glück gehabt, hatte vorgestern mit nem kleinen plus alle verkauf, aber dafür hab ich bei gpc anständig geblutet!jetzt würde auf keinen fall mehr verkaufen!

[schlobb]

Antwort auf Beitrag Nr.: 32.085.335 von Belu1972 am 19.10.07 15:58:59

Bin auch raus - konnte meine noch fuer 0.29 abgeben. Glueck gehabt. Wann steigst Du denn wieder ein? Ich denke dass Dor schon Potential haette.

s.

[ansepe63]

Hi,
weiß jemand was am Montag bei Dor zu der Nichterteilung der FDA gesagt wurde. Gibt es neue Termine bzgl. Zulassung????

[taipan11]

es gibt wieder news.

http://biz.yahoo.com/iw/080213/0361249.html


gruß

taipan11

[taipan11]

und noch eine news.

http://biz.yahoo.com/iw/080214/0362175.html

gruß

taipan11

[taipan11]

war doch gut, nicht zu verkaufen, sondern zu warten, bis sich die situation gebessert hat und der kurs wieder steigt.

gruß

taipan11

[taipan11]

bid/ask ist in fra sehr hoch.
bin mal gespannt, ob es heute in fra einen handel gibt.

gruß

taipan11

[taipan11]

ist hier eigentlich außer mir, noch wer investiert?


gruß

taipan11

[taipan11]

keiner mehr investiert?
macht nichts, werde mich halt alleine über den kursanstieg freuen.

gruß

taipan11

[taipan11]

und noch eine news.

http://biz.yahoo.com/iw/080215/0362440.html

man kann nicht behaubten, dass hier nicht gearbeitet wird.

gruß

taipan

[taipan11]

sorry heißt natürlich behaupten.

gruß

taipan11

[vinod]

Antwort auf Beitrag Nr.: 33.378.894 von taipan11 am 15.02.08 11:35:58

Hai, hier ist noch jemand investiert. Bin beim Absturz im Oktober nicht rechtzeitig rausgekommen. Und glaube, dass ich es mal nicht bereuen werde.Das nenn ich Hoffnung. Werde mir nacher die news ansehen

Gruß vinod

[taipan11]

hallo vinod,

schön, dass doch noch wer mit im boot sitzt und in dieser schlechten allgem. marktlage kursgewinne erwirtschaftet.
die bewertung ist ja ein witz.
bald werden wir höhere kurse sehen.

gruß

taipan11

[taipan11]

[taipan11]

so ist mir derzeit zu mute, wenn ich auf den
kurs schaue.

gruß

taipan11

[vinod]

Antwort auf Beitrag Nr.: 34.198.631 von taipan11 am 29.05.08 18:09:53

Hai Taipan 11,einen wunderschönen Abend

Schön mal hier wieder jemanden zu sehen. Bei dem Kurs kommt zwar nicht gerade Freude auf, aber ich glaube an die Zulassung von orBec. Die Versuche sind jetzt in der dritten Phase, und wenn die gut abgeschlossen werden, sieht es hier schnell auch anders aus.
eIN bLICK IN MEINE kRISTALLKUGEL UND MEINE kARTEN SAGEN dIE zULASSUNG KOMMT! Wünsche Dir noch einen schönen Abend. Hast Du generell Interesse an Pharmatiteln?

[taipan11]

hallo von vinod,

ich glaube auch, dass das mit der zulassung von orbec noch was
wird. deshalb bin ich hier noch drinnen.
weißt du, wann die 3 phase abgeschlossen werden soll.
heuer noch?
bin hier schon sehr lange drinnen (seit Ende 2003)und habe nach
der verweigerten zulassung nochmals aufgestockt.
ich bin sonst in keiner bio/pharma aktie investiert.
ist auch keine gute zeit für diese werte.
ich versuche immer einzelwerte auszusuchen, wo die story stimmt.


gruß

taipan11

[vinod]

Antwort auf Beitrag Nr.: 34.207.956 von taipan11 am 30.05.08 20:37:10

Hai taipan 11

Ich will dorbiop nächste Woche mal anschreiben wann die 3. Phaase abgeschlossen sein wird.
Ich bin noch an einem anderen Wert interessiert. Das Unternehmen heißt Lev Pharma und die Aktie ist auf www.onvista.de unter der wknr. A0LGJ1 zu finden. Die haben ein Konkurrenzprodukt zum dem von Jerini und soweit ich weiß, wird die FDA am 14 Oktober über die Zulassung entscheiden. Beim ersten Zulassungsantrag hat die FDA Verbesserungen gefordert. In der Ausgabe des 'Aktionärs' vom 19.12.07 stehen künftige Zulassungstermine. Vielleicht interessiert es Dich ja. Schönen Abend noch
Gruß Vinod

[taipan11]

Antwort auf Beitrag Nr.: 34.213.276 von vinod am 01.06.08 17:03:14

hallo vinod,

finde ich eine gute idee, wenn du sie anschreibst.
kannst du mir dann bescheid geben, was sie antworten?
wäre super.
ich bin sonst in rohstoffwerten investiert.
auschließlich in explorerwerten, da ich nicht weiß, welche firma die chinesische oder indische microsoft wird, aber eines weiß ich sicher, dass die asiaten noch sehr lange rohstoffe brauchen, um ein westliches niveau zu erreichen.

einen schönen sonntag noch

taipan11

[taipan11]

p.s

habe mit biotechwerten einiges an geld verbrannt, deshalb habe ich mich von diesem segment gelöst.

gruß

taipan11

[vinod]

Hi taipan11
Habe jetzt endlich eine Antwort:
We are still working with FDA on protocolldesign, and as a result we havent give any guidance on final trial design to the street. When we have it, it will be announced. But we said, that once started(which we expected 3Q 2008) the new confirmatory Phase 3 trail will take about 15 moth to complete.
Eine Kurzübersetzung meiner amerik. Freundin lautet: sie arbeiten noch an den Bedingungen für das Protoll und die Rahmendaten werden dann bekanntgegeben. Die Phase 3 beginnt im 3. Quartal diesen Jahres und dauert 15 Monate.
Für weiter Fragen soll ich ihn anrufen. Sie arbeiten momentan noch an anderen deals.
Naja das mit der 3. Phase wird ja dann noch dauern. Für mich lohnt es sich im Moment aber nicht, auszusteigen. Und so hoffe ich auf den Zeitraum in 1,2 Jahren.
Bin ebenfalls in einigen Rohstoffen investiert so z.B. Mexican Silver. Kennst Du Eurogas?
Gruß Vinod

[vinod]

Hi T11

Hoffe,dass es Dich noch gibt? Jedenfalls was Dor anbetrifft.
Kennst Du Playfair Mining?
Gruß Vinod

[taipan11]

Antwort auf Beitrag Nr.: 34.304.129 von vinod am 15.06.08 09:15:10

hallo vinod,
vielen dank für das posten der antwort.
ich muss mir übers we überlegen, ob ich noch so lange warten möchte.
es werden doch noch knapp 2 jahre.
habe jetzt leider keine zeit mehr, melde mich aber anfang nächster woche wieder

gruß und schönes we

taipan11

[taipan11]

hallo vinod,

kenne deine rohstoffwerte nicht genauer, habe nur mal von eurogas
u. mexican silver beiläufig gehört.
bin z.b. in maximus ventures investiert.versuche derzeit lieber weniger verschiedene aktien zu haben, dafür mehr davon und versuche auch geduld mit diesen aktien zu haben, wenn die Story stimmt.
bei dor habe ich bisher auch geduld gehabt, aber mir dauert es einfach noch zu lange, bis es hier, wenn überhaupt, zur zulassung kommt.


gruß

taipan11

[XQC]

Antwort auf Beitrag Nr.: 34.315.567 von taipan11 am 17.06.08 12:53:08

Hi Taipan11 !

Bist Du noch drin ???

Wenn ja, schau Dir mal die Financials an...

...das nächste Q wird schwarze Zahlen bringen...


durchhalten ...

[taipan11]

Antwort auf Beitrag Nr.: 36.165.190 von XQC am 08.12.08 12:09:56

hallo xqc,

bin zu 0,13$ ausgestiegen. habe derzeit nur rohstoffwerten im depot.
verfolge aber den kurs von dor.
ist sicher ein interessanter kurs für einen wiedereinstieg.
mal sehen.

gruß

taipan11

[XQC]

DOR BioPharma Receives SPA Clearance From the FDA to Begin Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD
Monday January 5, 7:00 am ET


EWING, NJ--(MARKET WIRE)--Jan 5, 2009 -- DOR BioPharma, Inc. (DOR or the Company) (OTC BBORB.OB - News) announced today that it has reached agreement with the US Food and Drug Administration (FDA) on the design of a confirmatory, pivotal Phase 3 clinical trial evaluating its lead product orBec® for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD). The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure.
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An agreement via the SPA procedure is an agreement with the FDA that a Phase 3 clinical trial's design (e.g., endpoints, sample size, control group and statistical analyses) is acceptable to support a regulatory submission seeking new drug approval. After the study begins, the FDA can only change a SPA for very limited reasons.

Based on data from the prior Phase 3 study of orBec®, the upcoming confirmatory Phase 3 protocol will be a highly powered, double-blind, randomized, placebo-controlled, multi-center trial and will seek to enroll an estimated 166 patients. The primary endpoint is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value = 0.005) in the previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec® (i.e., 30 days following cessation of treatment).

"We are very pleased to gain SPA agreement with the FDA on our confirmatory, pivotal Phase 3 study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. "The depth and strength of our available Phase 3 data have allowed us to design and power this pivotal trial that we believe maximizes orBec®'s chances for success. With our primary endpoint of the 'treatment failure rate at Study Day 80,' we expect to replicate statistical significance in this clinically meaningful endpoint with orBec®. We expect to initiate this trial in the first half of 2009."

Dr. Schaber continued, "With the regulatory clarity received from FDA, we are now confident that we have a more clearly defined development path that has the potential to lead to regulatory approval of orBec®. We are excited to move forward with this trial in an effort to address the significant unmet medical need of GI GVHD."

About orBec®

Two prior randomized, double-blind, placebo-controlled Phase 2 and 3 clinical trials support orBec's® ability to provide clinically meaningful outcomes when compared with the current standard of care, including a lowered exposure to systemic corticosteroids following allogeneic transplantation. Currently, there are no approved products to treat GI GVHD. The first trial was a 60-patient Phase 2 single-center clinical trial conducted at the Fred Hutchinson Cancer Research Center. The second trial was a 129-patient pivotal Phase 3 multi-center clinical trial of orBec® conducted at 16 leading bone marrow/stem cell transplantation centers in the US and France. Although orBec® did not achieve statistical significance in the primary endpoint of its pivotal trial, namely median time-to-treatment failure through Day 50 (p-value 0.1177), orBec® did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005) and the median time to treatment failure through Day 80 (p-value 0.0226), as well as a 66% reduction in mortality among patients randomized to orBec® at 200 days post-transplant with only 5 patient (8%) deaths in the orBec® group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139). At one year post randomization in the pivotal Phase 3 trial, 18 patients (29%) in the orBec® group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).

In the Phase 2 study, the primary endpoint was the clinically relevant determination of whether GI GVHD patients at Day 30 (the end of treatment) had a durable GVHD treatment response as measured by whether or not they were able to consume at least 70% of their estimated caloric requirement. The GVHD treatment response at Day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the orBec® and placebo groups, respectively (p-value 0.02). Additionally, the GVHD treatment response at Day 40 (10 days post cessation of therapy) was 16 of 31 (52%) vs. 5 of 29 (17%) in the orBec® and placebo groups, respectively (p-value 0.007).

orBec® represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec® is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD. Beclomethasone dipropionate (BDP) is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. orBec® is formulated for oral administration as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract, and the other tablet is intended to release BDP in the distal portions of the GI tract.

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to DOR, orBec® also benefits from orphan drug designations in the US and in Europe for the treatment of GI GVHD, which provide for seven and 10 years of post-approval market exclusivity, respectively.

About GI GVHD

GI GVHD is a debilitating and painful disease and constitutes an unmet medical need. It is a common disorder among immunocompromised cancer patients after receiving hematopoietic cell transplantation. Unlike organ transplants where the patient's body may reject the organ, in GVHD it is the donor cells that begin to attack the patient's (host's) body -- most frequently the gastrointestinal tract, liver and skin. Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea. If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. DOR expects to begin a confirmatory Phase 3 clinical trial of orBec® for the treatment of GI GVHD in 1H 2009. orBec® is also currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. Additionally, DOR has a Lipid Polymer Micelle (LPM(TM)) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin, botulinum toxin and anthrax. DOR's ricin toxin vaccine, RiVax™, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

For further information regarding DOR BioPharma, Inc., please visit the Company's website at www.dorbiopharma.com.

This press release contains forward-looking statements that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its cash expenditures will not exceed projected levels, that it will be able to secure partnerships or obtain financing within the next nine months to meet operating expenses and to conduct its upcoming confirmatory Phase 3 trial of orBec®, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: the FDA's requirement that DOR conduct additional clinical trials to demonstrate the safety and efficacy of orBec® will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; DOR is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; orBec® may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Forms 10-Q and 10-KSB. Unless required by law, DOR assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

[XQC]

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD





PRINCETON, N.J., June 9 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc. (DOR or the Company) (OTCORB) (BULLETIN BOARD: DORB) , a late-stage biopharmaceutical company, announced today that it has received Protocol Assistance feedback from the European Medicines Agency (EMEA) on the design of its confirmatory, pivotal, Phase 3 clinical trial evaluating its lead product orBec(R) for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD).

The EMEA agreed that should the new confirmatory Phase 3 study produce positive results, the data would be sufficient to support a marketing authorization approval in all 27 European Union (EU) member states. In so doing, the EMEA agreed to the primary endpoint and the other principal design features of the new study. The EMEA's response is consistent with feedback previously received from United States Food and Drug Administration (FDA), paving the way for potential approval in the US and EU.

DOR and the FDA reached agreement on the design of the upcoming Phase 3 study via the Special Protocol Assessment (SPA) procedure. An agreement via the SPA procedure is an agreement with the FDA that a Phase 3 clinical trial's design (e.g., endpoints, sample size, control group and statistical analyses) is acceptable to support a regulatory submission seeking new drug approval.

Based on data from the prior Phase 3 study of orBec(R), the upcoming confirmatory Phase 3 clinical trial will be a highly powered, double-blind, randomized, placebo-controlled, multicenter trial and will seek to enroll an estimated 166 patients. The primary endpoint is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value = 0.005) in the previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec(R) (i.e., 30 days following cessation of treatment). The confirmatory Phase 3 clinical trial will be conducted at major transplant centers throughout the US and Canada.

"We are very pleased to obtain a positive response from the EMEA regarding the design of our upcoming confirmatory, pivotal Phase 3 study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. "The depth and strength of our available Phase 3 data have allowed us to design and power a pivotal trial that we believe maximizes orBec(R)'s chances for success. With our primary endpoint of the 'treatment failure rate at Study Day 80,' we expect to replicate statistical significance in this clinically meaningful endpoint with orBec(R)."

Dr. Schaber continued, "This feedback, in conjunction with the SPA agreement, clearly validates the direction of the orBec(R) clinical development path that has the potential to lead to regulatory approval of orBec(R) in both the US and the European Union. We are excited to move forward with this trial in an effort to address the significant unmet medical need of acute GI GVHD. We anticipate patient enrollment to commence in the second half of 2009."

About orBec(R)

Two prior randomized, double-blinded, placebo-controlled Phase 2 and 3 clinical trials support orBec(R)'s ability to provide clinically meaningful outcomes when compared with the current standard of care, including a lowered exposure to systemic corticosteroids following allogeneic transplantation. Currently, there are no approved products to treat GI GVHD. The first trial was a 60-patient Phase 2 single-center clinical trial conducted at the Fred Hutchinson Cancer Research Center. The second trial was a 129-patient pivotal Phase 3 multi-center clinical trial of orBec(R) conducted at 16 leading bone marrow/stem cell transplantation centers in the US and France. Although orBec(R) did not achieve statistical significance in the primary endpoint of its pivotal trial, namely median time-to-treatment failure through Day 50 (p-value 0.1177), orBec(R) did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005) and the median time to treatment failure through Day 80 (p-value 0.0226), as well as a 66% reduction in mortality among patients randomized to orBec(R) at 200 days post-transplant with only 5 patient (8%) deaths in the orBec(R) group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139). At one year post randomization in the pivotal Phase 3 trial, 18 patients (29%) in the orBec(R) group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).

In the Phase 2 study, the primary endpoint was the clinically relevant determination of whether GI GVHD patients at Day 30 (the end of treatment) had a durable GVHD treatment response as measured by whether or not they were able to consume at least 70% of their estimated caloric requirement. The GVHD treatment response at Day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the orBec(R) and placebo groups, respectively (p-value 0.02). Additionally, the GVHD treatment response at Day 40 (10 days post cessation of therapy) was 16 of 31 (52%) vs. 5 of 29 (17%) in the orBec(R) and placebo groups, respectively (p-value 0.007).

orBec(R) represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec(R) is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD. Beclomethasone dipropionate (BDP) is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. orBec(R) is formulated for oral administration as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract, and the other tablet is intended to release BDP in the distal portions of the GI tract.

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to DOR, orBec(R) also benefits from orphan drug designations in the US and in Europe for the treatment of GI GVHD, which provide for seven and 10 years of post-approval market exclusivity, respectively.

About Acute GI GVHD

Acute GI GVHD is a debilitating and painful disease and constitutes an unmet medical need. It is a common disorder among immunocompromised cancer patients after receiving hematopoietic cell transplantation. Unlike organ transplants where the patient's body may reject the organ, in GVHD it is the donor cells that begin to attack the patient's (host's) body -- most frequently the gastrointestinal tract, liver and skin. Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea. If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.

[taipan11]

ich stelle euch mal einen interessanten artikel (abseits von dor) zum lesen rein.
ist sicher wert den mal zu lesen.

gruß

taipan11

http://www.das-bewegt-die-welt.de/index.php?option=com_conte…

[carpe--diem]

DOR BIOPHARMA INC (U-DORB) - News Release
DOR BioPharma Announces $9.4 Million NIH Grant Award to Develop Thermostable and Rapidly Acting Vaccines

2009-09-21 07:00 ET - News Release






PRINCETON, N.J., Sept. 21 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc. (DOR or the Company), a late-stage biotechnology company, announced today that it has been awarded an approximate $9.4 Million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). The grant will fund, over a five-year period, the development of formulation and manufacturing processes for vaccines, including RiVax(TM), that are stable at elevated temperatures. The grant will also fund the development of improved thermostable adjuvants expected to result in rapidly acting vaccines that can be given with fewer injections over shorter intervals.


The development of heat-stable vaccines will take advantage of combining several novel formulation processes with well-characterized adjuvants that have been evaluated in numerous vaccine field trials. The formulation and process technology funded by the grant will be applied to the further development of RiVax(TM), a subunit vaccine for prevention of ricin toxin lethality and morbidity. The grant will also address the development of manufacturing processes and animal model systems necessary for the preclinical characterization of vaccine formulations. Further, the grant will fund the concurrent development of at least one other protein subunit vaccine, which is currently expected to be an anthrax vaccine. This could lead to new subunit vaccines that would bypass current cold chain requirements for storage and distribution. Vaccines to be stored in the Strategic National Stockpile (SNS) and used under emergency situations for biodefense are expected to have long-term shelf life.


"The novel technology supported by this grant will potentially develop new vaccines to address the practical issue of long-term stability in stockpiled vaccines and can subsequently be applied to other vaccine products," said Robert N. Brey, PhD, Chief Scientific Officer of DOR. "These new vaccines could be stored for long periods of time at ambient temperature, and avoid the current need for a well-controlled environmental cold chain. This would result in more useful vaccines for both civilian and military purposes."


"This grant award further validates the previous work and merits of our biodefense program," said Christopher J. Schaber, PhD, President and CEO of DOR. "We are very pleased that NIAID has chosen to support the development of a thermostable vaccine platform, as there are very few viable technology options at present that can effectively address heat stable vaccines. Our progress to date with RiVax(TM) has been impressive, and we believe that application of thermostabilization technology will accelerate the efforts to develop RiVax(TM) and other vaccines such as anthrax for potential use by the military and for the Strategic National Stockpile."


Dr. Schaber continued, "This $9.4 million grant puts our biodefense and vaccine business on solid footing and supports the necessary corporate infrastructure to continue to execute on these important programs."


About RiVax(TM)


RiVax(TM) is DOR's proprietary vaccine developed to protect against exposure to ricin toxin and is the most advanced vaccine in the company's portfolio. With RiVax(TM), DOR is the world leader in ricin toxin vaccine research. There are currently no vaccines available to prevent or treat ricin poisoning. The immunogen in RiVax(TM) induces a protective immune response in animal models of ricin exposure and consists of a genetically inactivated subunit ricin A chain that is enzymatically inactive and lacks residual toxicity of the holotoxin. One human Phase 1 clinical trial has been completed and a second trial is currently being conducted.


The development of RiVax(TM) has been sponsored through a series of overlapping challenge grants (UC1) and cooperative grants (U01) from the NIH, granted to DOR and to the University of Texas Southwestern Medical Center (UTSW) where the vaccine originated. The second clinical trial is being supported by a grant to UTSW from the US Food and Drug Administration Office of Orphan Products Development. DOR and UTSW have collectively received approximately $15 million in grant funding from the NIH for RiVax(TM).


Results of the first Phase 1 clinical trial of RiVax(TM) established that the immunogen was safe and induced antibodies anticipated to protect humans from ricin exposure. The outcome of the study was published in the Proceedings of the National Academy of Sciences (Vitetta et al., 2006, PNAS, 105:2268-2273). The second trial, sponsored by UTSW, is currently evaluating a more potent formulation of RiVax(TM) anticipated to result in higher antibody titers of longer duration in human subjects. DOR has adapted the original manufacturing process for the immunogen contained in RiVax(TM) for large-scale manufacturing and is further establishing correlates of the human immune response in non-human primates.


About Ricin Toxin


Ricin toxin is thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. It is second only to botulinum toxin as the most lethal natural toxin. Exposure to ricin results in general organ failure leading to death within several days of exposure. Ricin is highly toxic to humans and other mammals because it has the ability to enter virtually any type of cell and affect any organ in the body. Exposure to small amounts, especially by inhalation, leads to irreversible lung damage. The potential use of ricin toxin as a biological weapon of mass destruction has been highlighted in an FBI Bioterror report released in 2007 entitled Terrorism 2002-2005, which states that "Ricin and the bacterial agent anthrax are emerging as the most prevalent agents involved in WMD investigations" (www.fbi.gov/publications/terror/terrorism2002_2005.pdf).


The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack. RiVax(TM) would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.


About DOR BioPharma, Inc.


DOR BioPharma, Inc. (DOR) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec(R) (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of gastrointestinal Graft-versus-Host Disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. DOR expects to begin a confirmatory Phase 3 clinical trial of orBec(R) for the treatment of acute GI GVHD and a Phase 1/2 clinical trial of DOR201 in radiation enteritis in the second half of 2009. orBec(R) is also currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. Additionally, DOR has a Lipid Polymer Micelle (LPM(TM)) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. DOR's ricin toxin vaccine, RiVax(TM), has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.


For further information regarding DOR BioPharma, Inc., please visit the Company's website at http://www.dorbiopharma.com/." target="_blank" rel="nofollow ugc noopener">http://www.dorbiopharma.com/.


This press release contains forward-looking statements that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including DOR201, orBec(R) and LPM(TM), particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its cash expenditures will not exceed projected levels, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec(R) for gastrointestinal GVHD include the risks that: the FDA's requirement that DOR conduct additional clinical trials to demonstrate the safety and efficacy of orBec(R) will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; DOR is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; orBec(R) may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec(R). Factors affecting the development and use of DOR201 and LPM(TM) are similar to those affecting orBec(R). These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Forms 10-Q and 10-K. Unless required by law, DOR assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.


SOURCE DOR BioPharma, Inc.

DOR BioPharma, Inc.



CONTACT: Evan Myrianthopoulos, Chief Financial Officer, DOR BioPharma,
Inc., [phone]



Web site: http://www.dorbiopharma.com/

[Pokerlui007]

neue kurziele von euch für die nächsten 3-6Monate??

1$!?

[Latinl]

Antwort auf Beitrag Nr.: 38.022.073 von Pokerlui007 am 21.09.09 13:37:28

warum nicht