US Biotech unmittelbar vor dem nächsten Hype! - 500 Beiträge pro Seite

[dottore]

11. September 2009 06:15


ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), provided an update today on the Company's clinical development plan for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. Access' clinical development team recently met with its partners Aosaikang Medicinal Group (ASK) in Nanjing, China and JCOM, Ltd. ("JCOM") in Seoul, Korea, together with key opinion leaders in oncology indications to discuss the protocols for the three planned ProLindac combination studies. Access and its partners are finalizing development plans and protocols for clinical trials strategically designed to examine ProLindac in combination with gemcitabine and/or taxol in hepatocellular carcinoma (a form of liver cancer), pancreatic cancer and recurrent ovarian cancer.

Access previously announced positive safety and efficacy results from its Phase 2 monotherapy clinical study of ProLindac(TM) in late-stage, heavily pretreated ovarian cancer patients. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall.

The recent Phase 2 recurrent ovarian study explored three different dose levels and two dosing regimens of ProLindac as a monotherapy treatment for advanced ovarian cancer, to provide data on the monotherapy anticancer activity and safety of ProLindac. Of patients eligible for evaluation according to standard RECIST criteria, clinically-meaningful disease stabilization was achieved in 42% of all patients, and 66% of all patients in the higher dose groups. Sustained and significant reductions in Ca-125, the established specific serum marker for ovarian cancer, were also observed in several patients.

"Access is extremely pleased with the clinical progress to date, and look forward to initiation of clinical trials looking at ProLindac in combination with commonly used chemotherapies," stated Jeffrey Davis, President & CEO. "Our partners in the Far East hosted Access together with key opinion leaders in oncology indications to discuss various potential protocol options, and hope to start enrolling patients in up to three combination trials by the end of the year, depending upon regulatory approvals of the trial protocols and certain other matters."

[dynamo11]

super,das es noch Leben hier gibt!
Ich beobachte den Wert schon eine weile,und habe gestern mal zugeschlagen,und eine erste Position aufgebaut!
Ich halte den Wert für entwicklunsfähig,wenngleich man Ausdauer haben muß.Aber das bin ich ja von Curasan gewohnt!
Mal sehen was der markt heut aus der Meldung macht!

[dottore]

Antwort auf Beitrag Nr.: 37.963.133 von dynamo11 am 11.09.09 15:20:13

der Kurs hat in den letzten 52 Wochen schon über 350 % zugelegt. Und das Update ist keine absolut neue Sache, aber doch recht positiv zu bewerten. Ich erwarte hier eher bescheidene Kursgewinne für heute und sehe es eher als ein Investment, als den einen Zock

[dottore]

9/11/2009 9:03:51 AM * Access Pharma Signs Agreement To Manufacture Its FDA-Approved MuGard In U.S.

heute gleich 2 NEWS! UND beide potentiell bombastisch, aber wie gesagt, der Kurs ist schon weit gelaufen

[dynamo11]

aber gerade solche Titel sind für Überraschungen gut.Und in letzter zeit ist ja der kurs ein wenig zurückgekommen!

[dynamo11]

Ich sehe aber heut nur eine News!Meinst Du die zweite von gestern?

[dottore]

Antwort auf Beitrag Nr.: 37.963.949 von dynamo11 am 11.09.09 16:41:25

kann sein, dass die eine Nachricht schon von gestern ist. Ich habe das Veröffentlichungsdatum übernommen - in beiden Fällen

Weißt du, wo ich am schnellsten dran komme?

[dynamo11]

http://www.finanznachrichten.de/nachrichten-aktien/access-ph…

http://www.stockwatch.com/utilit/utilit_snapsh_result.aspx

Ich schau immer bei beiden Adressen nach aktuellem!!

[dottore]

danke,
finanznachrichten kannte ich schon stockwatch noch nicht

[dottore]

Antwort auf Beitrag Nr.: 37.963.477 von dottore am 11.09.09 15:57:49

hier der Inhalt zur Überschrift

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) has entered into an agreement with a leading commercial manufacturer to produce its FDA-approved MuGard for North American distribution. One or more U.S. market seeding studies could begin as early as Q4 2009, the company says.

In a comparison of cancer patients receiving standard oral mucositis care with those patients receiving MuGard , MuGard has been shown to significantly reduce the incidence and severity of the debilitating side effect of radiation treatment and chemotherapy.

Access has contracted with Accupac, Inc. to serve as its commercial manufacturer of MuGard in North America. Accupac manufactures, fills and packages a wide range of consumer commodity, over-the-counter (OTC) and prescription (Rx) products for the world's largest pharmaceutical and consumer products companies.

"Access is moving forward with the development of MuGard in North America," said Jeffrey B. Davis, Access' President & CEO. "Establishing our relationship with Accupac, a leader in liquid contract manufacturing, is critical to our successful commercialization of MuGard. In addition, Access is currently evaluating potential eMarketing partners as well as potential co-promotion or other licensing opportunities."

Access intends to use the initial batches of MuGard in connection with one or more market seeding studies to be conducted in the U.S. pursuant to protocols that are currently being developed. Access hopes to finalize these protocols and begin one or more market seeding studies in Q4 2009.

[dynamo11]

n 9/10/09, Access Pharma (ACCP.OB) announced that its clinical development team recently met with its partners Aosaikang Medicinal Group (ASK) in China and JCOM, Ltd. (JCOM) in Korea, along with key opinion leaders in oncology indications to discuss the protocols for the three planned ProLindac combination studies. Access and its partners are finalizing development plans and protocols for clinical trials strategically designed to examine ProLindac in combination with gemcitabine and/or taxol in hepatocellular carcinoma (a form of liver cancer), pancreatic cancer, and recurarent ovarian cancer.

Below is a summary from an update article posted in late August at BioMedReports.com based on information provided by the President and CEO of Access Pharma, Jeffrey B. Davis.

Access is working with the leading cancer doctors in China and Korea, together with the clinical teams at ACCP, ASK and JCOM, to put together protocols and plans for up to three combination trials for ProLindac in combination with gemcitabine in hepatocellular carcinoma and pancreatic cancer, and in combination with gemcitabine/Taxol in recurrent ovarian cancer (and be able to get first or second relapse patients in recurrent ovarian, in contrast to the very heavily pre-treated population which was part of our mono-therapy trial).

Access will be working closely with the KOL and with in-country regulators, with the goal of enrolling the first patients by year-end, depending upon regulatory approvals of the trial protocols and certain other matters. The company’s director of clinical development, Esteban Cvitkovic, is excited about these new indications, and believes that they represent a much quicker registration pathway to approval in Europe, and possibly the U.S., than going after colorectal cancer.

On 9/11/09, Access announced that it entered an agreement with a leading commercial manufacturer which specializes in liquid formulations to produce MuGard for distribution in North American markets. Access has contracted with Accupac, Inc. to serve as its commercial manufacturer of MuGard in North America. Accupac manufactures, fills and packages a wide range of consumer commodity, over-the-counter (OTC) and prescription (Rx) products for the world’s largest pharmaceutical and consumer products companies.

Access intends to use the initial batches of MuGard in connection with one or more market seeding studies to be conducted in the U.S. pursuant to protocols that are currently being developed, and the company hopes to finalize these protocols and begin one or more market seeding studies during 4Q09. Below are additional development milestones and catalysts expected before year-end for Access:

1. Final results (all 280 patients over the entire seven-week duration) for SpePharm's UK post-approval marketing study of MuGard with interim results demonstrating no cases of oral mucositis in 140 patients with head and neck cancer being treated with radiation therapy. Also, a continuous flow of clinical data (including journal publications and presentations at medical/scientific conferences) for MuGard expected throughout 2H09 as SpePharm is also conducting post-approval marketing studies in Germany and Italy. Access also expects to initiate similar marketing assessment studies within three months (mid-November) in North America as well.
2. Listing on either the AMEX or NASDAQ exchanges
3. MuGard commercial launch in Asia
4. North American Commercialization Strategy for MuGard: The company's strategy is to initiate GMP manufacturing of MuGard; continue to put the reimbursement strategy in place (get codes, etc.); and then go back to about 5-6 leading OM doctors to conduct US-based post-approval marketing studies. Access will proceed "as-if" preparing for a commercial launch alone while taking a position with potential new North America partners that they can do a new license deal (with better economics for Access, but give them control to do it all themselves), or a "co-promote" deal where Access retains the rights to co-promote MuGard in North America.
5. Licensing discussions for the company's cobalamin-based nanopolymer drug delivery technology for the oral administration of a basal (long-acting) insulin product following mid-June announcement that two bio-pharmaceutical companies will conduct preclinical, animal studies before proceeding to more formal negotiations. The results of these preclinical studies will be made public, including one North American biotech company and one European biotech company. Access is providing the oral insulin while the two interested companies will conduct one animal study each (including a rat and dog model) with data expected before year-end. Ongoing discussions with these companies may result in the evaluation of other drugs utilizing this delivery platform, including human growth hormone (hGH) and erythropoietin (EPO).

Please visit the stock research section of BioMedReports.com to view or download my latest 19-page PDF research report for Access Pharma published on 8/14/09, which includes an earnings model for MuGard through 2012 and key upcoming catalysts for the company that are expected to unlock substantial shareholder value. The stock research section also includes an updated report for Access written by Griffin Securities with a buy rating and $11 price target in addition to the most recent corporate presentation for the company.

Check out Access Pharma's Newsroom site for a compilation of links, videos, presentations, articles, and social media sites for the company and its executive leadership team. OneMedPlace also features a corporate profile page for Access Pharma, including a video interview conducted in mid-August with Mr. Davis regarding the clinical success of MuGard and the latest news surrounding its commercial launch. Access will be presenting at the Rodman & Renshaw 11th Annual Healthcare Conference in NY City at 10:45 am on Friday, September 11th. This year, a first, they will webcast video (rather than just audio with the slides) and Access will participate with that as well.

Disclosure: Long ACCP.OB.