loGen (fibrocystic breast disease) Phase III // Marktkap: 12,6 mio$ - 500 Beiträge pro Seite

[BrauchGeld]

Symbollon ist ein superzock ist loGen erfolgreich sehen wir mit leichtigkeit zweistellige kurse ,loGen zielt auf ein riesigen markt mit mehreren hundert millionen dollar potential .
Im 2Q 2007 soll die Rekrutierung abgeschlossen werden und im 1Q 2008 folgen die Phase III ergebnisse .
Die Aktie ist weder hier noch in USA selbst kaum bekannt.

Wer mut hat sollte zuschlagen ansonsten finger weg .


Symbollon Pharma (Symba.ob)

Marktkap: 12,6 mio$
Cash: 2,52 mio$
Kurs: 1 $

www.symbollon.com

"We expect to complete enrollment during the second quarter of 2007. The results of the IoGen Phase III clinical trial should then be available in the first quarter of 2008

"Despite terminating our relationship with our IoGen commercialization partner, we were able during 2006 to raise sufficient funds to enable us to enroll the Phase III pivotal clinical trial evaluating IoGen for the treatment of cyclic mastalgia (pain and tenderness) associated with fibrocystic breast disease," stated Paul C. Desjourdy, President and Chief Executive Officer of Symbollon. "We expect to complete enrollment during the second quarter of 2007. The results of the IoGen Phase III clinical trial should then be available in the first quarter of 2008. During the coming year, we expect to initiate the clinical development of Nasodine(TM), a new product utilizing our proprietary technology to eradicate multi-drug resistant pathogens from the nasal cavity. Nasodine is just the first of several new products that Symbollon intends to bring to market as we pursue our business strategy to build a strong, opportunistic pipeline of drugs."

Symbollon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary drugs based on its molecular iodine technology. Symbollon has initiated a Phase III clinical trial evaluating IoGen as a potential treatment for moderate to severe cyclic pain and tenderness (clinical mastalgia) associated with fibrocystic breast disease (FBD). FBD is a condition that affects approximately 20 to 33 million women in the U.S., and there are approximately 7 to 13 million women suffering from clinical cyclic mastalgia. The Company believes IoGen also may be useful in treating and/or preventing certain other female reproductive tissue proliferation, including endometriosis, ovarian cysts, and premenopausal breast cancer.

[BrauchGeld]

Der folgende Artikel ist schon etwas älter ,K.E. ist bereits abgeschlossen .

Symbollon hopes 'little bit' of cash takes it a long way
Boston Business Journal - October 20, 2006by Mark HollmerJournal staff
Print this Article Email this Article Reprints RSS Feeds Most Viewed Most Emailed
The following quote represents an enormous understatement in the biotechnology world: "We're looking to raise a little bit of extra money now."

"A little bit" might seem small out of context, but keep in mind biotechs are often looking for millions of dollars even when they want to raise small amounts of money.


Paul Desjourdy is the man behind the "little bit of extra money" quote. He's CEO of Symbollon Pharmaceuticals Inc. in Framingham.

And his quote is all the more understated because that money comes at a historic time for Symbollon, which was founded 20 years ago and is now at a juncture that's anything but "little."

Symbollon (OTCBB: SYMBA) expects to run out of its current cash reserves by early next year. And so it will seek to raise about $3 million to help finish enrollment in an ongoing Phase III clinical, or late stage, trial for LoGen, a treatment for excessive cell and cyst growth in female breast and reproductive tissue.

If all goes well, the three-employee company hopes to complete enrollment by the end of the year and obtain data from the results by next summer. Assuming the results are positive, the company will seek to replicate the data in another trial and file for domestic regulatory approval in 2009. Around that time, Symbollon also will seek a licensing partner to bring the drug to market.

It's a remarkable milestone for a company that employed no more than a dozen staff at its peak in the early 1990s.

Chief Scientific Officer Jack Kessler launched the company in 1986 to create a safe, corporate home for a number of patents he first wanted to license out.

The company has raised just $14 million in the 13 years since it went public in 1993 and began operating as a working company. At that time, Symbollon had 25 patents for iodine-based treatments that had promise in both women's health therapeutics and antimicrobial uses.

Symbollon initially focused on the antimicrobial path but switched to women's health about eight years ago, after deciding that treatments in this area offered greater economic opportunities for the fledgling company. And limited resources worked better focused on a single compound rather than divided among several.

That market switch became stronger after the company bought Mimetix, a private San Francisco company that had made strides in similar patent areas.



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Symbollon Pharmaceuticals Completes Private Placement to Accredited Investors

Symbollon Pharmaceuticals, Inc. (SYMBA) announced the completion of a private placement to accredited investors in December 2006 and January 2007 raising net proceeds of $2,368,038 for an aggregate of 3,213,632 shares of Class A common stock and 2,410,224 redeemable warrants. The purpose of the financing is to fund the ongoing Phase III pivotal clinical trial evaluating IoGen for the treatment of pain and tenderness associated with fibrocystic breast disease and working capital needs.

Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals, commented, "We are extremely pleased that we were able to complete this private placement. We remain focused on progressing our Phase III clinical trial as we continue to take the necessary steps to seek approvals to market IoGen(TM) for the initial indication of breast pain associated with fibrocystic breast."

Mr. Desjourdy emphasized that, "As we enter into 2007, completing the enrollment of the IoGen Phase III study remains our number 1 priority. Presently, we have over 70 patients randomized on drug. We are expecting to randomize the remaining patients during the first half of 2007. The recently completed financing will provide us with adequate resources to compete the enrollment process."

Mr. Desjourdy further explained that, "We are interested in developing data during 2007 regarding IoGen's potential to treat such other indications as breast cancer and endometriosis. Such data should enhance the program's value and increase our ability to enter into a licensing relationship. Our other priorities for 2007 include initiating development activities for certain antimicrobial applications covered by our technology. We have identified over 6 potential products that we believe address large unmet market needs. As we await the pivotal Phase III data from the ongoing IoGen study, we are focused on building a strong clinical pipeline based on our proprietary technology."

[koalabaer25]

Antwort auf Beitrag Nr.: 29.250.280 von BrauchGeld am 10.05.07 14:05:37

Die Aktie war im Jahr 2000 bei 13 $. Lilly wollte Symbollen damals übernehmen. Der Deal kam aber nicht zustande und der Kurs brach ein.
Muß man eine Finanzierung befürchten, da 2,5 Mill. $ Cash nicht gerade viel sind?

Kommt auf die Watchlist, Umsätze sind sehr gering.

[BrauchGeld]

Antwort auf Beitrag Nr.: 29.257.584 von koalabaer25 am 10.05.07 19:46:00

Das Geld wird laut angaben bis zu den ergebnissen im 1Q 2008 reichen danach dürfte eine weitere K.E. anstehen und das hoffentlich zu wesentlich höheren kurs .

Name and Address of Beneficial Owner Amount and Nature of Beneficial Ownership (1) Percent of Class (2)

Anthony J. Cantone (3)

2,025,759

14.7%

Dr. Jack H. Kessler (4)(5)
925,233
7.0%

Paul C. Desjourdy (4)(6)
925,200
6.9%

Richard M. Lilly (7)
638,202
5.0%

Dr. James C. Richards (4)(8)
224,951
1.8%

Eugene Lieberstein (4)(9)
123,618
*



Overview

IoGen

Despite the fact that our commercialization partner for the IoGen™ program, Gardent Pharmaceuticals, Inc. (formerly known as Bioaccelerate Holdings, Inc.), was not able to meet their financial obligations to fund the IoGen pivotal Phase III clinical trial, we made significant progress toward completing the enrollment for the IoGen Phase III study. By the end of 2006, we had randomized approximately half of the 130 patients for the Phase III study. Through financings completed during the summer and winter of 2006, we raised over $3.5 million of additional funding. These resources should allow us to complete the patient enrollment for the Phase III pivotal clinical trial evaluating IoGen for the treatment of cyclic mastalgia (pain and tenderness) associated with fibrocystic breast disease. We now expect to complete the enrollment during the second quarter of 2007. The results for the IoGen pivotal clinical trial should then be available in the first quarter of 2008.

Because Gardent was not able to meet their financial obligations under their arrangement covering IoGen, in August 2006 the parties mutually agreed to terminate their exclusive worldwide licensing and co-marketing agreement covering the use of IoGen for the treatment of pain and tenderness associated with fibrocystic breast disease. Upon termination of the agreement all rights to IoGen licensed to Gardent in the agreement reverted back to Symbollon.

During 2006, independent scientific data was published focusing on the possible use of molecular iodine, the active agent in IoGen, to treat breast cancer. The results of such research identified molecular iodine as a possible treatment for breast cancer. This research recommends the initiation of human clinical trials testing molecular iodine as an adjuvant therapy for breast cancer. We intend to pursue this possible use for IoGen in the future.

Product Pipeline

Two significant events occurred to help advance our business strategy to develop a family of safe, broad-spectrum antimicrobial products based on our proprietary free molecular iodine platform technology that will eradicate pathogens without drug resistance. First, we received regulatory guidance from the FDA concerning the appropriate preclinical steps necessary to initiate human clinical trials for our new drug, Nasodine™. The FDA has requested that Symbollon conduct a 30-day repeat dose animal study prior to filing an investigational new drug (IND) application to evaluate Nasodine for the elimination of drug-resistant strains of Staphylococcus aureus (Staph), like methicillin-resistant Staph (MRSA), in the nasal cavity. With the increasing threat of the spread of multi-drug resistant “superbugs”, we anticipate that Nasodine will help eradicate these disease-causing pathogens.

Nasodine represents a safe alternative to existing antibiotics which are suffering from ever decreasing effectiveness due to resistance. In America alone, every year about 2 million people acquire bacterial infections while in the hospital and approximately 90,000 of them die as a result, according to the Centers for Disease Control and Prevention in Atlanta. Staph is one of the key pathogens causing those infections, and subsequent deaths. While Staph is often found on human skin, one of its preferred habitats is the nasal cavity. Today, the only approved product to eliminate Staph in the nose is an antibiotic. Unfortunately, there is limited use of this product in the healthcare system because of the fear of resistance. Therefore, Staph-based infections continue to rise. Nasodine has the advantage that it can be used prophylacticly without fear of drug resistance. The need for Nasodine is real; it has been estimated that every patient hospitalized with a Staph infection cost the healthcare system about $14,000. In an ideal world, all at-risk patient populations and health care workers would utilize Nasodine to help eliminate the chance of infections. Some of the at-risk patient populations include HIV, surgical and hemodialysis patients. Symbollon believes the market opportunity for Nasodine could exceed $200 million annually.

The second key advancement occurred when we filed a patent application covering use of our free molecular iodine technology to eradicate pathogens and inhibit superantigens from activating immune cells in the upper respiratory tract. This expanded coverage for our technology protects its use to block the ability of Staph superantigens from binding to lymphocytes inside the upper respiratory tract. We believe that the ability to block superantigens T-cells induction of the immune reaction may minimize or inhibit massive cytokine release and thereby minimize or inhibit the severe reactions observed in asthma, sinusitis and rhinitis.

Our business strategy is to build a strong, opportunistic pipeline of drugs based on our proprietary platform technology. Our healthcare system is under attack as antibiotics become increasingly ineffective in dealing with bacterial infections. We believe that our free molecular iodine technology can play a significant role in eradicating various types of infections based on its superior microbial characteristics. Our technology has the ability to safely kill all known forms of pathogens with no drug resistance. We estimate that these new products will address potential market opportunities worth billions of dollars. With the combination of our new family of antimicrobial products and IoGen, our treatment for fibrocystic breast disease in pivotal phase III clinical trials, we truly believe the future is bright for Symbollon, and its shareholders.

[BrauchGeld]

Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals, stated, "That the new web site should be a valuable tool for women throughout the country providing educational information to assess their condition. Symbollon believes that the internet offers a unique opportunity to attract women to its ongoing Phase III study for IoGen™ for the initial indication of breast pain associated with fibrocystic breast disease. In the site's first few weeks of existence, several women have been identified for possible inclusion in the study. We are expecting to complete patient enrollment during the first half of 2007."

http://www.mybreastpain.com/

Symbollon is seeking volunteers to participate in a Phase III clinical trial. The trial is designed to evaluate the effectiveness of a novel iodine-based drug, IoGen, in treatment of moderate or severe breast pain associated with fibrocystic breast disease (FBD). There are scientific data that explore the relationship between iodine and mammary tissue. At least three previous human clinical studies indicate that iodine can effectively treat the symptoms associated with FBD.

Participants will receive either a trial drug or placebo pill (which contains no active medication) for 6 months. Participation in the study will require 2 initial screen visits, qualified participants will be asked to schedule 6 more study visits and to complete a short daily pain diary while they are in the study. Participants will be compensated for the time and travel.

WHAT IS CLINICAL BREAST PAIN?
Breast pain, or mastalgia, in most cases is a benign breast syndrome. Survey data suggested that about 65% of premenopausal women regularly experience up to 4 days of breast pain, tenderness and/or swelling during menstrual cycle. Breast pain may be associated with the menstrual cycle (cyclic mastalgia) or not (non-cyclic mastalgia). Physicians recognize two types of cyclic breast pain based on pain severity and length: symptomatic pain, which is considered “normal” and lasts up to 4 days, and “clinical” which is more severe, prolonged (6 days and longer) type of pain. Cyclic breast pain occurs in both breasts and it may differ from month to month but always gets worse before a period and it may be associated with breast lumps and/or breast thickening, sometimes referred to as FBD.
Women most frequently describe their breast discomfort as: sharp shooting pain, dull aching pain, pain from movement and pain from pressure. Commonly women can not perform some or all of their everyday, normal activities, they can not hug their loved ones, their breasts are very painful when anything touches them, and analgesics do not relieve such pain.

The causes of breast pain are not well understood, however, the most reasonable explanation of breast pain is subtle hormonal imbalance.

WHAT IS FIBROCYSTIC BREAST DISEASE?
Fibrocystic breast disease (FBD) is benign (non-cancerous) changes in the tissues of the breast. The condition is so commonly found in breasts, it is believed to be a variation of normal; therefore many clinicians consider the term "disease" to be misleading and prefer to use term "change". It is estimated that more than 60% of women between the ages of 30 and 50 will experience such change during their lifetime. Symptoms of FBD include: a dense, irregular and lumpy "cobblestone" consistency of the breast tissue; periodic or persistent breast discomfort; fullness of breast(s); dull, heavy pain and tenderness; premenstrual tenderness and swelling. Symptoms typically peak just before each menstrual period, and improve immediately after the menstrual period.
Women often discover the existence of this condition when during their monthly breast self-exam. As frightening as it may be it's important to remember that most breast lumps are not breast cancer. However, all breasts lumps must be investigated to rule out breast cancer and/or to begin immediate treatment if breast cancer is diagnosed.

The cause of FBD is not completely understood, but the changes are believed to be associated with ovarian hormones since the condition usually subsides with menopause, and may vary in consistency during the menstrual cycle. There is no safe and effective treatment for FBD. Oral contraceptives and synthetic androgen may be prescribed in severe cases, when the potential benefit is thought to outweigh the potential adverse effects. The effectiveness of Vitamin E, Vitamin B-6, herbal preparations, such as evening primrose oil, and dietary changes are somewhat controversial and have been questioned in recent randomized trials.

[BrauchGeld]

http://www.encyclopedia.com/doc/1Y1-99744600.html

Research Calls for Use of Molecular Iodine to Treat Breast Cancer

From: MARKET WIRE | Date: 10/31/2006

Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) today provided a review of recent independent scientific publications focused on the possible use of molecular iodine, the active agent in Symbollon's drug, IoGen(TM), to treat breast cancer. The results of such research identify molecular iodine as a possible treatment for breast cancer. This research recommends the initiation of human clinical trials testing molecular iodine as an adjuvant therapy for breast cancer.

"We believe that the current research provides substantive support for the initiation of human clinical studies on the use of molecular iodine as a treatment for breast cancer," stated Paul Desjourdy, the President and CEO of Symbollon Pharmaceuticals, Inc. "The possibility that IoGen may be used as a treatment for breast cancer makes it all the more important that Symbollon expedite the commercialization timeline for IoGen."

Past studies by independent researchers have supported the possible effectiveness of molecular iodine as a treatment for breast cancer. The key unknown has been the process through which molecular iodine works. Recent research has uncovered important new insights into the mechanism of action of molecular iodine. For example, researchers at Drexel University College of Medicine have been investigating the biochemical pathways of iodine metabolism in the breast. Their most recent work demonstrates that molecular iodine alters the gene expression profile in the human breast cancer cells (MCF-7). Dr. Bernard Eskin remarked that "these changes may be responsible for molecular iodine's inhibition of breast cancer promotion" that has been repeatedly observed in animal models.

Dr. Carmen Aceves of the department of Physiology at the University of Mexico has studied the differences between iodide and molecular iodine. In Dr. Aceves' studies, virgin Sprague-Dawley rats received short or continuous treatment with either molecular iodine or iodide and the induction and promotion of mammary cancer was evaluated. Rats that were treated with molecular iodine continuously exhibited a substantially lower rate of mammary cancer (30%) compared to rats treated with iodide (72.7%). Dr. Aceves concluded that continuous molecular iodine treatment has a "potent antineoplastic effect" on the progression of mammary cancer. An upcoming manuscript by Dr. Aceves compares the uptake and antiproliferative effect of molecular iodine versus iodide in human breast cancer cells (MCF-7). In contrast to iodide, which depends entirely on the sodium/iodide symporter protein (NIS) for uptake into cells, the uptake of molecular iodine occurred by facilitated diffusion and was independent of NIS. Iodine was incorporated into protein and lipid fractions only when molecular iodine was administered, and the administration of molecular iodine had an anti-proliferative effect on the growth of MCF-7 cells that was not exhibited with iodide. Dr. Aceves concluded that "molecular iodine treatment should be tested in clinical trials as an adjuvant of breast cancer therapy."

Some researchers have been investigating the connection between certain well understood observations regarding breast tissue and iodine. It has been observed that frequent childbirth and a long lactation period are known to reduce the risk of breast cancer. Elevated dietary intake of iodine is also associated with a reduced risk of breast cancer. These associations have intrigued scientists since the absorption of iodine in the breast occurs in the same ductal epithelium where the majority of breast cancers arise. There is at least one common factor that may link these two observations. During late pregnancy and lactation the proteins that transport (NIS) and oxidize (LPO) iodide are very active in mammary tissue. Recent research has allowed scientists to place these observations into a model that demonstrates how iodine could impact breast cancer risk.

During the past decade researchers at Mount Sinai Medical School in New York have demonstrated that the protein that transports iodide (NIS) into breast cells is over-expressed in 80-90% of human breast cancers. Molecular iodine is formed when iodide is oxidized; however, the lactoperoxidase protein (LPO) that oxidizes iodide in breast cells during pregnancy is rarely expressed in human breast cancer cells. Recently, Dr. Keisuke Iwamoto of the David Geffen School of Medicine at UCLA has shown that both proteins (NIS and LPO) must be present for iodine to induce apoptosis (death) in cancer cells. Dr. Iwamoto concluded that unless iodide is oxidized it can serve to enhance the growth of breast cancer cells. This observation is consistent with earlier research at the Geffen School of Medicine which showed that both NIS and LPO must be present to kill non-small lung cancer cells. The observations are also consistent with the conclusions drawn by Godbole and coworkers who studied molecular iodine induced apoptosis in MCF-7 cells and concluded that molecular iodine activates a caspase-independent and mitochondria-mediated apoptotic pathway.

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http://findarticles.com/p/articles/mi_m0ISW/is_256/ai_n62588…

Iodine treatment of fibrocystic breast disease
Townsend Letter for Doctors and Patients, Nov, 2004 by Alan R. Gaby

One hundred-eight women with fibrocystic breast disease were treated with a preparation containing molecular (diatomic elemental) iodine at a dose of 0.08 mg per kg of body weight per day orally for nine months. Ninety-eight percent of the women were pain-free by the end of the study and objective improvement was seen in 71.8% of cases. Sixty-five percent of the women had a reduction in breast size coincident with clinical improvement. In a larger series of women (n = 1,365) treated with molecular iodine, side effects (usually minor) occurred in 10.9% of cases; these included acne, nausea, diarrhea, hair thinning, hyperthyroidism (0.1% incidence), hypothyroidism (0.3% incidence), skin rash, headache, or transient increase in breast pain (5.7% incidence).

Two other groups of women were treated with Lugol's solution (a preparation containing 95% sodium iodide and 5% free iodine) and iodized casein, respectively. The response rate with Lugol's solution was 70%, and with iodized casein was 40%. Molecular iodine was associated with a lower incidence of thyroid dysfunction than the other preparations.

Comment: Fibrocystic breast disease is one of the most common health problems in women. Although the symptoms are frequently minor, some women experience debilitating pain and discomfort. Treatments that are often effective include complete avoidance of dietary caffeine and other methylxanthines and supplementation with 400 to 800 IU per day of vitamin E. There are anecdotal reports that thiamine supplementation (100 mg per day) is also beneficial.

For women who do not respond to these treatments, oral iodine preparations are an important option. The molecular iodine used in the current study is not commercially available, but a compounding pharmacist should be able to make a similar preparation. Lugol's solution is readily available, but it has a lower success rate and causes a higher incidence thyroid dysfunction than does molecular iodine. Thyroid function should be monitored periodically in people taking pharmacological doses of iodine or iodides. Side effects may include metallic taste, excessive salivation, runny nose, and skin rash.

[BrauchGeld]

Symbollon Pharmaceuticals Announces First Quarter 2007 Results
Tuesday May 15, 4:41 pm ET


"We have made substantial progress in the completing the enrollment of the IoGen Phase III study, with 100 patients randomized to date and an additional 40 patients currently enrolled in the screening process," stated Paul C. Desjourdy, President and Chief Executive Officer of Symbollon. "Based on the progress we have made, we plan to end the enrollment of the study on June 15th. The results of the IoGen Phase III clinical trial should then be available in the first quarter of 2008."

[BrauchGeld]

ältere infos........

http://www.symbollon.com/video/iogen128.mpg

http://www.symbollon.com/video/tn_jan2006_interview.wmv


Posted on: Wednesday, 22 December 2004, 12:00 CST

Symbollon Initiates Phase III Fibrocystic Breast Disease Pivotal Clinical Trial for IoGen; Company To Build Upon Successful Phase II Study As Patient Enrollment Begins in January
Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) today announced it has begun a multi-center Phase III pivotal clinical trial of its proprietary iodine-based oral drug, IoGen(TM), in patients with moderate to severe periodic breast pain associated with symptomatic fibrocystic breast disease (FBD). The randomized, double-blind, placebo-controlled, single-dose study will evaluate the clinical effects of IoGen. The study will include about 175 euthyroid, premenopausal women who are unresponsive to conservative treatment.

Patients will receive one 6.0 mg tablet of IoGen or placebo daily for six months. The primary objective of the study is the evaluation of efficacy of IoGen by comparing the proportion of patients in the treatment and placebo groups that experience a clinically meaningful reduction in breast pain and tenderness, as measured with patient self-assessment daily diary data after therapy for 6 months. Nodularity will be used as a secondary efficacy endpoint. Nodularity will be evaluated by physicians' assessment.

Fibrocystic breast disease is a benign breast condition affecting approximately thirty percent of the women of childbearing age, which represents in the United States over 20 million women. Believed to be caused by a hormonal imbalance, fibrocystic breast disease is characterized by breast pain, lumpiness or tenderness. Publications covering previous independent third party testing utilizing iodine to treat collectively over 1,500 women with fibrocystic breast disease have reported 60% or greater clinical improvement in their breast disease. Symbollon's previous Phase II clinical trial evaluating IoGen for the treatment of FBD achieved a statistically significant reduction of patient's pain and tenderness for the 6 mg dose group compared to placebo.

Dr. Jack Kessler, the Chief Executive Officer of the Company, said that "The purpose of this trial is to establish the effectiveness of IoGen in a pivotal trial setting. Based on our two previously successful molecular iodine Phase II studies, we are confident that we can replicate these favorable outcomes in our Phase III study."

Dr. Kessler further noted that "As part of this study the Company anticipates that certain sites will be performing tests to measure for the presence of iodinated arachidonic acid derivatives in the breast duct fluid of patients. The presence of these antiproliferative iodolipods could help explain how IoGen eliminates benign excess cell growth in women's breast and open the door to further testing to establish IoGen as a possible breast cancer treatment and/or preventative."

The Company anticipates that the trial will take about 12 months to complete and will cost approximately $1.25 million to conduct.

[BrauchGeld]

Symbollon Pharmaceuticals Receives Regulatory Guidance From the United Kingdom
Wednesday May 30, 10:54 am ET


FRAMINGHAM, MA--(MARKET WIRE)--May 30, 2007 -- Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB - News) announced that representatives from the company recently met with the United Kingdom regulatory authorities (the MHRA) seeking their input and guidance regarding the nonclinical and clinical issues on the development of IoGen(TM) as a treatment for moderate to severe cyclic breast pain and tenderness associated with fibrocystic breasts.

Based on a review of Symbollon\'s ongoing clinical development program in the United States, the MHRA concurred with the indication for IoGen focused on symptomatic relief of moderate or severe pain and tenderness in patients with cyclic mastalgia. They also agreed with the use of placebo-controlled studies. This will allow Symbollon to submit its ongoing Phase III study in support of regulatory marketing approval.

\"The United Kingdom has been at the forefront in researching and treating patients with breast pain and tenderness. Their receptiveness to placebo-controlled trials for IoGen is indicative that there are currently no safe and effective treatments available to women suffering from this condition,\" said Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals.

Based on the MHRA comments, and consistent with the guidance from the FDA, Symbollon plans to submit the Mimetix data as part of its clinical data package required to meet the ICH Guidelines for human exposure. The MHRA did not request any additional animal studies be undertaken by Symbollon prior to its planned regulatory submission in 2009.

\"Based on this input and guidance, coupled with the other countries we have spoken with, the IoGen program remains on target to submit for regulatory approval in the United States and Europe in 2009. With the enrollment of the ongoing Phase III pivotal trial for IoGen closing shortly, we anticipate the public release of the data from that trial in the first quarter of 2008,\" remarked Mr. Desjourdy.

[BrauchGeld]

Symbollon Pharmaceuticals Closes Enrollment of Phase III Pivotal Trial for IoGen
Tuesday June 19, 9:58 am ET


Results to Be Published in First Quarter 2008


FRAMINGHAM, MA--(MARKET WIRE)--Jun 19, 2007 -- Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB - News) today announced the closing of patient enrollment in its IoGen(TM) Phase III pivotal trial. The study, being conducted by physicians throughout the U.S., is designed to evaluate the effectiveness of IoGen, a treatment which may be the first FDA-approved, non-hormonal therapy for moderate to severe cyclic pain and tenderness (clinical mastalgia) associated with fibrocystic breast disease (FBD).

With enrollment closed there are 115 patients randomized to date and an additional 30 patients currently enrolled in the screening process. The study's enrollment is in line with Symbollon's target to randomize 130 patients in the study. The results of the study should be available in the first quarter of 2008.

"We are extremely pleased to have accomplished this important milestone in the clinical progress of IoGen," said Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals. "Prior to this study, we had collected clinical data on approximately 3,000 women with FBD. Based on that significant clinical data, we look forward to the outcome of this study."

[BrauchGeld]

Cobalis hat versagt aber vielleicht wird Symbollon mich glücklicher machen.

[ComMOD [Mod]]

Thread wurde auf Wunsch eines Users reaktiviert.

ComMOD

[StaatsKnecht]

Antwort auf Beitrag Nr.: 33.598.862 von ComMOD am 10.03.08 16:26:13

Danke ComMOD !

Phase 3 ergebnisse für diesen monat geplant....könnte ein interessanter zock werden


Symbollon Pharma (Symba.ob)

Marketcap: 8,6 million $
Shares Outstanding : 15 million
Price: 0,57$

Massive Insider activity
http://www.nasdaq.com/asp/quotes_sec.asp?mode=&kind=&timefra…

http://finance.yahoo.com/q/it?s=SYMBA.OB

Symbollon Pharmaceuticals Signs Term Sheet to Acquire Chinese Pharmaceutical Company
Monday March 10, 10:25 am ET
http://biz.yahoo.com/iw/080310/0372651.html

Hotchicksstockpicks.com
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Results of Pivotal Study to Be Published in March 2008

Symbollon Pharmaceuticals Completes Phase III Pivotal Trial for IoGen
Thursday February 7, 12:28 pm ET

FRAMINGHAM, MA--(MARKET WIRE)--Feb 7, 2008 -- Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB - News) today announced the completion of its IoGen(TM) Phase III pivotal trial. The study, conducted by physicians throughout the U.S., is designed to evaluate the effectiveness of IoGen, a treatment which may be the first FDA-approved, non-hormonal therapy for moderate to severe cyclic pain and tenderness (clinical mastalgia) associated with fibrocystic breast disease (FBD).

With the last of the 140 patients randomized in the trial having completed the dosing stage of the study, Symbollon is focused on closing the database. The Company anticipates that the database will be locked in March 2008 and plans to release the trial results at that time.

"We believe that the release of the Phase III data will be the most significant milestone in Symbollon's history," said Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals. "Prior to this study, we had collected clinical data on approximately 3,000 women with FBD. The current Phase III study will help determine whether IoGen can be commercialized as the first non-hormonal drug approved to treat women suffering from FBD."

Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB - News) is a specialty pharmaceutical company focused on the development and commercialization of proprietary drugs based on its molecular iodine technology. Symbollon is conducting a Phase III clinical trial evaluating IoGen as a potential treatment for moderate to severe periodic pain and tenderness (clinical mastalgia) associated with fibrocystic breast disease (FBD). FBD is a condition that affects approximately 20 to 33 million women in the U.S., and there are approximately 7 to 13 million women suffering from clinical periodic mastalgia. The Company believes IoGen also may be useful in treating and/or preventing endometriosis, ovarian cysts, and premenopausal breast cancer. Symbollon is also in preclinical development of antimicrobial products based on the same molecular iodine technology, and intends to investigate the potential effectiveness of its technology in applications such as dermatology, oral care, upper respiratory tract conditions, urinary tract infection and wound care. For more information about Symbollon, please visit the company's website at http://www.symbollon.com.

[StaatsKnecht]

http://www.symbollon.com/SYMBA%20TEAR%20SHEET%20REVISION%201…

INVESTMENT HIGHLIGHTS
•Unique platform technology with multiple drug opportunit ies.
•IoGen could be 1st non-hormonal breast cancer agent.
•IoGen Phase III pivotal data first quarter 2008.
•New compound to enter clinical trials in 2008.

MARKET OPPORTUNITY
Approximately 30 million American women suffer from fibrocystic breast disease (FBD), many of whom endure severe and disabling pain. Eight clinical trials have been completed with 3,000+ patients exposed to the active agent. Phase II clinical data indicates IoGen is an effective therapy for treatment of FBD.Phase III pivotal trial results are anticipated during the 1stquarter 2008
The company believes that the U.S. market opportunity for IoGen as a treatment for FBD could exceed one billion dollar of annual sales. Together with the additional potential indications for IoGen, including breast cancer, Symbollon anticipates IoGen will be a break-through drug in women’s health. Upon receipt of the Phase III study results, Symbollon intends to license the global marketing rights to IoGen.