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SYMBA @ .193!
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SYMBA @ .18!
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SYMBA second round, Tin Tin Tin!!
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Symbollon Pharmaceuticals, Inc.
37 Loring Drive
Framingham, MA 01702
Outstanding Shares
16,473,340 as of Aug 13, 2008
Massive Insider activity
http://www.nasdaq.com/asp/quotes_sec.asp?mode=&kind=&timeframe=&intraday=&charttype=&splits=&earnings=&movingaverage=&lowerstudy=&comparison=&index=&symbol=SYMBA&symbol=PP&symbol=DNDN&symbol=PRAN&symbol=ALSE&symbol=EPCT&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&FormType=&mkttype=&pathname=&page=filings&selected=SYMBA
http://finance.yahoo.com/q/it?s=SYMBA.OB
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).
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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.
Symbollon Pharmaceuticals, Inc. (OTC BB: SYMBA) 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 (I2) for pain/tenderness associated with fibrocystic breast disease (FBD) and/or with potential to treat cancer. Enrollment for the study closes at the end of June 2007 and results are expected to be published in Q1 2008.
The Company believes IoGen has the ability to eliminate excess cell growth in female reproductive tissue, including the breast, ovaries and uterus. Other indications for IoGen include the treatment and/or preventing endometriosis, ovarian cysts, and pre-menopausal breast cancer. The company has 25 patents in the US, with foreign counterparts, covering the technology.
While there are several breast cancer drugs on the m arket, all available hormonal therapies have significant adverse effects. In contrast, IoGen is a non-hormonal treatment that allows for safe long-term use with little or no sides effects. In fact, in the last Phase II study of IoGen there were no drug-related adverse events reported.
“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, 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 time line for IoGen.”
Recent Developments
Symbollon announced that it would seek regulatory guidance in commercialization of IoGen in Europe. The company targeted The United Kingdom, Germany and Sweden. Symbollon has met with representatives of these regulatory bodies and has received guidance and comments, which should accelerate the commercialization of IoGen in Europe. The Company has also met with Canadian regulators and has received consistent comments that will allow for a regulatory filing after completion of the planned clinical trials.
In addition, Symbollon Pharmaceuticals announced that it is closing the enrollment of its IoGen Phase III pivotal pain study in June 2007 and anticipates announcing the study results in first quarter of 2008. The ongoing IoGen study has over 25 active sites across the United States. The study has been registered with FDA under the Protocol Registration System at ClinicalTrials.gov.
About IoGen
Symbollon has initiated a pivotal 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 characterized by benign excess cell growth (fibrosis) and mastalgia. Benign fibrosis is a chronic condition that affects approximately 20 million to 33 million women in the U.S. In addition, there are approximately 7 million to 13 million women suffering from clinical cyclic mastalgia.
Product Focus
Symbollon’s free molecular iodine technology has potential uses in a number of application areas, which can be broadly grouped into two areas: women’s healthcare (as mentioned above) and antimicrobial applications.
Symbollon is in preclinical development of antimicrobial 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.
Symbollon has commercialized one animal drug, a bovine teat sanitizer, for use on the dairy farms to disinfect cow’s udders. The product is a powdered concentrate that delivers high levels of molecular iodine for fast and effective elimination of all pathogens.
