Symbollon Pharmaceuticals Completes Phase III Pivotal Trial For IoGen

Main Category: Women's Health / Gynecology
Also Included In: Pain / Anesthetics;  Clinical Trials / Drug Trials
Article Date: 11 Feb 2008 - 1:00 PDT

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Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) announced the completion of its IoGen™ 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. (OTCBB: 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 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.

Forward-Looking Statement

This news release contains statements by the Company that involve risks and uncertainties and may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including, but not limited to, the risks and uncertainties associated with whether (i) future clinical trial results will support the use of IoGen for the treatment of fibrocystic breast disease, (ii) the clinical data acquired from Mimetix Inc. will be acceptable exposure data for IoGen, (iii) Symbollon will be able to obtain the resources necessary to continue as a going concern, (iv) IoGen will successfully complete the regulatory approval process, (v) competitive products will receive regulatory approval, (vi) the Company's ability to enter into new arrangements with corporate partners and (vii) such other factors as may be disclosed from time-to-time in the Company's reports as filed with the Securities and Exchange Commission.

Symbollon Pharmaceuticals, Inc.