FRAMINGHAM, Mass., Nov. 16, 2004 (PRIMEZONE) -- Symbollon Pharmaceuticals, Inc. (OTCBB:SYMBA) today provided an update on its efforts to seek regulatory approval for IoGen(tm) in Canada.
Symbollon recently met with Canadian regulatory authorities seeking their input and guidance regarding submission of a New Drug Submission covering the use of IoGen(tm) as a treatment for moderate to severe cyclic breast pain and tenderness associated with fibrocystic breast. Based on the guidance received from the Canadian regulatory authorities, Symbollon plans to seek marketing approval for IoGen once it has exposed at least 500 patients to IoGen. Since the applicable regulatory guidelines usually require 1,500 patients be exposed to a drug, the requirement for 500 additional patients provides Symbollon with substantial relief from the applicable guidelines.
Paul Desjourdy, President of Symbollon Pharmaceuticals commented, "It is important for us to get clarification from Health Canada regarding the data required to make a submission for IoGen. We plan to aggressively pursue the collection of the remaining data required for approval. In fact, we are ready to initiate our first Phase III pivotal trial for IoGen."
Symbollon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary drugs based on its molecular iodine technology. Symbollon already has completed Phase I and II clinical trials 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 endometriosis, ovarian cysts, and premenopausal breast cancer.
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 complete the development process for IoGen and to continue its operations, (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 (including with respect to IoGen) 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. Given these uncertainties, current or prospective investors are cautioned not to place undue reliance on any such forward-looking statements.