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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

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

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.

About 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 Phase III trials for IoGen and the other clinical development activities related to 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.

Source: Business Wire

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