SOURCE: Symbollon Pharmaceuticals, Inc.

October 20, 2005 11:01 ET

Symbollon Pharmaceuticals, Inc. to Start Study Focused on Proliferative Benign Breast Tissue

IoGen May Help Reduce Incidence of Breast Cancer in This at-Risk Patient Population

FRAMINGHAM, MA -- (MARKET WIRE) -- October 20, 2005 -- Symbollon Pharmaceuticals, Inc. (OTC BB: SYMBA) today announced its intention to start a clinical trial that will focus on the treatment of patients with proliferative benign breast disease. The open-label, single-center study will evaluate the clinical effects of IoGen™, an oral dosage form of Symbollon's proprietary molecular iodine technology, in about 20 women.

Patients will receive one 6.0 mg tablet of IoGen daily for one year. The primary objective of this study is the evaluation of the effect of IoGen in patients who have benign proliferative breast disease. The response of the mammary gland to IoGen will be objectively evaluated using PET tomography scanner. PET scan imaging will allow the physician to directly evaluate the effect of IoGen on the metabolic status of the proliferative benign breast tissue.

Dr. Jack Kessler, the Chief Scientific Officer of Symbollon, said that "In a recent study conducted at the Mayo Clinic it was determined that benign breast diseases are an important risk factor for breast cancer. That study indicated that women with proliferative benign breast disease experienced an increased risk of breast cancer for up to 25 years. Recent scientific publications have identified molecular iodine, IoGen's active agent, as an inducer of antiproliferative and apoptotic mechanisms through the formation of iodolactones. The purpose of this pilot study is to investigate the antiproliferative actions of IoGen in this at-risk group of women. If IoGen can reduce tissue proliferation, the incidence of breast cancer in these women may be diminished."

The study will be conducted by Mitchell Levy, M.D., F.A.C.S., at his breast clinic (The Breast Center, Inc.) in Plantation, FL. "Women with proliferative benign breast tissue need to be carefully monitored for any changes in their breast histology," stated Dr. Levy. "If a drug reduces or eliminates proliferative breast tissue it may have a positive effect on the risk of breast cancer in women with proliferative benign breast disease."

About IoGen

IoGen is an oral dosage form of Symbollon's technology, which generates molecular iodine in situ in the stomach of the patient. IoGen is presently in Phase III clinical trials for the treatment of moderate to severe periodic breast pain and tenderness (mastalgia) associated with fibrocystic breast disease (FBD). FBD is a benign breast condition characterized by lumpiness, breast pain and tenderness. FBD affects approximately 30 to 50% of the women of childbearing age, which represents about 20 to 33 million women in the United States. It has been estimated that moderate to severe mastalgia occurs in approximately 11 to 20% of the women of childbearing age, or about 7 to 13 million women in the United States.

About Symbollon 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 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. For more information about Symbollon, visit the company's website at

Symbollon Safe Harbor 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.

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