Published: October 20, 2005
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
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(TM), 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 http://www.symbollon.com.
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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