Boston - FRAMINGHAM -- Symbollon Pharmaceuticals, Inc. announced today that they have initiated a two-year carcinogenicity study in Sprague Dawley rats for IoGen. This toxicity study is intended to probe the possible effects on rodents of supraphysiological doses of IoGen. In the study, the animals will be given doses up to approximately 100 times the equivalent human dose being taken in the ongoing Phase III pivotal study for IoGen. The protocol for the two-year study has completed a special protocol assessment review by the FDA.
Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals, commented that, "Initiating the CARC study now is an important step toward meeting the Company's planned United States regulatory submission covering IoGen for the treatment of breast pain associated with fibrocystic breasts in 2009."
In preparation of the two-year CARC study, Symbollon previously conducted a dose-ranging study in rodents for the purpose of determining the appropriate doses at which to conduct the two-year study. Upon review of the dose-ranging study, the FDA provided its recommendation for the appropriate dose to carry forward into the two-year study. In the dose ranging study, no adverse effects were observed up to doses of approximately 50 times the equivalent human dose of 6.0 mg administered in the Phase III study. Since the goal of the study is to elicit an adverse response, the FDA has recommended that we increase dose levels up to approximately 100 times the human equivalent in the hope of observing some adverse responses.
About 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.