SOURCE: Symbollon Pharmaceuticals, Inc.

August 02, 2006 09:53 ET

Symbollon Receives Regulatory Guidance for Development of Products in Upper Respiratory Tract

FRAMINGHAM, MA -- (MARKET WIRE) -- August 2, 2006 -- Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) is pleased to announce it has received regulatory guidance concerning the appropriate preclinical steps necessary to initiate human clinical trials for its new drug, Nasodine™. After discussions with the FDA, the company is planning to conduct a 30-day repeat dose animal study prior to filing an investigational new drug (IND) application in 2007. Nasodine is a proprietary formulation designed to eliminate drug-resistant Staphylococcus aureus (Staph) in the nasal cavity. Symbollon believes the market opportunity for Nasodine could easily be in the hundreds of millions per year.

Part of Symbollon's business strategy is to develop a family of safe, broad-spectrum antimicrobial products based on its proprietary free molecular iodine platform technology that will eradicate pathogens without genetic drug resistance. With the increasing threat of the spread of multi-drug resistant "superbugs," Symbollon anticipates that its new line of products will help eradicate these disease-causing pathogens. This new line of products represents a safe alternative to existing antibiotics which are suffering from ever decreasing effectiveness due to genetic drug resistance. The company is considering antimicrobial product opportunities for the upper respiratory tract, oral cavity and skin.

"We are pleased to have received guidance from the FDA regarding the appropriate preclinical activities necessary to initiate human clinical studies on Nasodine," commented Paul Desjourdy, the President and CEO of Symbollon Pharmaceuticals, Inc. "We believe the healthcare system is in need of a product that can be used to prevent Staph infections caused by contaminated nasal cavities. In America alone, every year about 2 million people acquire bacterial infections while in the hospital and approximately 90,000 of them die as a result, according to the Centers for Disease Control and Prevention in Atlanta. Staph is one of the key pathogens causing those infections, and subsequent deaths. Nasodine has the unique advantage that it can be used prophylacticly without fear of genetic drug resistance. In an ideal world, all at-risk patient populations and health care workers would utilize Nasodine to help eliminate the chance of infections. Some of the at-risk patient populations include HIV, surgical and hemodialysis patients."

About Symbollon Pharmaceuticals, Inc.

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.

Forward-Looking 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, (vii) the Company's partner for IoGen will be able to meet its financial obligation to pay for the IoGen clinical development and (viii) such other factors as may be disclosed from time-to-time in the Company's reports as filed with the Securities and Exchange Commission.

Contact Information

  • CONTACT:
    Paul C. Desjourdy
    President and CEO
    Symbollon Pharmaceuticals, Inc.
    (508) 620-7676, x202
    www.symbollon.com

    Heather Kerwin
    Investor Relations
    Premier Funding & FMS
    480 648-8224
    hkerwin@premierfundingservice.com

    Symbollon Pharmaceuticals, Inc.
    37 Loring Drive
    Framingham, MA 01702
    Phone: (508) 620-7676
    Fax: (508) 620-7111