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ActivBiotics Receives Orphan Drug Designation from the European Medicines Agency for Superoxide Dismutase Mimetic, M40403, in Oral Mucositis Indication


2/5/2008 7:30:12 AM

WELLESLEY HILLS, Mass., Feb. 5 /PRNewswire/ -- Joseph F. Finn, Jr., CPA, the Assignee for the Benefit of Creditors of ActivBiotics, announced today that The Committee for Orphan Drug Products of the European Medicines Agency (EMEA) has granted Orphan Drug Designation for M40403 for the prevention of oral mucositis (OM) in head and neck cancer patients receiving radiotherapy.

The development of oral mucositis during radiation therapy of head and neck cancers is the major reason for poor compliance with and early discontinuation of radiation therapy by patients being treated for their condition.

European Union Orphan Drug Designation was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect not more than 5 in 10,000 persons in the European Union. Orphan Drug Designation provides an important economic incentive for the development of new products in the cancer field. EU Orphan Designation provides for 10 years of market exclusivity, reduction in EU regulatory fees, and additional regulatory support for R&D initiatives.

ActivBiotics has also applied for Orphan Drug Designation with the U.S. Food and Drug Administration.

About M40403

This investigational small molecule mimics the action of a natural component of the cells, an enzyme called superoxide dismutase. Superoxide dismutase is thought to have a double effect, first through the reduction of inflammation, and secondarily through the decreased rate of programmed cell death (apoptosis). As mucositis involves inflammation, the positive effect of the M40403 over this process is expected to have a beneficial effect in the condition. M40403 has shown efficacy in an animal model where oral mucositis was induced by acute irradiation. The compound has been evaluated in approximately 700 subjects in several Phase I and II clinical trials, and was shown to be safe and well-tolerated.

About Oral Mucositis

Oral mucositis is a side effect experienced by cancer patients undergoing chemotherapy or radiation therapy. There are approximately 140,000 head and neck cancer patients in the European Union; patients receiving radiation therapy are at risk of developing oral mucositis. In addition to killing tumor cells, radiation therapy also adversely affects surrounding tissues including the inner lining (mucosa) of the mouth. The resulting "oral mucositis;" is the number one patient-reported debilitating side effect of cancer therapy. The condition is debilitating, resulting in ulcers, severe pain, dryness of the mouth, and inability to swallow. Oral mucositis often leads to breaks in antineoplastic therapy. Currently, there are no satisfactory methods for the treatment of oral mucositis in patients with solid tumors in the European Union.

About ActivBiotics

ActivBiotics is currently in the process of selling its proprietary assets, including M40403, through an Assignment for the Benefit of Creditors. The bidding for the assets, which may be purchased separately or in combination, will be conducted on March 14, 2008. Any person interested in purchasing the assets or learning more about the bidding process should contact Mr. Joseph F. Finn, Jr., CPA.

Bidding packages, which contain technical information and the terms of sale, have been assembled and are ready to be distributed subject to a potential purchaser entering into a standard form confidentiality agreement.

Request for Further Information

Interested parties can obtain a bidder's package by contacting Joseph F. Finn, Jr., CPA (jffinnjr@earthlink.net, phone 781-237-8840), Finn, Warnke & Gayton, 167 Worcester Street, Suite 201, Wellesley Hills, MA 02481-3613. For technical information or questions regarding the products, please contact Christo Shalish, cshalish@activbiotics.com.

CONTACT: Joseph F. Finn, Jr., CPA of Finn, Warnke & Gayton for
ActivBiotics, +1-781-237-8840, jffinnjr@earthlink.net

Web site: http://www.activbiotics.com//



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