WELLESLEY HILLS, Mass., March 6 /PRNewswire/ -- Joseph F. Finn, Jr., CPA, the Assignee for the Benefit of Creditors of ActivBiotics, announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted Orphan Drug Designation for M40403 for the prevention of radiation -- or chemotherapy -- induced oral mucositis (OM) in cancer patients.
The development of oral mucositis is a major, debilitating side-effect in the radiation and chemotherapy of cancer. Oral mucositis is one of the main reasons for poor compliance with and early discontinuation of therapy by patients being treated for their condition. Nearly half a million patients develop oral mucositis each year across all cancer indications, and of these 90% are associated with solid tumors. Although the estimated potential of the total oral mucositis market is $1- 2 billion, this therapeutic area is one of high unmet medical need, with few successful treatment options available.
By targeting various early stage inflammatory pathways implicated in the development of oral mucositis, M40403 may have particularly unique potential as a successful therapeutic in this disorder.
FDA's Orphan Drug Act 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 200,000 persons in the United States. Orphan Drug Designation provides an important economic incentive for the development of new products in the cancer field. US Orphan Designation provides for 7 years of market exclusivity, reduction regulatory fees, and additional regulatory support for R&D initiatives.
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 pharmacologic effect during the early stages of tissue damage, 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 20-30% of cancer patients undergoing chemotherapy or radiation therapy. Patients receiving radiation therapy are at particular risk of developing oral mucositis, with essentially all cases 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. Patients with severe oral mucositis and reduced immunity, such as cancer patients receiving radio and chemotherapy, frequently develop serious opportunistic infections leading to further complications in patient care. Oral mucositis often leads to breaks in antineoplastic therapy, reducing the effectiveness of cancer treatment. In severe cases, patients will also need parenteral nutrition, and may require opiates for pain control of the mucositis. Currently, there are no satisfactory methods for the treatment of oral mucositis in patients with solid tumors in the US.
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 (email@example.com, 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, firstname.lastname@example.org.