ActivBiotics Receives FDA Orphan Drug Designation for Superoxide Dismutase Mimetic, M40403, in Oral Mucositis of Cancer



    WELLESLEY HILLS, Mass., March 6 /CNW/ -- 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.
    
    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 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.
    
    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.




For further information:

For further information: Christo Shalish of ActivBiotics, Inc., 
+1-617-901-4511, cshalish@activbiotics.com Web Site:
http://www.activbiotics.com

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