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Wednesday February 18, 7:01 am Eastern Time
Company Press Release
DynaGen Receives Notice of Allowance for U.S. Patent for its Immunomodulator in the Treatment of HIV
CAMBRIDGE, Mass.--(BW HealthWire)--Feb. 18, 1998--DynaGen Inc. (NASDAQ:DYGN - news; BSE:DYG) today announced that it has received a Notice of Allowance from the U.S. Patent Office for its patent application covering the use of its immunomodulator (ImmuDyn(TM)) in the treatment of HIV/AIDS. ImmuDyn is a proprietary lipid preparation that has shown promise in overseas clinical studies in the treatment of HIV infection. In human clinical trials, ImmuDyn has demonstrated an acceptable safety profile with no significant side-effects.
During the past two years, DynaGen has evaluated ImmuDyn in other conditions such as immune thrombocytopenic purpura (ITP), and autoimmune disease in which platelets are destroyed by the body's own immune system. The results of ITP human trials are equally encouraging. DynaGen is focusing its research efforts on ImmuDyn in the treatment of ITP, for which it has obtained orphan drug status from the FDA. DynaGen has formed a subsidiary, Apex Pharmaceuticals Inc., which will be independently funded to further develop and commercialize ImmuDyn.
''This patent will secure for DynaGen a strong proprietary foundation in the HIV arena for our ImmuDyn product,'' said Michael Sorell, M.D., director of DynaGen. ''Although our initial focus is for the use of ImmuDyn in ITP, we have plans to pursue its application in other immune function disorders including HIV,'' he added.
DynaGen has filed patent applications for ImmuDyn for the treatment of ITP as well as for neutropenia associated with cancer chemotherapy.
DynaGen Inc. is a healthcare company founded in 1988. DynaGen's other major business activities include the BioLocator(TM) technology for the efficient and accurate localization and tracking of breast tumors, and the development of its multisource pharmaceutical business through its two subsidiaries, Able Laboratories, Inc. of South Plainfield, N.J., which manufactures tablets and suppositories, and Superior Pharmaceutical Company of Cincinnati, Ohio, a distributor of generic drugs with annual revenues in excess of $25 million.
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Any statements which are not historical facts contained in this press release are forward-looking statements that involve risks and uncertainties. Please refer to the risk factors identified in the company's recent report on Form 10-K, including those relating to commercialization of products and the company's limited manufacturing and marketing experience. There can be no assurance that the anticipated benefits from the issuance of such a patent will be realized.
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Wayne Schumacher
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