Company Also Completes FDA Submission for Removal of Clinical Hold
BERKELEY HEIGHTS, N.J., June 10 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced that the Company has received notice of allowances for two major patents from the European Patent Office for its pipeline product, tesetaxel, a leading oral taxane. The patents relate to composition of matter for the tesetaxel drug substance and to processes for its synthesis. The Company plans to broadly secure validation of these patents throughout the major countries in Europe. The European patents complement existing patents that have already issued in the United States. Genta holds worldwide exclusive licenses to these patents.
In a related matter, the Company announced that it had submitted a "complete response" to the Food and Drug Administration (FDA) and had requested that the clinical hold that had been placed on tesetaxel be lifted in order to allow resumption of clinical trials. Among other items, the submission included requested toxicokinetic analyses and a proposal for a new clinical study. Initial action by FDA on this submission is expected in the second quarter of 2008.
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. However, both prototype agents suffer from serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side- effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
With administration as an oral capsule, tesetaxel was developed to
maintain the high antitumor activity of the taxane drug class while
eliminating infusion reactions, reducing neuropathy, and increasing patient
convenience. The oral route also enables development
|SOURCE Genta Incorporated|
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