Genta Announces Licensing Agreement for Worldwide Development and Commercialization of a Leading Oral Taxane,...(inical trials has been myelosuppression ...),Health

Date:3/7/2008

inical trials has been myelosuppression, chiefly neutropenia. Due to the occurrence of severe neutropenia that led to fatal outcomes in several patients with advanced cancer, the drug was placed on clinical hold by the U.S. Food and Drug Administration (FDA). Resumption of clinical trials is subject to the lifting of this clinical hold.

"During our extended analysis of this compound, FDA provided clear and specific guidance regarding the tasks that would be required to lift the clinical hold," commented Dr. Raymond P. Warrell, Jr., Chairman and Chief Executive Officer of Genta. "We believe these tasks are straightforward and we look forward to resuming key clinical trials. We are very pleased to add this important late-stage asset to our pipeline portfolio. Tesetaxel may leverage the considerable anticancer activity of this important drug class with fewer side-effects and improve outcomes for patients."

About Tesetaxel

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 of novel schedules that may expand dosing options when tesetaxel is used alone or in combination with other anticancer drugs. Preclinically, tesetaxel has demonstrated substantially higher activity against cell lines that were resistant to paclitaxel and docetaxel, since acquired r
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SOURCE Genta Incorporated Copyright©2008 PR Newswire. All rights reserved

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