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 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 resistance is not mediated by the multidrug-resistant p-glycoprotein.
As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with other taxanes. Moreover, unlike other oral taxanes that are currently in clinical development, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity.
More than 250 patients worldwide have been treated with oral tesetaxel in Phase I and Phase 2 clinical trials. The major side-effect of tesetaxel in clinical 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.
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma. The Company has recently filed an amendment to its New Drug Application to the Food and Drug Administration requesting approval for the use of Genasense plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The leading drug in Genta's Small Molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same drug class as paclitaxel and docetaxel. Ganite and Genasense are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: http://www.genta.com.
This press release may contain forward-looking statements with respect
to business conducted by Genta Incorporated. By their nature,
forward-looking statements and forecasts involve risks and uncertainties
because they relate to events and depend on circumstances that will occur
in the future. Forward- looking statements include, without limitation,
-- the Company's ability to obtain necessary regulatory approval for
Genasense(R) from the U.S. Food and Drug Administration ("FDA") or
European Medicines Agency ("EMEA");
-- the safety and efficacy of the Company's products or product
-- the Company's assessment of its clinical trials;
-- the commencement and completion of clinical trials;
-- the Company's ability to develop, manufacture, license and sell its
products or product candidates;
-- the Company's ability to enter into and successfully execute license
and collaborative agreements, if any;
-- the adequacy of the Company's capital resources and cash flow
projections, the Company's ability to obtain sufficient financing to
maintain the Company's planned operations, or the Company's risk of
bankruptcy if it is unsuccessful in obtaining such financing;
-- the Company's ability to secure the consent of the Company's
shareholders to approve certain covenants in connection with financial
transactions entered into by the Company;
-- the adequacy of the Company's patents and proprietary rights;
-- the impact of litigation that has been brought against the Company and
its officers and directors and any proposed settlement of such
-- the other risks described under Certain Risks and Uncertainties Related
to the Company's Business, as contained in the Company's Annual Report
on Form 10-K and Quarterly Report on Form 10-Q.
The Company does not undertake to update any forward-looking
statements. There are a number of factors that could cause actual results
and developments to differ materially. For a discussion of those risks and
uncertainties, please see the Company's Annual Report on Form 10-K for 2007
and its most recent quarterly report on Form 10-Q.
Genta Investor Relations
|SOURCE Genta Incorporated|
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