Business and Finance
Under terms of the agreement, Daiichi Sankyo will receive upfront payments, payments pursuant to the achievement of certain milestones, and royalties on product sales.
"Tesetaxel has demonstrated promising antitumor activity with an
acceptable safety profile that offers potential use in a variety of cancer
types," commented
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.
"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
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 resistance is not mediated by the multidrug-resistant p-glycoprotein.
About Genta
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 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, which has recently entered clinical trials
as a potential treatment for diseases associated with accelerated bone loss.
Ganite(R) and Genasense(R) are available on a "named-patient" basis in
countries outside the
Safe Harbor
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, statements about:
-- 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 candidates; -- 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, and the Company's ability to obtain sufficient financing to maintain the Company's planned operations; -- 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 litigation; -- the Company's ability to regain compliance with the NASDAQ's listing qualifications; and -- 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 2006 and its most recent quarterly report on Form 10-Q.
CONTACT: Nichol Harber Genta Investor Relations 908-286-3980 info@genta.com
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