Genta Initiates Once-Weekly Treatment Schedule for Tesetaxel a Novel Oral Tubulin Inhibitor, in New Dose-Ranging Study
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA) announced that the Company has initiated a new dose-ranging study of tesetaxel, the Company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.
“Since the activity of certain taxanes may be schedule-dependent, we plan to evaluate both dosing regimens to ensure we have maximized the potential efficacy and safety of tesetaxel in our late-stage clinical programs.”
Genta has recently completed a dose-ranging and pharmacokinetic study using tesetaxel administered once every 3 weeks, a schedule that has shown anticancer activity in several Phase 2 clinical trials. This schedule has been extensively evaluated in a series of Phase 1 and Phase 2 trials that together have enrolled more than 280 patients. Data from the recently completed study of the once-every-3-week schedule have confirmed safety findings previously reported for this regimen, and the results have been submitted for presentation to the annual meeting of the American Society of Clinical Oncology (ASCO) that is scheduled in June 2010. The new trial is the first clinical study to test an alternative dosing regimen in which the drug will be administered once weekly for 3 consecutive weeks, followed by 1 week off treatment. The goal of the study will be to establish safety and a suitable dose for extended testing in late-stage clinical trials.
“Weekly dosing schedules of other taxanes have been increasingly incorporated into so-called “dose dense” chemotherapy programs, particularly in breast cancer,” commented Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “Since the activity of certain taxanes may be schedule-dependent, we plan to evaluate both dosing regimens to ensure we have maximized the potential efficacy and safety of tesetaxel in our late-stage clinical programs.”
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 of these 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 with a goal of maintaining the high antitumor activity of the taxane drug class while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables the development of novel schedules that may expand dosing options when tesetaxel is used alone or in combination with other anticancer drugs, including “all oral” chemotherapy programs. 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 have been developed, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug may offer substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 280 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials.
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® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense® is being developed as an agent that may enhance the effectiveness of current anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from its recently completed randomized Phase 3 study of Genasense® in patients with advanced melanoma (the AGENDA trial). The leading drug in Genta’s Small Molecule program is Ganite® (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 proprietary oral formulations of the active ingredient in Ganite®, which have completed preliminary clinical study as a potential treatment for diseases associated with accelerated bone loss. The Company is developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta intends to evaluate the clinical activity of tesetaxel in a range of human cancers. 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: www.genta.com.
Safe Harbor
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* the commencement and completion of any clinical trials;
* the Company’s assessment of its clinical trials;
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* 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.
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 2008 and its most recent quarterly report on Form 10-Q.
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Genta Investor Relations
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info@genta.com
