Genta, Inc (fka GNTAQ)

[The Holder]

Fantastic Tesetaxel News This Morning

Genta Initiates New Clinical Trial of Tesetaxel, the Leading Oral Taxane in Clinical Development 01/14 08:05 AM



BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)-- Genta Incorporated (GNTA:$0.0054,$-0.0007,-11.48%) announced it has initiated a new clinical trial with tesetaxel, the latest addition to Genta’s oncology product portfolio. Unlike standard taxanes such as paclitaxel (Taxol®), which must be infused intravenously, tesetaxel is administered by mouth as a capsule. The new study will examine the clinical pharmacology of the drug over a narrow dosing range around the established Phase 2 dose. As a late Phase 2 agent, the Company believes tesetaxel is the leading oral taxane currently in clinical development.
“Taxanes are the most widely used class of anticancer compounds,” commented Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “Successful development of an oral taxane has been a research goal that has eluded many pharmaceutical companies. Tesetaxel has already been tested in more than 250 patients with various types of cancer in the U.S., Europe, and Japan. By eliminating serious hypersensitivity infusion reactions, as well as potentially reducing nerve damage and overcoming resistance to standard taxanes, tesetaxel may offer important new treatment options for patients with advanced cancer.”
“Having been associated with this drug since its original Phase 1 trial, I am delighted to lead this key study that will enable the pivotal trials to proceed,” said Dr. Anthony Tolcher, Director of Clinical Research, South Texas Accelerated Research Therapeutics, San Antonio, TX. “Completed Phase 2 studies of tesetaxel in advanced breast, colon and stomach cancer have shown promising activity. We believe the innovative development strategy created for tesetaxel may enable this drug to become the first oral taxane to achieve regulatory approval.”
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 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 1 and Phase 2 clinical trials.