We are all excited about Genasense potential, but has anyone really discussed the potential of Tesetaxel? Good lord! This could actually be even bigger than Genasense.
Tesetaxel is a novel oral semi-synthetic taxane. Taxanes, such as paclitaxel (Taxol®) and docetaxel (Taxotere®), are mainstays of modern anticancer therapy. These drugs are believed to kill cancer cells by disrupting critical cellular proteins. Taxanes have been formally approved by FDA for the treatment of breast, lung, ovarian, gastric, and prostate cancers. However, all currently approved taxanes require intravenous (IV) infusion under close medical supervision. Moreover, both paclitaxel and docetaxel can cause severe, occasionally fatal, infusion reactions, which require pre-medication with steroids and antihistamines. Other serious reactions associated with taxanes include long-lasting damage to peripheral nerves (neuropathy). An oral taxane with the anticancer activity of the IV drugs could provide substantially greater patient safety (by eliminating infusion reactions and precluding the need for pre-medication), a high level of patient convenience, and potentially greater flexibility to explore novel dosing schedules that might improve overall outcomes for patients.
In preclinical testing, tesetaxel has shown clear anticancer activity, including activity against cancer cells that were resistant to paclitaxel and docetaxel. Typically, cancer cells become resistant to taxanes by a mechanism known as “multidrug resistance” that is mediated by a factor called p-glycoprotein. Resistance to tesetaxel did not appear to be mediated by this mechanism, suggesting that tesetaxel might be useful for diseases that are resistant to conventional taxanes.
Genta Incorporated (OTCBB: GNTA.OB) announced it has initiated a new clinicaltrial 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 rangearound 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."
Genta Incorporated (OTCBB: GNTA) announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that tesetaxel, the latest addition to Genta's oncology product portfolio, has been granted designation as an "Orphan Drug" for treatment of patients with advanced gastric cancer. Orphan drug status provides for a period of marketing exclusivity, certain tax benefits, and an exemption from certain fees upon submission of a New Drug Application. As a late Phase 2 agent, the Company believes tesetaxel is the leading oral taxane currently in clinical development.
