NOV-002, the lead compound acts as a chemoprotectant and an immunomodulator. It is marketed in Russia by PharmaBAM under the trade name Glutoxim®, and has been administered to over 5,000 patients, demonstrating clinical efficacy and excellent safety. The U.S.-based Phase 1/2 clinical trial of NOV-002 for non-small cell lung cancer (NSCLC) has been completed, with positive results. During an End-of-Phase 2 meeting, the FDA agreed that advancing NOV-002 into a pivotal Phase 3 trial in advanced NSCLC, in combination with first-line chemotherapy, is warranted. In May 2006, Novelos finalized a Special Protocol Assessment (SPA) with the FDA for a single pivotal trial, obtained Fast Track designation in August 2006, and this Phase 3 trial commenced in November 2006. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer, and is in addition being developed for acute radiation injury.
Did you know Russians outlive Americans with Chemo?
No...I did not know that!
Reply:yes
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment