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.
2007-01-17 08:57:02 · 2 answers · asked by Bixbyte 4 in Health ➔ Diseases & Conditions ➔ Cancer
Novelos' pipeline of drugs is based on oxidized glutathione, a natural metabolite that is part of the glutathione pathway. This pathway is the primary determinant of intracellular redox (oxidation/reduction) potential and, as such, plays a key role in cell protection (e.g. detoxification) and in regulation of cell signaling pathways (e.g. leading to cytokine production). Novelos’ lead products are believed to act, in part, via post-translational modification (glutathionylation) of critical regulatory proteins that mediate processes including immune function, cell proliferation and tumor progression (in combination with chemotherapy). They may also sensitize tumor cells to certain chemotherapeutic drugs by modifying drug detoxification processes.
2007-01-17 09:00:19 · update #1
NOV-205, a second compound acts as a hepatoprotective agent with immunomodulating and antiinflammatory properties. Russian clinical studies in hepatitis B and C patients showed that after treatment with NOV-205, viral load was undetectable in a high proportion of patients and serum biochemical markers of liver damage were significantly decreased. Novelos' IND for NOV-205 as mono-therapy for chronic hepatitis C has been accepted by the FDA, and a U.S. Phase 1b trial in patients who previously failed treatment with pegylated interferon plus ribavirin is ongoing.
2007-01-17 09:11:29 · update #2