Novelos Therapeutics , Inc.
biotechnology
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Novelos Therapeutics, Inc. (OTCBB: NVLT) is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of Cancer and Hepatitis. NOV-002, the lead compound in Phase 3 development for lung cancer under a Special Protocol Assessment (SPA) and Fast Track, acts together with chemotherapy as a chemoprotectant and chemopotentiator by regulating redox-sensitive cell signaling pathways. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer. NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-205 is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in Russia where they were originally developed. 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. NOV-002, the lead compound, acts as a chemoprotectant and a chemopotentiator. NOV-002 was approved in Russia where it is marketed by PharmaBAM under the trade name Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with cisplatin-based chemotherapy increased the one-year survival of advanced NSCLC patients from 17% to 63% (p
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