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Noble 4th Annual Equity Conference, August 18, 2008 (Archived)

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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 < 0.01) and improved tolerance of chemotherapy (p < 0.05) versus the control. In a controlled, randomized U.S. Phase 2 trial, advanced NSCLC patients treated with NOV-002 in combination with paclitaxel and carboplatin demonstrated improved objective tumor response (p < 0.05) and improved tolerance of chemotherapy (p < 0.01) versus the control. Novelos finalized a SPA with the FDA (May 2006) for a single pivotal Phase 3 trial in advanced NSCLC in combination with first-line chemotherapy, obtained Fast Track designation in August 2006 and commenced the trial in November 2006. Target enrollment of 840 patients was reached in March 2008 and trial conclusion is expected mid-2009. NOV-002 is also in Phase 2 development to treat chemotherapy-resistant ovarian cancer and early-stage breast cancer.

NOV-205, a second compound acts as a hepatoprotective agent with immunomodulating and antiinflammatory properties. 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 was concluded based on favorable safety profile. Russian clinical studies in hepatitis B and C patients showed that after relatively short treatment periods (1 to 2 months) with NOV-205, viral load was undetectable in a high proportion of patients and serum biochemical markers of liver damage were significantly decreased.

Novelos' intellectual property is very strong. The intellectual property includes 5 U.S., 2 European and 1 Japanese patents. Overall, Novelos filed more than 30 patent applications worldwide, with coverage including composition of matter, method of use and manufacturing. The breadth of the intellectual property will also allow Novelos to expand its pipeline by claiming and commercializing additional compounds that are based on oxidized glutathione.

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