NOV-002

NOV-002, a proprietary formulation of oxidized glutathione, is the lead compound of Novelos Therapeutics Inc (NVLT). NOV-002 acts as a chemopotentiator and a chemoprotectant, in combination with chemotherapy, by regulating redox-sensitive cell signaling pathways. Novelos is conducting an international pivotal Phase 3 trial of NOV-002 for treatment of advanced lung cancer, under a Special Protocol Assessment (SPA) and Fast Track. Trial conclusion is expected in early 2010. NOV-002 is approved and marketed in Russia by Pharma BAM under the trade name Glutoxim®. It has been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety data.

Novelos’ randomized, open-label, international, pivotal Phase 3 trial is evaluating NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone, in approximately 900 patients with Stage IIIb/IV NSCLC. The trial, with a primary efficacy endpoint of improvement in median overall survival, is being conducted across approximately 12 countries and 100 clinical sites. Novelos commenced the trial in November 2006, and reached target enrollment of 840+ patients in March 2008. This pivotal Phase 3 trial is expected to conclude in early 2010.

U.S. Phase 2 Results

In a controlled randomized U.S. Phase 1/2 clinical trial, advanced NSCLC patients (n=29) treated first-line with NOV-002 in combination with paclitaxel and carboplatin demonstrated improved objective tumor response (p < 0.05) and higher tolerance of chemotherapy (p < 0.01) versus active control (n=15).

A U.S. Phase 2 neoadjuvant breast cancer trial is ongoing at University of Miami and Medical University of South Carolina to evaluate the ability of NOV-002 to enhance the effectiveness of chemotherapy. To date, as presented at San Antonio Breast Cancer Symposium in December 2008, 6 pathologic complete responses occurred in the first 15 women (40%) that have completed chemotherapy and undergone surgery, which is much greater than <20% historical expectation in HER-2 negative patients. Furthermore, NOV-002 decreased hematologic toxicities.

A U.S. Phase 2 platinum-resistant ovarian cancer trial at Mass General Hospital and Dana Farber was presented at ASCO in May 2008. NOV-002 (plus carboplatin) slowed disease progression in 60% of evaluable patients (9 out 15), mostly fourth-line, with median PFS of 15.4 weeks – almost double the historical control of 8 weeks. Furthermore, hematologic toxicity was mild, suggesting possible mitigating effect of NOV-002.

== Sources ==

http://clinicaltrials.gov/ct2/show/NCT00347412?term=nov-002&rank=1

http://clinicaltrials.gov/ct2/show/NCT00499122?term=nov-002&rank=2

http://www.novelos.com/docs/Cancer_Research_NOV-002_article_4-15-08.pdf

http://www.novelos.com/docs/Expert_Opinion_NOV-002_Article_6-08.pdf

www.novelos.com


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