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Nonconformity of NOV002 Used in Phase 3 NSCLC Trial Sponsored by Novelos Therapeutics, Inc to NOV002 (Glutoxim(R)), Used in Phase 1/2 NSCLC and all Previous Trials
Date:6/29/2010

SAINT PETERSBURG, June 29, 2010 /PRNewswire/ -- The Company VAM is the developer of product Glutoxim(R) registered in Russia in 1998, registration No. P N002010/01. We possess significant knowledge and experience in manufacturing of this product as well as in the clinical development application of Glutoxim(R). In accordance with an Agreement dated June 20, 2000, the company VAM diligently and successfully transferred all of the "know-how", manufacturing and quality assurance information on the active drug substance and finished injection forms of the product Glutoxim(R) to Novelos Therapeutics, Inc.

Up to October 2005, the active pharmaceutical ingredient used in Glutoxim(R) (US code name NOV002) was synthesized according to the original manufacturing process and technology transferred from the company VAM to Novelos. The original NOV002 (Glutoxim(R)) used in the Phase 1/2 NSCLC and all previous trials met predetermined clinical endpoints and yielded encouraging results.

After the completion of the Phase 3 NSCLC trial and learning that NOV002 had failed to meet clinical endpoints, VAM requested Novelos to provide samples of products used in the Phase 3 trial. At VAM's request, an independent chemical and biological analysis of the samples was performed in the State Technological Institute of Saint-Petersburg and State Research Trial Institute of Military Medicine.

Expert opinions - excerpts[1]

Technological Institute

"On the basis of data generated by the element analysis it is possible to make a conclusion, that all three presented dry samples considerably differ
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SOURCE Pharma Vam
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