ANYONE KNOW? New Chemo awaiting FDA approval?

Novelos Therapeutics Enrolls 1st Patient in Pivotal Phase 3 Lung Cancer Trial
Monday November 6, 8:30 am ET
Full Enrollment Expected in 1Q 2008

NEWTON, Mass.--(BUSINESS WIRE)--Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the first patient has been enrolled in the pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy. Thomas Lynch, M.D. and Panos Fidias, M.D. from Massachusetts General Hospital (MGH) are the trial co-Chairs. Dr. Lynch is Director of MGH's Center for Thoracic Cancers and Dr. Fidias is Clinical Director for the Center.

This randomized, open-label, international Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) and will study 840 patients with Stage IIIb/IV NSCLC.

As the largest provider of care to cancer patients in New England and a leading center in the United States, the Massachusetts General Hospital Cancer Center stands at the forefront in the fight against cancer. Additional information is available at www.massgeneral.org/cancer

The drug acts as a chemoprotectant and immunomodulator helping to reduce bad side-effects of chemo on the body.

The drug is already marketed by pharma BAM in Russia under the name Glutoxim. First trials were held in Russia 10 years ago on 5000 patients. In US the pharma Novelos will be holding the trial.