Lung Cancer Blog: New Lung Cancer Drug
The drug trial will test the drug, designated NOV-002, in combination with currently used chemotherapy to treat patients with advanced non-small-cell lung cancer who have not undergone any previous treatment. The company hopes to begin enrolling patients in the phase III study by the third quarter of 2006.
Novelos Therapeutics, Inc., is a Boston-based biotechnology company focused on the development of therapeutics to treat cancer and hepatitis. Today's announcement marks the first time the company has been given FDA approval for a large clinical trial that often forms the final testing in humans before submission to the FDA for approval to sell the drug.
NOV-002, is approved and marketed in the Russian Federation by Pharma BAM under the trade name Glutoxim. It has been administered to over 5,000 patients, and been found to be effective and safe.
The drug is designed to provide patients with protection from highly toxic chemotherapy agents, and to enhance the body's immune response to cancer. The result is that patients are better able to tolerate chemotherapy allowing them to undergo more treatment cycles.
Determining whether that translates into longer survival will be the research objective of the phase III trial. Novelos will seek approval of the final study design under a FDA's Special Protocol Assessment (SPA) during the first half of 2006.
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Lung Cancer Blog: New Lung Cancer Drug
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