NOV-002, our lead compound currently in Phase 3 development for non-small cell lung cancer (NSCLC), acts together with chemotherapy as a chemoprotectant and an immunomodulator. In May 2006, we finalized a Special Protocol Assessment (SPA) with the FDA for a single pivotal Phase 3 trial in advanced NSCLC in combination with first-line chemotherapy, and received Fast Track designation in August 2006. The primary endpoint of this trial is improvement in median overall survival. Patient enrollment commenced in November 2006 and is ongoing. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer and, in addition, is being developed for treatment of acute radiation injury.
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| Date: | Sep 4, 2008 |
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| Price: | Free |
| Pages: | 5 |
| Document Type: | Adobe Acrobat Reader |
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