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Nereus Pharmaceuticals Initiates ADVANCE, a Randomized Phase 2 Clinical Trial of NPI-2358 in Non-Small Cell Lung Cancer
Date:3/23/2009

SAN DIEGO, March 23 /PRNewswire/ -- Nereus Pharmaceuticals, Inc., a pioneer in drug discovery from marine microbial sources, today announced that it is conducting a randomized Phase 2 clinical trial evaluating the vascular disrupting agent (VDA) NPI-2358 in combination with standard chemotherapy (docetaxel) in patients with non-small cell lung cancer (NSCLC). This study follows on positive outcomes in the Phase 1 study assessing the safety, pharmacokinetics and efficacy of the combination.

Preclinical and clinical data suggest that VDAs may be complementary or synergistic with chemotherapeutics and anti-angiogenesis agents due to the different targets and mechanisms of action. In addition, the non-overlapping side effect profile of VDAs compared to most other anti-cancer treatments makes them ideal candidates to employ in new combination therapies. Models combining NPI-2358 with docetaxel have produced particularly positive results in both efficacy and tolerability.

The ADVANCE (Assessment of Docetaxel and Vascular Disruption in Non-Small Cell Lung Cancer) trial will assess NPI-2358 in combination with docetaxel compared to docetaxel alone in patients with NSCLC who previously failed at least one chemotherapy regimen. Overall survival will be the primary endpoint of the trial, and progression free survival and tumor response rates will be compared as secondary endpoints. Approximately 150 patients will participate in the trial at clinical trial sites in the U.S., Australia, India, and South America.

"This is an exciting time, as positive results for the combination of NPI-2358 and docetaxel appear to be translating well from the bench to the bedside. We will now be able to test the improvement in efficacy with the addition of NPI-2358 to the standard of care," said Dr. Shirish Gadgeel, M.D., Assistant Professor at the Barbara Ann Karmanos Cancer Institute in Detroit, Michigan where the first patient to
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