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Nereus Pharmaceuticals Initiates Clinical Trial of NPI-2358 in Non-Small Cell Lung Cancer Following Encouraging Phase 1 Data
Date:3/20/2008

SAN DIEGO, March 20 /PRNewswire/ -- Nereus Pharmaceuticals, Inc., a pioneer in drug discovery from marine microbial sources, today announced that enrollment has begun in a Phase 1b study evaluating the vascular disrupting agent (VDA) NPI-2358 in combination with standard chemotherapy in patients with non-small cell lung cancer (NSCLC). This study follows on positive outcomes in a Phase 1 single-agent clinical trial assessing the safety, pharmacokinetics, pharmacodynamics (PK/PD) and efficacy of NPI-2358 in various tumor types.

The open-label Phase 1b study will assess escalating doses of NPI-2358 in combination with docetaxel in patients with NSCLC who previously failed at least one chemotherapy regimen. The existing preclinical and clinical data suggests that VDAs may be complementary or synergistic with chemotherapeutics and anti-angiogenesis agents due to the different targets and mechanisms of action. NPI-2358 has a dual effect on tumors: It selectively attacks existing tumor blood vessels leading to hemorrhagic tumor necrosis without affecting normal vasculature, and it has a direct apoptotic effect on tumors cells. NPI-2358 in combination with chemotherapeutic agents in human xenograft models of NSCLC and other cancers was markedly more effective than either treatment alone.

"We are excited to have a leading role in the clinical development of Nereus' NPI-2358 for the treatment of non-small cell lung cancer. At The Sir Charles Gairdner Hospital, we felt this combination study with NPI-2358 was a high priority given the favorable preclinical and clinical data we have seen," said Michael Millward, M.D., Cancer Council Professor of Clinical Cancer Research at The University of Western Australia based at Sir Charles Gairdner Hospital, Perth.

"Our clinical program for NPI-2358 holds promise in non-small cell lung cancer, a large market indication where novel compounds could make a significant impact on patients. We're pleased to advance
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SOURCE Nereus Pharmaceuticals, Inc.
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