March 20, 2008 - Nereus Pharmaceuticals, Inc., a pioneer in drug discovery from marine microbial sources, 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... Nereus' Press Release -
