March 23, 2009
Phase 2 study of NPI-2358 for non-small cell lung cancerNereus Pharmaceuticals announced that it is conducting a randomized Phase 2 clinical trial evaluating the vascular disrupting agent (VDA) NPI-2358. 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. Approximately 150 patients will participate in this multinational trial. Overall survival will be the primary endpoint of the trial, and progression free survival and tumor response rates will be compared as secondary endpoints.
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.
For more information please call (858) 587-4090 or visit www.nereuspharm.com.