Positive interim results from Nereus Pharmaceuticals' plinabulin VDA study for advanced NSCLC

Nereus Pharmaceuticals, Inc., a pioneer in drug discovery from marine microbial sources, today announced positive interim results from a randomized Phase 2 clinical trial evaluating the vascular disrupting agent (VDA) plinabulin (NPI-2358) in combination with standard chemotherapy (docetaxel) in patients with advanced non-small cell lung cancer (NSCLC). This data is consistent with the favorable outcomes seen in the Phase 1 portion of the study, which assessed the safety, pharmacokinetics and efficacy of the combination.

The ADVANCE (Assessment of Docetaxel and Vascular Disruption in Non-Small Cell Lung Cancer) trial is investigating plinabulin in combination with docetaxel compared to docetaxel alone in patients with advanced NSCLC who previously failed at least one prior chemotherapy regimen. Overall survival is the primary endpoint of the trial, and progression free survival and tumor response rates are being evaluated as secondary endpoints. Approximately 150 patients are expected to participate in the study at clinical trial sites in the U.S., Australia, India, and South America, of which 110 have been enrolled.

The interim results were presented in a poster at the 2009 EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics meeting in Boston, Massachusetts by the lead author Dr. Rebecca Heist, M.D., M.P.H., Assistant Professor in Medicine, Massachusetts General Hospital Cancer Center. The data indicated that the combination of plinabulin and docetaxel is tolerable, and suggested that the plinabulin combination improves tumor response rate by demonstrating that out of 57 evaluable patients an estimated 26 percent of those treated with plinabulin and docetaxel had a greater than or equal to 30 percent shrinkage of tumors (standard response criteria) compared to 3 percent of those treated with docetaxel alone.

“The positive preclinical and early clinical data continues to translate well in the clinic in non-small cell lung cancer, where patients could benefit from a new treatment that improves the outcomes of current chemotherapy regimens. Vascular disrupting agents could represent a significant advance in cancer treatment, particularly in NSCLC where indications have been positive for use of VDAs with standard of care cytotoxic and vascular targeted agents, as well as for use in patient subsets with particular unmet needs such as those with squamous cell carcinoma,” said Kobi Sethna, President and CEO, Nereus Pharmaceuticals, Inc.