TUSTIN, CA, Dec 06, 2011 (MARKETWIRE via COMTEX) — Peregrine Pharmaceuticals, Inc. PPHM +30.03% today announced preliminary results from a randomized Phase II trial showing a 50% improvement in overall tumor response rates (ORR) in non-small cell lung cancer (NSCLC) patients. Patients treated with bavituximab plus carboplatin and paclitaxel currently demonstrate an ORR of 39%, versus 26% in patients treated with carboplatin and paclitaxel alone. This preliminary analysis using RECIST guidelines included all 86 front-line, Stage IV NSCLC patients randomized in this Phase II trial.

Peregrine plans to report on secondary endpoints, including median progression-free survival (PFS) and overall survival (OS) once reached during 2012. Bavituximab’s therapeutic potential is being evaluated in three randomized Phase II trials in front-line NSCLC, second-line NSCLC, and front-line pancreatic cancer, as well as in four investigator-sponsored trials (ISTs) in additional oncology indications with clinical data from each study expected in 2012.

The open label, multicenter, randomized trial was designed to evaluate the safety and efficacy of Imprime PGG in combination with a monoclonal antibody (cetuximab) and a standard chemotherapy regimen (carboplatin and paclitaxel) compared to cetuximab alone with the same chemotherapy.

“This is an important milestone in developing more effective treatments for NSCLC patients,” said Dan Conners, president of Biothera’s Pharmaceutical Group. “It is also a significant step forward in Biothera’s overall clinical development plan for Imprime PGG.”

The primary objective for the study is to determine the anti-tumor effects of Imprime PGG when used in combination with cetuximab and standard chemotherapy, based on overall response rate as assessed by RECIST (Response Evaluation Criteria in Solid Tumors) and evaluated by a blinded independent review committee.

The finding comes from an analysis of the FLEX study, published online November 4 in the Lancet Oncology. It was presented earlier this year at the World Conference on Lung Cancer, and reported at the time by Medscape Medical News.

The analysis shows that NSCLC patients who have a high expression of epidermal growth-factor receptor (EGFR) in their tumors have the best response when cetuximab (a monoclonal antibody directed against EGFR) is added to chemotherapy. This high EGFR expression was found in 31% of patients who were tested.

Pulmotax is a single antibody immunohistochemistry test created to detect the expression of TLE3 in non-small cell lung cancer (NSCLC). Prior data have linked TLE3 expression specifically to response to taxane therapy in breast and ovarian carcinoma patients. The study was presented yesterday at the annual meeting of the American Association of Cancer Research (AACR) in Washington, D.C. by Douglas T. Ross, M.D., Ph.D., Chief Scientific Officer of Clarient.

Cambridge, Mass. (PRWEB) February 22, 2010 — Merrimack Pharmaceuticals, Inc. announced today that the first patient has received an initial dose in a Phase 1/2 clinical study combining MM-121 with Tarceva® (erlotinib) in patients with non-small cell lung cancer (NSCLC). This is the first of multiple trials that Merrimack and sanofi-aventis expect to initiate in 2010 as part of a broad Phase 2 clinical development program for MM-121.