Peregrine's Bavituximab shows significant tumor response rate during Phase II Lung Cancer trial Print E-mail
By Staff and Wire Reports   
Tuesday, 06 December 2011 09:50
Shares of Peregrine Pharmaceuticals (NASDAQ: PPHM) are on the rise after the company 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.

"These first randomized clinical data indicate bavituximab is an active anti-tumor agent and heightens our enthusiasm for the bavituximab program, including the upcoming results from seven ongoing trials in different oncology indications," said Kerstin B. Menander, M.D. Ph.D., head of medical oncology at Peregrine Pharmaceuticals. "Bavituximab targets a specific marker on tumor blood vessels but not on healthy vessels, offering a very basic mechanism of action and resulting in broad potential in the treatment of cancer patients. These results go a long way toward supporting our phosphatidylserine (PS)-targeting platform in a randomized trial setting, indicating bavituximab's anti-tumor activity in combination with chemotherapy."

"Across our bavituximab trials, the clinical data have been remarkably consistent with promising tumor response and patient survival," said Steven W. King, president and chief executive officer of Peregrine. "With seven trials advancing, we are driving our bavituximab oncology program to multiple near-term clinical data reports, importantly the unblinding of our randomized Phase II trial in second-line NSCLC patients in the first half of next year. We are excited to be developing new therapeutic options for treating patients with the deadliest forms of cancer."

Peregrine is focused on the research, development and commercialization of therapeutics for cancer and a wide range of viral diseases. The company is engaged in the development of monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection. It was founded in 1981 as the Techniclone Corporation and changed its name to Peregrine Pharmaceuticals in 2000. The company also provides comprehensive biomanufacturing services through its wholly-owned subsidiary Avid Bioservices, Inc.

Peregrine has developed proprietary therapeutic technologies as its core platforms which include: phosphatidylserine (PS)-targeting therapy for cancers and for viral diseases and tumor necrosis therapy (TNT). Its clinical-stage platform technologies include phosphatidylserine (PS)-targeting therapy for cancers and viral diseases and tumor necrosis therapy (TNT). The company's targeted Tumor Necrosis Therapy technology (TNT) uses monoclonal antibodies designed to bind to DNA-histone H1 complex which is exposed primarily in the dead and dying cells that are present in abundance at the center of tumors.

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