Peregrine Pharmaceuticals, Inc. Completes Patient Enrollment In Phase Ib Bavituximab Hepatitis C Trial
TUSTIN, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. , a biopharmaceutical company developing targeted therapeutics for the treatment of cancer and hepatitis C virus (HCV) infection, today reported that patient enrollment has been completed for the company's Phase Ib repeat dose, dose escalation study of bavituximab in patients with chronic HCV infection. The primary objective of the study is to determine the safety, distribution and pharmacokinetic properties of bavituximab as a multiple dose monotherapy in HCV patients. Changes in viral load, measured as serum HCV RNA levels, are also being monitored.
"Completing patient enrollment in this study ahead of schedule is a positive development for Peregrine and for the momentum of the bavituximab HCV program," said Steven W. King, president and CEO of Peregrine. "We believe that bavituximab has the potential to be a significant new therapy for HCV patients, and achieving this milestone will allow us to continue advancing bavituximab through clinical development. We are already actively designing the next bavituximab HCV clinical studies, and the data we obtain from this repeat dose trial should be extremely valuable in helping us to optimize those plans."
Twenty-four patients (four cohorts of six patients each) were enrolled in the study with each cohort scheduled to receive four doses of bavituximab over a 14-day period. Subjects received bavituximab at escalating dose levels of 0.3, 1, 3 or 6 milligram per kilogram (mg/kg) of body weight. Patients in all cohorts are being followed for 12 weeks. Final data from the trial will be available when patients complete the 12 week follow-up and data analyses are complete. Initial data from the trial is expected to be available during the first quarter of 2007.
Previously Peregrine reported preliminary results from a Phase la single dose, dose escalation study of bavituximab in patients who had failed other HCV regimens, which showed that the drug was well tolerated and demonstrated encouraging signs of anti-viral activity. Final results from the Phase I single dose study will be presented at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston on October 30, 2006.
About Bavituximab
Bavituximab is the first agent in a new class of anti-phosphotidylserine (PS) immunotherapeutics that targets and binds to cellular components that are normally not present on the outside of cells, but which become exposed on certain virally infected cells and on the surface of enveloped viruses. Bavituximab is a monoclonal antibody that helps stimulate the body's immune defenses to destroy both the virus particles and the infected cells. Similar to their proposed anti-viral mechanism, anti-PS agents also bind to phospholipids exposed on tumor blood vessels in all solid cancers tested to date. Bavituximab is in Phase I clinical trials for the treatment of solid tumor cancers in the U.S. and a combination trial with chemotherapy in cancer patients in India will soon be underway. Additional information on bavituximab's clinical programs can be found at http://www.peregrineinc.com/content.php?mi=Mzc=
About Peregrine
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing five separate clinical trials in cancer and HCV infection with its lead product candidates bavituximab and Cotara(R) in the U.S. and India. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.
Safe Harbor Statement:
Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceutical's intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that bavituximab's safety profile in a repeat dose trial or in a combination therapy trial will not be at the same safety level as was found in the phase la trial, the risk that the results of future trials will not correlate to the results from the phase la trial, and the risk that bavituximab will not be as well tolerated at ascending doses. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2006, and the quarterly report on Form 10-Q for the quarter ended July 31, 2006. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contacts: GendeLLindheim BioCom Partners Investors Media info@peregrineinc.com Barbara Lindheim (800) 987-8256 (212) 918-4650
Peregrine Pharmaceuticals, Inc.CONTACT: GendeLLindheim BioCom Partners, Investors: info@peregrineinc.com,1-800-987-8256, or Media: Barbara Lindheim, +1-212-918-4650