More than Half of Study Patients Completing Treatment and Assessed for Tumor; Progression to Date Have Demonstrated Stable Disease or Objective Response
TUSTIN, CA, USA | Mar 22, 2007 | Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted therapeutics for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that enrollment of the planned 12 evaluable patients in its Phase lb cancer trial has been completed. This trial at clinical sites in India is designed to assess the safety of bavituximab in combination with common chemotherapy agents in advanced cancer patients with metastatic disease who had failed prior therapy. Data from this study are expected to support the initiation of Phase II cancer trials later this year.
To date, the safety profile of bavituximab in combination with chemotherapy appears similar to that seen in advanced cancer patients undergoing chemotherapy treatment alone. Nine patients have completed their course of therapy and have been assessed for tumor response at the eight week scheduled MRI or CT scan. Of these, more than half of the patients achieved either disease stabilization or an objective tumor response. "Disease stabilization" is defined as less than a 20% increase in the size of the tumor up to a 30% reduction in tumor size, while "objective response" is defined as greater than a 30% reduction in tumor size. Both stable disease and objective response are considered potential signs of anti-tumor activity. Patients demonstrating either an objective tumor response or stable disease have been offered continued treatment with the combination regimen on a compassionate use basis.
"We are encouraged by the results seen to date in this first test of bavituximab in combination with common chemotherapy regimens," said Steven W. King, president and CEO of Peregrine. "Achieving stable disease and objective responses in these very ill advanced cancer patients is a promising sign, and we look forward to reporting top-line results as soon as patient follow-up and data analysis are complete. We are optimistic that these results, in combination with data from our ongoing U.S. Phase l cancer trial, will support advancing bavituximab into more extensive combination therapy cancer trials later this year."
The Phase Ib open label trial is designed to characterize the safety, tolerability and pharmacokinetics of bavituximab given in combination with standard chemotherapy regimens including docetaxel, gemcitabine and carboplatin/paclitaxel. These regimens are commonly used for treating major solid cancers, and the enrolled patients include those with breast, ovarian and lung cancers. Study patients are considered enrolled and evaluable for safety analysis after completing four of the planned eight weekly doses of bavituximab in combination with chemotherapy. The chemotherapy agent was administered for up to eight weeks on its standard prescribed administration schedule. Patients are also being evaluated for tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) parameters, receiving CT or MRI scans prior to therapy and at week eight, although this assessment is not a formal endpoint of the study.
Study participants are being followed for an additional four weeks after their last dose of bavituximab. Patients with stable or improved disease may continue with chemotherapy and bavituximab on a compassionate use basis. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.
Bavituximab is a monoclonal antibody that targets and binds to a phospholipid called phosphatidylserine, which is located on the inside of normal cells but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Bavituximab is currently in clinical trials in the U.S. and India for the treatment of solid tumors and in the U.S. as a treatment for chronic hepatitis C infection. Extensive preclinical data demonstrate good anti-tumor activity in a variety of tumor types, especially when bavituximab is administered in combination with chemotherapy or radiation.
About Peregrine Pharmaceuticals
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 in the U.S. and India with its lead product candidates bavituximab and Cotara(R). 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 Pharmaceuticals’ 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 will not work as well in other chemotherapy regimes and the risk that the results of future larger trials will not correlate to the results of this smaller Phase Ib trial. 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 January 31, 2007. 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
SOURCE Peregrine Pharmaceuticals, Inc
