Phase Ib Trial Is Evaluating Bavituximab Administered With Common Chemotherapy Regimens
Nov 17, 2006 - 10:32:00 PM
, Reviewed by: Priya Saxena
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"We are encouraged that the regulatory and logistical requirements for initiating this trial have proceeded so smoothly and we look forward to working with our clinical sites to complete patient enrollment in this study over the next few months. We believe the results from this study, in combination with data from our ongoing U.S. cancer trial, will help support advancing bavituximab into Phase II combination therapy cancer trials in 2007."
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By Peregrine Pharmaceuticals, Inc,
[RxPG] 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 initiation of patient treatment in its Phase lb clinical trial to evaluate its lead anti-phospholipid immunotherapy agent bavituximab given in combination with common cancer chemotherapy agents. The trial is expected to enroll up to 12 patients at three clinical sites in India.
"We are very pleased that patient dosing is underway in this clinical study of bavituximab in combination with commonly-used chemotherapy drugs because preclinical studies support the concept that chemotherapy and bavituximab should have synergistic anti-tumor effects," said Steven W. King, president and CEO of Peregrine. "We are encouraged that the regulatory and logistical requirements for initiating this trial have proceeded so smoothly and we look forward to working with our clinical sites to complete patient enrollment in this study over the next few months. We believe the results from this study, in combination with data from our ongoing U.S. cancer trial, will help support advancing bavituximab into Phase II combination therapy cancer trials in 2007."
The Phase Ib trial is designed to test the safety and tolerability of bavituximab over an 8-week administration period when given with standard chemotherapy regimens including docetaxel, gemcitabine and carboplatin/paclitaxel. These regimens are commonly used for treating major cancer types, including breast, lung and pancreatic cancer, and patients with these various types of cancer are potentially eligible for the trial. Study endpoints include safety and drug pharmacokinetics. Patients will also be evaluated for tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, although this assessment is not a formal endpoint of the study. Patients will be followed for an additional four weeks after their last dose of bavituximab and may continue with chemotherapy according to standard-of-care guidelines. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.
Preclinical studies have confirmed that bavituximab acts synergistically when administered in combination with chemotherapy in major tumor types. Preclinical studies presented at the AACR annual meeting showed the potential of a bavituximab equivalent plus chemotherapy or radiation to increase survival in resistant breast and brain cancer, a very positive result in these models of advanced disease. A study published in the International Journal of Cancer demonstrated that a bavituximab equivalent given in combination with gemcitabine showed encouraging efficacy in animal models of pancreatic cancer, including reductions in metastatic disease, and an article in Cancer Research reported that a bavituximab equivalent plus docetaxel inhibited tumor growth by 93% in a model of advanced breast cancer.
Bavituximab is currently in clinical trials in the U.S. for the treatment of solid tumors and chronic hepatitis C infection. Clinical data to date has shown that bavituximab is generally safe and well tolerated.
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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. (www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at 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 the Company will not be able to enroll a sufficient number of patients to complete the clinical study, the risk that enrollment will be slower than expected, the risk that the results from the clinical study will not be consistent with the results from previous clinical studies of bavituximab or the results from the preclinical studies supporting the combination therapy regime and the uncertainties associated with conducting clinical studies in, and complying with the regulatory requirements of, India. 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.
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