Promising Clinical Data in Breast and Liver Cancers Further Expand the Broad Therapeutic Potential of Peregrine's Bavituximab
In a Phase I trial of bavituximab with paclitaxel in five evaluable patients with HER-2 negative metastatic breast cancer(1), two patients achieved a complete tumor response, one achieved a partial response, and two had progressive disease according to Response Evaluation Criteria In Solid Tumors (RECIST) measurement criteria. The trial is also investigating the dynamics and potential effects of circulating tumor cells (CTC) and microparticles shed from dying tumor cells for possible correlations with therapeutic response. For further information about this trial, please visit http://www.peregrinetrials.com, or http://www.clinicaltrials.gov/ct2/show/NCT01288261?term=bavituximab&rank=7.
"Investigator-sponsored trials provide us with an efficient and cost-effective opportunity to evaluate bavituximab in an expanded range of potential therapeutic indications and treatment combinations. We are pleased with the data generated to date in these ISTs in breast and liver cancer and look forward to additional data from the studies as more patients are enrolled and follow-up continues," said
In a second poster presentation(2), clinical investigators presented data from a Phase I/II trial investigating bavituximab with sorafenib in patients with advanced hepatocellular carcinoma (liver cancer). Of the nine patients enrolled in the phase I portion of the study, no dose-limiting toxicities or serious adverse events were observed and the trial is now enrolling in the phase 2 part of the study.
"Sorafenib has been shown to increase the exposure of bavituximab's PS target on tumor blood vessel cells, and combination therapy with the two agents has shown synergistic efficacy in preclinical models," said
For further information about this trial, please visit http://www.peregrinetrials.com, or http://www.clinicaltrials.gov/ct2/show/NCT01264705?term=bavituximab&rank=10.
In a third poster presentation(3), researchers presented data showing robust anti-tumor responses in a challenging preclinical prostate cancer model when an animal version of bavituximab was combined with androgen deprivation therapy (ADT).
"Using the TRAMP model of prostate cancer in which mice are genetically engineered to continually generate prostate cancer, the combination regimen of bavituximab with ADT remarkably resulted in complete inhibition of cancer in roughly 40% of the animals, preventing tumor growth until the animals died of old age," said
Presentation Details
1. Presentation Title: Microparticle generation and activation after treatment with paclitaxel and bavituximab combination therapy in metastatic breast cancer
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Poster Board Number: 21
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2. Presentation Title: A phase I study of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC)
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Poster Board Number: 9
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3. Presentation Title: Cure of castration-resistant prostate cancer in TRAMP mice by reactivating tumor immunity with a phosphatidylserine-targeting antibody
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Poster Board Number: 12
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About Peregrine's Investigator-Sponsored Trials (IST) Program
Peregrine's IST program offers oncologists the opportunity to conduct clinical trials investigating bavituximab's potential in additional indications and treatment combinations. To apply for Peregrine's IST program, please visit http://www.peregrineinc.com/pipeline/investigator-sponsored-trials.html.
About Bavituximab
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor. Bavituximab is currently being tested in seven clinical oncology studies including three randomized Phase II trials in front-line and second-line non-small cell lung cancer (NSCLC), front-line pancreatic cancer and four ISTs in additional oncology indications with clinical data from each study expected in 2012.
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Contact:Christopher Keenan orJay Carlson Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
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