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March 14, 2014
08:26 EDTPPHMPeregrine updates progress in IST Phase I/II trial of bavituximab with sorafenib
Peregrine Pharmaceuticals announced the presentation of an update to the ongoing Investigator-Sponsored Trial, or IST, of its immunotherapy bavituximab in combination with the chemotherapy sorafenib in patients with advanced hepatocellular carcinoma, or HCC, or liver cancer. In a presentation titled: "Combination of Bavituximab and Sorafenib Inhibits HCC Growth: Results of Preclinical Data and a Phase I Study" Dr. Adam Yopp, Assistant Professor of Surgery at the University of Texas Southwestern Medical Center, Dallas, Texas provided an overview of the preclinical data and the ongoing Phase I/II trial. "The Phase II portion of this trial is ongoing with 34 of the 38 intended patients currently enrolled, 10 of which are currently on treatment with the longest one on treatment for 18 months," said Dr. Yopp. "This open-labeled trial is almost complete and while the results are preliminary, they are promising. I am excited about this potential combination given the new understandings about bavituximab's mechanism and I look forward to sharing the full set of data from this Phase II trial later this year." The Phase II portion of this trial is a single-center, single-arm, non-randomized, open-label trial with the primary endpoint of radiologic time to progression with imaging occurring at 6 week intervals. Secondary endpoints of the trial include overall survival, progression free survival, safety and response rates. The trial is scheduled to enroll 38 patients with advanced liver cancer. In addition, in order to leverage recent understandings surrounding the immune-stimulatory mechanism of action of bavituximab, several additional components have been installed into this portion of the trial. These include plasma and serum collection and tissue biopsies for evaluating changes in immune response following bavituximab treatment. Specifically, to assess whether combination therapy reactivates tumor immunity by changing the tumor microenvironment from immunosuppressive to immunoreactive, changing the tumor infiltrating cell composition or inducing T cell response to tumor antigens.
News For PPHM From The Last 14 Days
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October 17, 2014
14:50 EDTPPHMBARDA asks labs to ramp up Zmapp production, Reuters says
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09:46 EDTPPHMSarepta soars after publication of Ebola drug candidate data
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October 15, 2014
12:36 EDTPPHMOn The Fly: Midday Wrap
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10:49 EDTPPHMEbola linked names rise again amid broader market sell-off
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10:49 EDTPPHMHigh option volume stocks
High option volume stocks: SNV FCG TXT MDSO PPHM NTRS CCL RGP LLTC SOCL
09:20 EDTPPHMOn The Fly: Pre-market Movers
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08:38 EDTPPHMPeregrine up 21% after saying will examine drug as potential Ebola treatment
08:15 EDTPPHMPeregrine says data support Phosphatidylserine as potential target in Ebola
Peregrine Pharmaceuticals announced the publication of a peer-reviewed manuscript, to appear in the Vaccines and Therapies for Biodefense Agents special edition of the peer-reviewed Journal of Immunology Research in a manuscript titled: "Effective Binding of a Phosphatidylserine-Targeting Antibody to Ebola Virus Infected Cells and Purified Virions," related to preclinical research demonstrating that the company's lead drug candidate bavituximab, a phosphatidylserine-targeting antibody, exhibits specific and strong binding to Ebola virions and Ebola virus-infected cells in vitro. Cyril Empig, Ph.D., associate research director at Peregrine Pharmaceuticals, said, "Our goal with this work was to continue exploring the potential of bavituximab in the antiviral arena and in this case, specifically in biodefense applications. With the increased focus on Ebola, there is an opportunity to take advantage of the specificity of bavituximab for Ebola virus and develop therapeutics or treatment regimens that could neutralize the virus. In addition, recently reported genomic sequence variations in EBOV suggest that drugs targeting specific viral non-variant proteins or protein sequences are at risk of failure as a result of virus escape mutations...Given these data, we are developing a plan to explore potential applications of bavituximab and PS-targeting antibodies in the treatment of Ebola."

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