Key Developments For Peregrine Pharmaceuticals Inc
Peregrine Pharmaceuticals Inc (PPHM.O) (Consolidated Issue listed on NASDAQ Capital Market)
Peregrine Pharmaceuticals Announces Promising Antiviral Data
Peregrine Pharmaceuticals announced that researchers presented positive data on progress in its federally funded preclinical viral hemorrhagic fever (VHF) program, confirming that its phosphatidylserine (PS)-targeting antibodies bind to VHF viruses and virally infected cells and increase survival in a model of lethal VHF infection. The data were presented at the 2009 Chemical and Biological Defense Science and Technology (CBD S&T) Conference in Dallas, Texas. Researchers presented interim data from Peregrine's multi-year program to assess the Company's PS-targeting antibodies as broad-spectrum agents for the treatment of viral hemorrhagic fevers, a potential biodefense threat. The studies evaluated the activity of Peregrine's PS-targeting antibodies against representatives of major VHF virus families. In these studies, researchers confirmed broad spectrum PS-targeting antibody binding to VHF viral particles and also demonstrated that Peregrine's PS-targeting antibodies bind to mammalian cells infected with hemorrhagic fever viruses. Initial pharmacokinetic and dosing studies also showed that the PS-targeting antibodies are sustainable in the blood at therapeutically relevant concentrations. Importantly, initial antiviral efficacy studies reported at the conference were encouraging, showing that a single dose of a PS-targeting antibody increased the survival of hamsters infected with lethal doses of viruses from two different VHF virus families.
Peregrine Pharmaceuticals Announces New Study In Clinical Cancer Research Of Bavituximab
Peregrine Pharmaceuticals announced that a newly published study shows that a phosphatidylserine (PS)-targeting antibody similar to the Company's lead product candidate bavituximab demonstrated potent anti-tumor activity when combined with radiation in a model of aggressive brain cancer, doubling the survival time of test animals and producing long-term cures. The study also provides further evidence that the anti-cancer activity of bavituximab and other PS-targeting antibodies reflects multiple novel mechanisms. This new study provides additional scientific evidence that PS-targeting antibodies, including bavituximab, employ multiple novel mechanisms to mobilize the immune system to combat cancer and that these mechanisms are enhanced by concurrent radiation therapy. These results provide a strong rationale for conducting future clinical trials of bavituximab in combination with radiation for the treatment of glioblastoma and other brain cancers. The study authors also assessed the mechanisms of the observed anti-tumor effects. Analysis showed that radiation induced PS exposure on tumor blood vessels and enhanced the ability of the bavituximab equivalent to mobilize immune system monocyte and macrophage cells to attack the tumor blood vessels. In addition, the authors showed that the bavituximab equivalent enhanced the ability of the immune system to generate cytotoxic T cells specific to the brain cancer cells used in the studies.
Peregrine Pharmaceuticals Receives Second Broad U.S. Patent For Anti Viral Applications of Phospholipid Targeting Antibodies
Peregrine Pharmaceuticals announced that the U.S. Patent and Trademark Office has issued U.S. Patent Number 7,611,704, which includes broad claims covering anti-viral uses of phosphatidylserine (PS)-targeting antibodies including Peregrine's lead clinical compound, bavituximab. PS is a marker exposed on the surface of virally infected cells that can be targeted to treat a broad spectrum of virus infections. The new patent covers compositions and methods of treating virus infections using bavituximab and similar antibodies, either alone or as immunoconjugates attached to anti viral agents, as well as in combination with other anti-viral agents.
Peregrine Pharmaceuticals Reports 61% Objective Response Rate in 46-Patient Bavituximab Phase II Trial in Advanced Breast Cancer
Peregrine Pharmaceuticals announced positive results from its Phase II trial evaluating bavituximab in combination with docetaxel in patients with advanced breast cancer. Preliminary data at the end of the six planned treatment cycles in the Phase II study showed that 28 of 46, or 61%, of all patients enrolled in the trial achieved an objective tumor response according to RECIST criteria. This data compares favorably with data from a published study showing an objective tumor response rate of 41% in a similar patient population receiving the same dosing regimen of docetaxel administered as a single agent. The primary objective of the multi-center, open-label Phase Il study is to assess the overall response rate to bavituximab and docetaxel. In this trial's Simon two-stage design, 15 patients were initially enrolled in the study followed by an additional 31 patients after the pre-specified primary efficacy endpoint for expanding the study was met, bringing the total to 46 patients. Initial data from the first set of 15 patients in the study was reported in an oral presentation at the 2009 ASCO Annual Meeting. Recent analysis showed the median progression-free-survival (PFS) of patients enrolled in the initial 15-patient cohort of the study was 7.4 months, a promising early result. Patient follow-up in the trial is continuing.
Peregrine Pharmaceuticals Announces Positive Results From Phase II Bavituximab Lung Cancer Trial
Peregrine Pharmaceuticals announced additional positive results in its Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel in patients with non small cell lung cancer (NSCLC). Data previously reported from the initial cohort of 21 patients in the study had indicated that 11 of 17 evaluable patients with locally advanced or metastatic NSCLC achieved an objective tumor response according to RECIST criteria. Recent analysis from the 21 patient cohort now shows the median progression-free-survival (PFS) for these patients was 6.5 months, which compares favorably with the PFS range of 4.2 to 4.5 months reported in a similar patient population receiving carboplatin and paclitaxel as a single agent in NSCLC trials that were the basis for the design of the ongoing bavituximab study. The primary objective of the multi-center, open-label Phase II NSCLC study is to assess the overall response rate to bavituximab with carboplatin and paclitaxel. In the trial's Simon two-stage design, 21 patients with previously untreated locally advanced or metastatic NSCLC were initially enrolled, and 17 of these patients were deemed evaluable. In this initial cohort, 11 of the 17 evaluable patients achieved an objective tumor response by the time that treatment with the combination of bavituximab, carboplatin and paclitaxel was completed.
