Targeting phosphatidylserine, a type of fat molecule found in the cell membranes, is a new approach to treat cancers and viral infections. Working on this new approach is clinical-stage biopharmaceutical company Peregrine Pharmaceuticals Inc. (PPHM).
For readers who are new to Peregrine, here's what to expect in the coming months...
The company's pipeline includes a first-in-class monoclonal antibody - Bavituximab and a tumor necrosis therapy - Cotara, both of which are currently in phase II clinical development.
Bavituximab, which targets phosphatidylserine, or PS, is being evaluated as a potential treatment for non-small cell lung cancer, pancreatic cancer and hepatitis C virus infection. Cotara is being tested as a potential therapy for the treatment of glioblastoma multiforme, the deadliest form of brain cancer.
By binding to phosphatidylserine that becomes exposed on the outside of cells that line tumor blood vessels, Bavituximab blocks PS-mediated immunosuppressive signals, thereby enabling the immune system to recognize and fight the tumor. Phosphatidylserine, usually located inside the membrane of healthy cells, as such, is a highly immunosuppressive molecule.
Two phase II trials are underway with Bavituximab in patients with non-small cell lung cancer, or NSCLC.
In one phase II study, Bavituximab in combination with Carboplatin and Paclitaxel is being tested in patients with previously untreated non-small cell lung cancer. (Front-Line NSCLC Trial).
In another study, Bavituximab in combination with Docetaxel is being studied in patients with previously treated locally advanced or metastatic non-small cell lung cancer. (Second-Line NSCLC Trial)
The front-line NSCLC trial has enrolled 86 patients and interim data from this trial is expected by the end of this year.
According to Peregrine, in a prior single-arm phase II study in 49 patients with previously untreated non-small cell lung cancer, Bavituximab in combination with Carboplatin and Paclitaxel demonstrated a median overall survival of 12.4 months, median progression-free survival of 6.1 months and objective response rate of 43%. A separate historic control trial which tested Carboplatin and Paclitaxel alone in a similar patient population showed a median overall survival of 10.3 months, median progression-free survival of 4.5 months and objective response rate of just 15%.
The second-line non-small cell lung cancer trial for Bavituximab has enrolled 121 patients and data from this trial is expected to be unblinded in the first half of 2012.
According to the company, the combination of Bavituximab and Docetaxel has a good chance to improve tumor response rate since Docetaxel increases the exposure of Bavituximab's phosphatidylserine target and thereby improve overall survival for non-small cell lung cancer patients who have already failed a prior treatment.
Bavituximab is also being evaluated in investigator-sponsored trials for advanced hepatocellular carcinoma, prostate cancer, breast cancer and non-small cell lung cancer.
Apart from oncology indications, Bavituximab is also tested as a potential treatment for hepatitis C virus infection. A phase II trial, which has enrolled 66 patients with previously untreated genotype-1 HCV (hepatitis C virus) infection, is currently underway. Patients are receiving daily oral Ribavirin with either weekly Bavituximab or Pegylated interferon alpha-2a for up to 12 weeks and are being tested for safety parameters and antiviral activity.
Once all the patients enrolled in the HCV trial have completed 12 weeks of therapy, the company expects to report early-virologic response, or EVR, data by the end of this year or early next year.
As regards the brain cancer therapy - Cotara, Peregrine plans to meet up with the FDA this quarter (4Q) to determine its optimal registration pathway. In a phase II trial, which enrolled 41 patients with recurrent glioblastoma multiforme, a single infusion of Cotara has demonstrated a median overall survival of 8.8 months.
A quick look at the balance sheet...
The company has incurred net losses in most fiscal years since it began operations in 1981 and has an accumulated deficit of $304 million.
To date, no revenue has been generated from the commercial sale of products. Peregrine currently derives revenue from contract manufacturing services provided by its subsidiary Avid Bioservices Inc. and licensing revenues related to agreements associated with the company's technologies under development.
At July 31, 2011, the company had $16.54 million in cash. In a recent SEC filing, the company has revealed that its ability to continue clinical trials and development efforts is highly dependent on the amount of cash and cash equivalents on hand combined with the ability to raise additional capital to support future operations.
Shares of Peregrine Pharma underwent a 1-for-5 reverse stock split on October 19, 2009. Over the past 52-weeks, the stock traded within a range of $0.95 to $3.10. PPHM closed Wednesday's trading at $1.11, up 1.8%.
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