Peregrine Pharmaceuticals (NASDAQ:PPHM), announced the peer-reviewed publication of clinical data from a Phase I investigator-sponsored trial evaluating the company's lead investigational immunotherapy bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer. The manuscript details the results of the Phase I trial showing that the combination produced an objective tumor response in 85% of patients, including 15% of these patients achieving a complete response, measured in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
"The publication of these data marks an important milestone in the development of this novel therapeutic in a difficult to treat patient population," said Alison Stopeck, M.D., the principal investigator on the trial and Professor, Department of Medicine and Associate Director for Translational Research at the Stony Brook Cancer Center in Stony Brook, New York. "The regimen was very well tolerated and the clinical responses were encouraging. The data also suggest bavituximab may uniquely affect the coagulation system in a beneficial way for cancer patients. It is my belief that the combination of bavituximab with weekly paclitaxel is a feasible regimen that is associated with a promising response rate in patients with metastatic breast cancer and warrants further clinical exploration."
In the online released manuscript, researchers at the University of Arizona Medical Center led by Alison Stopeck, M.D. enrolled 14 patients with metastatic breast cancer (MBC) and while all were evaluable for toxicity, 13 were evaluable for response and progression free survival (PFS). These patients with HER2-negative MBC were treated with paclitaxel (80 mg/m2) weekly for three weeks of each four-week cycle and bavituximab (3 mg/kg) administered weekly beginning on day 15 after two weekly doses of paclitaxel. Results from 13 evaluable patients showed that 11 patients (85%) achieved an objective response, including two patients (15%) that achieved a complete response (CR), 9 patients with partial responses (PR) and 2 patients with progressive disease (PD). Median PFS for the combination of bavituximab with weekly paclitaxel was 7.3 months. In addition, the combination of bavituximab and paclitaxel was safe and well-tolerated with the majority of grade 1 or 2 adverse events being paclitaxel related. Approximately half of these patients were classified as "triple negative," a traditionally difficult-to-treat patient population. In addition, treatment with bavituximab reduced circulating PS-expressing microparticles (exosomes) which are immunosuppressive.
"These compelling results in a very difficult to treat patient population provide the foundation to move with confidence into a later stage trial," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine Pharmaceuticals. "These data build upon our historical clinical experience in the area of breast cancer and when combined with recent preclinical data demonstrating bavituximab's ability to promote antitumor immune activity, increase our understanding of the immune-stimulatory aspects of bavituximab."
These results appear in the March issue of the peer-reviewed journal, Cancer Medicine, in a manuscript titled: "A Phase I Clinical Trial of Bavituximab and Paclitaxel in Patients with HER-2 Negative Metastatic Breast Cancer."
The online article is available at: http://onlinelibrary.wiley.com/doi/10.1002/cam4.447/full (Original Source)
Shares of Peregrine opened today at $1.38 and are currently trading down at $1.37. PPHM has a 1-year high of $2.09 and a 1-year low of $1.19. The stock's 50-day moving average is $1.39 and it's 200-day moving average is $1.41.
On the ratings front, Peregrine has been the subject of a number of recent research reports. In a report issued on March 13, MLV & Co. analyst Thomas Yip reiterated a Buy rating on PPHM, with a price target of $3.50, which implies an upside of 153.6% from current levels. Separately, on January 16, Roth Capital's Joseph Pantginis reiterated a Buy rating on the stock and has a price target of $5.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Thomas Yip and Joseph Pantginis have a total average return of 2.3% and 12.1% respectively. Yip has a success rate of 33.3% and is ranked #2314 out of 3560 analysts, while Pantginis has a success rate of 54.8% and is ranked #124.
Peregrine Pharmaceuticals Inc is a biopharmaceutical company with a portfolio of monoclonal antibodies in clinical trials for treatment & diagnosis of cancer. With its phosphatidylserine-targeting platform, it is pursuing two clinical programs in cancer.