Biopharmaceutical company, Peregrine Pharmaceuticals (NASDAQ:PPHM has reported that the that top-line data from the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer were presented in an oral presentation at the European Society for Medical Oncology 2016 Congress.
— Company Has Identified Beta-2 Glycoprotein-1 (β2GP1) as a Biomarker that Correlates with Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination Compared to Chemotherapy Alone —
— Ongoing SUNRISE Trial Biomarker Analysis Expected to Identify Additional Biomarkers Associated with Patients Benefiting from Bavituximab Treatment that Will Help Guide Program’s Future Clinical Development —
TUSTIN, Calif., Oct. 10, 2016 (GLOBE NEWSWIRE) — Peregrine Pharmaceuticals, Inc. (PPHM) (PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today reported that top-line data from the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) were presented in an oral presentation at the European Society for Medical Oncology (ESMO) 2016 Congress. The presentation included interim efficacy and safety outcomes, as well as initial findings from the company’s ongoing biomarker analysis of samples collected during the study. The SUNRISE Phase III trial was discontinued earlier this year based on a pre-specified interim analysis although patient treatment and follow-up in the study were allowed to continue. The pre-planned biomarker analysis has been taking place as patient follow-up has continued and available results were evaluated as part of the recent top-line data analysis.
The study protocol pre-specified the collection of thousands of patient samples for exploratory analyses over a wide range of possible biomarkers, including pre-treatment levels of beta-2 glycoprotein-1 (β2GP1). Data presented at ESMO demonstrated that patients with pre-treatment β2GP1 levels between 200 and 240 (representing approximately 30% of randomized patients) achieved a statistically significant, 5.5-month improvement (13.2 months vs. 7.7 months) in median overall survival (OS) as compared to patients in the control group with the same range of β2GP1 levels [p = 0.049; hazard ratio (HR) = 0.67]. A similar trend was observed with pre-treatment β2GP1 levels ≥ 200 µg/mL (representing approximately 50% of randomized patients) with 11.9 months vs. 10.1 months median OS in favor of the bavituximab-containing group (p = 0.155; HR = 0.81). Taken together, this strongly suggests β2GP1 levels may be useful for identifying patients who are more likely to benefit from a bavituximab containing therapeutic regimen. Numerous additional biomarkers are currently being analyzed with the goal of developing a multi-marker signature that can potentially identify patients that are likely to receive significant clinical benefit from a bavituximab-containing therapeutic regimen.
Top-line results reported at ESMO today were based on a data cut-off after 70% (330/473) of the targeted OS events had been reached and demonstrated the addition of bavituximab to docetaxel did not result in improvement of the study’s primary endpoint of OS in the intent-to-treat population. Median OS for the bavituximab plus docetaxel group was 10.7 months as compared to 10.8 months for the placebo plus docetaxel control group (HR = 1.110; p = 0.382). Median progression free survival (PFS) for the bavituximab-containing group was 4.1 months compared to 3.9 months for the control group (HR = 0.97; p = 0.803). Objective response rates based on independent central review are currently 13% and 11% (p = 0.53) for the bavituximab-containing and control groups, respectively. Additionally, the safety profile of the combination of bavituximab with docetaxel was similar to placebo plus docetaxel.
“With every clinical trial we conduct, we are constantly reminded of the difficulty involved in treating patients with non-small cell lung cancer. This continues to prove to be a very challenging cancer to combat and the need for effective treatments remains high,” David R. Spigel, MD, chief scientific officer and program director of Lung Cancer Research at the Sarah Cannon Research Institute and one of the lead investigators in the SUNRISE trial. “The findings with regard to β2GP1 that have been collected as part of the ongoing SUNRISE trial data analysis are interesting and support further investigation.”
Shares of Peregrine Pharmaceuticals (NASDAQ:PPHM) are actively moving -9.1517% thus far today on the news and have traded in the range of $0.3700 – 0.4370 during the session. A number of research firms have recently weighed in on the stock, providing future price targets. The covering firms currently have a consensus one-year price target of $1.0000 on the stock. This is according to brokerage analysts polled by Thomson Reuters First Call. This is the average number from the individual targets provided by the firms. Analysts are projecting earnings per share of $-0.0300 for the next fiscal quarter. For the current year, analysts are predicting earnings of $-0.1200 per share according to First Call.
In looking at where the stock is trading on a technical level, the stock is trading -0.6231% away from its 50-day moving average of $0.3966. Based on the most recent available data, the equity is -70.3684% off of its 52-week high of $1.3300 and +35.8966% away from its 52-week low which is $0.2900.
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Today, the stock opened at $0.4300 and the last bid at the time of writing stood at $0.3941. During the session thus far, the equity dipped down to $0.3700 and touched $0.4370 as the high point. Peregrine Pharmaceuticals Inc. has a market cap of $95.52M and has seen an average daily volume of 1125920 over the past three months.
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