Peregrine Pharma (PPHM) Moves Higher on Positve ASCO Data
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Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) reported today that data was presented at the 2013 ASCO Annual Meeting from two clinical trials evaluating the company's lead clinical candidate bavituximab. In the first study presented, interim data from a Phase I trial evaluating bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer (MBC) showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria.
In the second study, results from a randomized Phase II trial of bavituximab plus gemcitabine in patients with non-resectable Stage IV pancreatic cancer demonstrated more than a doubling of the overall response rate (ORR) and an improvement in overall survival (OS), including a delayed separation in the Kaplan-Meier survival curve that is commonly seen in clinical studies of promising cancer immunotherapies. These presentations were made at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
"The results of this Phase I breast cancer trial are encouraging as there were no new safety signals and excellent clinical responses," said Alison Stopeck, MD, Associate Professor of Medicine and Director, Clinical Breast Cancer Program at the University of Arizona Cancer Center. "There were several laboratory correlative studies associated with the trial which confirmed the safety of bavituximab with regard to coagulation parameters."
In this open-label trial, 14 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) was administered weekly beginning on day 15 after two weekly doses of paclitaxel. Interim results from 13 evaluable patients showed that 11 patients (85%) achieved an objective response, including 2 patients (15%) that achieved a complete response (CR). In addition, the combination of bavituximab and paclitaxel was safe and well-tolerated.
"The data from this study strongly support advancing the program into later stage clinical studies in advanced breast cancer," said Joseph Shan, vice president of clinical and regulatory affairs of Peregrine. "In addition to the impressive overall response rate, we are also seeing interesting trends in correlative lab results which we are evaluating as potential biomarkers."
In the pancreatic cancer study, the final results from a company-sponsored, open-label, randomized Phase II clinical trial of bavituximab and gemcitabine in 70 patients with previously untreated, Stage IV pancreatic cancer continued to show encouraging activity in this patient population with very advanced disease. Results showed that the combination of bavituximab plus gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm). In the trial, 9 of 32 (28%) patients treated with a combination of bavituximab and gemcitabine achieved an objective tumor response as compared to 4 out of 31 (13%) in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75).
The trial included the enrollment of patients with advanced metastatic disease, including poor performance status (ECOG 2) and significant liver involvement associated with rapid disease progression. Results from a subgroup analysis showed that the effect of bavituximab plus gemcitabine was more pronounced in patients with ECOG d 1 and those without hepatic metastases.
In the second study, results from a randomized Phase II trial of bavituximab plus gemcitabine in patients with non-resectable Stage IV pancreatic cancer demonstrated more than a doubling of the overall response rate (ORR) and an improvement in overall survival (OS), including a delayed separation in the Kaplan-Meier survival curve that is commonly seen in clinical studies of promising cancer immunotherapies. These presentations were made at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
"The results of this Phase I breast cancer trial are encouraging as there were no new safety signals and excellent clinical responses," said Alison Stopeck, MD, Associate Professor of Medicine and Director, Clinical Breast Cancer Program at the University of Arizona Cancer Center. "There were several laboratory correlative studies associated with the trial which confirmed the safety of bavituximab with regard to coagulation parameters."
In this open-label trial, 14 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) was administered weekly beginning on day 15 after two weekly doses of paclitaxel. Interim results from 13 evaluable patients showed that 11 patients (85%) achieved an objective response, including 2 patients (15%) that achieved a complete response (CR). In addition, the combination of bavituximab and paclitaxel was safe and well-tolerated.
"The data from this study strongly support advancing the program into later stage clinical studies in advanced breast cancer," said Joseph Shan, vice president of clinical and regulatory affairs of Peregrine. "In addition to the impressive overall response rate, we are also seeing interesting trends in correlative lab results which we are evaluating as potential biomarkers."
In the pancreatic cancer study, the final results from a company-sponsored, open-label, randomized Phase II clinical trial of bavituximab and gemcitabine in 70 patients with previously untreated, Stage IV pancreatic cancer continued to show encouraging activity in this patient population with very advanced disease. Results showed that the combination of bavituximab plus gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm). In the trial, 9 of 32 (28%) patients treated with a combination of bavituximab and gemcitabine achieved an objective tumor response as compared to 4 out of 31 (13%) in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75).
The trial included the enrollment of patients with advanced metastatic disease, including poor performance status (ECOG 2) and significant liver involvement associated with rapid disease progression. Results from a subgroup analysis showed that the effect of bavituximab plus gemcitabine was more pronounced in patients with ECOG d 1 and those without hepatic metastases.
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