Top-Line Results Demonstrate Signs of Anti-Tumor Activity in Difficult to Treat Patient Population; Company Evaluating Next Steps for Advancing Bavituximab Pancreatic Program
TUSTIN, CA, USA I February 13, 2013 I Peregrine Pharmaceuticals (NASDAQ: PPHM) today announced results from its 70 patient open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in patients with previously untreated, advanced Stage IV pancreatic cancer. The trial included the enrollment of patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression. Results showed that the combination of bavituximab and 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, patients treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 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).
"We are pleased with the results seen in this very difficult to treat patient population," said Kerstin Menander, MD, PhD, head of medical oncology at Peregrine. "Although the median overall survival improvement is modest, further analysis of the data including subgroups shows some very interesting and potentially promising trends. We look forward to presenting the full data set from this trial later this year at an upcoming scientific meeting."
The pancreatic cancer trial is a randomized, open-label Phase II trial evaluating bavituximab with gemcitabine versus gemcitabine alone in up to 70 patients with previously untreated stage IV pancreatic cancer. The trial allowed the enrollment of patients 18 and older without any age limit, distant organ involvement and ECOG performance status of 0-2. In this trial, bavituximab was generally safe and well tolerated in combination with gemcitabine with similar adverse events occurring in both arms.
"In light of this data, as well as other recent developments in the treatment of pancreatic cancer, we are actively evaluating the next steps for advancing the bavituximab pancreatic program," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. "Subgroup analyses from the trial are yielding additional information that we believe will be important in guiding the anticipated future development of bavituximab in this challenging indication. We are considering potential development pathways that would allow us to take advantage of bavituximab’s broad potential when combined with other cancer agents. We look forward to providing updates as these plans come together."
Bavituximab is being evaluated by Peregrine and individual clinical investigators in a variety of treatment settings for patients with non-small cell lung cancer in both the front and second-line settings, as well as breast, prostate, liver and rectal cancers in combination with approved chemotherapies and radiation.
About Bavituximab
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. Bavituximab is the lead drug candidate from the company’s PS technology platform and is currently being tested in seven clinical trials, including two randomized Phase II trials in front-line and second-line non-small cell lung cancer, and five investigator-sponsored trials (ISTs) in additional oncology indications. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
SOURCE: Peregrine Pharmaceuticals
Post Views: 224
Top-Line Results Demonstrate Signs of Anti-Tumor Activity in Difficult to Treat Patient Population; Company Evaluating Next Steps for Advancing Bavituximab Pancreatic Program
TUSTIN, CA, USA I February 13, 2013 I Peregrine Pharmaceuticals (NASDAQ: PPHM) today announced results from its 70 patient open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in patients with previously untreated, advanced Stage IV pancreatic cancer. The trial included the enrollment of patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression. Results showed that the combination of bavituximab and 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, patients treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 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).
"We are pleased with the results seen in this very difficult to treat patient population," said Kerstin Menander, MD, PhD, head of medical oncology at Peregrine. "Although the median overall survival improvement is modest, further analysis of the data including subgroups shows some very interesting and potentially promising trends. We look forward to presenting the full data set from this trial later this year at an upcoming scientific meeting."
The pancreatic cancer trial is a randomized, open-label Phase II trial evaluating bavituximab with gemcitabine versus gemcitabine alone in up to 70 patients with previously untreated stage IV pancreatic cancer. The trial allowed the enrollment of patients 18 and older without any age limit, distant organ involvement and ECOG performance status of 0-2. In this trial, bavituximab was generally safe and well tolerated in combination with gemcitabine with similar adverse events occurring in both arms.
"In light of this data, as well as other recent developments in the treatment of pancreatic cancer, we are actively evaluating the next steps for advancing the bavituximab pancreatic program," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. "Subgroup analyses from the trial are yielding additional information that we believe will be important in guiding the anticipated future development of bavituximab in this challenging indication. We are considering potential development pathways that would allow us to take advantage of bavituximab’s broad potential when combined with other cancer agents. We look forward to providing updates as these plans come together."
Bavituximab is being evaluated by Peregrine and individual clinical investigators in a variety of treatment settings for patients with non-small cell lung cancer in both the front and second-line settings, as well as breast, prostate, liver and rectal cancers in combination with approved chemotherapies and radiation.
About Bavituximab
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. Bavituximab is the lead drug candidate from the company’s PS technology platform and is currently being tested in seven clinical trials, including two randomized Phase II trials in front-line and second-line non-small cell lung cancer, and five investigator-sponsored trials (ISTs) in additional oncology indications. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
SOURCE: Peregrine Pharmaceuticals
Post Views: 224
