Data From the Trial to Be Presented at 2013 ASCO Annual Meeting
TUSTIN, CA, USA I April 29, 2013 I Peregrine Pharmaceuticals (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced the completion of patient enrollment in an investigator-sponsored Phase I trial evaluating bavituximab in combination with the chemotherapeutic agent paclitaxel in patients with metastatic HER2-negative breast cancer. Peregrine’s lead clinical candidate, bavituximab, is a phosphatidylserine (PS)-targeting monoclonal antibody that has demonstrated promising tumor response and survival trends in two prior Phase II advanced breast cancer trials evaluating the compound in additional treatment combinations. Bavituximab is currently being evaluated in several oncology clinical trials including the lead indication of second-line non-small cell lung cancer (NSCLC), which is anticipated to advance into a pivotal Phase III trial later this year.
“This represents another important milestone achieved for our bavituximab oncology program,” said Joseph S. Shan, M.P.H., vice president of clinical and regulatory affairs of Peregrine. “Two prior bavituximab clinical trials have demonstrated impressive tumor response rates as well as very encouraging overall survival trends in patients with advanced breast cancer. We look forward to data from this investigator-sponsored trial being presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.”
Interim data from the trial presented at the 2012 Annual Meeting of the American Association for Cancer Research (AACR) showed that in five evaluable patients with HER2-negative metastatic breast cancer, two patients achieved a complete tumor response, one achieved a partial response, and two had progressive disease according to Response Evaluation Criteria In Solid Tumors (RECIST) measurement criteria1.
1. Microparticle generation and activation after treatment with paclitaxel and bavituximab combination therapy in metastatic breast cancer. http://www.peregrineinc.com/images/stories/pdfs/aacr_2012_mbc_ist.pdf
About the Phase I Breast Cancer Trial
In this Phase I single-arm, open-label trial, 14 patients with HER2-negative metastatic breast cancer were enrolled. Patients were treated with paclitaxel (80 mg/m2) weekly for three weeks out of each four-week cycle and bavituximab (3 mg/kg) weekly. The primary endpoint is to determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy. Patients will also be assessed for overall response rate and median progression free survival (PFS) according to RECIST criteria. For further information about this trial, please visit http://www.clinicaltrials.gov/ct2/show/NCT01288261?term=bavituximab&rank=7
About Peregrine’s Investigator-Sponsored Trials (IST) Program
Peregrine’s IST program provides oncologists the opportunity to conduct clinical trials with bavituximab and is a cost effective way to further investigate bavituximab’s therapeutic potential in additional oncology indications and treatment combinations. To learn more about Peregrine’s IST program, please visit http://www.peregrineinc.com/pipeline/investigator-sponsored-trials.html.
About Breast Cancer
The World Health Organization reports that breast cancer is the most commonly diagnosed cancer in women and is second only to lung cancer as a leading cause of female cancer deaths. About 1 in 8 U.S. women will develop invasive breast cancer over the course of her lifetime. About 39,520 women in the U.S. were expected to die in 2011 from breast cancer. HER2-negative accounts for approximately 75% of metastatic breast cancers.
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-targeting technology platform and is currently being evaluated in several solid tumor indications, including non-small cell lung cancer, pancreatic cancer, breast cancer, liver cancer and rectal cancer. 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 third-party customers. Additional information about Peregrine can be found at www.peregrineinc.com.
SOURCE: Peregrine Pharmaceuticals
Post Views: 147
Data From the Trial to Be Presented at 2013 ASCO Annual Meeting
TUSTIN, CA, USA I April 29, 2013 I Peregrine Pharmaceuticals (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced the completion of patient enrollment in an investigator-sponsored Phase I trial evaluating bavituximab in combination with the chemotherapeutic agent paclitaxel in patients with metastatic HER2-negative breast cancer. Peregrine’s lead clinical candidate, bavituximab, is a phosphatidylserine (PS)-targeting monoclonal antibody that has demonstrated promising tumor response and survival trends in two prior Phase II advanced breast cancer trials evaluating the compound in additional treatment combinations. Bavituximab is currently being evaluated in several oncology clinical trials including the lead indication of second-line non-small cell lung cancer (NSCLC), which is anticipated to advance into a pivotal Phase III trial later this year.
“This represents another important milestone achieved for our bavituximab oncology program,” said Joseph S. Shan, M.P.H., vice president of clinical and regulatory affairs of Peregrine. “Two prior bavituximab clinical trials have demonstrated impressive tumor response rates as well as very encouraging overall survival trends in patients with advanced breast cancer. We look forward to data from this investigator-sponsored trial being presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.”
Interim data from the trial presented at the 2012 Annual Meeting of the American Association for Cancer Research (AACR) showed that in five evaluable patients with HER2-negative metastatic breast cancer, two patients achieved a complete tumor response, one achieved a partial response, and two had progressive disease according to Response Evaluation Criteria In Solid Tumors (RECIST) measurement criteria1.
1. Microparticle generation and activation after treatment with paclitaxel and bavituximab combination therapy in metastatic breast cancer. http://www.peregrineinc.com/images/stories/pdfs/aacr_2012_mbc_ist.pdf
About the Phase I Breast Cancer Trial
In this Phase I single-arm, open-label trial, 14 patients with HER2-negative metastatic breast cancer were enrolled. Patients were treated with paclitaxel (80 mg/m2) weekly for three weeks out of each four-week cycle and bavituximab (3 mg/kg) weekly. The primary endpoint is to determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy. Patients will also be assessed for overall response rate and median progression free survival (PFS) according to RECIST criteria. For further information about this trial, please visit http://www.clinicaltrials.gov/ct2/show/NCT01288261?term=bavituximab&rank=7
About Peregrine’s Investigator-Sponsored Trials (IST) Program
Peregrine’s IST program provides oncologists the opportunity to conduct clinical trials with bavituximab and is a cost effective way to further investigate bavituximab’s therapeutic potential in additional oncology indications and treatment combinations. To learn more about Peregrine’s IST program, please visit http://www.peregrineinc.com/pipeline/investigator-sponsored-trials.html.
About Breast Cancer
The World Health Organization reports that breast cancer is the most commonly diagnosed cancer in women and is second only to lung cancer as a leading cause of female cancer deaths. About 1 in 8 U.S. women will develop invasive breast cancer over the course of her lifetime. About 39,520 women in the U.S. were expected to die in 2011 from breast cancer. HER2-negative accounts for approximately 75% of metastatic breast cancers.
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-targeting technology platform and is currently being evaluated in several solid tumor indications, including non-small cell lung cancer, pancreatic cancer, breast cancer, liver cancer and rectal cancer. 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 third-party customers. Additional information about Peregrine can be found at www.peregrineinc.com.
SOURCE: Peregrine Pharmaceuticals
Post Views: 147
