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Re: cjgaddy post# 58740

Wednesday, 12/01/2010 9:53:58 AM

Wednesday, December 01, 2010 9:53:58 AM

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PR 12-1-10: PPHM’s 1st IST: Liver Cancer at UTSW, Bavi+Sorafenib, ~50 patients, open-label…

“Peregrine Announces Initiation of Phase I/II Investigator-Sponsored Trial in Liver Cancer
• Investigators Evaluating Novel Monoclonal Antibody Bavituximab in Combination With Sorafenib

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=533969

TUSTIN & DALLAS: 12/01/10 -- Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced the initiation of an investigator-sponsored trial (IST) for patients with advanced hepatocellular carcinoma (HCC), or liver cancer. This Phase I/II trial will treat patients with Peregrine's investigational monoclonal antibody bavituximab in combination with sorafenib.

"Our research has demonstrated that sorafenib increases the exposure of the highly immunosuppressive molecule phosphatidylserine (PS) on tumor vasculature, providing more of a specific target for bavituximab," said Adam C. Yopp, M.D., lead investigator of this trial and assistant professor of surgery at the University of Texas Southwestern Medical Center. "We are eager to determine if combining the growth-blocking mechanisms of sorafenib with the vascular-targeting and immune-reactivation mechanisms of bavituximab offers additive anti-tumor effects for patients with HCC."

Currently, Peregrine's bavituximab is being evaluated in combination with chemotherapy in multiple Phase II trials in non-small cell lung cancer and advanced breast cancer, as well as a Phase Ib trial for hepatitis C virus (HCV) and HIV coinfection.

"In prior studies, bavituximab has demonstrated broad therapeutic potential in multiple oncology indications," said Marvin R. Garovoy, M.D., head of clinical science at Peregrine Pharmaceuticals. "Our IST program is designed to provide valuable clinical data on bavituximab's potential use in different therapeutic combinations and indications. We also expect to further clarify details of bavituximab's multiple mechanisms of action, and to identify specific biomarkers that could ultimately help to measure and predict bavituximab's potential anti-tumor and immunostimulatory effects. We look forward to collaborating with Dr. Yopp and his team, as well as other investigators who have applied for our program."

ABOUT THE PHASE I/II HCC TRIAL
In this Phase I/II non-randomized, open-label trial, patients with advanced HCC will receive bavituximab weekly and sorafenib (400 mg) twice daily, until disease progression or toxicity. Phase I of the trial is dose escalation (0.3, 1 or 3 mg/kg) to determine the maximum tolerated dose (MTD) and Phase II is expansion of the study at the MTD. Approximately 50 patients will be enrolled in this trial.

Primary objectives are to determine the MTD of bavituximab in patients with advanced HCC treated with sorafenib and the radiographic median time to progression. Secondary objectives include response rate, progression free-survival, overall survival, safety and tolerability. Further information about this trial is available at http://PeregrineTrials.com and University of Texas Southwestern Medical Center Clinical Trials, and will be available at http://ClinicalTrials.gov .

[ UTSW Clinical Trials: “A Phase I/II Study of Bavituximab and Sorafenib In Patients With Advanced Hepatocellular Carcinoma”
Protocol#: 062010-150
http://www8.utsouthwestern.edu/patientcare/dallas/clinicaltrials/medical/advertisement.html?formId=84884

UTSW Trials Search: http://www.utsouthwestern.edu/utsw/cda/dept226287/files/308724.html ]

ABOUT PEREGRINE'S INVESTIGATOR-SPONSORED TRIALS (IST) PROGRAM
Peregrine's IST program offers oncologists the opportunity to conduct clinical trials using bavituximab in the following indications:
• Breast cancer
• Hepatocellular carcinoma
• Brain cancer
• Prostate cancer
• Pancreatic cancer
• Non-small cell lung cancer
• Colorectal cancer
• Melanoma
• Fibrosarcoma
• Renal cancer
• Urinary bladder cancer
• Hodgkin's lymphoma
• Ovarian cancer

To apply for Peregrine's IST program, please visit http://www.peregrineinc.com/pipeline/investigator-sponsored-trials.html .

ABOUT HEPATOCELLULAR CARCINOMA (HCC)
According to the National Cancer Institute, primary liver and bile duct cancers are the sixth most common cause of cancer death in men, and ninth most common in women. Approximately 24,000 new cases of these two cancers are expected to be diagnosed this year in the United States, with approximately 19,000 deaths attributable to these forms of cancer. The most common risk factor for liver cancer is chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. Currently approved treatment options for HCC are surgery, radiation, chemotherapy, targeted therapeutics, tumor ablation, and tumor embolization.

About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection 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. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Peregrine Contact: Amy Figueroa, Peregrine Pharmaceuticals, (800) 987-8256, info@peregrineinc.com

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12-1-10: PPHM’s 1st IST goes after Liver Cancer – only Pancreatic is tougher…
CANCERS WITH “HIGH UNMET MEDICAL NEEDS”
TIME Mag. 9-14-09 “The State of Cancer”
5-Yr. Survival Rates (Cancers Diag. 1996-2004):
• Prostate 99%
• Melanoma 92%
• Breast/women 89%
• Rectum 67%
• Kidney 67%
• ALL CANCERS: 66%
• Colon 65%
• Leukemia 51%
• Ovary 46%
• Brain 35%
• Stomach 25%
Lung 16%
Liver 11%
• Pancreatic 5%

1-13-10: CEO STEVE KING’S 16MIN. TALK AT ONEMEDFORUM2010 (SANFRAN)
…SK: ”The [next] study we have discussed with the FDA is Bavi+Doce in 2nd-line NSCLC. In this patient population, they have about a 6% resp. rate; so, a high unmet medical need, and we think an excellent opportunity for development. The trial design we’ve agreed to with the FDA is essentially a registrational Ph.2 design; it’s going to be about a 120 patient study, double-blinded, placebo-controlled… the goal being, if we see positive results & excellent results, that we really want to be able to take advantage of that and potentially approach the agency about Accelerated Approval. . . Other trial designs that we are in the process of planning is a front-line Bavi+CP combination. . . We’ve been approached by a number of investigators, and we ourselves are very interested, particularly in the Pancreatic and Liver cancer indications as some next steps. But again, one of the reasons we brought Marv [Dr. Marvin Garovoy - see http://tinyurl.com/yz4fwyv ] on board was really to help shore up the ability to run Investigator-Sponsored Studies (IST’s).”
http://tinyurl.com/yb7v2u4

1-11-10: Dr. Marvin Garovoy (Ex-XOMA VP) joins PPHM as Head/Clin.Science
…Dr. Garovoy will have primary responsibility for establishing & supervising an Investigator-Sponsored Trials (IST) pgm, as well as expanding scientific outreach & assisting with clinical trial design for the Bavi & Cotara pgms.
…CEO SK: ”These ISTs can be a very important part of our overall clinical dev. pgm, potentially providing invaluable info. that might not otherwise be obtained from our company-initiated trials.”
…Dr. Garovoy, “Bavituximab is a promising new approach with broad potential for the treatment of solid cancers and other diseases. Based on the encouraging results seen in early clinical trials, I welcome the opportunity to collaborate with clinical researchers to establish the investigator-sponsored studies that will enhance our understanding of the clinical potential of this exciting new agent."
http://tinyurl.com/yz4fwyv

7-14-10: Peregrine’s Ambitious Goal for Bavi: Accelerated Approval after Phase II: http://tinyurl.com/35ncd9h
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