Pro-Pharmaceuticals Inc. engages in the discovery, development and commercialization of advanced treatment of cancer and fibrosis. The company today said it plans to submit a phase III trial design for DAVANAT to the U.S. Food and Drug Administration during the second half of this year.
DAVANAT is Pro-Pharmaceutical’s lead product candidate for cancer patients. Data from the phase II trial for end-stage colorectal cancer patients demonstrated that DAVANAT used in combination with 5-FU extended median survival 46 percent longer than the best standard of care as determined by the patients’ physicians.
“I believe that DAVANAT will be a game-changer in cancer treatment, and I am looking forward to providing hands-on support to Pro-Pharmaceuticals as we design the phase III trial for DAVANAT(R),” Dr. Peter G. Traber, part of the company’s FDA approval strategy and trial design team stated in the press release. “We plan to submit the trial design to the FDA during the second half of 2010 as we move toward the goal of commercializing DAVANAT.”
Dr. Traber was elected to Pro-Pharmaceuticals’ board of directors in 2009. He is president emeritus and former CEO of Baylor College of Medicine. He is currently chair of the board CEO of biotechnology company TerraSep, LLC.
Previously, Dr. Traber served as senior vice president of Clinical Development and Medical Affairs and chief medical officer of GlaxoSmithKline. He has also served as CEO of the University of Pennsylvania Health System, as well as chair of the Department of Internal Medicine and Chief of Gastroenterology for the University of Pennsylvania School of Medicine.
Theodore D. Zucconi, Ph.D., CEO of Pro-Pharmaceuticals, noted Dr. Traber’s industry experience and said the company is confident his background will add value to the company’s efforts to gain FDA approval for DAVANAT.
“Dr. Traber brings to the Pro-Pharmaceuticals team years of successful experience in drug development and approval. He has gained a thorough understanding of our trial results and our products,” Dr. Zucconi stated. “We believe Dr. Traber to be a valuable asset in producing a comprehensive phase III design with a greater probability of a successful FDA approval.”
For more information, visit www.pro-pharmaceuticals.com