Pro-Pharmaceuticals plans to submit Phase III trial design for DAVANAT to FDA

Pro-Pharmaceuticals, Inc.May 24 2010

Pro-Pharmaceuticals, Inc. (OTCBB: PRWP), the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced plans to submit a Phase III trial design for DAVANAT^® to the U.S. Food and Drug Administration (FDA) during the second half of 2010. The Company has added the talent of Peter G. Traber, M.D., to its FDA approval strategy and trial design team. Dr. Traber is a respected researcher, medical, regulatory and clinical expert, and serves on the Company's Board of Directors.

“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. 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," said Theodore D. Zucconi, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. "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."

One strategy Dr. Traber and Pro-Pharmaceuticals may pursue includes a Special Protocol Assessment (SPA), which, if successful, involves agreement in advance from the FDA that a Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval.

"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^®," said Dr. Traber. "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 Chief Executive Officer of Baylor College of Medicine. Dr. Traber currently is Chair of the Board and Chief Executive Officer of TerraSep, LLC, a Mountain View, CA biotechnology company. Previously, Dr. Traber was Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer of GlaxoSmithKline. He has also served as Chief Executive Officer 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.