SAN DIEGO--(BUSINESS WIRE)-- Apricus Biosciences, Inc., (“Apricus Bio”) (Nasdaq: APRI) today announced the formation of a Clinical Advisory Board focused on the development of its investigational oncology compound, PrevOnco™. The Clinical Advisory Board is chaired by Stephen B. Howell, who also serves as Chairman of the Company’s Scientific Advisory Board (“SAB”). Additional members of the Clinical Advisory Board include, Drs. Ghassan K. Abou-Alfa, Melanie Thomas, Robert G. Gish and Yehuda Patt.
Apricus Bio is developing PrevOnco, a marketed anti-ulcer compound, lansoprazole, to treat patients with advanced, unresectable hepatocellular carcinoma (“HCC”), or liver cancer. The Company is finalizing the Special Protocol Assessment (“SPA”) Phase 3 registration protocol for a comparator study against doxorubicin in patients who have failed treatment with Nexavar® (the currently marketed first-line anti-cancer treatment for patients with either HCC, or advanced renal cell carcinoma). Subject to positive data, the Phase 3 study would be expected to support the filing of a New Drug Application for marketing approval in the U.S. and Europe. Management expects to submit the SPA Phase 3 protocol to the U.S. Food & Drug Administration (“FDA”) before year-end 2010.
In the U.S., Nexavar is marketed by Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc., and is approved in more than 90 countries for the treatment of patients with liver cancer.
Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are pleased to be able to, once more, tap the extraordinary expertise of Dr. Howell. Additionally, we are delighted to welcome Drs. Abou-Alfa, Thomas, Gish and Patt. Together, they will be instrumental in helping us move this important clinical program forward.”
Dr. Howell, Chairman of the Company’s SAB, commented, “We have assembled an impressive group of key opinion leaders. Having been involved in the clinical development of Nexavar, their experience in developing new HCC therapies will be invaluable to us as we finalize the SPA for submission to the FDA.”
Dr. Howell is a medical oncologist and Professor of Medicine at the University of California, San Diego. He also serves as Associate Director for Clinical Research and Director of the Cancer Therapeutics Training Program at the Moores Comprehensive Cancer Center at the University of California, San Diego, and runs the Clayton Foundation Drug Resistance Laboratory at the Cancer Center. During his career, Dr. Howell has co-founded three pharmaceutical companies, including DepoTech (1989), Beacon Laboratories (1995), and Targa Pharmaceuticals (2003), serving as Medical Director of each. He holds a number of patents for his innovative work in chemotherapeutics, drug-delivery systems, and diagnostic assays and is the recipient of numerous awards. He is currently one of the main organizers of the American Association of Cancer Research.
Dr. Ghassan K. Abou-Alfa is a board-certified medical oncologist at Memorial Sloan-Kettering Cancer Center, specializing in primary liver cancer (hepatocellular carcinoma), pancreas, gallbladder, and bile duct tumors. He is involved in research focusing on improving the effectiveness of cancer therapy by incorporating small, novel biological molecules that target cancer into the treatment of chemotherapy-resistant gastrointestinal malignancies, particularly hepatobiliary and pancreatic cancers. Dr. Abou-Alfa received his M.D. from American University of Beirut, and completed residencies and fellowships at Yale University School of Medicine.
Dr. Melanie Thomas, M.S., is an Associate Professor and Associate Director of Clinical Investigations and the Grace E. DeWolf Chair of Medical Oncology at MUSC Hollings Cancer Center in Charleston, South Carolina. She earned her M.D. from Boston University School of Medicine and her M.S. from Harvard University. Dr. Thomas’ professional interests include, hepatocellular, pancreatic, gallbladder, biliary and colorectal cancer.
Dr. Robert G. Gish serves as Chief of Clinical Hepatology, Professor of Clinical Medicine and co-director of the Center for Hepatobiliary Disease and Abdominal Transplantation (CHAT) at the University of California, San Diego School of Medicine. He is a NIH-funded researcher whose work focuses on the epidemiology of liver disease, biomarkers for liver disease and multi-targeted therapies for liver cancer. Dr. Gish received his medical degree from the University of Kansas in Kansas City. He completed his internship and residency in internal medicine at the University of California, San Diego School of Medicine and a fellowship in Gastroenterology and Hepatology at the University of California, Los Angeles. He is board certified in Internal Medicine and Gastroenterology and has the advance Certificate of Added Qualification (CAQ) in Liver Transplantation and is a UNOS certified Liver Transplant Physician.
Dr. Yehuda Patt is a Professor of Internal Medicine and the Director of Gastrointestinal Oncology Research at the University of New Mexico Cancer Center in Albuquerque, NM. He attended the Hebrew University and Hadassah Medical School, and completed his residency at Sheba Medical Center in Tel Aviv, Israel, and fellowship at the Anderson Hospital and Tumor Institute in Houston, Texas.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to successfully develop PrevOnco or obtain FDA approval for the proposed Phase 3 SPA, enter into partnership agreements and successfully execute business plans. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
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Apricus Bio Investor Relations
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INDUSTRY KEYWORDS: Health Biotechnology Oncology