Friday, November 06, 2009
BGMC Only Hospital in South Florida Selected to Participate in nH1N1 Clinical Trial
Ft. Lauderdale, FL - Broward General Medical Center has been selected as the only hospital in South Florida to participate in a randomized study of the antiviral activity, safety and tolerability of intravenous Peramivir in adult and adolescent hospitalized patients with confirmed or suspected influenza infection. The study, expected to begin this November, is under the auspicious of the IRB/Ethics Committee of Health and Human Services (HHS), which has awarded BioCryst Pharmaceuticals, Inc., a $77.2 million contract to complete the study at specific hospitals throughout the U.S. and abroad. The outcome of the Phase 3 study will determine if the medication receives U.S. regulatory approval. The Food and Drug Administration (FDA*) has granted fast track review.
"We are honored to be the sole hospital chosen in South Florida to participate in this potentially life-saving initiative,” said James Thaw, chief executive officer, BGMC. “I’m extremely proud to announce that the study will be overseen by the noted Internist and Pulmonologist, Gary J. Richmond, M.D., chief of Medicine and the medical director of Respiratory Care Services at Broward General. “There are no anti-viral, intravenous or injectable medications approved at this time to treat hospitalized patients who are acutely ill with the influenza, or for any kind of influenza indication,” continued Thaw.
“The fact that Broward General has been selected for this timely study indicates an enormous recognition about the fine capabilities of our medical team here,” said Richmond. “This study will determine if a once or twice daily intravenous treatment is safe and effective for patients with acute influenza. The population we study will include patients from 12 years old to the elderly who have underlying cardiac or pulmonary disease. The protocol will be enrolling 300 patients."
Facts & Figures
According to the U.S. Centers for Disease Control & Prevention (CDC), on average 5 to 20 percent of the population gets the flu each year in the U.S.; more than 200,000 people are hospitalized from flu complications and about 36,000 people die from flu-related causes.
Peramivir is an anti-viral agent that was discovered by BioCryst which inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against pandemic H1N1 swine flu origin viral strains. Peramivir has been studied in patients with complicated and uncomplicated influenza. BioCryst's partner, Shionogi & Co., Ltd. is currently preparing to file for regulatory approval in Japan this year.
About Gary J. Richmond, M.D., F.A.C.P., F.C.C.P.
Dr. Richmond is recognized for his appointments as principal investigator on more than 150 medical research projects over the past 22 years. He received his medical degree from New York Medical College, Valhalla, New York. He completed his internal medicine internship and residency training at Beth Israel Medical Center, New York and Pulmonary Fellowship at the University of California, San Francisco. Dr. Richmond is a Fellow of the American College of Chest Physicians and the American College of Physicians. He is the Chief of Medicine at Broward General Medical Center, Medical Director of Respiratory Care Services at Broward General Medical Center and Medical Director of the Broward College Respiratory Care program.
About Broward General Medical Center
Broward Health, providing service for more than 50 years, is a nationally recognized system offering world-class health care services to our neighbors in South Florida. One of the 10 largest public health systems in the nation, Broward Health includes Broward General Medical Center, North Broward Medical Center, Imperial Point Medical Center, Coral Springs Medical Center, Chris Evert Children’s Hospital, Broward Health Weston and more than 30 facilities of the Community Health Services and Broward Health Physician Group. For more information visit www.BrowardHealth.org.