Carlton E. Turner, PhD, Carrington's president and CEO, stated, "We are focusing our full attention on advancing DelSite's GelVac nasal powder delivery platform for vaccines and therapeutics, and the H5N1 bird flu antigen was selected specifically for this effort. We completed all toxicology studies last year and reported results in January 2008. Receiving the current shipment of the non-egg-based, clinical-grade bird flu antigen for human studies was the next step in our efforts. Our regulatory pathway has been determined with the FDA, and we intend to proceed with clarity of purpose to the Phase I safety and effectiveness human trial with the nasal powder bird flu vaccine later this year."
Dr. Turner added, "The success of Wyeth's Prevnar(R) pneumococcal vaccine and Merck's Gardasil(R) vaccine for cervical cancer has created a renewed interest in vaccines. According to a report by the Pharmaceutical Research and Manufacturers of America, more than 50 companies had 146 vaccines in various stages of development in 2007. Of these, 138 were classical liquid vaccines requiring needles, cold storage (2-8 degrees C), cold chain distribution (2-8 degrees C), and adjuvants and/or preservatives. Five were nasal mist vaccines with the same requirements except for needles, one was an influenza dermal patch, and two were powder formulations. Simply put, those requiring needles are not distributor- or user-friendly, and those requiring cold storage are not distributor- and may not be user-friendly."
"A simple, less expensive, easy-to-distribute, user-friendly delivery
system would serve to complete the vaccine paradigm shift away from needles
and cold storage/distribution as was started by FluMist(R), a liquid nasal
spray flu vaccine," Dr. Turner added. "Dr. Nayer Khazani, a specialist in
internal medicine who also does research and teaches at Stanford University
Medical Center, wrote in an article (February 2, 2008) in the San Francisco
|SOURCE Carrington Laboratories, Inc.|
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