IRVING, Texas, Feb. 14 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that its wholly-owned subsidiary DelSite Biotechnologies, Inc. received a shipment of clinical-grade H5N1 (bird flu) antigen from a major pharmaceutical company to commence production, under cGMP requirements, of clinical quantities of DelSite’s nasal powder bird flu (H5N1) vaccine. The nasal powder bird flu vaccine is scheduled to begin testing in a Phase I human clinical trial later this year.
The vaccine will utilize DelSite’s proprietary GelVac(TM) nasal powder delivery platform, which offers many distinct advantages over traditional vaccine delivery systems: (1) easy, needle-free, self-administration, not requiring healthcare professionals; (2) enhanced protection because administration of vaccine into nasal cavity stimulates both a systemic response and mucosal response; (3) no adverse side effects caused by preservatives; (4) stability at room temperature, which eliminates the need for cold storage or cold chain distribution, thereby opening distribution to Third World countries where refrigeration is often not available; and, (5) a demonstrated shelf life of an influenza vaccine of three years, enabling potential stockpiling in the event of a pandemic.
As a prelude to the Phase I human trials, in January 2008 toxicology studies were successfully completed on a GelVac nasal powder (H5N1) influenza vaccine. The GelVac nasal powder platform has also successfully completed a Phase I safety study in which the delivery device provided a consistent, greater-than-90-percent delivery of the powder to the desired site in the nose.
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 Chronicle, stating that ' ... as delivery systems move from needles to patches and nasal powders, prevention (and even cure) may come without the sting.’ His comments underscore our belief that the GelVac nasal powder platform developed by DelSite will complete this total paradigm shift and, clearly, without a sting.”
“GelVac(TM) powder has been shown to work with and stabilize many antigens and protein and peptide therapeutics,” continued Turner. “All formulations tested are stable at room temperature, require no needles, no preservatives, no cold storage and can be shipped anywhere free of the restrictive cold chain distribution systems associated with other vaccines. As a nasal powder, it is patient-friendly and does not require administration by a medical professional. No painful injection could mean greater public acceptance and thus public protection on a broader scale against specific diseases.”
“At the corporate level, we are analyzing our business models and exploring strategies to move all our business units forward. We have invested more than $54 million in DelSite and have incurred financial losses over recent years. As a company we are dedicated to funding DelSite’s initiatives and programs. The fact that a major pharma company has twice provided us, free of cost, a non-egg based H5N1 bird flu antigen produced under the restriction required for human use, indicates that much of the heavy lifting may be behind us.”
About Carrington
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based, biopharmaceutical and consumer products company currently utilizing naturally-occurring complex carbohydrates to manufacture and market products for mucositis, radiation dermatitis, wound and oral care, as well as to manufacture and market the nutraceutical raw material Manapol(R) and cosmetic raw material Hydrapol(TM). Carrington also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. Carrington’s DelSite Biotechnologies subsidiary is developing its proprietary GelSite(R) technology designed to provide controlled release of peptide and protein-based drugs. Carrington’s technology is protected by more than 130 patents in 26 countries. Select products carry the CE mark, recognized by more than 20 countries around the world. For more information, visit http://www.carringtonlabs.com.
Certain statements in this release concerning Carrington may be forward-looking. Actual events will be dependent upon a number of factors and risks including, but not limited to: subsequent changes in plans by the Company’s management; delays or problems in formulation, manufacturing, distribution, production and/or launch of new finished products; changes in the regulatory process; changes in market trends; and a number of other factors and risks described from time to time in the Company’s filings with the Securities & Exchange Commission.
CONTACT: Carlton E. Turner, Chief Executive Officer of Carrington
Laboratories, Inc., +1-972-518-1300
Web site: http://www.carringtonlabs.com/
