WASHINGTON, March 24 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that Dr. Kenneth Yates, President of its subsidiary DelSite Biotechnologies, presented details of its ground-breaking GelVac(TM) nasal powder influenza vaccine to the World Vaccine Congress in Washington D.C. The vaccine has the potential to greatly improve inoculation rates prior to the influenza season or in the event of an avian flu pandemic. Unlike conventional vaccines, the GelVac(TM) vaccine provides benefits that include room temperature stability, needle-free administration and stimulation of mucosal and systemic immunity by prolonging the time the vaccine remains in the nasal cavity. Stimulation of both mucosal and systemic immunity can potentially lead to an increase in the vaccines protective ability.
Industry experts agree that development of vaccines has been the most significant contribution ever made to improving our public health. Vaccines based on new delivery technologies, such as DelSite’s GelVac(TM) powder system, could be critical to improving the control and prevention of disease in the future. New innovative vaccination approaches that could more efficiently immunize large populations in a relatively short period of time will be essential as we develop strategies to control emerging infectious diseases, such as the bird flu.
With the current vaccines and delivery systems and according to the CDC, the seasonal flu is still responsible for approximately 36,000 deaths and more than 200,000 hospitalizations each year in the United States.
Dr. Yates’ presented results from the company’s preclinical studies conducted with DelSite’s avian influenza vaccine using the GelVac(TM) nasal powder vaccine delivery system at the World Vaccine Congress in Washington, DC. The presentation included the results of a Phase I clinical trial, without any viral material, which demonstrated that the system was safe, well tolerated and well accepted by test subjects, and that doses were consistently and reproducibly delivered to the nasal cavity. A summary of this presentation can be found on DelSite’s website at http://www.delsite.com/newfiles/wvc_yates_march_06.html .
“As U.S. and world health experts are now suggesting that the possibility of an avian flu pandemic in the near future is very real, further investigation of this emerging science could not be timelier and, following current regulatory guidance, we are working as expeditiously as possible to test this vaccine in people,” said Dr. Yates.
“Based on feedback from policymakers, we are pushing our efforts to initiate a Phase I safety clinical trial in man using our GelVac(TM) vaccine late this year or early next and a Phase II trial late next year,” said Dr. Carlton Turner, President & CEO, Carrington Laboratories.
About GelVac(TM) Nasal Powder Influenza Vaccine
DelSite’s GelVac(TM) avian flu vaccine is uniquely suited to meeting the challenges of a pandemic:
* Stable at room temperature, the vaccine requires no refrigeration for shipping or prolonged storage -- facilitating both stock-piling and rapid distribution. * The powder is easily administered -- and could be self-administered, if necessitated by an overwhelmed health care system. * The powder gels on contact with nasal fluid, prolonging the nasal residence time and sustaining the antigen release potentially allowing for an enhanced protection.
Nasally administered vaccines form a first-line of immune defense for the upper respiratory system -- a common entry point for influenza virus -- as well as prompting the body’s normal systemic immune response.
On March 1, DelSite announced an agreement with Invitrogen Corporation to develop a manufacturing process capable of producing sufficient avian flu antigen for human clinical trials.
About the World Vaccine Congress
Information about the conference is available at http://www.lifescienceworld.com/2006/wvcm_CA
About Carrington
Carrington Laboratories, Inc., is an ISO 9001-certified, research-based biopharmaceutical company currently utilizing naturally-occurring complex carbohydrates to:
* manufacture and market products for mucositis, radiation dermatitis, wound and oral care; * manufacture and market the nutraceutical and cosmetic raw materials Manapol(R) and Hydrapol(TM); and * market consumer products under various brands. About DelSite
DelSite Biotechnologies, Inc. was formed based on discoveries at Carrington Laboratories, Inc., and is a wholly owned subsidiary of Carrington. DelSite Biotechnologies is a drug-delivery and biotechnology company established to provide the pharmaceutical and biotechnology industries with novel delivery solutions for vaccines and therapeutic agents.
About GelVac(TM) delivery system
The GelVac system is a proprietary nasal powder vaccine delivery system, based on the GelSite(R) polymer, the primary functional ingredient. Dry powder formulations provide several potential advantages including better stability, room temperature storage and no need for mercury or other preservatives. Nasal immunization induces both systemic and mucosal immune responses.
About GelSite(R) polymer
Carrington’s patented GelSite polymer, extracted and purified from the Aloe vera plant, is a member of a family of carbohydrates that the U.S. Food and Drug Administration has classified as “Generally Regarded As Safe” (GRAS). It is water-based and capable of changing from a solid or liquid into a gel upon contact with body fluids -- a process called in situ gelation -- making possible the sustained release of vaccines and other pharmaceuticals over prolonged periods of time.
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, including the Form 10-Q, filed November 14, 2005.
Carrington Laboratories, Inc.
CONTACT: Richard Baker, +1-202-585-2084, or Ryan Seggel, +1-202-585-2806,both of Carrington Laboratories, Inc.
