IRVING, Texas, Jan. 15 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that its wholly owned DelSite Biotechnologies, Inc. subsidiary has successfully completed preclinical toxicology studies of its GelVac(TM) nasal powder influenza vaccine under FDA-reviewed protocols. Successful toxicology studies in two animal models using the H5N1 (bird flu) antigen were required in order to proceed with a planned Phase I clinical trial later this year. The bird flu antigen used in these preclinical studies was from a non-egg-based source.
This vaccine candidate is believed to be the only nasal powder vaccine under development that, if approved, could be shipped without refrigeration to peoples' homes and self-administered in the event of a pandemic outbreak of avian bird flu.
The toxicology studies were conducted at Charles River Laboratories, Preclinical Services, Wilmington, MA, a contract research organization well known for its work in preclinical studies of viral antigens. After administering one or two doses to test subjects at the highest dose tested, testing results showed the vaccine is safe and nontoxic and thus established the base for moving into the Phase I clinical study of the vaccine in humans subject to normal FDA regulatory procedures.
Separately, DelSite successfully completed its second pre-IND meeting with the FDA last November, which was held at the request of the FDA to discuss and clarify protocols related to the use of the H5N1 antigen. Previously, a Phase I human safety study on the GelVac(TM) platform (without an antigen) showed the delivery platform was safe and well tolerated. The GelVac(TM) nasal powder formulation with the H5N1 vaccine antigen is planned to enter a Phase I study in 2008.
"The successful completion of these preclinical toxicology studies is a major milestone in developing this H5N1 vaccine based on our GelVac(TM) nasal powder technology," stated Carlton E. Turner, PhD, president and CEO of Carrington. "In addition, the completion of the second pre-IND meeting has clearly laid out the development path toward clinical studies. These developments further demonstrate the feasibility of the GelVac(TM) nasal powder platform technology which can greatly expand the availability and coverage of vaccines with its distinct advantages over current liquid needle-based and nasal mist formulation technologies."
Dr. Turner added, "There is a true paradigm shift underway in vaccines from the classical needle delivery to a more user-friendly application. FluMist(R) by MedImmune started the shift, and I believe our nasal powder technology will complete the shift to a patient-friendly vaccination formulation and will open up markets that cannot be served by current vaccines systems."
Dr. Yawei Ni, chief scientific officer of DelSite, added, "Our nasal powder vaccine platform has been shown to work with many antigens, is stable at room temperature, requires no needles, no preservatives, and no cold storage, and can be shipped free of the restrictive cold chain distribution systems associated with vaccines. Moreover, our system is particularly well suited for influenza pandemic preparedness, bio-defense applications, and vaccine coverage in areas lacking basic infrastructures."
GelVac(TM) powder platform possesses other distinct, practical features. The GelSite(R) polymer used in the formulation is derived from a natural source and is stable over four years at room temperature. The polymer binds to and stabilized proteins and peptides. An influenza vaccine incorporating a, non-egg based, H1N1 antigen in the GelVac(TM) formulation has been stable at ambient room temperature for 36 months.
The nasal cavity is increasingly recognized as the ideal immunization route since most infectious diseases enter the body through mucosal surfaces such as those found in the nasal cavity, the lungs, and the intestines. Nasal immunization not only induces a systemic response, but also induces mucosal response, providing protection at the entry point. GelVac(TM) is a novel in- situ gelling powder formulation for nasal delivery. The GelSite(R) polymer enables in-situ gelling of the vaccine powder, which changes into gel particles upon exposure to nasal fluids present in the nasal passage. This gel adheres to the mucosal lining and provides prolonged residence time and sustained antigen release that, in turn, increase antigen delivery.
Carrington's wholly owned subsidiary DelSite Biotechnologies, Inc. is developing its proprietary GelSite(R) technology designed to provide controlled release of peptide and protein-based drugs and vaccines. DelSite is currently developing a nasal powder vaccine using its GelVac(TM) formula with the H5N1 avian flu antigen. This work is partially funded by two grants from NIAID (National Institute of Allergy and Infectious Diseases) of NIH (National Institutes of Health) under the Department of Health and Human Services.
A Drug Master File (DMF) has been filed with the FDA for GelSite(R) polymer which may be made in kilogram quantities under cGMP guidelines in an ISO-certified facility.
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 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//