IRVING, Texas and CARLSBAD, Calif., March 1 /PRNewswire-FirstCall/ -- DelSite Biotechnologies, Inc., a subsidiary of Carrington Laboratories, Inc. , and Invitrogen Corporation today announced that DelSite Biotechnologies has selected Invitrogen Corporation’s PD-Direct(TM) services to develop a process for a cell-based avian H5 influenza whole virion antigen to be incorporated in DelSite’s nasal vaccine product.
DelSite is developing a nasal powder vaccine for pandemic avian influenza that combines its proprietary GelVac(TM) vaccine delivery system with an avian H5 influenza whole virion antigen. Preclinical studies were initiated in December 2004 under a $6 million, 3-year biodefense grant, and formulation development has been ongoing using antigen produced at laboratory scale. The agreement with Invitrogen will allow DelSite to transition from the current lab scale procedures to a scalable manufacturing process in advance of initiating cGMP production for clinical trials.
In 2005, the Company completed a Phase I clinical trial of the GelVac(TM) delivery system, without antigen, that demonstrated that GelVac(TM) is safe and well tolerated and that doses were consistently and reproducibly delivered to the nasal cavity.
“DelSite is clearly taking a leading position in the biotechnology industry for developing solutions to the growing avian flu concern with its antigen-based nasal vaccine system. We are excited about the opportunity to contribute to this critical program in protecting our families from the risks of avian flu,” noted Dr. Trent Carrier, Director of Business Development at Invitrogen.
“We are very pleased to be working with Invitrogen in the development of our whole virion influenza vaccine,” said Dr. Kenneth (Bill) Yates, president of DelSite. “Invitrogen’s experience in developing GMP manufacturing processes will accelerate the clinical development of our avian flu vaccine.”
About GelVac(TM) and GelSite(R)
The GelVac(TM) system is a nasal powder vaccine delivery platform based on GelSite(R) polymer. Dry powder formulations provide several potential advantages, including better stability, room temperature storage and no need for preservatives. Nasal immunization induces both systemic and mucosal immune responses.
GelSite(R) polymer is a high molecular weight anionic polysaccharide that exhibits distinct chemical and functional properties proprietary to the Company. GelSite(R) is water-based and is capable of in situ gelation, i.e., changing from a solid or liquid into a gel upon contact with body fluids leading to sustained-release of active biomolecules. It also has demonstrated mucoadhesive properties making it highly suitable for mucosal delivery.
GelSite(R) nasal powder formulations have the potential to be used for the delivery of vaccine antigens as well as therapeutic agents. GelSite(R) is not an adjuvant and is a member of a family of plant polysaccharides classified by the FDA as Generally Regarded as Safe (GRAS). Recently, the Company has filed a Drug Master File for the use of the polymer for mucosal delivery of bioactive therapeutics and vaccines.
About Invitrogen’s PD-Direct(TM) Services
Invitrogen brings together the capabilities of world class Gibco(R) products and services with industry leading BioReliance viral development services to provide deep experience across the entire bioproduction lifecycle. The PD-Direct(TM) services team combines broad expertise in process development for viral, cell culture, microbial, and cell therapy products with new technologies designed to solve the key challenges of bioproduction. The latest of these new technologies, Revolution(TM), combines an advanced cell engineering technology to accelerate the natural process of evolution with high throughput screening to optimize clients’ production cell lines for expression levels, growth performance, or product characteristics. Invitrogen’s PD-Direct(TM) services are designed to address both individual process development needs as well as to provide fully integrated process development solutions.
About DelSite
DelSite Biotechnologies, Inc., a wholly-owned subsidiary of Carrington Laboratories, was established to commercialize its novel polymer drug delivery technology. Currently, DelSite is focused on developing delivery systems for vaccines and therapeutic proteins and peptides that could benefit from improved intranasal, topical and injectable routes of administration. For more information please visit http://www.delsite.com .
About Invitrogen
Invitrogen provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen’s own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen’s products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company globally employs approximately 4,800 professionals and had revenues of approximately $1.2 billion in 2005. For more information, visit http://www.invitrogen.com .
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 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, including the Form 10-Q, filed November 15, 2005.
Carrington(R), Manapol(R), AloeCeuticals(R), Hydrapol(TM), GelSite(R) and GelVac(TM) are trademarks, registered trademarks or service marks of Carrington Laboratories, Inc., in the United States and/or other countries. All other trademarks or service marks contained herein are the properties of their respective owners.
Carrington Laboratories, Inc.; DelSite Biotechnologies, Inc.
CONTACT: Carlton E. Turner, CEO of Carrington Laboratories, Inc.,+1-972-518-1300, or cturner@carringtonlabs.com ; or Kenneth [Bill] Yates,President of DelSite Biotechnologies, Inc., +1-972-717-5009, orbyates@delsite.com ; or Greg Geissman, +1-760-476-7032, orGregory.geissman@invitrogen.com , or Eric Endicott, +1-760-268-7438, orEric.endicott@invitrogen.com , both of Invitrogen Corporation
