DelSite Biotechnologies Announces Agreement With Invitrogen Corporation For Process Development Of Avian H5 Influenza Nasal Vaccine
Irving, TX - DelSite Biotechnologies, Inc., a subsidiary of Carrington Laboratories, Inc., and Invitrogen Corporation recently announced that DelSite Biotechnologies has selected Invitrogen Corporation's PD-Direct™ 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™ 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™ delivery system, without antigen, that demonstrated that GelVac™ 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™ and GelSite®
The GelVac™ system is a nasal powder vaccine delivery platform based on GelSite® 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® polymer is a high molecular weight anionic polysaccharide that exhibits distinct chemical and functional properties proprietary to the Company. GelSite® 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® nasal powder formulations have the potential to be used for the delivery of vaccine antigens as well as therapeutic agents. GelSite® 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.
SOURCE:Invitrogen