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Carrington Subsidiary DelSite and Nastech Sign Technology Evaluation Agreement for GelSiteŽ Polymer
Tuesday, April 10, 2007
Nastech to Evaluate Carrington's GelSite® for Potential to Further Enhance Intranasal Delivery of Nastech's Peptide and Protein Therapeutics in Liquid Formulations
Irving, TX -- Carrington Laboratories, Inc. (Nasdaq: CARN) today announced that its wholly-owned subsidiary, DelSite Biotechnologies, Inc., entered into a non-exclusive technology evaluation agreement with Nastech Pharmaceutical Company Inc. for the purpose of evaluating DelSite's versatile and unique GelSite® polymer for enhancing intranasal delivery of peptide and protein therapeutics. Financial terms of the agreement were not disclosed.
The goal of the program is to assess whether the GelSite® polymer, in combination with Nastech's tight junction modulating technology, can increase bioavailability and provide additional pharmacokinetic profiles that could be useful for future development of Nastech's intranasally delivered peptides and proteins. As part of the agreement, DelSite will conduct initial formulation development of the GelSite® polymer with Nastech formulations and will provide Nastech with final formulation characterization support.
GelSite® polymer is a novel, naturally occurring, mucoadhesive ionic carbohydrate polymer capable of forming a gel when brought into contact with nasal fluids. Gelling occurs with liquid as well as powder formulations and provides sustained release and prolonged nasal residence time that may enhance the nasal delivery of therapeutics or vaccines.
DelSite has evaluated GelSite® polymer for delivery of various protein/peptide therapeutics and vaccine antigens and has completed a series of toxicology studies on this polymer. A Drug Master File (DMF) for use of GelSite® polymer in mucosal applications was filed in 2005 and was recently updated with both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA). Carlton E. Turner, PhD, president and CEO of Carrington Laboratories and DelSite Biotechnologies, commented, "Nastech is a leader in the nasal delivery of therapeutic peptides and proteins in the pharmaceutical industry. GelSite® is a very versatile and unique polymer that has been successfully formulated for intranasal delivery of vaccines. GelSite's® unique properties, in combination with Nastech's cutting-edge tight junction modulating technologies, provide a potential opportunity to further expand nasal delivery of therapeutics."
DelSite's most advanced technology platform incorporating GelSite® polymer is a nasal powder vaccine delivery system (GelVac™) that has been developed and successfully tested in preclinical immunogenicity studies and in a Phase I clinical safety study (without an antigen). Several vaccine candidates have been investigated, including influenza, human Papillomavirus (HPV) and, most recently, Shigellosis and HIV. GelVac™ powder combines the advantages of nasal delivery and a powder formulation that enables storage and stability at room temperature, prolonged shelf life, preservative-free and needle-free administration, and induction of both mucosal and systemic immune responses. Importantly, this powder formulation may also be reconstituted for injection with a strong immune-enhancing effect, thus allowing it to meet specific needs of different vaccines.
Carrington's wholly-owned subsidiary DelSite Biotechnologies, Inc. is developing its proprietary GelSite® technology designed to provide controlled release of peptide and protein-based drugs. DelSite is currently developing a nasal powder vaccine using its GelVac™ formula with the H5N1 avian flu antigen. This work is partially funded by two grants from the Department of Health and Human Services.
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® and cosmetic raw material Hydrapol™. 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® 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.
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