Carrington Laboratories, Inc.'s wholly-owned subsidiary, DelSite Biotechnologies, announced the results from a Phase I clinical trial demonstrated that the GelVac powder intranasal delivery system for vaccines was safe and well tolerated and doses were consistently and reproducibly delivered to the nasal cavity.
The clinical trial was designed to evaluate the GelVac system for safety, nasal deposition, nasal retention time and the single dose delivery device.
"The study demonstrated that GelVac powder was well tolerated, with no significant adverse events reported," said Kenneth (Bill) Yates, president of DelSite. "Studies showed that nasal deposition was consistent with quantifiable and reproducible amounts of powder delivered to the nasal cavity. The delivery device performed to expectations and the subjects self-reported that the intranasal product was easy to use and highly preferred over injections," he added.
Since the GelVac system eliminates the need for refrigeration, it provides one of the very few ways to facilitate the kind of accelerated vaccination programmes in third world countries called for at The World Health Organization annual assembly in Geneva, a release stated.
The GelVac powder system is based on the proprietary GelSite polymer, a high molecular weight ionic polysaccharide that exhibits distinct chemical and functional properties. GelSite polymer is capable of in situ gelation, i.e., changing from a liquid or a powder to a gel upon contact with body fluids.