From rxpgnews.com
Intranasal Delivery System for Vaccines Safe
By DelSite Biotechnologies,
May 20, 2005 - 6:01:38 PM
Carrington Laboratories, Inc.'s wholly-owned subsidiary, DelSite Biotechnologies, said results from a Phase I clinical trial demonstrated that the GelVac(TM) 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(TM) system for safety, nasal deposition, nasal retention time and the single dose delivery device. The study involved 15 healthy adult volunteers and was designed as a double blind, randomized vehicle-controlled three-way cross-over trial using two selected particle sizes of GelVac(TM) powder and a control powder. The subjects were randomly assigned to receive one dose of each of the three radio-labeled test materials.
"The study demonstrated that GelVac(TM) 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(TM) system eliminates the need for refrigeration, it provides one of the very few ways to facilitate the kind of accelerated vaccination programs in third world countries called for at The World Health Organization annual assembly in Geneva. GelVac(TM) should greatly simplify distribution and storage in third world climates and could speed the vaccination process with fewer highly trained healthcare professionals needed.
"The findings are key in advancing the development of a technology designed to make self-administered, needle-less delivery possible for routine vaccines, pandemic disease, biosecurity applications and other therapeutic modalities. Additionally, we have the added advantage of no mercury preservative being required and can produce the product in kilo quantities at our FDA-regulated cGMP facilities in Costa Rica," noted Carlton E. Turner, PhD, Carrington's chief executive officer. He added, "Our research and development group for vaccines is housed at DelSite's facilities in the Research Park at College Station, Texas. We now plan to provide our data to potential domestic and international partners and, when appropriate, share them with the scientific and business communities."
About GelVac(TM) and GelSite(R)
The GelVac(TM) powder system is based on the proprietary GelSite(R) polymer, a high molecular weight ionic polysaccharide that exhibits distinct chemical and functional properties. GelSite(R) polymer is capable of in situ gelation, i.e., changing from a liquid or a powder to a gel upon contact with body fluids.
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).
GelSite(R) is manufactured in kilogram quantities under FDA cGMP guidelines in Costa Rica at Carrington's wholly-owned subsidiary, Sabila Industrial. This bulk pharmaceutical and manufacturing plant and is also ISO certified.
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