NIH intended for development of oral prophylactic/therapeutic HIV vaccine.(National Institutes of Health)

2002 NOV 6 - (NewsRx.com & NewsRx.net) -- BioDelivery Sciences International (BDSI; BDSIW) announced that they have received a 2-year $600,000 National Institutes of Health (NIH) SBIR Grant to develop an oral form of a powerful HIV prophylactic/therapeutic vaccine with their patented Bioral drug delivery platform that is inexpensive, stable at room temperature, and is intended to induce protective, systemic and mucosal cell mediated immunity.

The development will be conducted in collaboration with Biokeys Pharmaceuticals, Inc., (BKYS.OB), an affiliated company, under a pre-existing research agreement. The BioDelivery team, led by Raphael J. Mannino (principal investigator of the grant) and Susan Gould-Fogerite, will work with Biokeys to develop the Biokeys Pharmaceuticals' EradicAide HIV prophylactic/therapeutic vaccine. BioDelivery will begin receiving the grant in the fourth quarter in periodic installments totaling $300,000 per year, as work progresses.

Nearly 30 million people have died and 40 million people are infected with HIV worldwide as the epidemic continues to spread at a rapid rate. Effective vaccines to control the spread of the infection are desperately needed. Collaborators have identified short segments (peptides) of the surface protein gp160 of HIV that induce cell-mediated immunity, and do not induce antibody responses. Cell-mediated immunity, consisting of CD8+ T cells that kill virus infected cells and CD4+ T helper cells, is important in preventing and controlling HIV infection. These peptides are highly conserved; that is, present in many strains of the virus. Several peptides have also been identified as targets of CD8+ cells in long-term nonprogressors, individuals who control HIV virus replication more effectively and remain healthy for many years.

Monkeys immunized by injection with Biokeys Pharmaceutical's cocktail of six peptides (EradicAide) were able to better control infection following challenge with a pathogenic strain of chimeric SHIV (recombinant Simian immunodeficiency virus with the surface protein from HIV). The immunized monkeys had lower levels of circulating virus (in some cases undetectable), maintained higher CD4+ helper T cell levels, and remained healthy for as long as 3 years. It is important to remember that no therapeutic vaccine completely prevents infection. The goal of vaccination is to induce immune responses that will reduce the infection, protect from serious consequences, and hopefully allow clearance of the organism.

BioDelivery scientists Susan Gould-Fogerite and Raphael J. Mannino (principal investigator of the grant) are collaborating with Biokeys to produce a version of the vaccine that can be given orally. The novel adjuvant/immunomodulating agent to be used is an extract of the envelope glycoproteins and lipids from parainfluenza type 1, Sendai virus derived envelope (SDE). This adjuvant is a potent stimulator of cell mediated immunity and has been shown to be safe in multiple animal studies and in a 2-year, 10-patient, clinical trial of an autologous, therapeutic HIV vaccine sponsored by BioDelivery. The delivery vehicles to be used are BioDelivery's patented cochleates.

BioDelivery's cochleate delivery vehicles (Bioral) constitute a broad-based enabling technology that has been used to mediate highly effective parenteral (injected) delivery of protein and peptide ...