PepTcell to Start Phase Ib Clinical Trials for Novel HIV Vaccine
News Jun 25, 2009
PepTcell Ltd. has announced that it has received approval from the MHRA to commence a Phase 1b clinical trial for its novel HIV vaccine in the UK.
PepTcell’s HIV-v vaccine offers new hope in the treatment and protection of HIV as it is the first vaccine to use a new approach for preventing and treating HIV by generating both a very strong B-cell and T-cell response from the immune system against regions of the virus that do not change from variant to variant. These features mean that the vaccine can be used to both treat people in the early phase of HIV infection and to protect people from getting the virus in the first place.
Wilson Caparros Wanderley, Chief Scientific Officer of PepTcell, says: “Based on results to date the vaccine produces a very strong response from both arms of the immune system after a single immunization, even without adjuvant. The response is sufficient to enable the immune system to target and kill human cells infected with the virus and with different variants of the HIV virus.”
The development of an effective vaccine against HIV has been extremely difficult, as HIV constantly mutates, changing how it appears to the immune system.
The PepTcell HIV-v vaccine has been designed to specifically target the key conserved regions of the virus, which are not subject to regular mutation. The immune system will thus learn to recognize those regions within HIV proteins that are highly conserved and hence present in all different strains of this highly variable virus.
Gregory Stoloff, CEO of PepTcell, says: “This vaccine has been designed after taking into account all the lessons learnt from the prior excellent work undertaken in this field, has employed the latest theories in the understanding of the immune system and the most up to date chemical manufacturing processes available. Therefore, this vaccine has the best chance of any previous attempt to provide the solution that has evaded us to date.
The Phase Ib trial will involve 55 HIV positive volunteers, and will assess both safety and tolerability as well as the effectiveness of the vaccine by monitoring blood levels of the virus and CD4+ T-cell count, an immune cell which is specifically infected with HIV.
The trial is expected to run for a year. The multi centre trial will be conducted at a number of HIV units in the UK.
PepTcell's HIV-v vaccine can be manufactured. The vaccine components are made synthetically thus allowing for increased purity and more efficient dosing of the vaccine compared to vaccines obtained or delivered via genetically modified organisms.
Furthermore, the vaccine remains stable at a range of temperatures making it a viable and credible option for clinical use, not only in developed countries, but also in developing countries where large scale cold storage and distribution are not always available.