Mymetics Corporation Announces Success of Its Preventive Vaccine Against HIV/AIDS and Commencement of European Phase 1 Human Clinical Trials
- Category: Vaccines
- Published on Monday, 09 February 2009 01:00
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Mymetics Corporation announced today that on February 11, in Montreal, at the 16th world Conference on Retroviruses and Opportunistic Infections (CROI), Dr. Sylvain Fleury, Chief Scientific Officer of Mymetics, will present the results of a second series of preclinical trials that confirm the success of its preventive vaccine against HIV/AIDS
NYON, Switzerland | February 9, 2009 | Mymetics Corporation (OTCBB: MYMX.OB), announced today that on February 11, in Montreal, at the 16th world Conference on Retroviruses and Opportunistic Infections (CROI), Dr. Sylvain Fleury, Chief Scientific Officer of Mymetics, will present the results of a second series of preclinical trials that confirm the success of its preventive vaccine against HIV/AIDS. To date, these results are the most promising and advanced in the world. Further, they confirm a decisive path towards the prevention of transmitting HIV/AIDS. These results are of such significance that the European authorities have authorised a phase 1 clinical trial on humans.
It is widely recognized that certain people exist that are naturally resistant to the HIV/AIDS infection and in particular an identified group of prostitutes in Kenya and Cambodia. These identified prostitutes have been followed for the past 13 years and have provided recurrent blood samples. Despite their exposure to multiple HIV positive individuals, these women remain HIV negative. The explanation for this natural resistance is well known; these prostitutes are protected by antibodies present in their vaginal secretions.
The same resistance has been noted in males who have naturally occurring neutralizing antibodies in their rectal secretions.
Mymetics has concentrated their research towards replicating this natural protection and to develop similar antibodies qualified as mucosal secretions (IgA antibodies in the vaginal secretions) as compared to blood antibodies (IgG antibodies circulating in the blood).
Thus, the preventive vaccine formulation developed by Mymetics specifically induces the production of IgA antibodies, whereas all the other vaccine antidotes are aimed at the production of IgG antibodies in the blood. It is this fundamental difference in approach that explains the success of Mymetics' research compared to the announced failures of other research laboratories. As a result, Mymetics' vaccine stimulates a defence mechanism effectively blocking entry of the virus at the mucosal level, the gateway to entry and infection of humans.
The completion of the preclinical tests (on the monkeys) is achieved through a viral test (viral challenge) for which Mymetics chose the Chinese Macaqua Mulata species of monkey as they most closely resemble humans in virus transmission. One group is vaccinated and the other is used as reference group. Then, the two groups receive several doses of the virus, the goal being to establish that the vaccinated group resists the infection and that the non-vaccinated group becomes infected by the virus.
The results of the recent viral test, carried out in Beijing, could not have been more compelling: the vaccinated group either proved 100% resistant to the virus or remained at a non detectable level, whereas the non-vaccinated group were completely infected.
Moreover, the results obtained in July 2008 at the Institute of Animal Laboratory Science (ILAS) of the Chinese Academy of Science were verified by an independent laboratory, the Center for Diseases Control (CDC) of Beijing. The CDC employed a measurement technique five times more precise than that of the ILAS. The high degree of specificity and quality of these second series of results confirming the original observations is all the more impressive.
Based on these most promising results and the excellence of the research, the Belgian Health Ministry, acting on behalf of the European Authority, authorised expeditiously (16 days) the approval to commence Phase I Human Clinical Trials.
In order to avoid the potential criticism of the low number of animals in the two test groups, Mymetics presented its results to Prof. Chris Miller of the University of California (UC Davis), whose laboratory is considered by the scientific community the best center of preclinical studies on macaques. Dr. Miller is the Leader of the Virology and Immunology Unit at the California Regional Primate Research Center (CRPRC) and has been part of the simian AIDS research effort at the CRPRC since 1987. Qualifying their results as excellent, Dr. Miller confirmed his agreement for his laboratory to complete further studies on groups of macaques.
Through its heterologous viral challenge results, unique in the world, Mymetics affirms its position of leader in the mucosal approach of producing neutralizing antibodies, whereas the research of the other laboratories is almost singularly concentrated on blood antibodies. The objective of the new study with Dr. Chris Miller is to obtain indisputable results and to accelerate research and human clinical trials of Mymetics' vaccine.
Mymetics' corporate objective is to develop vaccines and therapies to prevent and treat the effects of certain retroviruses and other infectious diseases, including HIV/AIDS and Malaria. In Q4 2008 Mymetics commenced Phase 1 Human Clinical trials of their HIV/AIDS preventative vaccine candidate which showed extremely promising results (see Press Release September 16, 2008) as well as continuing Mymetics' long term Malaria vaccine in Phase Ib Human Clinical trials in Tanzania. Mymetics' long-term growth strategy includes the diversification of its pipeline by the development or the acquisition of new prophylactic or therapeutic vaccines.
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SOURCE: Mymetics, Inc.