HIV/AIDS Preventive Vaccine Of Mymetics: Green Light From EU To Start Phase I Human Clinical Study

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Immune System / Vaccines
Article Date: 13 Feb 2009 - 6:00 PDT

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Mymetics Corporation (OTCBB: MYMX) announces the confirmed success of its preventive vaccine against HIV/AIDS. To this day, these results are the most promising and advanced in the world. They confirm a decisive breakthrough in the HIV/AIDS prevention. To such an extent that European authorities have just authorized the launch of the Phase I human clinical study.

On February 10th, in Montreal, for the 16th Conference on Retroviruses and Opportunistic Infections (CROI), Dr. Sylvain Fleury, Mymetics' Scientific Chief Officer, has presented the results of a second round of preclinical tests, which confirm the success of its preventive HIV/AIDS vaccine.

It is now known that some individuals are naturally resistant to the infection from HIV/AIDS virus, despite a high degree of exposure to this virus, in particular during non protected sexual activities (notably prostitutes in Kenya and Cambodia). Those rare individuals have been identified 20 years ago from diverse populations with different ethnic backgrounds. Despite their high exposure to the virus with different HIV positive individuals, these prostitutes for example, stay HIV negative. The explanation for this natural resistance is the presence, in vaginal secretions of women - or rectal secretions of men - of specific IgA antibodies. Replicating this natural protection, Mymetics' preventive vaccine formulation induces IgA antibodies at the mucosal level, rather than IgG antibodies circulating in the blood.

Thus, Mymetics' preventive vaccine is based on an approach targeting specifically IgA antibodies, whereas all other vaccine projects have opted to target IgG antibodies, or specific cytotoxic cells against the HIV virus. This innovative approach, with mucosal antibodies rather than blood antibodies, explains Mymetics' success compared with the deceptions met by other laboratories, since its vaccine stimulates defence mechanisms blocking the virus entry at the mucosal level, the first entrance door of the virus.

In the last step of the preclinical trials, Mymetics has done a viral challenge with macaques, the species closest to humans when it comes to the development of the pathology. One group is vaccinated and the other one is the control group. Both groups then receive numerous doses of the virus to test the vaccine's efficacy.

Mymetics viral challenge results in Beijing have proven excellent. The vaccinated group is almost completely resistant to the virus and the non vaccinated control group is completely infected. The results obtained with the Institute of Laboratory Animal Science (ILAS) of the Chinese Academy of Sciences were checked (blind test) by an independent lab, the Center for Diseases Control (CDC) of Beijing with the same final outstanding results, using a measuring technique 5 times more sensitive, corresponding to the occidental standards.

On the basis of these results and the excellence of the project, the Belgian Ministry of Health, in the name of European authorities, has authorized (in 16 days) launching the Phase I human clinical study.

What is more, so as to block possible critics, in particular the small number of animals used in the two test groups, Mymetics has presented those extremely promising results to Dr. Chris Miller, of the University of California, whose preclinical research centre on macaques is considered by the scientific community one of the best. Dr. Miller is one of the very few who has already developed a vaccine approach at the mucosal level. Having qualified Mymetics' results as excellent he has confirmed his interest for a joint collaboration, notably for new studies on groups of macaques. These results are unique in the world, and puts Mymetics clearly in a leading position in targeting neutralizing antibodies at the mucosal level versus the approach of most other laboratories which focus on blood antibodies. The goal of the repetitive study that Mymetics plans to do with Dr. Miller is to transform stable results in indisputable results, to be able, at last, to accelerate clinical tests on humans. Because HIV/AIDS prevention is a real issue at world level which calls for an urgent mobilisation.

About Mymetics Corporation

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. Mymetics starts Phase I Human Clinical trials of its HIV/AIDS preventive vaccine candidate which showed extremely promising results up till now as well as continuing Mymetics' Malaria vaccine currently in Phase Ib Human Clinical trials in Tanzania. Long range growth plans, key to Mymetics' development, include in-house R&D or acquisitions of prophylactic or therapeutic vaccines against infectious diseases.

Mymetics Corporation

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