Sunday, December 19, 2004

Mymetics Receives NIH Approval to Advance HIV Vaccine Into Late Preclinical Studies

"Mymetics Corporation announced today that it has received approval from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to begin advanced preclinical testing of the Company's trimeric gp41 vaccine in nonhuman primates. The study will run through the end of the third quarter of 2005, testing the second generation of HIV vaccines in development. Based on the results of the NIH-approved study, Mymetics expects to initiate advanced toxicology testing by the end of 2005 in preparation for filing an Investigational New Drug (IND) application in 2006."

Their vaccine approach is based on a concept not generaly accepted in the scientific community : they think that gp41 (HIV protein responsible for fusion with the cell to be infected) "subtly" mimics IL-2, an immune system protein. For this reason, they think that the immune system is somewhat unable to produce effective antibodies against HIV. I can't say I'm convinced by this, but the vaccine approach (trimeric gp41) might be worth trying. However, note gp41 is usually masked by gp120, so antibodies can't easily reach it.

Dr. Sylvain Fleury, Chief Scientific Officer of Mymetics, commented, "We are greatly pleased to have received our first formal recognition from the NIH for our program in HIV vaccinology. We have had strong results in this program to date, including neutralizing antibodies capable of blocking transcytosis and primary T cell and macrophage infections by primary HIV isolates. Our goal with the NIH-approved study is to further examine the potential of our gp41 vaccine approach and to gain additional data, including immunogenicity and stability, relevant to advancing our next-generation product."

Mymetics' Chief Executive Officer, Christian J.-F. Rochet, stated, "The NIAID-approved studies will place us among a small group of research teams poised to enter the clinic with a promising vaccine candidate. As we have previously announced, we anticipate signing in 2005 a partnership agreement with a major health sciences company to assist us in human clinical trials, for which we plan to file by 2006, pending the results of our preclinical program."

In 2003, Mymetics created its first-generation trimeric gp41 HIV vaccine candidate. The Company is now developing next-generation vaccines that contain a more complete sequence of the wild-type gp41, including key neutralizing epitopes. A primary objective in the Company's vaccine design program is to impair the molecular mimicry between gp41 and the IL-2 cytokine (Interleukin-2) of the infected host. Mymetics' researchers discovered this mimicry in 1997 and believe that it is a major reason underlying the shutting down of the immune system seen in patients with HIV and AIDS.

Mymetics Corporation is a biotechnology company focused on the development of human and animal vaccines and therapies in the field of retroviral and viral autoimmune diseases, including HIV-1 infection. The Company's key discovery is a fundamental though subtle three-dimensional mimicry between the viral envelope glycoprotein gp41 of HIV-1 and the IL-2 cytokine (Interleukin-2) of the infected host. Based on this understanding of molecular mimicry, Mymetics has been able to engineer gp41 proteins capable of eliciting neutralizing antibodies against primary HIV-1 strains and has also designed specific therapeutic molecules which have the potential to prevent and/or delay the disease. Mymetics' platform technology can also be applied to other retrovirus-related diseases that involve similar mimicries, including certain oncoviruses often associated with human leukemia.

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