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OTCQB: MYMX

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Additional Relevant Details The blinded study was led by Dr. Ruth Ruprecht, Scientist & Director of the Texas Biomed AIDS Research Program and was funded by the Bill & Melinda Gates foundation. During the first part of the study the Mymetics’ two-component virosome-based HIV vaccine was able to show significant efficacy of 87% in delaying the time to persistent infection versus the control group after 7 intravaginal virus challenges. The study aimed to mimic the exposure of women to semen from HIVinfected men, although the viral dose of each of these 7 animal challenges represented about 70,000 times the average human HIV dose passed during sexual intercourse from an HIV-infected male to an uninfected female. During the second part of the study the animal viral challenge dose was increased by 50% starting from the 8th challenge onward, reaching more than 100,000 times the average amount of virus passed from an infected man to a female partner. At this virus dose, the vaccine did not show significant protection in the animals as the immune system was overloaded.

http://www.mymetics....

Clinical Data The study involved 36 Indian origin rhesus macaques (monkeys) with 12 animals per group for more statistical power, compared two antigen vaccination regimens with placebo and was followed by intra-vaginal heterologous challenges with live virus. This study was designed to replicate a successfully completed smaller study at the Institute of Laboratory Animal Science (ILAS) in Beijing, China in which the two-component vaccine protected all Chinese rhesus macaque monkeys against repeated virus exposures from persistent infection – an unprecedented result.1 One of the vaccine components further showed a strong safety and tolerance profile in a Phase I clinical trial in human volunteers.2 With its HIV-1 (human immunodeficiency virus type 1) vaccine candidate, produced through its proprietary virosome technology, Mymetics aims to provide both a first line of defense through mucosal protection as well as a second line of defense against infection through the generation of blood antibodies. Mymetics has produced the tested HIV vaccine construct for clinical trials in liquid form and, since last year, is developing a new generation of needle-free and cold chain independent virosomal vaccine construct with the support of the European Horizon 2020 Program (MACIVIVA Project no. 646122), which would be very suitable for developing countries.

http://www.mymetics....

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