Mymetics Corporation, a pioneer in the development of vaccines preventing early transmission of human infectious diseases, announced that its innovative Malaria vaccine has successfully completed a Phase Ib clinical trial in Tanzania. The study confirms that the company's virosome-based vaccine is well tolerated and safe for adults and children as young as 5 years of age. The vaccine induced specific, long-lasting antibody responses against the key AMA-1 and CSP-1 Malaria antigens in semi-immune subjects, lasting up to 12 months for CSP-1.

Mymetics' Malaria vaccine uses influenza-based virosomes as the antigen carrier -- already approved as a vaccine carrier in more than 40 countries -- with two synthetic peptide vaccine components that mimic the native structure of important antigens found during the key stages in the Malaria parasite's life cycle.

In the Phase Ib trial, conducted in cooperation with the Swiss Tropical and Public Health Institute (Swiss TPH) and Pevion Biotech Ltd., the vaccine was tested during a 12-month period on 40 healthy, semi-immune volunteers (32 children, 8 adults) in Tanzania under endemic conditions. Each subject received two injections that were well tolerated by both adults and children as young as 5 years of age, without any safety issues.

The results showed a high sero-conversion rate for most subjects. The highest percentage of long-lasting sero-converted children following injection of the vaccine was 70% at day 180 for the AMA-1 antigen (against the merozoite), while for the CSP-1 antigen (against the sporozoite) 83% of children were positive for up to 365 days.

"These exciting results are especially promising compared to previous clinical studies, as the group was semi-immune and the trial was carried out without special precautions to avoid parasite exposure -- conditions that normally make it very difficult to trigger a strong immune response," said Professor Marcel Tanner, Director of the Swiss Tropical and Public Health Institute.

"Mymetics' Malaria vaccine is one of only a few that target the blood and liver stages of the Malaria parasite's life cycle, an approach we believe is more likely to achieve efficacy in providing protection and parasitemia control," added Sylvain Fleury, CSO of Mymetics Corporation.

Following this successful Phase Ib trial, Mymetics is now preparing the next phase of development of the multi-stage vaccine with additional promising Malaria antigens. While achieving sterile immunity is the ideal objective, a vaccine that efficiently reduces or controls liver and erythrocyte infection could also reduce parasitemia and symptoms, significantly decreasing mortality and morbidity in children. Mymetics is working closely with not-for-profit organizations to fund these next stages of development.

Mymetics Corporation acquired the Malaria program, including this study, from Pevion Biotech in October 2007. The clinical trial was initially launched by Pevion Biotech Ltd. and the Swiss Tropical and Public Health Institute. The study was performed at the Bagamoyo Research & Training Centre (BRTC) of the Ifakara Health Institute (IHI), Tanzania, under the leadership of Dr. Blaise Genton and Dr. Salim Abdulla.

Mymetics currently has 5 vaccines in its pipeline: HIV-1/AIDS, Influenza, Respiratory Syncytial Virus, Malaria and Herpes Simplex Virus. The company's HIV vaccine is entering a new proof-of-concept preclinical trial following unprecedented results in a first study, and is also currently in a Phase I clinical trial in human volunteers. A Phase 1b clinical trial for its Malaria vaccine on children in Tanzania has been successfully completed, while RSV and HSV vaccine candidates are in the preclinical phase. The Influenza vaccine has been out-licensed to Solvay Pharmaceuticals (now Abbott).

Source
Mymetics Corporation
Swiss Tropical and Public Health Institute