Study results from US Military Malaria Vaccine Program announced

Apr 28 2010

Bioject Medical Technologies Inc. (OTCBB: BJCT), a leading developer of needle-free injection therapy systems (NFITS), today announced that the US Military Malaria Vaccine Program presented results of its study using the Biojector®2000 with a recombinant DNA vaccine at two recent conferences. A Cooperative Research and Development Agreement was signed with the Navy in April 2009 to work together on the study. On April 12, 2010, the results were presented at the Keystone Conference in Colorado and on April 26, 2010, the results were presented at the 13th Annual Conference on Vaccine Research sponsored by the National Foundation for Infectious Diseases and held in Bethesda, Maryland.

Malaria is a disease which can be transmitted to people of all ages. It is caused by parasites of the genus Plasmodium that are spread from person to person through the bites of infected mosquitoes. If not treated promptly with effective medicines, malaria can often be fatal. About 3.3 billion people - half of the world's population - are at risk of malaria. Every year, this leads to about 250 million cases of malaria and nearly one million deaths from the disease. People living in the poorest countries are the most vulnerable.

This study is the US Military Malaria Vaccine Program's first clinical trial of a DNA vaccine in over five years. The Navy selected Bioject's needle-free injection delivery technology for this trial based on its earlier data. The DNA vaccine was administered to healthy adult research volunteers in order to prime their immune responses prior to the administration of a second, adenovirus-vectored vaccine, which has undergone extensive testing by the US Military Malaria Vaccine Program during the past several years. Genetically based vaccines such as DNA plasmids and adenovirus vectors induce strong cell-mediated immunity, which is believed to be important in protection against the hepatic stage of malaria. Study results showed that four of 15 volunteers receiving this DNA prime adenovirus boost vaccine regimen were sterilely protected against malaria, and it appeared that protection was mediated by the cellular responses (as measured by ex vivo IFN-g ELISpot assay) without any contribution from antibody response.

The vaccine was developed by the Naval Medical Research Center (NMRC) with support from USAID, the Congressionally Directed Peer Review Medical Program, and the Military Infectious Diseases Research Program. The DNA vaccine was manufactured by Vical, Inc, San Diego, CA and the adenovirus vaccine was manufactured by GenVec, Inc, Gaithersburg, MD. The vaccine was tested by the US Military Malaria Vaccine Program which is a joint service program of NMRC and the Walter Reed Army Institute of Research. The vaccine is owned by NMRC.

"We are very pleased with the results and are looking forward to next steps with the US Navy to further develop this vaccine for malaria. The US military has been very supportive of our needle-free injection technology, using it in clinical studies, as well as commercial applications in their military immunization programs," said Dr. Richard Stout, Bioject's Executive Vice President and Chief Medical Officer.