Sanaria's PfSPZ Vaccine Provides High Level Defense Against Malaria In U.S. Navy and Army Clinical Investigation

ROCKVILLE, Md., Jan. 12, 2017 /PRNewswire/ -- Sanaria Inc. continues to achieve success in its coordinated efforts to develop a safe, effective and affordable vaccine that delivers protection against malaria in individuals and can be used in mass vaccination campaigns to eliminate the disease.

Research published today in JCI Insight by a team of clinical investigators at the Naval Medical Research Center and Walter Reed Army Institute of Research led by Capt. Judith Epstein, M.D., and Maj. Kris Paolino, M.D., reports that Sanaria^® PfSPZ Vaccine protected against two strains of Plasmodium falciparum malaria. Furthermore, protection was achieved with just three doses of the vaccine and against a strain of parasite similar to one in the vaccine for at least 24 weeks.

Sanaria founder and CEO Stephen Hoffman, M.D., said, "The findings from this research, particularly the protection achieved with just three doses of vaccine and the protection against parasites significantly different than those administered, lay a solid foundation for the ongoing clinical trial expected to finalize the immunization regimen required for licensure of Sanaria PfSPZ Vaccine."

The article in JCI Insight titled "Protection against Plasmodium falciparum malaria by PfSPZ Vaccine" notes that volunteers in the study received three to five rapid 0.5 mL injections by direct venous inoculation of the PfSPZ Vaccine, which consists of live, purified, weakened malaria parasites that cannot cause malaria.

The clinical trial included 69 volunteers, 19 to 45 years old. Forty-five volunteers received at least one dose of the vaccine, 22 volunteers were control subjects.

Three weeks after last immunization, 25 of the 28 volunteers (89%) who received either 3 or 5 doses of PfSPZ were protected against malaria parasites similar to those in the vaccine that were transmitted by exposure to malaria-infected mosquitoes. Four out of five vaccinated subjects (80%) were protected against parasites different from those in the vaccine. Twenty-four weeks after last dose of vaccine, 15 of 24 volunteers (63%) were protected against parasites similar to those in the vaccine.

Future clinical trials of Sanaria PfSPZ Vaccine in Africa, the U.S., and Europe are expected to lead to licensure of the vaccine for use individuals from non-malarious areas of the world who travel to malarious areas and in mass vaccination programs intended to halt transmission and eliminate malaria in the countries most affected by malaria. According to the World Health Organization, African children are hardest hit, and the disease primarily affects individuals in 17 African nations, with those in the Democratic Republic of Congo and Nigeria most often infected.

Martina Oneko, M.D., principal investigator of an ongoing clinical trial being conducted as a collaboration between the Kenya Medical Research Institute and the U.S. Centers for Disease Control and sponsored by the Vaccine Research Center, NIAID, NIH, assessing the tolerability, safety, immunogenicity, and protective efficacy of Sanaria PfSPZ Vaccine in Western Kenya, said, "The results of clinical trials of this vaccine in the U.S. and Africa were critical to our decision to move forward with our current trial of PfSPZ Vaccine involving more than 400 infants in Kenya. This represents significant progress toward the development of a regimen for PfSPZ Vaccine that we anticipate will provide high level efficacy for malaria prevention in all age groups in Africa."  

PfSPZ Vaccine also targets the prevention of malaria in tourists, diplomats, business travelers, aid workers, industrial workers, and military personnel traveling or working around the world. The clinical trial reported today in JCI Insight was funded by the U.S. Department of Defense (DoD) through the Joint Warfighter Medical Research Program, the Military Infectious Diseases Research Program, and U.S. Navy Advanced Medical Development, with additional support from Sanaria.

Kenneth A. Bertram, M.D., Principal Assistant for Acquisition for the US Army Medical Research and Materiel Command (USAMRMC), Ft. Detrick, Maryland, said, "Our military continues to be at risk from malaria as it deploys worldwide. We are excited about the results of this clinical trial, and are now investing in the ongoing clinical trial to finalize the vaccination regimen for PfSPZ Vaccine. Because this disease has such strong potential to interrupt our mission of national defense and creates an ongoing, adverse impact on this nation's military readiness, malaria vaccine development continues to be among our highest priorities. We look forward to working with Sanaria and other colleagues to develop and license a safe, effective malaria vaccine for U.S. service members and the world community."

Sanaria receives research support and funding from multiple institutions in the United States, Europe, and Africa, most of which participate in the International PfSPZ Consortium. Sanaria will continue its fund-raising efforts to expand its research and clinical programs.

About Sanaria Inc.: Sanaria Inc. was founded in 2003. The Company's mission is to develop and commercialize whole-parasite malaria vaccines that confer high-level, long-lasting protection against Plasmodium falciparum, the parasite responsible for most of the malaria-associated severe illness and death worldwide, and the other parasites that cause human malaria, and to use these vaccines to eliminate malaria. Sanaria's corporate headquarters, administrative, research, development, and manufacturing operations are located in Rockville, Maryland. The Company's website is sanaria.com.

This news release contains certain forward-looking statements that involve known and unknown risks and uncertainties, which may cause actual results to differ materially from anticipated results or achievements expressed or implied by the statements made. Such statements include the availability of an effective vaccine, the expectations for eliminating malaria, and beliefs concerning the suitability of a successful vaccine. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the Company's ability to raise sufficient funds, the regulatory approval process, clinical trials results, the Company's patent portfolio, dependence on key personnel and other risks associated with vaccine development. For further information contact Alexander Hoffman, [email protected], 301-339-0092 or Jamie Baum, newsPRos, PR Counsel, 847-502-3825, [email protected].

SOURCE Sanaria Inc.

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