In the Mali study, five doses of PfSPZ Vaccine were administered to 44 subjects and saltwater placebo was given to 44 subjects. Volunteers were followed for six months through the subsequent rainy season to determine the presence of malaria parasites in the blood. While a staggering 93% of the placebo group had one or more infections, only 66% of the vaccinated subjects acquired an infection and in those vaccinated subjects who became infected, the time to infection was delayed. This represents 48% protective efficacy by time-to-event analysis and 29% efficacy by proportional analysis. There were no differences in adverse events between the vaccinated group and the placebo group.
Sanaria CEO, Stephen L. Hoffman, MD said, "These are extremely encouraging results as we have seen significant protection with a dosage regimen that we know to be sub-optimal. We are now building on the protective efficacy seen in this first, landmark study of efficacy of PfSPZ Vaccine in Africa in current clinical trials of PfSPZ Vaccine underway in Tanzania, Equatorial Guinea, Burkina Faso, Germany, the U.S., and of course in Mali. We feel that we are moving rapidly toward establishing a dosage regimen that will provide the high level protection needed by the billions of people at risk every day from this lethal disease."
PfSPZ Vaccine is composed of live, radiation-attenuated purified, cryopreserved malaria parasites, which are administered in a 0.5 mL injection rapid direct venous inoculation.
African children are hardest hit by malaria. The World Health Organization estimates that in 2015 malaria caused 214M clinical episodes and 438,000 deaths worldwide; others have estimated up to 730,500 malaria deaths in 2015. This enormous morbidity and mortality occurs despite investment of billions of dollars in malaria control efforts. Malaria is also a concern for tourists, diplomats, business travelers, aid workers, industrial workers, and military personnel worldwide.
Professor Ogobara Doumbo, MD, PhD, Director of the Malaria Research Training Center at the University of Bamako, Mali, said, "Many of us living in countries where people's lives are devastated by malaria have been waiting decades for a highly effective malaria vaccine. Over the past decade we have studied many experimental malaria vaccines in Mali. This is by far the best result we have ever obtained. We are excited and encouraged by these new results, and are proud to have hosted the first field efficacy trial of PfSPZ Vaccine in Africa here in Mali, and are expectantly awaiting the results of our second study."
"These important results provide the evidence that protection against infection, not just disease, can be sustained for at least half a year. This is clearly a cornerstone for us to finally hone in on a PfSPZ Vaccine regimen that will provide high level, lasting protection to people living in malaria affected areas," said Professor Marcel Tanner, President of the Swiss Academy of Sciences and Director Emeritus, Swiss Tropical and Public Health Institute. "Such a vaccine is an essential tool to achieve elimination. We are excited about current and all planned future clinical trials of PfSPZ Vaccine that now stretch across Africa from Tanzania in the East to Equatorial Guinea in the West."
About Sanaria Inc.: Sanaria's mission is to commercialize whole-parasite malaria vaccines that confer high level, long-lasting protection against malaria, and use these vaccines to prevent malaria in individuals and eliminate malaria from entire regions. Sanaria (http://www.sanaria.com) is based in Rockville, Maryland.
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@example.com, 301-339-0092.
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