Sanaria® PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation

ROCKVILLE, Maryland, Sept. 26, 2016 /PRNewswire/ -- Sanaria Inc. today announced it has received U.S. Food and Drug Administration (FDA) Fast Track designation for its preventative vaccine for malaria, Sanaria^® PfSPZ Vaccine.  Sanaria believes its PfSPZ Vaccine is the only malaria vaccine to have ever received this distinction.

According to the FDA, "Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier." A drug (or vaccine) that receives Fast Track designation is eligible for Accelerated Approval and Priority Review, which can considerably speed the time to market.

Sanaria^® PfSPZ Vaccine is in clinical trials in subjects ranging in age from 6-month old infants to adults in the U.S., Europe and Africa. These trials are intended to finalize an immunization regimen to be taken forward into pivotal phase 3 clinical trials that will, if successful, provide the necessary data for licensing the vaccine.

Stephen Hoffman, CEO of Sanaria, said, "U.S. FDA Fast Track designation for our malaria vaccine is a strong indicator that we've gotten beyond the proof of science and are moving toward licensure. We are hopeful PfSPZ Vaccine will be the world's first FDA licensed malaria vaccine, and we will be able to use it to halt transmission and eliminate Plasmodium falciparum malaria from geographically defined regions and provide protection against malaria to travelers and military personnel visiting malaria endemic regions."

Sanaria's primary mission is to develop a highly effective vaccine to eliminate malaria from geographically defined areas through mass immunization campaigns, and protect non-immune visitors, including military personnel, going to regions where malaria is transmitted. In phase 1 studies led by the Vaccine Research Center, National Institute of Allergy and Infectious Disease - NIH published in Science (2013)¹ and Nature Medicine (2016)², Sanaria^® PfSPZ Vaccine, protected 100% of subjects at 3 weeks after the last dose of vaccine and 55% at 14 months. Completed and ongoing follow-on studies at military and civilian sites in the U.S. and in Germany and Africa are designed to optimize the immunization regimen, so as to achieve high-level protection against all strains of Plasmodium falciparum malaria.