Sanaria® PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation - Seite 2

To date, 1,165 volunteers have received Sanaria's PfSPZ-based products in more than two dozen clinical trials in the USA, Europe and Africa. Clinical trials are in progress in Tanzania, Kenya, Mali, Burkina Faso, Germany and two sites in the USA, and are intended to begin soon in Equatorial Guinea.

Dr. Kenneth A. Bertram, Principal Assistant for Acquisition for the US Army Medical Research and Materiel Command (USAMRMC), Ft. Detrick, Maryland stated, "The U.S. military continues to be at risk from malaria as we deploy world-wide. We eagerly await a vaccine against this deadly and incapacitating disease. We are excited to continue working with Sanaria, the FDA, and academic partners to develop a safe and effective malaria vaccine for U.S. service members and the world community."

The next trials are also intended to begin the process of establishing the logistics for delivering and administering the vaccine to hundreds of thousands of individuals in mass campaigns. A phase 3 trial in Equatorial Guinea is being planned with funding provided by the Government of Equatorial Guinea and a consortium of three U.S. energy companies including Marathon Oil, Noble Energy, and Atlantic Methanol Production Company.

Dr. Hassan Mshinda, Director General of the Tanzanian Commission on Science and Technology, the African organization that provided funds for the first PfSPZ trial in Africa, said, "We are excited to have the Ifakara Health Institute, a Tanzanian Institute, be working with Sanaria and partners in Equatorial Guinea to move toward phase 3 clinical trials and mass vaccine administration elimination campaigns."

The clinical development plan for PfSPZ Vaccine is regularly updated at meetings of the International PfSPZ Consortium (I-PfSPZ-C), which are attended by representatives of more than 30 organizations from more than 15 countries.

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.