SANARIA'S MALARIA VACCINE YIELDS UNPRECEDENTED PROTECTION IN PHASE 1 CLINICAL TRIAL
Vaccine was Safe, Easily Administered and Highly Protective
(Rockville, MD, August 8, 2013) – Results of a phase I clinical trial of the Sanaria® PfSPZ Vaccine to combat malaria, published today in the online issue of Science magazine, show that the vaccine provided complete protection against malaria in subjects who were exposed to Plasmodium falciparum parasites. Plasmodium falciparum is the malaria parasite that causes more than 600,000 deaths annually.
"While we're still in the early stages of testing, we believe this vaccine will be used to eliminate malaria," said Stephen L. Hoffman, CEO of Sanaria. "It's reasonable to suggest that within three-to-five years, a safe, reliable vaccine could be a commercial reality and provide medical benefit to a huge population."
The current trial was primarily funded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) with additional support from the Naval Medical Research Center and Sanaria. Sanaria has also received research support and funding from multiple other institutions in the United States, Europe, and Africa during the past decade and will continue its fund-raising efforts to expand its research and clinical programs.
"Scientists have struggled to produce an effective malaria vaccine for more than three decades," Hoffman said. "These results show that we have a safe, successful, injectable vaccine that has the potential to save millions of lives."
Princeton professor, former president of Merck Vaccines, and Sanaria board member, Dr. Adel Mahmoud concluded that, "This whole-parasite vaccine, produced in a form that can be easily administered, is now shown to stimulate immunity with a clear dose response leading to full protection. Not only was the vaccine fully protective, it was remarkably safe and well-tolerated."
In the clinical trial reported in Science, volunteers received intravenous injections of Sanaria® PfSPZ Vaccine, which consists of live, weakened, purified malaria parasites that do not cause illness. None of the six volunteers who received the highest dosage developed malaria after being bitten by malaria parasite-infected (disease transmitting) mosquitoes. The trial included 40 adult volunteers, ages 20-44, enrolled, vaccinated and assessed under the direction of the principal investigator, Robert Seder, M.D., and clinical team at the Vaccine Research Center, NIAID, NIH, Bethesda, MD.
Future clinical trials of the PfSPZ Vaccine in Africa, the U.S., and Europe are expected to lead to licensure of an affordable vaccine for use in mass administration campaigns in countries most affected by malaria. According to the World Health Organization, African children are hardest hit, and the disease primarily strikes in 17 African nations, with people in Democratic Republic of Congo and Nigeria most often stricken.
Salim Abdullah, Chief Executive Director of Tanzania's Ifakara Health Institute, the site of the next clinical trial of the PfSPZ Vaccine, said, "This great advance in the development of a whole parasite vaccine immediately opens up important opportunities for immunization studies in malaria endemic countries. My colleagues and I are very excited about working with Sanaria."
In addition to the benefit to residents of Africa and other parts of the world with malaria, the vaccine is intended for use by tourists, diplomats, business travelers, aid workers, and military personnel to prevent malaria.
Taken from the WHO webpage:
There were about 219 million cases of malaria in 2010 and an estimated 660 000 deaths. Most deaths occur among children living in Africa where a child dies every minute from malaria. Country-level burden estimates available for 2010 show that an estimated 80% of malaria deaths occur in just 14 countries and about 80% of cases occur in 17 countries. Together, the Democratic Republic of Congo and Nigeria account for over 40% of the estimated total of malaria deaths globally.
About Sanaria Inc.:
Sanaria Inc. is a socially focused, for-profit company, founded in 2003. The Company's mission is to develop and commercialize whole-parasite malaria vaccines that confer high-level, long-lasting protection against malaria. Sanaria's corporate headquarters, administrative, research, development, and manufacturing operations are located in Rockville, Maryland. The Company's website is sanaria.com.
Except for historical information, this news release contains certain forward-looking statements that involve known and unknown risk and uncertainties, which may cause actual results to differ materially from any future results, performance or achievements expressed or implied by the statements made. Such statements include the availability of an effective vaccine, the expectations for conquering malaria, beliefs concerning the suitability of a successful vaccine, and the establishment of a path toward prevention of infection. 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, dependence on third parties, clinical trials results, the Company's patent portfolio, ability to commercialize the vaccine, dependence on key personnel and other risks associated with vaccine development.