Functional Technologies Corp in cooperation with University of Toronto scientists, today announced promising initial results of a revolutionary yeast-based approach for the treatment of malaria. In pre-clinical proof-of-concept tests involving four separate animal trials (mouse models), including one looking at uptake and three for potency, a positive effect against malaria was demonstrated using Functional Technologies' specifically enhanced yeast. Importantly, no toxicity was reported, even at 100 times the effective dosage.

In this novel approach to malaria treatment, the yeast is used both to produce and deliver a protein that neutralizes malarial parasites. After the protein-laden yeast is ingested, the active proteins bind to the parasites in the bloodstream, rendering them benign. In sharp contrast to conventional and widely used chemical treatments that often pose significant side effects for the patient, Functional Technologies' yeast application has not shown such side effects at the doses used in the preliminary mice studies. In the aforementioned mouse trials, the anti-malarial protein was detectable in the bloodstream after oral administration; the company believes this indicates the potential for an orally-applied product. Oral dosing is generally considered the most cost-effective, safe and convenient method available for treatment programs in impoverished countries.

Dr. Ian Crandall, a leading malaria researcher and professor of pharmaceutical sciences at the University of Toronto, working with Dr. Subrata Chowdhury, the company's primary scientist on the project, directed the testing of the malaria-infected mice. Dr. Crandall commented: "As far as I am aware, this is a totally fresh approach to malaria treatment that is showing early and promising efficacy and safety. It presents a completely new area of study alongside the traditional ways in which malaria has been addressed through synthetic drugs. We may be onto something very exciting, and I look forward to being involved in the next phases of research."

Garth Greenham, president and chief operating officer of Functional Technologies Corp., commented on the study: "Our purpose in releasing these proof-of-concept results is to make potential partners and collaborators aware of our malaria program, and help accelerate testing and development of this potentially safe, natural and cost-effective treatment." Greenham added, "Our yeast-based solution needs to be investigated thoroughly to determine its potential for improving human health, and specifically in many of the world's most at-risk populations."

Pre-clinical Trials and Company Background

The animal proof-of-concept studies for efficacy involved groups of 20 infected mice in four cohorts treated at different dosage levels. Positive results included a statistically significant reduction and delay in the onset of malarial symptoms, and an improvement in the health status in the test group versus the control group. In addition, the test group showed a slowing of the weight loss that accompanies malaria infection. Dr. Crandall commented on the results: "Although the number of animals used in the tests was limited, the results strongly suggest that the animals receiving the active protein were both healthier and had a reduced number of parasites. Given the difficulties in optimizing the most effective dosing, timing and delivery in preliminary mouse models, my opinion is that by improving these treatment details we could achieve a complete cure in mouse infections. Of course, there's a long way to go for human treatment, but these are very interesting results that merit further study."

Functional Technologies' research and development has focused on highly advanced proprietary technologies to enhance the natural properties of yeast and algae, two of nature's microscopic workhorses. Yeast is widely accepted as a safe food technology and is currently used in the production of numerous consumer foods and beverages. In addition to focusing on resolving food safety and quality issues, the company's scientists have long been researching the use of yeast biologics for drug delivery.

The company's malaria program was developed over the last two years by an in-house research team led by Subrata Chowdhury, PhD. Planning and implementation of these animal model studies took place over the last 12 months and the analysis was completed over the last two months.

Facts on Malaria

Malaria, a mosquito-borne parasitic disease, remains one the world's most significant health problems, annually infecting over 250 million people and claiming almost one million lives, the majority of them children in sub-Saharan Africa. Symptoms, which include fever, headache and vomiting, usually appear 10-15 days after a person is bitten by a mosquito. Left untreated, malaria can quickly become life-threatening by disrupting the blood supply to vital organs and causing an overwhelming inflammatory response.

About half of the world's population is at risk for malaria, which is also a major threat in Asia and Latin America, and to a lesser extent in the Middle East and parts of Europe. According to the World Health Organization, in 2008 the disease was present in more than 100 countries and territories. While there are about a dozen different drugs used to treat malaria, in many parts of the world the parasites have developed resistance. As such, there is a desperate need for new classes of anti-malarial treatments, particularly ones that can be delivered in a manner that suits rural and impoverished populations. Governments, aid agencies and the private sector, notably the Bill and Melinda Gates Foundation, spend almost $2 billion annually fighting malaria by sending medicines and supplies to countries hard-hit by this deadly infection.