Researchers at Wayne State University's Department of Nutrition and Food Science believe they've uncovered a unique method to control and regulate cholesterol using biologically active molecules isolated from ProAlgaZyme™ ("PAZ") -- a proprietary algal infusion produced by Health Enhancement Products, Inc., of Scottsdale, Arizona (OTCBB:HEPI).
The company has filed a new patent application to describe the method or methods of cholesterol regulation, which are considered novel and scientifically significant. Dr. Smiti Gupta, associate professor at Wayne State University and the principal investigator leading the research team, will be providing additional information in the near future. The scientific team is planning a press conference to announce details of the discoveries once the intellectual property has been fully protected.
Results of this most recent study indicate that these biologically active molecules regulate cholesterol metabolism by stimulating genetic signals that help spur the creation of HDL and simultaneously slow down the degradation of existing HDL particles back to the LDL form of cholesterol.
The isolated molecules have been shown to significantly raise HDL, the 'good' cholesterol, from 105.27 to 138.69 mg/dl (approx. 32%), and lower LDL, the 'bad' cholesterol from 131.00 to 79.57 mg/dl (approx. 39%), in a previous Wayne State study using hamsters on a high-fat diet. An earlier human study was conducted in Cameroon, as well.
"The mechanisms that presented themselves are not obvious and therefore are very patentable," states Dr. Denis Callewaert, a biotech consultant retained by Health Enhancement Products. "The isolated bioactive compounds derived from the ProAlgaZyme™ infusion are influencing the regulation of certain genetic functions and they are working in vivo, in living animals, not just in the laboratory. Typically, drug companies begin with synthetic compounds that might work with cells cultured in the laboratory. But, these compounds often fail when subsequently introduced into living organisms, whether mouse or human."
Callewaert sums up the current shortcomings in the drug development process: "Most drug compounds fall short when bridging the chasm between cell cultures and living organisms. The bioactive compounds we've been isolating have already been proven to work well in humans and hamsters without any apparent adverse side effects. This can dramatically shorten the lead time to market for an effective cholesterol management drug. And, from everything we've seen to date, there don't appear to be any adverse side effects."
Health Enhancement Products is in the process of funding a massive safety-toxicity and dose-response test to study potential side effects. Previous studies indicate that adverse events have not been detectable at dosage levels that show significant improvements in cholesterol levels. This is encouraging news for the science team.
The potential market for cholesterol-lowering drugs, food ingredients, natural supplements and functional foods is vast. The market for statins and similar prescription drugs in the U.S. alone topped $28 billion in 2009 and there are huge swaths of the population that can't tolerate the current crop of cholesterol-lowering drugs because of diabetes, kidney problems or other maladies. The market is ripe for a new approach to cholesterol management.
"This brings us one step closer to realizing the full potential of these compounds in many different applications," says John Gorman, Health Enhancement Products, Director. "The progress over the last few weeks has been remarkable and we're positioning our company to make a move in several vertical markets."
Coronary atherosclerosis prevalent even in low-risk adults with normal cholesterol levels