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Technologie BiolActis Inc. reports its randomized and double-blinded clinical trial results for MPM-SL0905

-- DATA CONFIRM THE METABOLIC IMPACT OF BIOLACTIS' TECHNOLOGY --


Montreal, Canada - April, 2009 - Technologie BiolActis Inc., announces its clinical data for MPM-SL0905, a first-in-class lipid-regulating product (fermented whey protein hydrolysate trademarked CardiolActis®), to be used either as an ingredient in stand-alone functional/medical foods or as an OTC/adjunct to therapy for the normalization of adults with high levels of LDL-Cholesterol (LDL-C) and triglycerides (TGs), defined as 130 mg/dL or higher but below 400 mg/dL.  The clinical trial was carried out by a Contract Research Organization and followed the highest clinical standards (GCPs) as a randomized, double-blind, conform parallel groups (placebo-controlled) and multi-centered (9).  The objective of the trial was to evaluate the safety and efficacy of MPM-SL0905 over a 12-week duration with 3 visits.  The trial was conducted in Germany on a total of 161 randomized participants (47% in hospital lipid outpatient clinic and 53% general practitioners) for whom the diet was not controlled (free-living).  The volunteer study participants were given bid either 15 g MPM-SL0905 or an iso-proteic, -carbohydrate, -calcium placebo provided as a ready-to-mix powder juice formula to be prepared at home.

The trial demonstrated that MPM-SL0905 was beneficial for all study participants (131 participants completed the entire trial) and showed an significant impact on circulating glucose and blood lipid levels.  The positive impact seen on Total-C, LDL-C and lipid ratios depended on the type of medical setting into which participants were monitored.  Study participants randomized in a hospital lipid outpatient clinic had their LDL-C decreased compared to baseline by an average of 6 % and up to 12% for maximum responders (p=0.04 vs placebo) after 12 weeks. This reduction was rapidly achieved only after 3 weeks and maintained throughout the study (p<0.001 vs placebo).  There were also significant impacts on TGs (p=0.004) and HbA1c (p=0.03) for all study participants.  Study participants with both, high LDL-C and TGs (>150 mg/dL), saw their TGs strikingly reduced by an average of 20% and reaching 50% for maximum responses.  Key lipid secondary endpoints such as Total-C (p=0.002 vs placebo), ratios of Total-C/HDL-C (p=0.01 vs placebo) and LDL-C/HDL-C (p=0.02 vs placebo) were also positively impacted.  Finally, relative LDL-C reduction over 12 weeks was greater for volunteer participants with a body morphogenic index (BMI) above 25 Kg/m2 thus suggesting that MPM-SL0905 is likely to be useful for individuals with an overweight condition.
 
It is important to note that study participants having impaired fasting glucose (between 100-125 mg/dL) benefited from MPM-SL0905 since significant effect was seen for HbA1c (p=0.05). This significant result was achieved although this subgroup did not exhibit high HbA1c value at baseline (5.9%).  Altogether, these results suggest an important metabolic impact of MPM-SL0905 on a variety of markers associated with increased CV risks and obesity and deserves further investigation for metabolic syndrome and diabetes.  Moreover, preliminary analysis of body morphogenic animal experiments indicated a trend towards improvement of lean body mass suggesting that MPM-SL0905 favours a better balance between fat and muscle thus making it useful product in a context of weight management.  In addition, MPM-SL0905 was tested in a variety of animal models and showed effects on weight loss, satiety and glucose management. 
 
"In this first clinical trial, MPM-SL0905 has proven to be efficacious for the management of blood lipids and to some extent for the management of circulating glucose without exhibiting side effects while being well tolerated," commented Dr. Pierre Lemieux, President and CEO of BiolActis. "These confirmatory data are critical for further regulatory submissions that are in preparation for market approval and to get exclusive claims for MPM-SL0905," added Dr. Lemieux. "MPM-SL0905 is the only whey protein-based product that can deliver both LDL-C- and TGs-lowering benefits that is clinically proven. The unique and patented manufacturing process of BiolActis for MPM-SL0905 results in a highly controlled bioactive complexes that contain a biological mixture acting in synergy to capture multiple biochemical pathways underlining complex metabolic disorders such as hyperlipidemia, diabetes and obesity."  Dr. Lemieux also added that MPM-SL0905 may replace and complement established lipid management drugs and products such as phytosterols, soy protein, fish oils and statins which have some problems when the dosage is increased and not providing further benefits.  "According to the American Heart Association and the Heart and Stroke Foundation of Canada, the cost of cardiovascular diseases and stroke in North America only for 2006 is estimated at $453 billion" added Dr. Pierre Lemieux. "It is predicted that statins will continue to dominate the cardiovascular disease market during the 2008-2012 period.  The pharmaceutical industry has recognized the importance of wider lipid management strategies and is looking to improve the performance of statins with more complete and safer products." added Dr. Lemieux.

The clinical trial on MPM-SL0905 is a landmark in terms of standards as opposed to the usual small-scale trial published on whey proteins or other lipid-lowering natural products, which are usually reported not to be definitive or conclusive in terms of efficacy.  The primary endpoint as well as important secondary endpoints confirmed the positive results obtained by BiolActis' previous R&D, toxicology, and preclinical programs.  "MPM-SL0905 provides what either dietary supplements or natural products usually lack: the consistency, reliability and established efficacy of a pharmaceutical product," said Dr Lemieux. "While MPM-SL0905 can effectively lower TGs and LDL-C levels it provides the advantages of a product from natural origin (being 100% dairy) that is clinically validated but most importantly with the convenience of having a product exhibiting no side effects such oily and loose stools, diarrhoea, LDL-C elevation, bleeding time prolongation and overall immune suppression like it is unfortunately reported for 2 popular products found in the market place.  In contrast, it is important to note that individuals taking MPM-SL0905 benefited from a 40% reduction of the incidence of flu and colds as opposed to the individuals taking the placebo suggesting an action on the immune system. BiolActis had previously filed a patent on the mechanism of action on the immune system (Modulation of the Th-17 pathway) for its products and is now in the middle of filing a new patent protecting a newly identified molecular mechanism of MPM-SL0905.

Safety and Additional Information about MPM-SL0905

In terms of safety there were no clinically and statistical significant differences between the MPM-SL0905-treated group and placebo while MPM-SL0905 was well tolerated throughout the trial without any signs of hypoglycemia or hepatotoxicity which is in contrast to some known lipid management agents. The drop-out rate was equivalent for the individuals taking MPM-SL095 or the placebo and gastrointestinal disorders were the most frequently reported AEs for the duration of the study and were quoted as unrelated to the trial products and were of mild intensity for both treatment group. The use of lipid-lowering agents should be considered only when reasonable attempts have been made to obtain satisfactory results with natural methods and one should be advised that use of lipid-lowering products does not reduce the importance of adhering to diet and to a lifestyle change.

About Technologie BiolActis Inc.
www.biolactis.com

Technologie BiolActis Inc is a private Canadian biotechnology company that discovers innovative products for the management of metabolic disorders with integrated production and research and development expertise in order to reach the market through a fast-track process.  BiolActis offers a portfolio of branded metabolic biotechnology products. Using an exclusive process, BiolActis is well positioned in the global obesity and metabolic-disorders market.  Through strategic alliances and partnerships, as well as through clinical studies, the Company continues to demonstrate the immense beneficial effects of these products. BiolActis develops and markets new formulas and original products for specific applications in high growth markets such as the biopharmaceutical, OTC, nutraceutical, and cosmeceutical markets.

CONTACT:     Dr. Pierre Lemieux, President and CEO, Technologie BiolActis, Inc.
Tel.: 450 781 1303, plemieux@biolactis.com
 

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