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New Obesity Drug Receives Ethical Approval for clinical trials

Posted on December 3, 2009

obese-on-scaleHELSINKI, 3rd December 2009 — After two decades of scientifically and medically proven success in their field, Lightlake Therapeutics’ experts have been granted ethical approval to begin selecting and gene testing subjects for a trial of a simple, safe and effective treatment for what the World Health Organisation has described as a global epidemic of unhealthy eating and obesity.

A Phase II trial for the everyday treatment against obesity and the overeating of unhealthy food, by nasal spray and a behavioural programme, will aim to prove that Lightlake’s treatment can break the addictive habit of unhealthy eating, significantly reduce weight, and train the mind to embark on a healthier dietary lifestyle and sustained weight-loss.

Obesity is an epidemic that is resulting in millions of preventable deaths worldwide. (1) The American Cancer Society estimates that over 100,000 Americans are dying from obesity and over eating related cancers every year and the estimated healthcare cost alone is $147 billion every year. (2)

By 2012, it’s expected that more than two billion people will be overweight and 600 million will be obese. The U.S. Center for Disease Control and Prevention and Department of Health in the UK both estimate that 60% of men and 50% of women and 25% of children will be obese by 2050 if current trends continue. (3)

Lightlake has been given ethical approval to begin subject selection for Phase II clinical trial under the direction of its trial coordinator Professor Hannu Eero Rafael Alho, Professor of Addiction Medicine, University of Helsinki. The Trial is being conducted in conjunction with the National Institute for Health and Welfare, in Helsinki. It will last 6 months and results are expected in the fall of 2010.

Lightlake is pioneering the treatment of one of the world’s biggest killers and will be initially focused on addressing one form of obesity – Binge Eating Disorder (BED) – that effects one in three obese people. To date existing interventions from diets to drugs and surgery have failed to deliver a sustainable solution to the obesity epidemic that is resulting in the global healthcare crisis. Those products currently on the market have questions of efficacy and may come with undesirable side effects. This trial marks a new departure in the treatment of obesity.

Lightlake Therapeutics is an international team of research scientists, pharmacologists and doctors backed by investors, who are pioneering the search for a safe, effective and simple treatment for the epidemic of obesity and unhealthy eating. Its expertise is derived from an existing treatment that has recorded a 78% success rate in treating the over consumption of alcohol.

Dr-David-SinclairDr. David Sinclair, Ph.D., Lightlake’s Chief Science Officer says:

“Most human behaviour is driven by a system of reinforcement controlled by powerful brain chemicals. We have learnt how to regulate these brain chemicals using an active compound that is extremely safe and effective, so that bad eating habits are progressively reduced, and good eating is promoted. Delivery is through a pocket sized nasal spray that is easy and convenient to carry. The treatment begins working progressively from the first day to reduce the urge to eat unhealthily. One of the real marvels of the treatment is that it changes what you think about. Dieting and most other weight reduction procedures have the opposite effect. They make you think more and more about problem foods. Our method makes the person no longer consider consuming the specific foods that are unhealthy.”

The active compound used is patented to Lightlake Therapeutics for the treatment of eating disorders and obesity.

Says Dr. Roy Eskapa, author of The Cure for Alcoholism:

“Everyone is looking for the holy grail of a safe and effective treatment of obesity with minimal side effects. Many who have attempted the journey have fallen along the way. It’s interesting to see that Lightlake’s intervention is based on a successful treatment for alcoholism. It’s a large leap from alcohol to obesity but Dr David Sinclair’s experience and proven success brings believability and credibility to the possibility. ”

This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” estimates,” “predicts,” “projects,” “potential” or “continue” or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this presentation to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.

Notes to Editors

Dr. David Sinclair, Ph.D. – Chief Science Officer, Lightlake Therapeutics Inc

Dr. Sinclair began in alcoholism research at University of Cincinnati, discovering that the usual treatment, forced abstinence, actually increases craving. After getting his doctorate, he joined the unit on prevention and treatment of addictions for Finland’s National Institute for Health and Welfare. He subsequently worked on the preclinical studies and clinical trials proving the concept and on practical implementations. His work is featured in Dr. Roy Eskapa’s 2008 book, The Cure for Alcoholism. Based on his work, Dr. Sinclair published a behavioural programme for those with impulse disorders known as the Sinclair Method that has proved highly effective in a wide range of applications. He has patented similar treatments for various forms of drug addiction including the use of naltrexone for treating amphetamine abuse, and has been studying the use of naltrexone for pathological gambling and a new treatment for panic disorders.

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