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13.03.2007
RAMAT GAN, Israel, Obecure has conducted the first initiation visit for its Phase II clinical trial to evaluate the efficacy of the company’s OBE101 drug candidate for prevention of weight gain in patients treated with Zyprexa, (olanzapine) an antipsychotic medication. The study is a double-blinded, placebo-controlled multicenter trial in about 78 subjects over a period of four months. The study, approved by Health Canada and the central IRB, will be conducted at several psychiatric medical centers across Canada and will start at Penticton, BC. The trial is being conducted with the partial financial support of Eli Lilly & Co., the manufacturer of Zyprexa.
“Significant weight gain has been an unwanted side effect among patients taking Zyprexa,” said Dr. Joseph Albeck, a Clinical Instructor in Psychiatry at McLean Hospital and Harvard Medical School and the principal investigator of the study. “Our goal in this study is to see if combining OBE101 with Zyprexa will prevent the weight gain without interfering with the antipsychotic benefits.”
“Both Zyprexa and OBE101 impact the histamine receptor in the brain which controls our craving for food,” said Dr. Nir Barak, Chief Scientific Officer of Obecure. “Whereas Zyprexa, an inhibitor of the histamine receptor, triggers eating, OBDE101, an activator of the same receptor, suppresses food craving. Consequently, we expect OBE101 to offset the effect of Zyprexa and spare the patients unwanted weight gain.”
“We believe that this is the first serious attempt to neutralize the weight gain associated with a variety of psychiatric medicines,” said Dr. Yaffa Beck, CEO of Obecure. “We are especially excited about the prospects for OBE101 because it has a proven safety profile and has been shown to be effective in counteracting the weight gain in initial, independently conducted pilot studies in first episode patients starting Zyprexa treatment.”
In January of this year, Obecure commenced another Phase II study aimed at evaluating the efficacy of OBE101 for weight loss in obese patients in the U.S.
In addition, the U.S. National Institute of Health (NIH) has agreed to undertake a study comprising 80 human subjects that will examine the drug’s mechanism of action by evaluating its impact on energy consumption and expenditure.
OBE101 is comprised of betahistine, a drug currently prescribed for vertigo in many countries. However, the drug is not FDA approved and is therefore not available in the U.S. A recent post-marketing survey, citing worldwide treatment of more that 100 million patients, shows that the drug has a remarkable safety profile.
OBE101’s use for weight management, alone or in combinations, is protected by worldwide patent-pending applications including in the U.S.
About OBE101
The idea for using betahistine in weight management is based on breakthrough research carried out in obese patients by Dr. Nir Barak, a nutritional and internal medicine expert who serves as Obecure's Chief Scientific Officer.
Dr. Barak’s research successfully demonstrated the key role that histamine receptors and OBE101 play in controlling appetite and the desire for fat consumption. In a double-blinded pilot study, involving 20 human subjects over four weeks, OBE101 reduced both calorie and fat intake in the treatment group, resulting in significant weight loss versus placebo.
About Obecure
Founded in 2005, Obecure Ltd. is a biopharmaceutical company dedicated to the development of weight management drug therapies. The Company is currently pursuing the clinical development of its lead compound OBE101 for three indications: (i) general obesity and (ii) weight gain associated with anti-psychotic drug therapy and (iii) as adjunct to statin therapy for improving blood lipid profiles. In addition, the Company is evaluating additional proprietary analogues for both weight gain and weight loss in preclinical models.
Obecure has a worldwide exclusive license from Mor Research Applications Ltd., the Technology Transfer Office of Clalit HMO to clinically develop and commercially exploit the technology, as developed by Dr. Nir Barak, a specialist in nutrition and internal medicine at the Rabin Medical Center in Tel Aviv.
Obecure is a subsidiary of Bio-Light Life Science Investments Ltd., an investment company, traded on the Tel Aviv Stock Exchange (TASE:BOLT)
For more information visit www.obecure.com or contact:
Yaffa Beck, CEO
ObeCure Ltd.
5-7 Shoham St.
Ramat Gan, Israel 52521
Tel: +972-3-7534100
yaffa@bio-light.co.il |