A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females
REHOVOT, Israel, November 06, 2007 /PRNewswire/ -- Meditor Pharmaceuticals Ltd. announced today that the primary end point and safety evaluation in the Phase II, Randomized Double Blind, Placebo-Controlled Dose-Escalating Study in Migraine patients was successfully completed. This event marks a major milestone in the development program of the compound MTR106 (tablet formulation of MTR104). MTR104 is a low molecular weight S-Alkylisothiouronium derivative.
This Phase II study was designed to assess the pharmacokinetics, safety and efficacy of MTR106 in female patients suffering from migraine without aura. The study population consisted of forty (40) female patients ranging from 22-57 years of age. The average duration of migraine attacks was 16.6 +/- 10 hours with a frequency of 2.8 +/- 1.3 attacks per month. The subjects were randomized in a ratio of 4:1: treatment to placebo respectively, constituting 4 groups of 10 patients each. Treatment arms of MTR106 or placebo were administered at escalating doses of 25, 50, 75 and 100 mg.
MTR106 was found to be safe and well tolerated. No serious adverse events occurred in the 4 studied doses and no symptoms related to chest pain or changes in heart rate or blood pressure were observed. The study results demonstrated that at 2 hours and at the 3rd and 4th hours post-treatment more patients treated with MTR106 had pain relief compared to those treated with placebo.
About Meditor Pharmaceuticals:
Meditor Pharmaceuticals Ltd. is a biopharmaceutical company dedicated to the development and commercialization of proprietary products for the therapeutic management of acute and chronic hypotension and hypotension-related disorders. The lead development compound is a low molecular weight S-Alkylisothiouronium derivative that addresses a variety of acute and chronic therapeutic indications associated with hypotension. The clinical development program is focused on the development of lead compound MTR104 for the treatment of three main medical targets: MTR107 (i.v. formulation) for Intradialytic Hypotension, MTR106 (immediate release oral tablet formulation) for Migraine, and MTR105 (i.v. formulation) for the treatment of hypotension associated with cardiac (CABG) surgery. Meditor's patent portfolio provides the company with a strong proprietary position in the U.S. and worldwide. For more information on the company and its drug development activities, please visit http://www.meditorpharma.com
For all inquiries please contact Michael Schultz, R.Ph., VCG & Associates, Inc. at 636-329-1452 or Dr. David Coffin-Beach at (904) 501-5882
CONTACT: Michael Schultz, R.Ph. of VCG & Associates, Inc.,+1-636-329-1452; or Dr. David Coffin-Beach, +1-904-501-5882, both forMeditor Pharmaceuticals Ltd.
Web site: http://www.meditorpharma.com/
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Posted: November 2007