REHOVOT, Israel, June 11 /PRNewswire/ -- Meditor Pharmaceuticals Ltd. announced today the results of the Phase II, Randomized Double Blind, Placebo-Controlled Dose-Escalating Study in Migraine patients.
This Phase II study was designed to assess the pharmacokinetics, safety and efficacy of MTR-106 tablets in female patients suffering from migraine without aura. The study population consisted of forty (40) female patients. The average age of participants was 37 +/- 9 years. 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 MTR-106 or placebo were administered at escalating doses of 25, 50, 75 and 100 mg.
Analysis of the data showed that at 2 hours post-treatment significantly more subjects treated with MTR-106 had pain relief compared to those receiving placebo (71% and 25% respectively; p=0.025), and more patients treated with MTR-106 were pain free compared to those receiving placebo (26% and 13% respectively). Of those treated with MTR-106, 23% had sustained pain free at 24 hours post-treatment. No clinically significant changes of the heart rate or the blood pressure were noted regardless of the MTR-106 dosage.
Dr. Amnon Mosek, Deputy Chief Department of Neurology, Director of the Headache Clinic at Tel Aviv Medical Center and also one of the Principal Investigators for the Study observed: "The results of this study show that MTR-106 tablets were effective in the treatment of acute migraine without aura in females and its efficacy is comparable to that of the triptans. Its probable non-serotoninergic activity might enable those who are non-responders to triptans to achieve relief from acute migraine."
Dr. Adrian Harel, CEO of Meditor was quoted as saying: "We are planning to present these exciting results in an International Conference for Migraine in Europe. We are also meeting with the regulatory authorities to further develop and commercialize the drug. The company is actively looking for strategic partners to boost the development of this promising drug in the Migraine field."
About Meditor Pharmaceuticals: Meditor Pharmaceuticals Ltd. is a biopharmaceutical company dedicated to the development and commercialization of proprietary products for the therapeutic management of Migraine and acute hypotension and hypotension-related disorders. The lead development compound is a unique 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 therapeutic 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 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 Mr. Rafi Barkan, Chairman at +972 8 930 3307 or Dr. Adrian Harel, CEO at +972 8 930 3305.
CONTACT: Mr. Rafi Barkan, Chairman, +972 8 930 3307, or Dr. Adrian Harel,
CEO, +972 8 930 3305, both of Meditor Pharmaceuticals Ltd.
Web site: http://www.meditorpharma.com/