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This Phase II study was designed to assess the pharmacokinetics, safetyand efficacy of MTR-106 tablets in female patients suffering from migrainewithout aura. The study population consisted of forty (40) female patients.The average age of participants was 37 +/- 9 years. The average duration ofmigraine attacks was 16.6 +/- 10 hours with a frequency of 2.8 +/- 1.3 attacksper month. The subjects were randomized in a ratio of 4:1: treatment toplacebo respectively, constituting 4 groups of 10 patients each. Treatmentarms of MTR-106 or placebo were administered at escalating doses of 25, 50, 75and 100 mg.
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Analysis of the data showed that at 2 hours post-treatment significantlymore subjects treated with MTR-106 had pain relief compared to those receivingplacebo (71% and 25% respectively; p=0.025), and more patients treated withMTR-106 were pain free compared to those receiving placebo (26% and 13%respectively). Of those treated with MTR-106, 23% had sustained pain free at24 hours post-treatment. No clinically significant changes of the heart rateor the blood pressure were noted regardless of the MTR-106 dosage.
Dr. Amnon Mosek, Deputy Chief Department of Neurology, Director of theHeadache Clinic at Tel Aviv Medical Center and also one of the PrincipalInvestigators for the Study observed: "The results of this study show thatMTR-106 tablets were effective in the treatment of acute migraine without aurain females and its efficacy is comparable to that of the triptans. Itsprobable non-serotoninergic activity might enable those who are non-respondersto triptans to achieve relief from acute migraine."
Dr. Adrian Harel, CEO of Meditor was quoted as saying: "We are planning topresent these exciting results in an International Conference for Migraine inEurope. We are also meeting with the regulatory authorities to further developand commercialize the drug. The company is actively looking for strategicpartners to boost the development of this promising drug in the Migrainefield."
About Meditor Pharmaceuticals: Meditor Pharmaceuticals Ltd. is abiopharmaceutical company dedicated to the development and commercializationof proprietary products for the therapeutic management of Migraine and acutehypotension and hypotension-related disorders. The lead development compoundis a unique low molecular weight S-Alkylisothiouronium derivative thataddresses a variety of acute and chronic therapeutic indications associatedwith hypotension. The clinical development program is focused on thedevelopment of lead compound MTR104 for the treatment of three maintherapeutic 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 cardiacsurgery. Meditor's patent portfolio provides the company with a strongproprietary 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.
SOURCE Meditor Pharmaceuticals Ltd.
