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.
SOURCE Meditor Pharmaceuticals Ltd.
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Related links:
http://www.meditorpharma.com
CONTACT:
Mr. Rafi Barkan, Chairman, +972 8 930 3307,
or Dr. Adrian Harel, CEO, +972 8 930 3305, both of Meditor
Pharmaceuticals Ltd.
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