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MTR106 tablets were found to be effective in Acute Migraine Attacks
June 11, 2008

REHOVOT, Israel, June 11 - 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 to 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 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.


Two New Appointments at Meditor Pharmaceuticals Ltd.
May 12, 2008

REHOVOT, Israel, May 12 /PRNewswire/ -- Meditor Pharmaceuticals Ltd. announced today the appointment of Prof. Arie Schachner to serve as a Senior Medical Advisor to the company.

Dr. Schachner has been a member of Meditor's Scientific Advisory Board since 2001 and will now take a more active role in the Clinical Development program.

Prof. Schachner was the founder and Head of the Cardiac Surgery Department at Wolfson Medical Center and Tel Aviv University Sackler Medical School. He is an opinion leader in the Cardiac Surgery area, he is a distinguished member of several professional societies and has many publications in this field. Prof. Schachner will collaborate with recently appointed CEO, Dr. Adrian Harel, in the ongoing Phase II Clinical trial on Hypotension in patients undergoing Cardio Artery Bypass Graft (CABG) patients and in designing future clinical trials.

Dr. Adrian Harel joined Meditor in January 2008. He combines a broad scientific education with extensive industry experience. He holds a Ph.D. in Neurobiology, from the Weizmann Institute of Science, and was a postdoctoral at Washington University. Dr. Harel has many years of experience in the pharmaceutical and biotech industry. Dr. Harel has extensive Drug research & development know-how and GMP production and manufacturing knowledge.

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 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 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 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 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.


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
November 6, 2007

REHOVOT, Israel, Nov. 6 /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 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

Meditor Pharmaceuticals Provides Updates on Phase II Eastern European Clinical Study to Assess the Pharmacokinetics and Pharmacodynamics of Orally Administered MTR106 During the Treatment of Acute Migraine Attacks Without Aura in Females
October 4, 6:23 pm ET

REHOVOT, Israel, Oct. 4 /PRNewswire/ -- Meditor Pharmaceuticals Ltd. announced today that a Phase II Eastern European based clinical trial for its proprietary lead development compound MTR106 (tablet formulation of MTR104), a low molecular weight S-Alkylisothiouronium derivative that addresses a variety of acute and chronic therapeutic indications, is progressing on schedule for completion by the end of calendar 2006.

This Phase II, randomized double blind, placebo-controlled dose-escalating GCP study, will assess efficacy, pharmacokinetics and pharmacodynamics of MTR106 tablets during the treatment of acute migraine attacks without aura in females.

To assess safety, preliminary efficacy, tolerability, and the pharmacokinetic parameters of MTR106 tablets, the product is being administered in four escalating doses to females suffering from migraine without aura. The primary clinical endpoints are to reduce the intensity of migraine pain within 2 hours post treatment and to demonstrate the absence of drug-related adverse events.

Meditor Pharmaceuticals Ltd. is an Israel-based pharmaceutical development company founded to develop and commercialize a class of small organic synthetic molecules with profound cardiovascular pharmacologic activity. The lead development compound is MTR104, a low molecular weight S-Alkylisothiouronium derivative that addresses a variety of acute and chronic therapeutic indications. 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 www.meditorpharma.com

Meditor Pharmaceuticals Ltd. is continuing with the development of its lead compound while currently seeking offers from pharmaceutical manufacturers having the potential to develop, register and commercialize MTR106. For all inquiries please contact Michael Schultz, R.Ph., VCG & Associates, Inc. at 636-329-1452 or Dr. David Coffin-Beach at 416-725-3956.

 

Meditor Pharmaceuticals Provides Update on Phase II Trial Assessing the Pharmacokinetic and Pharmacodynamic Effects of Intravenously Administered MTR107 in ESRD Patients
September 27, 5:23 pm ET

REHOVOT, Israel, Sept. 27 /PRNewswire/ -- Meditor Pharmaceuticals Ltd. announced today updated progress on a Phase II clinical trial for its proprietary development compound MTR107 (i.v. formulation of MTR104), a low molecular weight S-Alkylisothiouronium derivative that addresses a variety of acute and chronic therapeutic indications associated with hypotension. Current study enrollment projects a completion date of December 2006.

This Phase II double blind clinical trial will evaluate the pharmacokinetic and pharmacodynamic effects of MTR107 in twelve patients with End Stage Renal Disease (ESRD).

Intradialytic hypotension (IDH) is the most common adverse event during routine hemodialysis. IDH has been reported in 15-25% of all hemodialysis treatment groups, with elderly patient groups reporting levels exceeding 95%. Many adverse hemodialysis events -- including headaches, lightheadedness, nausea, cramps, and seizures, are associated with IDH. All of these symptoms can cause patient morbidity. These complications may repeatedly interrupt dialysis sessions, resulting in insufficient uremia toxin removal. Interruptions due to IDH both increase the costs of the dialysis treatment sessions and long-term care of less healthy hemodialysis patients.

Meditor Pharmaceuticals Ltd. is an Israel-based pharmaceutical development company founded to develop and commercialize a class of small organic synthetic molecules with profound cardiovascular pharmacologic activity. The lead development compound is MTR104, a low molecular weight S-Alkylisothiouronium derivative that addresses a variety of acute and chronic therapeutic indications associated with hypotension. 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 www.meditorpharma.com .

Meditor Pharmaceuticals Ltd. is continuing with the development of its lead compound while currently seeking offers from pharmaceutical manufacturers having the potential to develop, register and commercialize MTR107. For all inquiries please contact Michael Schultz, R.Ph., VCG & Associates, Inc. at 636-329-1452 or Dr. David Coffin-Beach at 416-725-3956.


Meditor Pharmaceuticals Initiates Phase II Trial For Intradialytic Hypotension
April 20, 2006

Meditor Pharmaceuticals Ltd. announced today the initiation of a Phase II clinical trial for their proprietary lead development compound MTR 104, a low molecular weight SAlkyisothiouronium derivative that addresses a variety of acute and chronic therapeutic indications associated with hypotension.

The Phase II trial of MTR 104 is for Intradialytic Hypotension (IDH). This Phase II double blind clinical trial, under U. S. FDA IND No 66505, will involve  End Stage Renal Disease (ESRD) patients who experience Intradialytic hypotension (IDH), the most common adverse event during routine hemodialysis . Meditor Ltd. will be moving forward in conducting additional clinical trials in chronic indications such as Migraine.

Meditor Ltd. has retained VCG & Associates, Inc. (VCG&A) to evaluate offers from pharmaceutical manufacturers having the potential to develop and commercialize MTR 104 in the above selected therapeutic categories.

Meditor is an Israel based pharmaceutical development company founded to develop and commercialize a class of compounds that control Nitric Oxide overproduction. The lead development compound is MTR 104. The patent portfolio of Meditor provides the company with a strong proprietary position in the U.S. and worldwide.

VCG & Associates, Inc. (VCG&A) is an independent strategic marketing organization specializing in the commercialization of pharmaceuticals, diagnostics and devices for small to medium size late stage pharmaceutical and healthcare companies.

VCG & Associates, Inc.
http://www.vcgassociates.com

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