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Morria Biopharmaceuticals Plc Announces the Initiation of a Phase II Clinical Multi-dose Study of MRX-4 in Allergic Rhinitis
Date:6/24/2008

LONDON, June 24 /PRNewswire/ -- Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on the development of novel anti-inflammatory drugs, today announced that it has initiated a Phase II equivalent study of MRX-4, in a nasal aerosol formulation, in 105 patients suffering from allergic rhinitis (AR). The two-arm, randomized, multi-dose, double-blind, placebo-controlled study includes Rhinocort(R) as the steroid comparator arm. The study is expected to be completed by the end of Q3 2008.

The study is designed to evaluate the safety, tolerability, and efficacy of intranasal MRX-4 in AR patients outside of the local allergy season as compared with both placebo and an intranasal steroid. An experimental multi-functional anti-inflammatory drug (MFAID), MRX-4 is a non-steroidal potential treatment for AR that has generated promising pre-clinical efficacy data. In a Phase I equivalent trial completed in Israel earlier this year, it was shown to be well tolerated with no clinical significant adverse effects.

"We are excited about the opportunity to evaluate the safety and efficacy of MRX-4 in a multi-dose trial for treating allergic rhinitis," said Mark Cohen, chairman of the board of Morria. "MRX-4 could provide unique, non-steroidal, first-choice drug treatment for allergic rhinitis."

According to Dr. Yuval Cohen, Morria's president, it is rare for a first-in-man efficacy study in AR (phase II) to include a steroid comparator arm. "Most companies prefer waiting until they have generated substantial clinical efficacy data comparing their drug to a placebo before venturing to compare it to a standard market treatment, such as a nasal corticosteroid. Our decision to include the steroid comparator arm so early in our clinical development is a combination of our confidence in MRX-4's performance as well as the creativity of our clinical team in streamlining and maximizing the efficacy of our clinical development program. We believe that
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SOURCE Morria Biopharmaceuticals Plc
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2. Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients
3. Morria Biopharmaceuticals Plc Announces Regulatory Approval to Commence Phase II Clinical Study of MRX-4 in Allergic Rhinitis
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