SOURCE: Celsus Therapeutics

Celsus Therapeutics

April 17, 2013 08:00 ET

Celsus Therapeutics Announces Notification of Patents Granted

NEW YORK, NY and LONDON--(Marketwired - Apr 17, 2013) - Celsus Therapeutics (OTCQB: MRRBY), an emerging growth, development-stage biotech company, announced today that the United States Patent and Trademark Office (USPTO) has granted patents with claims covering Composition of Matter and Method of Treatments for clinical drug product candidates MRX-4 for the treatment of allergic rhinitis, MRX-5 for the treatment of inflammatory bowel disease, and MRX-6 for the treatment of dermatitis, and pre-clinical product candidate OPT-1 for the treatment of conjunctivitis. These therapeutic development programs are all part of Celsus' platform of multifunctional anti-inflammatory drugs (MFAIDs).

"We are pleased that the USPTO has issued the necessary patents protecting the intellectual property surrounding our clinical and pre-clinical drug candidates MRX-4, MRX-5, MRX-6, and OPT-1," commented Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics. "We are working every day to bring patients our first-in-class, multifunctional anti-inflammatory drugs for multiple, specific indications. Since November 2012, we have added an additional 4 US patents, strengthening our already outstanding intellectual property portfolio. Most recently we have received a Notice of Allowance for claims directed to 'a method of treating Crohn's disease and ulcerative colitis with MRX-5.'"

The Company has exclusive rights to 13 United States and 10 foreign issued patents; as well as 16 United States and 48 foreign patent applications, and two pending international patent applications. The Company has been issued patents in the United States directed to composition of matter claims covering its product candidates; and method of use claims covering the Company's therapeutic indications expiring between 2021 and 2024. Foreign issued patents expire between 2021 and 2026, depending on the specific product and indication. The Company's pending patent applications for composition of matter covering additional product candidates, formulations and indications, if issued, would expire in the United States and in countries outside of the United States between 2021 and 2032.

About MRX-4 -- Allergic Rhinitis
Celsus conducted a Phase II clinical trial of MRX-4 in patients with allergic rhinitis. Celsus sees this program as a gateway to addressing respiratory inflammation- including asthma and cystic fibrosis. In a double-blind, placebo controlled study, patients with AR were given twice-daily intranasal MRX-4 (2%) or placebo for 6 days, followed by an intranasal dose of allergen on the morning of the seventh day. This was followed by a clinical check-up to assess efficacy over the next 24 hours. A separate single-blind, placebo controlled intranasal steroid arm, serving as a positive control, was conducted with Rhinocort (budesonide). MRX-4 efficacy was determined by its control of six clinical symptoms associated with AR: rhinorrhea, nasal itching, sneezing, frontal headache, nasal congestion, and ear/palate itching. Patients treated with MRX-4 experienced a greater reduction in AR symptoms compared to placebo (p < 0.01). Furthermore, as observed in Phase I studies, no serious adverse effects were reported with the drug and pharmacokinetic analysis using ELISA did not detect MRX-4 in patients' serum.

About MRX-6 -- Dermatitis
In March 2011, a multi-center, randomized, vehicle (placebo) and active-controlled, dose ranging Phase II study of MRX-6 was initiated in 80 moderate to severe contact dermatitis (CD) patients. Patients were randomized to treatment for 21 days with one of three doses of MRX-6 (0.2%, 1%, & 2%), or with topical steroids. The primary efficacy outcome of the study is the difference in percentage change from baseline to day 21 in each patient's eczema area severity index (EASI) score, which measures the classic symptoms of CD, for treated versus vehicle hand or forearm. Results from approximately 30 patients in the highest dose (2%) cohort are expected in early May 2013, with the other arms reading out in H2 2013. The secondary outcome measure of the study is to evaluate the safety and tolerability of the three dose levels of MRX-6. This study was based on positive, statistically significant results from a single- center, double-blind, vehicle-controlled study of 11 patients published in 2007. This study showed a 70% reduction in physician visual assessment score for the MRX-6 treated hand or forearm compared to 36% for the vehicle treated hand or forearm (p=0.0024).

About Pre-Clinical Programs OPT-1 and MRX-5
Celsus also has other drug candidates in earlier stages of development, including OPX-1, a topical treatment for ocular inflammation, and MRX-5 for inflammatory bowel disease (IBD). OPX-1 is currently in pre-clinical testing. Potential indications for this candidate include post-operative inflammation, dry eye syndrome, and allergic conjunctivitis. MRX-5 has shown pre-clinical indications of efficacy in reducing inflammation that causes IBD in two separate IBD animal models.

About Celsus Therapeutics Plc.
Celsus Therapeutics is an emerging clinical stage company focused on the development of a new class of non-steroidal, synthetic anti-inflammatory drugs termed Multi-Functional Anti-Inflammatory Drugs or MFAIDs. Celsus's MFAIDs represent a new therapeutic platform for the treatment of a broad array of inflammatory diseases, such as allergies and autoimmune diseases. Presently, the Company has two lead drug candidates in its clinical pipeline, MRX-6, a topical cream for contact dermatitis and MRX-4, a nasal spray for treating allergic rhinitis (hay fever). Other potential treatments in preclinical development include OPX-1 for ocular inflammation, CFX-1 for cystic fibrosis, and MRX-5 for inflammatory bowel disease.

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