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The open label Phase IIa study is designed to assess the efficacy and safety of RHB-104 in Multiple Sclerosis (MS) patients. The study follows successful completion of 4 pre-clinical studies
A first Phase III clinical trial with RHB-104 for Crohn's disease (the "MAP US Study") is planned to commence by the third quarter of 2013. Recruitment of sites in the U.S., Canada and Israel is underway
TEL-AVIV, Israel, June 5, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, announced that patient screening has commenced in the Phase IIa, proof of concept, clinical study (the "CEASE-MS Study"), to assess the efficacy and safety of fixed dose combination RHB-104, a patent protected combination therapy of three antibiotics in a single capsule, as an add-on therapy to interferon beta-1a in patients treated for Relapsing Remitting Multiple Sclerosis ("RRMS").
The phase IIa CEASE-MS Study follows the successful completion of four pre-clinical studies with RHB-104.
Sixteen patients with RRMS are expected to participate in the open label Phase IIa CEASE-MS Study, which will be conducted at two medical centers in Israel. The study is designed to assess the efficacy and safety of RHB-104 in RRMS patients after 24 weeks of treatment, with the primary endpoint being the number of combined unique active lesions after treatment as compared to baseline. Patients will be followed-up for an additional term of 24 weeks after completing treatment with RHB-104. Secondary endpoints will include changes in pro-inflammatory cytokine markers,
Mycobacterium avium subsp. paratuberculosis (MAP) status, relapse rate, Expanded Disability Status Scale (EDSS) and safety and tolerability of RHB-104.
"We are very pleased that this important Phase IIa Multiple Sclerosis study is now underway,"
said Clara Fehrmann, RedHill's RHB-104 MS Product Manager. "There is an increasing awareness in the medical community to the possibility that a bacterial induced dysregulated immune system plays a critical role in the pathogenesis of MS. It is RedHill's hope that the CEASE-MS Study will demonstrate RHB-104's potential to become an effective treatment option for patients with MS."
Dr. Radi Shahien of Ziv Medical Center, Principal Investigator of the CEASE-MS Study added: "The MAP bacterium has been identified as a pathogen that may contribute to the development of MS. The CEASE-MS Study with RHB-104 aims to test this new hypothesis to the etiology of MS. RHB-104 has the potential to improve the lives of people with MS, and I am excited to be leading this important study."
Multiple Sclerosis is an inflammatory, demyelinating, and neurodegenerative disease of the central nervous system of uncertain etiology that exhibits characteristics of both infectious and autoimmune pathology. RHB-104 is a multifaceted drug that in addition to bactericidal properties against intracellular infections, has potentially distinct mechanisms of action that include both anti-inflammation and neuroprotection. The worldwide sales of MS therapies are estimated to have exceeded $14 billion USD in 2012
RHB-104 is also being evaluated for the treatment of Crohn's disease. The Company is planning to commence a first Phase III clinical trial (named "MAP US Study") for this indication by the third quarter of 2013, with recruitment of sites in the U.S., Canada and Israel underway.