Cytori Therapeutics, Inc. to Expand Scleroderma Focus to Broader Hand Therapy Franchise Under the Habeo Cell Therapy Brand
January 10, 2017 at 02:30 pm
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Cytori Therapeutics, Inc. as part of its corporate update at the Biotech Showcase, announced its intention to broaden its investigation of the ECCS-50 formulation of Cytori Cell Therapy® to include secondary Raynaud’s phenomenon (RP) beyond scleroderma, a problem that affects over one million patients worldwide. Habeo Cell Therapy (formerly ECCS-50) is the new brand name of Cytori Therapeutics’ hand therapy franchise. In addition to its substantial contribution to the disease burden of scleroderma, RP is a source of significant morbidity in several more common autoimmune and inflammatory conditions including rheumatoid arthritis, systemic lupus erythematosus (lupus), and Sjogren’s syndrome. Broadening of clinical interest to secondary RP in other autoimmune and inflammatory diseases is based in large part on 36-month follow-up data from the investigator-initiated, 12-patient, open-label SCLERADEC I trial, which reported a 90% reduction in the Raynaud’s Condition Score, a clinically validated scale for determining the degree of difficulty experienced by patients with RP. Earlier limited published data has also reported improvement in vascular architecture, hand color, and other direct and indirect indicators of vascular function. Cytori’s internal preclinical data provide further support for a potential role of Habeo Cell Therapy in the stabilization of the vascular endothelium, an important contributor to the vascular dysfunction found in patients with RP. RP is a key secondary endpoint in the STAR clinical trial, Cytori’s randomized, double-blind, placebo-controlled Phase 3 clinical trial in patients with scleroderma. Cytori anticipates unblinding of the trial data in mid-2017. The combination of the anticipated US-based STAR data with clinical data from the completed SCLERADEC I pilot trial, anticipated clinical data from the ongoing SCLERADEC II trial in Europe, the accumulated preclinical data, patient advocacy awareness, extensive market analysis, and Cytori’s intellectual property position provide compelling support for continued research, development and commercial planning of Habeo Cell Therapy in Secondary RP.
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