Cytori Therapeutics will expand the development of its ECCS-50 scleroderma treatment to include secondary Raynaud’s phenomenon (RP), under the brand Habeo Cell Therapy.
Habeo means “to hold” in Latin and represents Cytori’s belief that this therapy will become available in the future to treat hand dysfunction associated with scleroderma.
Raynaud’s phenomenon is a blood vessel disease that exists in two forms, primary and secondary. Primary RP is the most common form and is characterized by the narrowing of blood vessels in the hands and feet for a period of time, triggered by cold temperatures or stress, causing a decreased blood supply to these regions and leading to local cell death. These blood vessel abnormalities also exist in secondary RP, but are usually accompanied by autoimmune diseases.
“Pilot trial data suggest that our ECCS-50 cellular therapeutic may help to address secondary RP symptoms and other autoimmune and inflammatory conditions of the hand,” said Marc Hedrick, Cytori’s president and CEO, in a news release. “Our plan is to leverage published and ongoing preclinical and clinical data to expand our investigation of ECCS-50 to a much larger patient population with secondary RP under the new Habeo brand name.”
Interest in broadening the investigation of ECCS-50 to secondary RP is based on the results of the SCLERADEC I trial (NCT01813279), which investigated the safety of subcutaneous injection of autologous adipose-derived stromal vascular fraction (ECCS-50) into the fingers of 12 patients with hand dysfunction associated with scleroderma.
Results showed that patients treated with a single dose of ECCS-50 showed a significant improvement in hand function and in RP symptoms (90 percent reduction in the Raynaud’s Condition Score, a measure of disease severity).
A recent analysis showed that this improvement was sustained at three years after the injection, as measured by four parameters: the Cochin Hand Function Score, scleroderma-related disability and pain, and Raynaud’s Condition Score. Also, 83 percent of the patients had no symptoms of Raynaud’s in the weeks prior to each follow-up assessment, and maintained their improvement in hand strength and mobility scores since baseline.
Cytori’s internal data also supports the theory that Habeo Cell Therapy may stabilize the vascular endothelium (cells lining the blood vessels), thereby decreasing blood vessel anomalies leading to RP.
Raynaud’s symptoms are under investigation in two other Cytori’s cell therapy studies, the SCLERADEC II (NCT02558543) and the STAR trials (NCT02396238). The SCLERADEC II trial involves 40 patients with hand dysfunction due to scleroderma and is currently ongoing at three sites in France. Results are expected in mid-2017, when patient enrollment and treatment will be complete.
The STAR clinical trial is a Phase 3, FDA-approved placebo-controlled study currently ongoing in the U.S., involving 88 patients also with hand dysfunction associated with scleroderma. Results are also expected to be released in mid-2017.
Cytori believes that the combination of the results provided by the different trials, preclinical data, patient advocacy awareness and market analysis will support the development and commercial planning of Habeo Cell Therapy for patients with secondary Raynaud’s phenomenon.