Focused on clinical cell therapies
After raising over $25m through equity/warrant financings and extending the debt maturity, Cytori Therapeutics Inc (NASDAQ:CYTX) can focus on its late-stage R&D programmes. Its ADRC therapy clinical trials in scleroderma and knee osteoarthritis aim to show that the implantation of patient-derived cells can improve functional outcomes.
Pivotal ADRC scleroderma trial to begin shortly
Cytori's pivotal 48-week Phase III STAR trial, scheduled to start in mid-2015, will assess its cell therapy (ECCS-50) in up to 80 patients with impaired hand function from scleroderma. This study follows a Phase I/II pilot trial whereby treatment showed a 50% improvement at six months across four validated endpoints. Scleroderma affects about 50,000 US people. As no disease-modifying treatment has been approved, patients are often treated with immuno-suppressants carrying notable side effects. Cytori intends to independently commercialise its product in the US given its familiarity with many US scleroderma treatment centres.
Phase II knee osteoarthritis study underway
A 90-patient US Phase II study (ACT-OA) in knee osteoarthritis with ECCO-50 started in February 2015; data due in H116. The placebo-controlled trial will measure several pain and knee status measures at 48 weeks after a single treatment within two dose ranges. As one-third of adults over 65 years have osteoarthritis, the market potential is large and we expect Cytori to seek a partner if data are positive.
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