Cytori Therapeutics, Inc. (CYTX) provided preliminary data from a study evaluating a potential treatment for scleroderma based on the company’s cell therapy. The investigator-funded, open-label, pilot study is being conducted on patients with cutaneous systemic scleroderma in France.
12 patients were administered Cytori’s cell therapy, injected into their fingers. Safety and hand function improvement are the primary endpoints of the study which were measured by the Cochin hand functional scale at six months.
At the end of the two month follow-up period, no infection, ischemic complications or serious adverse events were observed. Moreover, there was a significant improvement in the Cochin hand function disability scale.
As far as secondary endpoints are concerned, there was a significant improvement in scleroderma health assessment questionnaire score and in Raynaud’s Severity Score. Also, there was a significant improvement in hand pain when measured by the visual analog pain scale.
Cytori is focused primarily on the development of treatments for cardiovascular disease and soft tissue injuries and burns based on its proprietary cell therapy formulation. The company’s cell therapy is based on the formulation of stem and regenerative cells derived from a patient’s own adipose (fat) tissue (ADRCs). The company has also designed the Celution System, a tissue processing system, to access the cells from a patient during the surgery procedure.
We note that last month Cytori’s Celution System gained approval from the Australian regulatory body for commercial use for autologous re-implantation or re-infusion of a patient’s ADRCs.
The company is currently conducting Athena, a multi-center, double-blind, randomized and placebo-controlled study for evaluating its cell therapy in 45 patients with chronic ischemic heart failure. The company expects to complete patient enrollment in the fourth quarter of this year. 6-month top-line data from the study is expected in the first half of next year.
Cytori carries a Zacks Rank #4 (Sell). Companies that currently look well-positioned include Gilead Sciences Inc. (GILD) and Actelion Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy), and Jazz Pharmaceuticals (JAZZ) with a Zacks Rank #2 (Buy).