April 27, 2016 8:32am
Star is a P$ FDA approved pivotal study investigating the efficacy and safety of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with impaired hand function from scleroderma
CYTX’s U.S. FDA approved P3 STAR trial has enrolled and treated its 60th patient (75% of target enrollment).
In addition, as per the trial protocol, an independent data monitoring committee has reviewed safety data from the initial 40 patients and recommended that the study continue as planned. The 60 procedures, including the fat harvest from small volume liposuction and the finger injections have all been completed successfully without complications.
The Bottom Line: The completion of enrollment will occur by mid-June. Then what …?
CYTX closed UP +$0.01 to $0.34 on 4.66 M shares <3 moth average = 1.733 m shares.
Cytori in January 2016 entered into an agreement with Idis to establish a Managed Access Program (MAP) for its cellular therapeutic in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. Managed Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available. The source of medicine funding varies and may include the hospital’s budget or country’s sickness fund or social security system.