Cytori slides after hours on trial halt

Cytori Therapeutics Inc. (NASDAQ:CYTX; Xetra:XMPA) fell $0.52 (25%) to $1.58 in early after-hours trading on Tuesday after halting enrollment in the U.S. Phase II ATHENA and ATHENA II trials evaluating its adipose-derived stem and regenerative cells (ADRCs). Cytori said it decided to halt the trials after observing cerebrovascular events in three patients, but added that symptoms were "fully resolved" in two patients with the third experiencing "substantial resolution." The company said the events might be related to "medical co-morbidities in the treated population" as cerebrovascular events were not observed in prior trials. The double-blind, placebo-controlled trials each sought to enroll 45 heart failure patients with ischemic heart disease who are already receiving maximal therapy with no options for revascularization.

Cytori, which previously expected to complete enrollment in ATHENA by year end, will provide a new timeline once it agrees to protocol revisions with FDA, investigators and its data monitoring committee. The company's ADRCs are processed by the Celution One System, a device used to process and purify adult stem and regenerative cells from adipose tissue. ...