June 28, 2016 8:59am

CYTX closed at $2.00 and is UP +$0.15 in the pre-market, it will “wither”

 

The past objective of the ATHENA program was assessment of safety and feasibility of Cytori Cell Therapy using the Celution® System for automated on-site manufacturing of the cellular therapeutic and intramyocardial delivery for treatment of chronic ischemic heart disease with left heart failure.

 

The ATHENA trials are two prospective, randomized (2:1, active: placebo), double-blind, controlled, parallel group trials (ATHENA and ATHENA II) each assessing Cytori® Cell Therapy™ [ATHENA: 40 million cells, 28 patients; ATHENA II: 80 million cells, 3 patients].

On the treatment day, patients underwent fat harvest via small volume lipoharvest followed by cell processing, electromechanical mapping of the left ventricle with subsequent injection of cells (or placebo) into viable myocardium intramyocardial.

 

The Bottom Line: Thirty-one patients (17 Cytori Cell Therapy, 14 placebo) were randomized prior to termination of enrollment, with 28 patients having 6 month or longer follow-up data. Trial enrollment was terminated prior to the planned target (45 patients per trial) due to the prolonged period of enrollment and safety reviews. ATHENA and ATHENA II trial data were combined for analyses.

Regarding safety, 18 of 31 patients (58.1%) were reported to have at least one serious adverse event during the trial (Cytori Cell Therapy 9/17 (52.9%), placebo 9/14 (64.3%)). Major Adverse Cardiovascular Events (MACE) occurred in 6/17 (35.3%) of ADRC patients and 3/14 (21.4%) of placebo patients. Two fatal events were reported during the trial with both occurring in the Cytori Cell Therapy group (myocardial ischemia – day 2 post-procedure, decompensation of heart failure – day 291 post-procedure).

The key results were:

  • Improvements in the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
  • The SF-36 (a validated questionnaire for generic health related quality of life) results showed trends
  • At 12 months, New York Heart Association class improved in 57% of ADRC-treated patients compared to 15% of placebo patients.
  • Echocardiogram and treadmill testing was performed at baseline and 6 months post-treatment showed no relevant differences between groups.
  • Heart failure hospitalizations were reported in 3/17 (17.6%) and 5/14 (35.7%) of cell treated and placebo treated groups respectively. Central adjudication of these events showed the respective numbers to be 2/17  (11.7%) and 3/14 (21.4%).

 

The trials were stopped for cost reasons ... and platform refocus, so what now with data?