September 22, 2015 9:40am

CLBS will advance “this” program without creating burden on its balance sheet. The Sanford Project will provide and cover the costs of two initial clinical performance sites. Sanford will support the trial by providing funding as well as operational resources to execute subject recruitment, enrollment, treatment and monitoring along with corresponding support services. PCT will provide CLBS03 for the study.  CLBS closed at $1.88 and opened DOWN -$0.09 or -4.79% to $1.79. Not a healthy response  - HOLD


 

CLBS has entered into a collaboration agreement with Sanford Research ("Sanford") to develop the CLBS' T regulatory cell therapy product candidate CLBS03 for the treatment of adolescents with recent-onset type 1 diabetes (T1D).

 

  • The initial focus of the collaboration will be the execution of a prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate the safety and efficacy of CLBS03 in adolescents;
  • The P2 study (The Sanford Project Trutina Study) has an open and active IND and subject enrollment is expected to commence as early as the first quarter of 2016;
  • The Sanford Project Trutina Study has a planned enrollment of 111 subjects across approximately 12-15 US sites. Subjects will be randomized to placebo or one of two active arms receiving either 10 or 20 million cells/kg;
  • The primary endpoint of the trial is preservation of C-peptide (a measure of the preservation of beta-cell function) in comparison to placebo.

 

The Bottom Line: Another P2 will take time to "actualize" with the results on “what” time lie for results. Add this trial to a LONG list of those trying to treat Type 1!