Kalytera Therapeutics, a clinical-stage biopharmaceutical company developing next-generation cannabinoid- derived therapeutics, has developed the multicenter location component of the plan for the proposed clinical trials to evaluate cannabidiol (CBD) for the prevention and treatment of Graft versus Host Disease (GvHD). Kalytera is developing this clinical trial plan with the intent of obtaining FDA and EMEA approval for commercialization.
Kalytera expects to finalize and publish the details of its clinical trial plan during the current quarter ending June 30, 2017. The plan will include the clinical trial designs, the anticipated timeline for initiation and completion, as well as the principal endpoints. The trials are intended to build on the encouraging data seen in the recently completed phase IIa clinical trial.
The European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting brings together thought leaders from Europe and the world to explore the latest allogenic hematopoietic stem cell transplantation (HCT) and cellular therapy research. Having met and conferred with many of the leading authorities at EBMT, Dr. Andrew L. Salzman, Kalytera’s chief executive officer, and Dr. Sari Prutchi Sagiv, Kalytera’s vice president of Scientific Operations, have developed a multi-center site plan for Kalytera’s planned clinical trials.
“Kalytera’s recent groundbreaking clinical trial with CBD as a treatment for GvHD generated a great deal of excitement at EBMT,” said Salzman. “The EBMT annual meeting brings together the world’s leading authorities in HCT, a lifesaving procedure for a number of diseases. HCT patients will benefit tremendously if the risk of GvHD can be substantially reduced.
“Based on the encouraging results from our Phase 2a studies, we believe that CBD has the potential to help patients with GvHD who routinely fail first-line therapy with steroids. Kalytera intends to undertake additional clinical studies in an effort to obtain regulatory approval to use CBD for the treatment and prevention of GvHD. Under Dr. Sagiv’s direction, we are working to complete our next, major clinical trial plan. We look forward to publishing the details of that plan this quarter.”