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Kalytera Therapeutics Announces Encouraging Results of a Phase 2a Clinical Study for the Treatment of Acute Graft versus Host Disease
Kalytera Therapeutics Announces Encouraging Results of a Phase 2a Clinical Study for the Treatment of Acute Graft versus Host Disease.
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[{"type":"text","content":"\n\n VANCOUVER, British Columbia, Feb. 22, 2017 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSXV:KALY) (“Kalytera”) is pleased to announce encouraging results from a Phase 2a study evaluating the safety and efficacy of cannabidiol (“CBD”), a primary constituent of the marijuana plant, for the treatment of acute (Grade 3-4) Graft versus Host Disease (“GvHD”).\n In the present study, ten patients with acute (Grade 3-4) GvHD that was refractory to standard treatment with high-dose steroids, were administered daily doses of CBD for up to three months. Nine of the ten patients enrolled in the study responded to treatment; seven achieved complete remission, and two achieved a near-complete response. Six patients are still alive with a median follow-up period of 13 months (range 5-30 months). Two patients (one with Grade 3 GvHD and one with Grade 4 GvHD) died from leukemia relapse, and two patients (one with Grade 3 GvHD and one with Grade 4 GvHD) died from GvHD-related infectious complications. No patient deaths were determined to be associated with CBD treatment.  Historical control data gathered at the same clinical site, the Rabin Medical Center, in Petah Tikva, Israel, examined 305 patients who underwent allogeneic hematopoietic cell transplantation without CBD therapy between May 2007 and December 2016. Of these 305 patients, 32 developed acute (Grade 3-4) GvHD. Among 12 patients with Grade 3 GvHD, three patients responded to first-line high-dose steroids and are alive, six patients died within four months from GvHD and its complications, one patient died after 12 months from a second malignancy, and two patients who were refractory to steroids are still alive (one patient after more than two years and one patient at three months). Among 20 patients with Grade 4 GvHD, all died within four months from GvHD and its complications. In the present study, among ten patients with steroid-refractory acute (Grade 3-4) GvHD, 90% achieved either complete remission (“CR”) or a near-complete response with CBD. Two patients died from GvHD and its complications (one patient with Grade 4 GvHD who achieved CR with CBD, but had a GvHD flare-up upon uninformed cessation of CBD; another patient with Grade 3 GvHD had to stop CBD after four days of treatment following a severe infection, thus e...