Kalytera Therapeutics

  • Category: Pharma
  • Investment Status: IPO
  • Medical Field: Oncology
  • Patent Status: 2 patents granted in the USA, pending in Europe and Israel
  • Development Status: Four clinical trials have been completed. Commencing 2 phase 2b trials in prevention and treatment of GVHD
  • Medical Center: Davidoff Center, Rabin Medical Center, Beilinson Hospital
  • Inventors: Dr. Moshe Yeshurun, Director of Bone Marrow Transplantation Department, Beilinson

Background: Graft-versus-host disease (GVHD) is a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The new, transplanted cells regard the recipient’s body as foreign and when this happens, these cells attack the recipient’s body. Mortality rates as a direct or indirect consequence of GVHD are up to 50% despite the prophylactic use of immunosuppressive drugs which are administered for prevention of GVHD. Conventional treatment of chronic GVHD requires prolonged periods of systemic immunosuppressive therapy with potent drugs such as corticosteroids and cyclosporine. Agents such as mycophenolate mofetil, rapamycin (sirolimus), imatinib and rituximab are used in patients with steroid-refractory chronic GVHD. All these treatments have limited effectiveness, and cause severe adverse effects with high morbidity and mortality due to infections. Thus, alternative approaches to the prevention and management of chronic GVHD are urgently needed.

Technology: We propose the use of Cannabidiol for the prevention and treatment of GVHD. Cannabidiol constitutes up to 40% of Cannabis sativa extracts, and is recognized as a major non-psychoactive cannabinoid, with a remarkable lack of any cognitive and psychoactive actions. CBD has potent anti-inflammatory and immunosuppressive effects. CBD has been shown to inhibit cancer cell growth and to reduce anxiety and nausea. We have completed four clinical studies in Israel in over 80 patients showing that administration of Cannabidiol to transplanted patients has reduced significantly the incidence and severity of acute and chronic GVHD after allogeneic stem cell transplantation.

Market: Over 25,000 allogeneic transplants are performed worldwide each year. GVHD is one of the main causes of death after allogeneic bone marrow transplants, which is responsible for the deaths of 5-15% transplanted. Cannabidiol can be administered to every patient undergoing allogeneic transplantation in order to prevent GVHD or for the treatment of acute or chronic GVHD.