Kalytera Therapeutics, Inc. last week announced that it had successfully completed the acquisition of Talent Biotechs Ltd., strengthening Kalytera’s position as an emerging market leader in cannabidiol (CBD) pharmaceuticals. CBD is considered to have a wide scope of potential medical applications, based on clinical reports showing the lack of side effects, particularly a lack of psychoactivity, and non-interference with several psychomotor learning and psychological functions.
Talent Biotechs is a privately held, Israeli-based company evaluating the use of CBD to prevent and treat Graft versus Host Disease (GVHD).
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. This treatment has limited effectiveness, and causes 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.
Talent Biotechs, using the invention of Dr. Moshe Yeshurun, Director of Bone Marrow Transplantation Department, Davidoff Center, Rabin Medical Center, Beilinson Hospital, near Tel Aviv, is working on the use of Cannabidiol for the prevention and treatment of GVHD.
CBD 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. A preliminary study in over 25 patients showed that administration of Cannabidiol to transplanted patients has reduced significantly the incidence and severity of acute and chronic GVHD after allogeneic stem cell transplantation.
“We feel incredibly fortunate to be continuing Talent’s groundbreaking work in GVHD,” said Andrew Salzman, M.D., Kalytera’s Chief Executive Officer. “There are currently few options to prevent or treat persons with GVHD, a large and critically underserved market. The results of Talent’s Phase 2 clinical studies are unprecedented, and mark a major milestone in the potential prevention and treatment of this severe and life-threatening disease. We are encouraged by the data and seek to rapidly advance the GVHD program into FDA Phase 2b clinical studies.”
“This is a transformational transaction for Kalytera,” said Robert Farrell, President, COO, and CFO of Kalytera. “Multiple studies have demonstrated that CBD, a non-psychoactive cannabis constituent, possesses remarkable therapeutic potential across a broad range of diseases and disorders. The acquisition of Talent and its late-stage GVHD program significantly advances Kalytera’s position as an emerging leader in CBD pharmaceuticals. We expect our work in GVHD to be the first of many programs that seek to investigate and commercialize this important compound.”