Kalytera Therapeutics,
Inc. announced that it has acquired Talent Biotechs Ltd., a privately
held Israeli company that develops Cannabidiol (CBD) based therapies for
diseases with high unmet medical needs. Talent is currently evaluating
the use of CBD to prevent and treat Graft versus Host Disease (“GvHD”),
a life-threatening condition that can occur following stem cell or bone
marrow transplants.
“We feel incredibly fortunate to be continuing Talent’s groundbreaking work in GvHD,” said Kalytera Chief Executive Officer Andrew Salzman, M.D., speaking in Tel Aviv in February.
“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.”
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.”
GvHD is an orphan disease that can arise following hematopoietic stem cell transplantation (“HCT”), a procedure where the stem cells of the bone marrow or peripheral blood of a healthy donor are transplanted into a new host after chemotherapy or radiation. HCT is a lifesaving procedure for many diseases of the blood and bone marrow including leukemia, Hodgkin and Non-Hodgkin lymphoma, multiple myeloma, sickle cell anemia, and thalassemia. While HCT procedures can be lifesaving, they pose many dangerous side effects, including infection and GvHD. GvHD is a major cause of illness and death following HCT.
CBD is a major component of Cannabis sativa, commonly known as marijuana. CBD possesses potent anti-inflammatory and immunosuppressive properties. Unlike the other major component of cannabis, tetrahydrocannabinol (“THC”), CBD is non-psychoactive and is well tolerated by humans when taken over extended periods of time. CBD has shown benefit in many types of inflammatory diseases including diabetes, rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease.
Kalytera now plans to initiate placebo-controlled, double blind, randomized studies of CBD for both the prevention and treatment of GvHD. These clinical studies may support U.S. Food and Drug Administration (“FDA”) Breakthrough Therapy and Fast Track Designations, which could accelerate the regulatory approval process.
Saltzman will be a featured speaker at the upcoming CannaTech conference in Tel Aviv, Israel, March 20-22, 2017. Dr. Raphael Meshchloum, the world renown pioneer in the field of cannabis research is co-chair of Kalytera’s Scientific Advisory Board.
“We feel incredibly fortunate to be continuing Talent’s groundbreaking work in GvHD,” said Kalytera Chief Executive Officer Andrew Salzman, M.D., speaking in Tel Aviv in February.
“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.”
Product is critical to some surgeries
“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.”
GvHD is an orphan disease that can arise following hematopoietic stem cell transplantation (“HCT”), a procedure where the stem cells of the bone marrow or peripheral blood of a healthy donor are transplanted into a new host after chemotherapy or radiation. HCT is a lifesaving procedure for many diseases of the blood and bone marrow including leukemia, Hodgkin and Non-Hodgkin lymphoma, multiple myeloma, sickle cell anemia, and thalassemia. While HCT procedures can be lifesaving, they pose many dangerous side effects, including infection and GvHD. GvHD is a major cause of illness and death following HCT.
CBD is a major component of Cannabis sativa, commonly known as marijuana. CBD possesses potent anti-inflammatory and immunosuppressive properties. Unlike the other major component of cannabis, tetrahydrocannabinol (“THC”), CBD is non-psychoactive and is well tolerated by humans when taken over extended periods of time. CBD has shown benefit in many types of inflammatory diseases including diabetes, rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease.
Completion of latest trials boosts company’s value
Talent the 2016 CannaTech summit pitch event winner, has completed its two clinical trials at the Rabin Medical Center in Tel Aviv, Israel, which explored the use of CBD in the treatment of GvHD to extremely promising results. To date, Kalytera has made cash payments to Talent totaling $10,000,000.Kalytera now plans to initiate placebo-controlled, double blind, randomized studies of CBD for both the prevention and treatment of GvHD. These clinical studies may support U.S. Food and Drug Administration (“FDA”) Breakthrough Therapy and Fast Track Designations, which could accelerate the regulatory approval process.
Saltzman will be a featured speaker at the upcoming CannaTech conference in Tel Aviv, Israel, March 20-22, 2017. Dr. Raphael Meshchloum, the world renown pioneer in the field of cannabis research is co-chair of Kalytera’s Scientific Advisory Board.
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