Phase 2 Trial Will Evaluate Medical Cannabis in Treatment of Graft Versus Host Disease

Kalytera will acquire Talent Biotechs phase 2 trial of cannabidiol in graft versus host disease.

Kalytera Therapeutics Inc has entered into a binding letter of intent (LOI) to acquire Talent Biotechs Ltd, an Israeli-based developer of proprietary cannabidiol (CBD) therapeutics.

Currently, Talent is advancing a phase 2 clinical program examining the use of CBD to prevent and treat Graft versus Host Disease (GvHD), according to a press release.

GvHD is a multisystem disorder that arises following stem cell or bone barrow transplants. It occurs when transplanted donor cells recognize the transplant recipient as foreign, and attacks the patient’s organs.

Under the LOI transaction terms, Kalytera has made a non-refundable payment of $1 million to Talent. According to the release, the acquisition is subject to final due diligence by Kalytera, and other customary closing conditions.

In May 2015, results from a phase 2a clinical study investigating the use of CBD for the prevention of GvHD were published, along with promising initial results. The results of the trial showed that CBD significantly decreased the incidence of acute and chronic GvHD following transplantation compared with historical control patients.

Several additional pilot studies in the treatment of GvHD are being conducted by Talent, and 4 orphan drug designations have been granted for the prevention and treatment of GvHD in the United States and Europe, according to the release.

“We are thrilled to announce the signing of this LOI, which brings us closer to acquiring a late-stage program in GvHD with strong proof-of-concept,” said David Stefansky, co-founder of Kalytera and chairman of the Board of Directors. “There are currently few options to prevent or treat GvHD. We feel incredibly fortunate to be working towards the advancement of this important program.”

The acquisition is expected to close on or before February 15, 2017, the press release reported.

“Multiple studies have demonstrated that CBD possesses remarkable therapeutic potential across a broad range of diseases and disorders,” said Andrew Salzman, MD, CEO of Kalytera. “The proposed acquisition of Talent and its late-stage GvHD program significantly advances Kalytera’s mission of becoming a global leader in CBD pharmaceuticals. We are encouraged by Talent’s GvHD data and we are hopeful that Kalytera will be able to rapidly advance the program into placebo-controlled, double blind, randomized studies.”