Tolarex wins Israeli approval to initiate Phase I/IIa GVHD study

Tolarex, a Hadasit Bio Holdings portfolio company, has received approval from the Ministry of Health of Israel to begin a Phase I/IIa clinical trial of its treatment for graft-versus-host disease.

Hadasit Bio Holdings said that the first in man trial, anticipated to begin shortly, will evaluate the safety and preliminary possible efficacy of Tolarex’s therapy. A total of 12 patients will be enrolled at two medical centers in Israel, Hadassah University Hospital in Ein Kerem included.

The therapies that currently exist to treat graft-versus-host disease (GVHD) are based on immunological suppression or the weakening of a patient’s immune system, have low efficiency, can cause severe side effects and expose the patient to various risks of infection, according to Hadasit Bio Holdings.

Tolarex’s technology, conversely, is based rather on inducing immune tolerance, whereby the implanted immune system is not weakened but instead encouraged to refrain from attacking the patient’s body, which in turn can more readily accept the new immune system, the company said.

Assuming positive results from the trial, Tolarex has plans to explore other potential applications of its treatment within the autoimmune and inflammatory disease market, including solid organ transplant and stent implantations.

Alon Moran, CEO of Tolarex, said: The green light from Israel’s Ministry of Health signifies the maturity of the technology and its readiness to transfer to the clinical stage. We are also hopeful that today’s news will advance negotiations towards joint development or commercialization of the technology with potential partners.