Pluristem to enroll participants for GvHD treatment at Sourasky
"We have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD."
By JERUSALEM POST STAFFTHE SOURASKY Medical Center in Tel Aviv 370(photo credit: Wikipedia)
Israeli biotech company Pluristem received clearance to move forward with Cohort II enrollment for its investigator-led Phase I/II study for the treatment of steroid-refractory chronic graft vs. host disease (GvHD).The study is being led by principal investigator Prof. Ron Ram, director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital.GvHD is a severe complication that can arise in those who have had allogeneic hematopoietic cell transplantation (HCT), where the donated cells attack the new host body after identifying it as foreign. The chronic form of this condition (cGvHD) often appears after 100 days following the transplant.The Pluristem study seeks to investigate whether injecting PLX-PAD cells could serve as an effective treatment. These tests are showing progress, with interim results for Cohort I (six patients with two injections of 150 million cells) concluding that PLX-PAD cells were safe, with no side effects reported. As such, the study can now enroll 14 patients in Cohort II who will be given four injections of 150 million cells.“From our experience in having treated six patients in the study to date, we have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD," Ram said in a statement."Patients with significant GvHD skin disorders previously unresponsive to multiple types of therapy showed remarkable response," he said. "Responses were also observed for severe mouth ulcers which prevented patients from eating solid foods. This resulted in a major improvement of quality of life and the tapering of steroid doses."“Pluristem is committed to contributing to the well-being and quality of life of our patients," stated CEO and president Yaky Yanay."cGvHD is an indication where we see a significant need to enhance the current course of treatment for this life-threatening condition among patients undergoing bone marrow transplants," he said."The preliminary results from Cohort I of this Phase I/II study, and prior preclinical data, both indicate that PLX-PAD cells may potentially treat cGvHD patients and mitigate symptoms. We are very pleased to cooperate with Prof. Ram and Sourasky Medical Center, and we place high importance in examining PLX-PAD for this indication.”
