Previously, graft-versus-host disease was a main concern in receiving bone marrow transplants for cancer patients. The disease develops when the immune system of the grafted bone marrow causes an attack against the recipient’s organs, including primarily the liver, intestines, and skin. Estimates claim that as many as 70 percent of patients develop graft verses host disease, which can be fatal if it reaches high grades, upon receiving bone marrow transplants. However, Envilex, which is held (92%) by Hadasit Bio (TASE: HDST, OTC:HADSY) developed the ApoCell treatment in the hopes of changing this.
The ApoCell treatment essentially triggers a response from the immune system to reduce adverse reactions during bone marrow transplants. Professor Dror Mevorach of the Hadassah Ein Kerem Medical Center proclaimed, “Removal of dying cells is a major mechanism used by our body in order to stop an inflammatory process. We are simply using it in a very specific and meaningful window of opportunity.” Enlivex has recently completed a clinical trial of the ApoCell treatment. The results indicate that it is safe for patients going through bone marrow transplants to use.
In the clinical trial, 13 patients in 3 clinical centers in Israel were given 4 doses of ApoCell in order to prevent Graft-versus-Host Disease. An external independent safety committee that monitored the results of the trial as it progressed resolved that no safety concerns were observed in any of the doses. In a comparison made between the ApoCell treated patient group and a matched historical control group composed of relevant patients with similar characteristics and treatment background, it was found that the occurrence of GvHD grades 2-4, the most dangerous levels of the disease, was reduced by half. Furthermore, among the groups that received the higher doses of ApoCell, no cases of GvHD grades 2-4 were observed Vs. 50% of a matched historical control group. Thus, Enlivex hopes that in the future GVHD will be one less thing cancer patients need to worry about.
As Alon Moran, CEO of Enlivex proclaimed: “We are very pleased with the final results of the trial which point to efficacy and safety of our treatment. ApoCell has the potential to allow the performance of an allogeneic bone marrow transplant while reducing the serious damage inflicted by GvHD. […] Moreover, the trial shows substantial signs for the efficacy of the treatment, expressed by reduced levels of high grade GvHD incidence. We believe that the trial results show real potential for dealing with this serious illness.”
He added, “To date there is no treatment, but assuming these results are repeated in a larger study, we will have a treatment that, on one hand allows the Graft-Vs-Leukemia effect (the graft fighting the cancer), and, on the other hand, allows for reducing GvHD’s destructive and potentially fatal effect so that ApoCell can act as an important component in the success of the bone marrow transplant procedure.”