Graft Versus Host Disease (GvHD) is a potentially lethal complication of hematopoietic cell transplantation (HCT) from a donor. When a patient receives a donor’s stem cells, the transplanted cells may identify the patient’s body as foreign and attack it. The chronic form of GvHD occurs at least 100 days following the transplantation. The GvHD market is predicted to exceed $500 million by 2023.
Preclinical studies showed that Pluristem’s PLX-PAD cell product potentially mitigates symptoms of cGvHD, and in addition the secretion profile and mechanism of action properties suggest that it may be a novel and effective treatment for the condition. Pluristem hopes to address this severe unmet medical need and help patients lead full lives after undergoing a transplant.
Clinical Development of PLX-PAD in cGvHD
A Phase I/II Study in cGvHD is Ongoing in Israel (N=20)
- Primary endpoint- To assess the safety and tolerability of PLX-PAD cell treatment in steroid-refractory or steroid-intolerance patients suffering from moderate-severe chronic GVHD
- Secondary endpoints –To assess the impact of PLX-PAD cell treatment on the quality of life; Relapse incidence; Overall survival rate
- Dosing regimen: 150 million cells injected intramuscularly (IM) on days 1 and 8 (group A), or injected on days 1, 8, 22 and 36 (group B)
- Follow-up period of 36 months
The study is conducted by Tel Aviv Sourasky Medical Center (Ichilov Hospital) in Israel. This is an investigator initiated study, meaning that Tel Aviv Sourasky Medical Center will support the study and is responsible for its design and implementation.
In October 2020, the Company reported clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II.