Shares of nano-cap stem cell therapy company Cellect Biotechnology Ltd – ADR (NASDAQ: APOP) were advancing strongly Monday.
Why Cellect Bio Is Rallying
The Tel Aviv, Israel-based company announced the publication in the peer-reviewed medical journal Bone Marrow Transplantation of an article entitled "Ex-vivo FAS-ligand to Improve Allograft Safety," which highlighted pre-clinical research findings that engraftment is robust following transplantation of treated graft.
The graft retained its immune reconstitution and anti-leukemic effects, the company said.
Cellect said it has initiated a Phase 1/2 study in adults undergoing stem cell transplant for the treatment of hematological malignancies. The primary endpoint is the overall incidence, frequency, and severity of adverse events potentially related to ApoGraft at 180 days after transplant.
ApoGraft is a technology developed by Cellect to produce stem cells through a simple, safe and relatively inexpensive process that will help prevent graft vs. host disease.
To date, there have not been any safety and tolerability concerns in patients transplanted using the ApoGradt process, and patient enrollment is continuing, the company said.
"Both, the principal investigator (PI) and independent data safety monitoring board (DSMB) agree that no serious adverse events (SAEs) reported during the course of the study were related to the ApoGraft process," according to Cellect.
Cellect said the data from pre-clinical research published in the paper was included in the IND application approved by the FDA in late 2019.
What's Next For Cellect
With all necessary approvals for initiating the trial and its academic partner Washington University now secured, the company said it plans patient enrollment once the COVID-19 pandemic mitigates and clinics can resume normal practices.
Cellect shares were rallying 78.9% to $4.24 at the time of publication Monday.