Pluristem Therapeutics (NASDAQ:PSTI) reported final results from a phase 1 trial of intramuscular injections of PLX-R18 in patients with incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).
The company said incomplete hematopoietic recovery, or poor graft function (PGF), is a life-threatening complication for patients undergoing HCT. Current standard-of-care does not result in satisfactory blood counts and patients are vulnerable to bleeding and recurrent infections, and require repeated transfusions of blood.
Data collected one year post-treatment with PLX-R18 showed that the therapy was well-tolerated with a favorable safety profile.
Patients treated with PLX-R18 showed an increase in all three blood cell types compared to baseline with platelets, hemoglobin and neutrophils levels increasing as early as 1 month after PLX-R18 administration and enduring up to 12 months.
The company said that following PLX-R18 therapy, the number of transfused units decreased from a mean monthly number of 5.09 for platelets and 2.91 for red blood cells at baseline to 0.55 for platelets and 0 for red blood cells at 12 months.
The company noted that observed annual mortality rate after PLX-R18 therapy was 18% compared to 29% in a cohort of allogeneic HCT recipients with incomplete hematopoietic recovery, obtained from a registry, representing a similar patient population.