- The stock price of Pluristem Therapeutics Inc. (NASDAQ: PSTI) increased from $4.52 to over $4.90 pre-market. This is why it happened.
The stock price of Pluristem Therapeutics Inc. (NASDAQ: PSTI) – a leading regenerative medicine company – increased from $4.52 to over $4.90 pre-market. Investors are responding positively to the company reporting positive topline results in its first study to evaluate the safety and exploratory efficacy of PLX-R18 in humans. And the company’s Phase I, open-label, dose-escalation study is evaluating the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).
Poor graft function is known as a life-threatening complication for patients undergoing HCT. Current standard-of-care treatments do not develop satisfactory blood counts in some or all blood cell lineages. And consequently, patients are vulnerable to bleeding and recurrent infections and require repeated costly transfusions of blood products – which only provide a short-term effect. Pluristem’s PLX-R18 is aiming to improve the standard of care by stimulating the regenerative potential of the bone marrow. This potentially enhances the production of all 3 blood cell lineages, differentiating it from other products which target only one of the three blood cell lineages.
The study enrolled 21 patients in the U.S. and Israel – who were at least three months after the HCT procedure (median: 236 days) and had low blood counts in at least one blood cell lineage. And they were assigned to one of three treatment arms: 1 million cells/kg, 2 million cells/kg, or 4 million cells/kg. Each patient received two treatments of the assigned dose.
The results had demonstrated that PLX-R18 has the potential to stimulate the implanted hematopoietic cells to realize their therapeutic potential and generate improved blood counts over the long term in all 3 blood cell lineages at once – a meaningful advantage over other existing and proposed treatments.
Available data at 6-month follow-up demonstrates:
— PLX-R18 was well-tolerated with a favorable safety profile.
— Statistically significant improvement from baseline counts was observed in all cohorts for hemoglobin and platelet counts (p<0.05). And the patients in the high dose arm (4 million cells/kg) exhibited statistically significant improvements in all three blood cells lineages (p<0.01).
— About 60% of patients exhibited improvements in all three blood cell lineages: hemoglobin, neutrophil and platelet counts, that are above the initial criteria for inclusion in the study.
— 13 patients were transfusion dependent at baseline. 6 of those became transfusion independent at six-month follow up. No patients who were transfusion independent at baseline became transfusion dependent.
“The promising topline results demonstrate insight into how PLX cells may provide a more effective therapeutic benefit than current technologies. We believe that PLX-R18 affects the regeneration activity of the hematopoietic cells. By supporting blood cell lineage’s recovery, this approach could be used to address a variety of hematological deficiencies. We intend to push forward the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field.”
— Pluristem CEO and President, Yaky Yanay
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