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Pluristem To Present Initial Results From Its Phase I HCT Study With PLX-R18 Demonstrating Safety And Efficacy At ASH Annual Meeting

PLX-R18 demonstrated significant clinical improvements in Hb, ANC, and PLT among the high-dose cohort PLX-R18 was found to be safe and well-tolerated Topline results from

· 11/18/2020 07:06
  • PLX-R18 demonstrated significant clinical improvements in Hb, ANC, and PLT among the high-dose cohort
  • PLX-R1was found to be safe and well-tolerated
  • Topline results from the full Phase I clinical trial expected in Q1 2021 (n=21)
     

HAIFA, Israel, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today reported the first clinical results for PLX-R18 in humans from its Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). The initial results consisted of the analysis of the first 19 patients enrolled, and not all patients completed a one year follow up.

The initial data from the Phase I trial demonstrated:

  • The treatment with PLX-R18 was found to be safe and well-tolerated.
  • An overall improvement was observed in most patients, with the high-dose cohort showing clinically meaningful improvements from baseline to 9-month in hemoglobin (Hb); absolute neutrophil count (ANC) a measure of white blood cells; and platelet count (PLT). In this cohort, Hb levels increased from 9.29±0.5 to 13.19±1.2 (p=0.0019), ANC increased from 1.09±0.6 to 5.13±1.7 (p=0.018) and PLT increased from 45.7±10 to 175.9±28 (p=0.000012).

Incomplete hematopoietic recovery poses a significant life-threatening condition to HCT recipients who fail to respond to standard of care treatments, making them vulnerable to infections and bleeding. PLX-R18 may address the unmet need in this patient population by stimulating the regenerative potential of bone marrow where other treatments have proven ineffective. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PLX-R18 in this indication.

presentation titled "Safety and Demonstrated Efficacy of Placenta-Derived Cell Therapy PLX-R18 in Subjects with Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation: A Phase I International Multi-Center Study" will be held by Mr. Hillard M. Lazarus, MD, FACP, Professor of Medicine, Case Western Reserve University, and Member of the study's Steering Committee at the virtual 62nd ASH Annual Meeting and Exposition on December 5, 2020.

Prof Hillard M. Lazarus commented on the results, "The use of Pluristem's PLX-R18 product candidate in a group of patients who had extremely low blood counts resulted in actual clinical improvement with a significant rise in critical blood counts."

Pluristem CEO and President Yaky Yanay stated, "These first PLX-R18 data in humans support our expectations that our PLX platform can yield multiple regenerative therapeutics. This significant milestone adds to a pivotal year ahead with four readouts in Critical Limb Ischemia (CLI), muscle regeneration following hip fracture, COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS), and HCT evaluating both our PLX-PAD and PLX-R18 product candidates. We are committed to developing solutions for unmet medical needs based on our expertise attained over a decade and supported by our advanced platform technology and in-house manufacturing capabilities."

The ASH Annual Meeting is the world's most comprehensive hematology event of the year featuring scientific abstracts highlighting updates on the most critical topics in hematology. With more than 18,000 members from nearly 100 countries, ASH is the world's largest professional society serving both clinicians and scientists around the world who are working to conquer blood diseases.