Top line efficacy results expected Q1 2021

HAIFA, Israel, Aug. 19, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today it has completed patient enrollment in its Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT), in the U.S. and in Israel.

Incomplete hematopoietic recovery poses a significant risk 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.

The Phase I multi-center, open-label, 3 cohort dose-escalating study is evaluating the safety of intramuscular (IM) injections of PLX-R18 cells in 20 subjects, with incomplete hematopoietic recovery persisting for at least 3 months after HCT. The follow up period is 12 months. Safety is the primary endpoint, with efficacy endpoints including changes in white blood cells, platelets counts, hemoglobin levels, changes in blood products requirements, and changes in quality of life. As previously reported, Pluristem expects to announce top line efficacy results during the first quarter of calendar year 2021.

"We are glad to meet an additional important clinical milestone that keeps us on track for our expected time to readout, and is one of four data readouts we expect to announce in the coming twelve months. We look forward to seeing data that may position PLX-R18 as an important drug candidate for hematological disorders. We would like to thank the medical teams across the clinical sites supporting our program in the most professional and caring way," stated Pluristem CEO and President, Yaky Yanay.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.