Pluristem reports positive results from phase I
- New therapy has the potential to generate improved blood counts in all three blood cell lines, a significant advantage over existing treatments
- Company to conduct analyst and investor call on May 3, 2021 at 10 a.m. EDT
HAIFA, Israel, April 29, 2021 (GLOBE NEWSWIRE) – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading regenerative medicine company, today reported positive results in its first study to assess the safety and exploratory efficacy of PLX-R18 in humans. The company’s open-label phase I dose escalation study evaluates the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery after hematopoietic cell transplantation (HCT).
Pluristem CEO and President Yaky Yanay said, “The promising first-rate results demonstrate how PLX cells can provide a more effective therapeutic benefit than current technologies. We believe that PLX-R18 affects the regenerative activity of hematopoietic cells. By supporting the recovering blood of the cell line, this approach could be used to treat a variety of hematological impairments. We intend to advance the clinical development of PLX-R18 with the aim of establishing it. as the new standard of care in the field. “
Poor graft function is a life-threatening complication for patients undergoing HCT. Current standard treatments do not make it possible to develop a satisfactory blood count in some or all of the blood cell lines. Therefore, patients are vulnerable to recurrent bleeding and infections and require repeated and expensive transfusions of blood products, which only produce a short-term effect. Pluristem’s PLX-R18 aims to improve the level of care by stimulating the potential for bone marrow regeneration. This potentially enhances the production of all three blood cell lines, differentiating it from other products that only target one of the three blood cell lines.
The study recruited 21 patients in the United States 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 line. 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.
Results demonstrate that PLX-R18 has the potential to stimulate implanted hematopoietic cells to realize their therapeutic potential and generate long-term improved blood counts in all three blood cell lines at once – a significant advantage over other existing treatments. and proposed.
Data available1 at six-month follow-up demonstrates:
- PLX-R18 was well tolerated with a favorable safety profile.
- A statistically significant improvement over baseline counts was observed in all cohorts for hemoglobin and platelet counts (p
- About 60% of patients showed improvements in all three blood cell lines: hemoglobin, neutrophils and platelet counts, which are above the initial criteria for inclusion in the study.
- 13 patients were dependent on the transfusion at baseline. Six of them became independent from transfusion after six months of follow-up. No patient who was initially transfusion independent became transfusion dependent.
The study supports previous preclinical findings, conducted via the United States Food and Drug Administration (FDA) Animal Rule in conjunction with the United States National Institutes of Health (NIH), in which PLX-R18 s’ has been shown to be effective in the treatment of bone marrow failure due to acute radiation syndrome (ARS).
PLX-R18 is the first product candidate manufactured using Pluristem’s proprietary serum-free media on its 3D bioreactor system.
The company will conduct an analyst and investor call on May 3, 2021, 10 a.m. EDT, for registration: https://Veidan.activetrail.biz/pluristem
1 Six-month follow-up data are available for 14 of the 21 patients treated: one patient was discontinued prematurely, three patients missed the 6-month visit, and three died before the 6-month visit (two fatal events in the 2 million cells, and a fatal event in the dose of 4 million cells). All fatal study events were considered unrelated to study treatment. Mortality rates were consistent with publicly available information (references: Gao et al 2020, Halahleh et al 2021, Tang et al 2018, Sun et al 2015, Zhao et al 2019)
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 cellular PLX product candidates and is currently conducting advanced stage clinical trials in multiple indications. The PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, muscle trauma, hematologic disorders, and radiation damage. Cells are grown using the company’s proprietary three-dimensional expansion technology and can be delivered to patients commercially, without tissue matching. Pluristem has a strong position in intellectual property; a GMP certified manufacturing and research facility owned and operated by the Company; strategic relations with the main research institutes; and a seasoned management team.
Safe Harbor Declaration
This press release contains forward-looking statements express or implied in the Private Securities Litigation Reform Act of 1995 and other US federal securities laws. For example, Pluristem uses forward-looking statements when discussing that PLX cells can provide a more effective therapeutic benefit than current technologies, that PLX-R18 can potentially enhance the production of three blood cell lines, the belief that PLX -R18 affects the regenerative activity of hematopoietic cells and its intention to advance the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field. These forward-looking statements and their implications are based on the current expectations of Pluristem’s management only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in the launch and / or success of its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses, and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with the Pluristem process; Pluristem’s products may end up being more expensive than expected; laboratory results may not translate to equally good results in actual clinical settings; the results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be enough; Pluristem’s products may harm recipients; changes in legislation may have a negative impact on Pluristem; the inability to develop and introduce new technologies, products and applications in a timely manner; loss of market share and price pressure resulting from competition, which could cause Pluristem’s actual results or performance to differ materially from those contemplated in these forward-looking statements. Unless otherwise provided by law, Pluristem assumes no obligation to publicly publish any revision of these forward-looking statements to reflect events or circumstances subsequent to the date hereof or to reflect the occurrence of unforeseen events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Director of Investor Relations