Pluristem Therapeutics Inc.
(NasdaqCM: PSTI) (DAX: PJT) today reported that data from clinical trials show the Company’s placenta-derived cell therapy,
, is safe and improves quality of life as well as other efficacy measurements in patients with Critical Limb Ischemia (CLI), the end-stage of Peripheral Artery Disease (PAD).
CLI Patients and Doctors Involved in Trials Share Their Stories on Video;
The three-month follow-up data involved 21 patients afflicted with CLI in two open-label, dose-escalation, Phase I clinical trials conducted at Duke University Medical Center, Stanford University Medical Center, the Center for Therapeutic Angiogenesis in Birmingham, Alabama and St. Franziskus Hospital, supported by the Charité - University Medicine Berlin. The results of these clinical trials have enabled Pluristem to select the target treatment dose of PLX-PAD for additional studies focused on the cell therapy’s efficacy. Pluristem has communicated with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) concerning the design of an optimal multinational study that will support an approval for marketing PLX-PAD for the treatment of CLI.
The two Phase I studies were designed to evaluate the safety of PLX-PAD cells and included accessing the patient’s immunological profile before and after the local administration of PLX-PAD. In addition, efficacy parameters were assessed and five different doses of PLX-PAD were evaluated. These studies were performed in parallel in the EU and USA and represent the first time that Pluristem’s PLX-PAD cells were administered to humans. PLX-PAD cells are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source.
Results included the findings that PLX-PAD cells can be administered safely as an “off-the-shelf” product without a need for matching between donor and patient. Additionally, efficacy was demonstrated across all doses with a statistically significant improvement noted in the pain score and quality of life. The intermediate dose also showed a statistically significant improvement in the Ankle Brachial Index (ABI), a measure of blood flow.