- Company steps up its clinical platform with pipeline of three late-stage clinical indications
- All late-stage programs are supported and funded by 3rd parties with over $19 million in non-dilutive funding awarded to PLX programs
- PLX-R18 advances towards pivotal trial in Acute Radiation Syndrome (ARS) with the NIH and with U.S. Department of Defense
- Multinational pivotal phase III CLI trial actively enrolling patients, phase III study in hip fracture to follow
Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, today reported financial results and corporate developments for its fourth quarter and fiscal year ended June 30, 2017.
“Fiscal 2017 has marked a significant advancement in our clinical development pipeline,” stated Pluristem Chairman and Co-CEO Zami Aberman. “We have completed patient enrollment in our Phase II Trial of PLX-PAD in Intermittent Claudication (IC) and expect clinical data from this study in the first half of 2018. We are currently in Phase III trials, with an ongoing pivotal Phase III study in Critical Limb Ischemia (CLI), and another Phase III planned for hip fracture. Our pipeline has been awarded non-dilutive funding of over $19 million, which we believe will cover significant portion of the costs of these studies. Our PLX-R18 development has had significant progress and is heading towards a pivotal trial as a countermeasure for Acute Radiation Syndrome (ARS) as the U.S. National Institutes of Health (NIH) concludes a successful Phase II equivalent animal dosing study, enabling the selection of optimal dosage for the Pivotal study. The NIH’s promising results have led to an additional agreement with the U.S. Department of Defense (DOD) to evaluate PLX-R18 based on the scope needed for the U.S. armed forces, thereby broadening PLX-R18’s potential to protect troops and civilians before and after a nuclear incident.”
Pluristem Co-CEO and President Yaky Yanay commented, “Looking ahead to fiscal 2018, we look forward to meeting our enrollment target for our Phase III CLI trial, which may put us in a position to apply for conditional marketing approval of PLX-PAD for the treatment of CLI in Europe through the Adaptive Pathways project. We intend to continue our work with U.S. agencies on PLX-R18, including the NIH and DOD, towards approval that would qualify PLX-R18 for stockpiling. Pluristem has worked diligently throughout the fiscal year to bring the benefits of cell therapies closer to the patients and healthcare systems that need them.”
Clinical and Corporate Highlights Include:
PLX-R18 Advances Towards Pivotal Trial in Treatment of ARS; Investigated by the NIH and DOD as ARS Antidote Both Before and After Radiation Exposure- During fiscal 2017, the U.S. NIH released data from a successful large animal study that evaluated PLX-R18 as an antidote for ARS when administered 24 hours after exposure to radiation. Study results showed that all three doses of PLX-R18 demonstrated improved survival rates compared to placebo. The PLX-R18-treated groups also showed better and faster recovery of blood lineages, a major component of recovery after radiation-induced damage to bone marrow. Safety data showed that PLX-R18 cells can be safely administered without determining an individual’s level of exposure to radiation and without any matching or blood tests, offering a significant and time-critical advantage when treating a mass casualty disaster.
In August 2017, we announced that the U.S. DOD will examine whether PLX-R18 administered prior to, or within the first 24 hours of, exposure to radiation will mitigate ARS. The DOD studies will be conducted in parallel with the NIH studies, allowing for a broader understanding of the potential therapeutic effects of PLX-R18 as a novel medical countermeasure for ARS. This announcement enjoyed broad media coverage, including features in media outlets such as CNN, I24 News and more.
Additional Regulatory Approvals for Pivotal Phase III CLI Trial; Actively Enrolling Patients with Goal of 40 Active Sites Worldwide by the End of 2017– Pluristem’s multinational Phase III study of PLX-PAD cells in the treatment of CLI is currently enrolling in the U.S., U.K., Germany and Austria. An interim efficacy analysis is planned based on data from the first 125 patients. Positive results are expected to lead to early conditional marketing approval in Europe via the Adaptive Pathways project. Following completion of the study, data from all 250 patients will be submitted to the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA) for full marketing approval.
Total of $19 million in Non-Dilutive Funding Awarded to PLX Programs- Pluristem’s planned Phase III study to support recovery following surgery for hip fracture was awarded an $8.7 million non-dilutive grant from the European Union’s Horizon 2020 program. Previously, Horizon 2020 awarded $8 million for Pluristem’s Phase III study in the treatment of CLI. The two grants are expected to cover a significant portion of the costs of these Phase III studies.