Pluristem in Key Discussions With Europe’s Adaptive Pathways Group on Phase II Protocol
Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, recently announced it has conducted detailed discussions with the European Adaptive Pathways Discussion Group regarding the clinical development plan for PLX cells in Critical Limb Ischemia (CLI) patients, and received guidance on the planned design of the initial Phase II trial of PLX cells in a subgroup of patients with severe CLI. Positive results from this trial could be sufficient for conditional approval to market PLX cells in this indication. Pluristem is receiving this in-depth guidance from European regulatory officials following the selection of this clinical program for the European Medicine Agency’s Adaptive Pathways project in May 2015.
In the discussions Pluristem also presented other indications for potential development through the Adaptive Pathways project; these were ischemic stroke, muscle wasting, hip fracture, and additional subgroups of CLI.
The Adaptive Pathways project is part of the European Medicine Agency’s (EMA) efforts to improve timely access for patients to new therapies. It targets treatments with the potential to heal serious conditions with an unmet medical need, and may reduce the time to a medicine’s approval or to its reimbursement for targeted patient groups.
“We are very pleased with the invaluable guidance we are receiving from EMA regulatory officials as we design our clinical trial protocol in a subgroup of CLI with particularly high unmet medical need,” said Pluristem CEO Zami Aberman. “As we previously announced, we plan to apply to expand our program in CLI to include additional subgroups of the disease for development via the Adaptive Pathways, and expect to apply for consideration of other important indications with large potential markets. We are also benefiting from high-level guidance on these initiatives. Development of indications via the Pathways project could potentially provide patients earlier access to our therapies, while creating value to our shareholders by shortening time to market. In parallel, we continue to advance our clinical development programs for PLX cells in the US.”
The purpose of Europe’s Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways Discussion Group provides detailed guidance to the applicant regarding the formal regulatory processes that precede a trial targeting early approval and further expansion of the indications.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team. For more information, visit www.pluristem.com.
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