MONTRÉAL, December 11, 2020 – ExCellThera Inc., a clinical-stage molecular medicine company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today that ECT-001 Cell Therapy has been granted PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) for use in urgent allogeneic haematopoietic stem cell transplants.
The PRIME designation provides a mechanism for accelerated assessment of medicines that target an unmet clinical need. PRIME is focused on improving clinical trial designs to speed market authorization, so that patients can have access to new and life-saving treatments as early as possible. This designation was granted to ECT-001 Cell Therapy based on promising results from several Phase I/II clinical trials for severe blood disorders.
“We are very pleased that the EMA has granted PRIME designation to ECT-001 Cell Therapy,” said Dr. Guy Sauvageau, CEO and founder of ExCellThera. “The data ExCellThera is collecting from the clinical trials shows that ECT-001 Cell Therapy vastly reduces the incidence of severe complications and improves outcomes for patients who require blood stem cell transplants, and we are looking forward to working with the EMA to initiate further studies and bring this curative therapy to more patients as quickly as possible.”
The ECT-001 technology, comprised of the UM171 small molecule and an optimized culture system, is used in novel curative blood transplant therapies for patients with blood cancers and disorders. ECT-001 Cell Therapy has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designation from the U.S. Food and Drug Administration as well as orphan medicinal product designation and advanced therapy medicinal product (ATMP) classification from the European Medicines Agency.
About ExCellThera Inc.
ExCellThera is a clinical-stage cell and molecular medicine company delivering molecules and bioengineering solutions to expand stem and immune cells for use in novel one-time curative therapies for patients with hematologic malignancies and other diseases. ExCellThera’s most advanced technology, ECT-001 Cell Therapy, combines a proprietary small molecule, UM171, and an optimized culture system. In pursuit of better treatments for patients, the company is building out its portfolio of products, as well as supporting best-in-class clinical trials. excellthera.com