ExCellThera announces results of clinical trial using ECT-001 for blood cancers
Posted on December 4th, 2018
MONTREAL, December 4, 2018 – ExCellThera Inc., a biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, today announced results from the Phase I/II clinical trial using its lead technology, ECT-001, for allogeneic stem cell transplant. The results of the study were presented at the 2018 American Society of Hematology (ASH) Annual Meeting in San Diego and demonstrated conclusively that blood cells expanded for seven days with ECT-001 are effective at providing substantial clinical benefits when compared to standard of care for bone marrow transplants.
“These results further validate our lead technology, ECT-001, which is also being used in an ongoing clinical trial for multiple myeloma and will be used in two new phase II studies scheduled to begin in Q1 2019,” said Dr. Guy Sauvageau, CEO and founder of ExCellThera. “The data presented at ASH shows that rapid engraftment of stem and immune cells expanded with ECT-001 can favorably compete – and improve upon – the current standard of care.”
The presentation detailed results from 21 patients with high-risk hematologic malignancies and multiple comorbidities engrafted with blood cells expanded with ECT-001 as part of a Phase I/II multicentre trial. The study showed that a 7-day ECT 001 expanded single cord blood unit provided substantial clinical benefits, including faster engraftment, fewer infectious complications, better HLA matching and very low treatment-related mortality, all the while saving production and hospitalization time and costs. Furthermore, a very low rate of significant chronic graft-versus-host disease (GvHD) was observed and patients’ overall quality of life, as measured by GvHD and relapse free survival (GRFS), is excellent.
With a median follow up of 14 months, there has been no moderate-severe chronic GvHD, and despite a median comorbidity index of 2 and some very high-risk patients, there has been only one (1) treatment-related mortality and only three (3) cases of relapse. At 12 months, overall survival, progression-free survival and GRFS were excellent at 95%, 77% and 67%, respectively. Immunosuppressive therapy was discontinued at 12 months in 76% of patients.
Dr. Sauvageau also commented that “These results indicate that ECT-001 expanded single cord transplants combine the advantages of conventional grafts using bone marrow (low chronic GvHD), peripheral blood (low treatment-related mortality) and cord blood (accessibility, low relapse and chronic GvHD) in a single, low cost, easy to produce 7-day culture product, which could lead to a paradigm shift in bone marrow transplantation.”
The ECT-001 technology is a combination of a small molecule, UM171, and an optimized culture system. The technology, capable of expanding the number of stem and immune cells exponentially in as little as seven days, is used in novel curative cord blood transplant therapies for patients with blood cancers, allowing more rapid engraftment, greatly reduced incidence of transplant-related mortality, low risk of chronic graft-versus-host disease and low risk of relapse, resulting in better outcomes for patients.
About ExCellThera Inc.
ExCellThera is a clinical stage biotechnology 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, autoimmune and other diseases. ExCellThera’s lead solution 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. www.excellthera.com