Kiadis Pharma BV, a clinical stage biopharmaceutical company developing treatments for blood cancers, has received the No Objection Letter from Health Canada for its new clinical study with ATIR. This study will be a phase II international multi-centre study with clinical sites in Canada and Belgium.
Up to 23 patients will be treated in this study to corroborate and extend the safety and efficacy results from Kiadis Pharma's previous phase I/II clinical study with ATIR. The coordinating investigator for the study will be Denis-Claude Roy, MD, professor of medicine at the University of Montreal. ATIR is a cell-based product designed to enable stem cell transplantations from mismatched (haploidentical) family donors.
“We are very happy that after having received approval from the Research Ethics Board of the Maisonneuve-Rosemont Hospital, we have now also gained approval from Health Canada and can commence with our new clinical study in Canada,” commented Manfred Ruediger, PhD, chief executive officer of Kiadis Pharma. “This study will be an important step forward in developing ATIR as an innovative therapeutic option for severely diseased blood cancer patients. Today, many of these patients die because a matched stem cell donor cannot be found.”
Dr Denis-Claude Roy added, “We are excited that we can start this phase II clinical study with ATIR in which we will treat blood cancer patients for whom a matched donor is not available for a standard transplantation procedure. This study provides these patients with the opportunity to receive a stem cell transplantation from a family member with ATIR added as an adjunctive treatment to provide rapid and potent immune protection and minimize post-transplant risks.”
ATIR is a cell based medicinal product candidate enabling stem cell transplantations from mismatched (haploidentical) family donors to patients suffering from blood cancer. Stem cell transplantation is the only potentially curative option for many patients but a matched donor is available for only half of the patients in need. ATIR thus has the potential to address this unmet need and to make stem cell transplantations available for patients worldwide.
Those T-cells in a haploidentical graft which would cause Graft-versus-Host-Disease (GvHD) are selectively eliminated using proprietary technology to produce ATIR. ATIR is administered as an adjunctive treatment on top of a haploidentical stem cell transplantation enhancing early immune reconstitution without causing GvHD.
In a phase I/II study with ATIR, safety and proof of concept were provided in terms of absence of grade III/IV GvHD, reduced rates of infection, reduced Transplant Related Mortality and high Overall Survival.
ATIR has been granted Orphan Drug Designation both in the EU and the USA. Together, both regions represent a combined primary market potential of more than EUR 1 billion per year.
Kiadis Pharma B.V. is a clinical stage biopharmaceutical company developing innovative and potentially life-saving therapies for patients with late stage blood cancers and related disorders, an area of significant unmet medical need.