~ Trial continues according to protocol with one dose ~
Amsterdam, The Netherlands, December 21, 2016, – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces an update on the second dose Phase II trial with ATIR101™ (CR-AIR-008). The Company will continue its CR-AIR-008 trial, treating patients with a single dose of ATIR101™ according to the recommendation of the Independent Data Monitoring Committee (IDMC) and according to the clinical protocol.
In this ongoing exploratory Phase II trial the safety and efficacy of a second dose of ATIR101™ is being tested in patients to investigate product flexibility in administering a further dose of ATIR101™ should it be needed by physicians. Fifteen patients have been recruited into the trial to date of which ten have received one or two doses of ATIR101™ after their haploidentical stem cell transplantation (HSCT). All ten patients received a first dose of the same efficacious level as the patients in the Company’s other trials, and, as in the other trials with a single dose of ATIR101™, no patient suffered from grade III/IV Graft-versus-Host-Disease (GVHD) upon infusion of the first dose. Subsequently, six of the ten patients received a second dose of ATIR101™. Following this second infusion, some of the six patients subsequently suffered from various grades of GVHD, including grade III/IV GVHD.
After consultation with the IDMC, the IDMC recommended to proceed according to the predefined safety measure set out in the trial protocol, which is to continue with the trial, dosing patients with one dose of ATIR101™ at the efficacious level but not to provide a second dose of ATIR101™. Patient safety is paramount to the Company, hence it fully supports this recommendation and will continue to enroll and treat patients until 15 patients have received at least a single dose of ATIR101™.
In the meantime, preparations for the Company’s Phase III trial with ATIR101™ (CR-AIR-009) are moving rapidly ahead, the trial having been submitted to regulatory authorities where it is currently under review for approval.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “Physicians who are familiar with ATIR101™ were interested to see us explore the potential flexibility of ATIR101™ in a small second dose protocol trial and this was the reason for this specific protocol design. As also reconfirmed by the first results of this second dose trial, ATIR101™ remains safe as a single dose regimen and the treatment of patients with ATIR101™ has shown very impressive safety and efficacy results as presented at ASH only two weeks ago. As previously communicated in August this year, our randomized, controlled, international Phase III trial will be conducted with a single dose of ATIR101™ to most closely mimic the set up, dose levels and dosing schemes as previously used in the Company’s CR-AIR-007 Phase II single dose trial, and to minimize Phase III study risks by not changing design vis-à-vis a Phase II trial. Conceptually, we still believe that a second dose of ATIR101™ might add benefit with even further improved relapse prophylaxis and infection control beyond the already demonstrated significant benefit of a single dose. Therefore, once the CR-AIR-008 trial is complete and all data have been fully evaluated, we will assess the dose level and timing of a second dose of ATIR101™ for possible future development.”