Participants in the trial ("An Open-Label Phase 1 Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of Adults With Steroid-Resistant Acute Graft Versus Host
Disease") must be adults who have undergone an allogeneic hematopoietic stem cell transplant (HSCT) to treat a hematological (blood) disorder and have subsequently been diagnosed with steroid -resistant Grade II-IV GvHD.
The MHC influences acute graft versus host
disease in MHC matched adults undergoing allogeneic bone marrow transplantation.
The company plans to conduct the Phase one clinical trial, which is entitled 'An Open-Label Phase 1 Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of Adults With Steroid-Resistant Acute Graft Versus Host
Disease', at a number of clinical centres in the UK and Australia.
Acute graft versus host
disease following liver transplantation: the enemy within.
The primary endpoints include acute graft versus host
disease (aGVHD) during the first 100 days and safety (defined as SAEs and AEs related to study treatment during six months post-transplant).
Mallinckrodt will have an exclusive period of up to nine months to conclude commercial and development agreements for two of Mesoblast's Tier 1 product candidates, MPC-06-ID in the treatment or prevention of moderate/severe chronic low back pain due to disc degeneration and MSC-100-IV in the treatment of acute graft versus host
disease, in all territories outside of Japan and China.
November 14, 2016 -- Mesoblast Limited (MESO) announced that the Phase 3 trial of its intravenous product candidate MSC-100-IV used as front-line therapy in children with steroid-resistant acute graft versus host
disease (aGVHD) had been successful in a pre-specified interim futility analysis.
Columbia, MD, announced that while preliminary results for two Phase III trials evaluating Prochymal for the treatment of acute graft versus host
disease (GvHD) showed significant improvements in response rates in difficult-to-treat liver and gastrointestinal GvHD, neither trial reached its primary endpoint.
Fungal infection and acute graft versus host
disease were suspected.
The study will also evaluate the safety and tolerability of BL-8040 in healthy donors, as well as graft durability, the incidence of grade 2-4 acute graft versus host
disease (GvHD), and other recipient related parameters in patients who have undergone transplantation of hematopoietic cells mobilized with BL-8040.