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news.Japanese pharmaceutical firm REGiMMUNE has started patient enrollment in a Phase II trial of its proprietary compound RGI-2001 for the treatment of Graft versus Host Disease (GvHD) associated with hematopoietic stem cell transplantation.
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The randomized, open-label, multicenter Phase II trial is being carried out in patients undergoing allogeneic hematopoietic stem cell transplantation (AHSCT).
It is being conducted in six US cancer centers which include the Fred Hutchinson Cancer Research Center, Stanford University Medical Center, the Ohio State University Medical Center, University of California, San Diego, Massachusetts General Hospital/Harvard University and University of Miami Sylvester Comprehensive Cancer Center.
The study was started after the completion of a Phase I trial in patients with bone marrow or peripheral blood stem cell transplantation leukemia patients following chemotherapy.
REGiMMUNE president and chief executive officer Haru Morita said," Our proprietary immune-regulating technology is initially being tested in the clinic with RGI-2001 to demonstrate its potential as an effective treatment to prevent graft rejection, without the risks associated with current therapies."
The company’s goal is to develop new products focused on therapeutic areas that can be addressed with immune-regulating technology including type 1 diabetes, celiac disease, and inhibitor formation in enzyme replacement therapies (ERT) such as hemophilia and lysosomal diseases.
The Phase II trial is the expansion of the company’s Phase I dose-escalation trial designed to evaluate the safety, tolerability and pharmacokinetic profile of the drug candidate in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment.