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PubMed | Sarah Cannon Center for Blood Cancer, Fred Hutchinson Cancer Research Center, University of Miami, Stanford University and 7 more.
Type: | Journal: Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation | Year: 2017

Regulatory T (Treg) cells play a central role in immune tolerance and prevention of aberrant immune responses. Several studies have suggested that the risk of GVHD after allogeneic hematopoietic cell transplantation (HCT) can be ameliorated by increasing Tregs. We have developed an approach of in vivo expansion of Tregs with RGI-2001, a novel liposomal formulation of a synthetic derivative of alpha-galactosylceramide, a naturally occurring ligand that binds to CD1 and activates and expands invariant natural killer cells. In preclinical studies, a single intravenous infusion of RGI-2001 expanded Treg and could ameliorate GVHD in a mouse model of allogeneic HCT. To explore the role of RGI-2001 in clinical HCT, we initiated a Phase IIa clinical trial (n=29), testing two different doses of RGI-2001 administered as a single infusion on day 0 of allogeneic HCT. RGI-2001 was well tolerated and without infusion reactions or cytokine release syndrome. A subset of patients (8/29, 28%) responded to RGI-2001 by inducing a markedly increased number of cells with a Treg phenotype. The Treg had a high Ki-67 index and were almost exclusively Helios


Naylor S.,D2D Inc. | Naylor S.,MaiHealth Inc | Cole T.,D2D Inc. | Cole T.,Triad Group
Drug Discovery World | Year: 2010

There is an emerging consensus that the development of Companion Diagnostics appears to offer a set of tools as well as the portent of relevant biological and clinical information that addresses many of the current problems that pharmaceutical companies must overcome. This in concert with the advent of personalised medicine and the demise of the therapeutic drug 'Blockbuster Model' has necessitated a re-evaluation of the pharmaceutical business model. The outcome of such considerations will be determined, in part, by the changing landscape, and influence of the various stakeholders associated with the pharmaceutical sector, including patients/consumers, physicians and healthcare providers, payors and Companion Diagnostic companies. In this paper we describe the difference in perceived value that each key stakeholder holds in regards to the pharmaceutical drug versus the Companion Diagnostic test. We also discuss the perspectives of both the pharmaceutical and Companion Diagnostic companies as they struggle to find appropriate business models. Such models must serve their individual company needs in terms of product value as well as support the very necessary collaborative efforts required to co-develop a therapeutic drug in conjunction with a Companion Diagnostic.


Naylor S.,D2D Inc. | Cole T.,D2D Inc.
Drug Discovery World | Year: 2010

Current escalating costs of drug discovery, development and drug launch continue to concern the pharmaceutical sector. This has been compounded by the advent of personalised medicine and its associated demands for individualised products as well as the demise of the 'blockbuster' model. In order to satisfy the demands afforded by this new paradigm, the next generation of drugs has to be safer and more efficacious and pharmaceutical companies must produce more genotype and/or phenotype-focused therapeutic agents. The development of Companion Diagnostics appears to offer a set of tools as well as the portent of relevant biological and clinical information that addresses many of the problems that the pharmaceutical companies must overcome. Here, we describe the current state of Companion Diagnostics and its impact on the pharmaceutical sector. We discuss the need for Companion Diagnostics in the drug discovery and development process. This perspective is augmented by a consideration of the development of Companion Diagnostics as well as a listing of the major companies providing tools, technologies, markers and services in this rapidly growing area.

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