Vertex obtains Fast Track Designation for VX-880 therapy from U.S. FDA
Category: #health  By Pankaj Singh  Date: 2021-03-12
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Vertex obtains Fast Track Designation for VX-880 therapy from U.S. FDA

Vertex Pharmaceuticals Incorporated has recently gained the Fast Track Designation from the U.S. FDA for the investigational allogeneic islet cell therapy derived from human cells, VX-880. In addition, the company has started the clinical trial of this therapy among patients with type-1 diabetes as well as with impaired hypoglycemic awareness & severe hypoglycemia.

VX-880 is capable of restoring the ability of the human body to regulate the glucose levels by restoring insulin production and other pancreatic islet cell functions. The clinical study of this therapy will involve the infusion of functional, fully-differentiated islet cells and the chronic administration of the concomitant immunosuppressive therapy for safeguarding islet cells from immune rejection.

According to Vertex’s EVP and Chief of Cell & Genetic Therapies, Bastiano Sanna, Ph.D., the VX-880 program was started at Dr. Doug Melton’s lab, which later made progress at Semma Therapeutics. The accelerated program was recently brought back to the clinic by the Vertex team. The company is thrilled to have received the FDA’s Fast Track Designation to facilitate the development and expedite the review of the therapy to cater to high unmet medical needs.

Camillo Ricordi, M.D., the VX-880 clinical trial’s Steering Committee Chair, Professor of Surgery, and Director of the DRI (Diabetes Research Institute) & the Cell Transplant Center at Miller School of Medicine, the University of Miami, has reportedly cited that the recent Fast Track Designation will drive the research efforts across the globe to treat type-1 diabetes. The experience of the field with limited availability of cadaveric islet transplants, where a few patients encountered prolonged insulin independence, will provide a crucial proof-of-concept for the potential of the VX-880 cell therapy to transform the lives of patients with type-1 diabetes.

Massachusetts General Hospital, the University of Pennsylvania, and the University of Miami Health System will operate as the 1st sites to conduct the clinical trial and are open for enrollment. Additional sites to further conduct the VX-880 study will be activated in 2021.

Source credit:

https://www.businesswire.com/news/home/20210310005218/en/Vertex-Announces-FDA-Fast-Track-Designation-and-Initiation-of-a-Phase-12-Clinical-Trial-for-VX-880-a-Novel-Investigational-Cell-Therapy-for-the-Treatment-of-Type-1-Diabetes

 



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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