Beta-O2 starts clinical trial for artificial pancreas

The ßAir Bio-Artificial Pancreas is aimed at ending insulin injections for type 1 diabetes patients.

Beta-O2 Technologies has announced that the first patient participating in the companys first broad study of the ßAir Bio-Artificial Pancreas has been successfully implanted. ßAir is in development as a treatment and a potential cure for type 1 diabetes (T1D). Approximately 3 million people have T1D in the US.

Eight participants who meet the study criteria will be enrolled in the trial at Uppsala University Hospital in Sweden. Last month, JDRF awarded Beta-O2 a grant to fund half of the $1 million, two-year, open label, pilot investigation which will evaluate the safety and efficacy of implanting the ßAir macro-encapsulation with human islets of Langerhans.

We look forward to the results of this study and to possibly discovering a new and effective treatment for type 1 diabetes, said Dr. Per-Ola Carlsson, principal investigator of the ßAir study, professor at the Department of Medical Cell Biology, and the Department of Medical Sciences, Uppsala University.

ßAir is composed of an immune protection unit, 68 mm in diameter and 18 mm wide, connected to two ports, also implanted under the skin, just under and to the right of the naval. The encapsulation contains islets of Langerhans, with its main constituent the beta-cells, which provide the insulin production in the body. Insulin is a hormone that is needed to transport sugar into cells, and thereby provide energy needed for daily life. The essential problem in T1D is that the body loses the insulin-producing beta-cells. The aim of the ßAir Bio-Artificial Pancreas is to eliminate the need for insulin injections and facilitate a natural flow of insulin, in accordance with the body's needs, and without creating highs and lows in insulin levels, which is what causes severe symptoms in diabetes patients.

Were excited about the start of this clinical evaluation of the Beta-O2 encapsulation technology, said Dr. Albert Hwa, JDRF Director of Discovery Research. Encapsulated cell replacement therapies have the potential to transform the management of type 1 diabetes, so encapsulation research is a high priority for JDRF. We partnered with Beta-O2 to help speed this critical human study so we look forward to its rapid full enrollment and the study results as key next milestones.

Beta-O2 chairman Dr. Dan Gelvan, who is managing director of life sciences at Aurum Ventures, one of the company's investors, estimates that if the current trial is successful, it will be necessary to carry out an efficacy trial among 50 patients, and that it will then be possible to market the product. The entire process should cost $15-20 million, in addition to the $23 million the company has raised since it was founded.

In the search for the holy grail of bio-artificial pancreases, there have always been three major obstacles: creating an implant that the body wont reject so that the patient doesnt need to take immunosuppressive drugs for the rest of their lives; finding a way to actively and regularly provide the correct amount of oxygen to the cells in the device in order to keep them happy, properly functioning and producing sufficient quantities of insulin; and finally, having enough cells in the device in the first place to generate as much insulin as the body needs at any given time," Gelvan says, " A normal pancreas has 1 million islets; 400,000 islets, however, are enough to get the job done. We believe we have created a healthy environment that will enable this many islets to live and function at an optimal level for an extended period of time.

We gained a great deal of confidence from the first in man study in 2013. Results demonstrated safety and the patient didnt take any immunosuppression drugs while implanted. Protocol then, however, called for using 160,000 cells, rather than the preferred 400,000. So, although the patient never became completely insulin-free; he did, however, need considerably less. We hope that in the current study, transplanting a large enough amount of cells, combined with the ßAir oxygenation system, will completely eliminate the need for insulin injections while the patients remain with the implant.

Beta-O2 was founded in 1994. Its investors are SCP Vitalife, Aurum Ventures, PItango Venture Capital, and Saints.

Published by Globes [online], Israel business news - www.globes-online.com - on October 22, 2014

Copyright of Globes Publisher Itonut (1983) Ltd. 2014

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