RALEIGH, N.C., July 16, 2014 (GLOBE NEWSWIRE) -- Islet Sciences, Inc. (OTCQB:ISLT), a biopharmaceutical company developing new medicines and technologies for the treatment and diagnosis of metabolic disease, announced today that its collaborators at the Yale University School of Medicine have published key data highlighting the efficacy of Islet's novel diabetes diagnostic in Endocrinology, the journal of the Endocrine Society. The study demonstrated improved detection of beta-cell loss, a key biomarker of diabetes progression, using a novel technology called droplet digital PCR (ddPCR).
In the peer-reviewed journal article, titled "Analysis of beta-cell death in Type 1 diabetes by droplet digital PCR1," the authors describe how this novel approach is the first to enable accurate quantification of the level of insulin (INS) DNA released into the blood specifically from dying beta-cells. This highly sensitive technique not only allowed researchers to distinguish patients with recent onset type 1 diabetes from non-diabetic control patients, but also for the first time provided evidence of ongoing beta-cell loss in non-diabetic patients who are at risk of developing disease based on family history and other factors.
Kevan Herold, M.D., commented, "In this study, we've successfully demonstrated that using ddPCR to determine the amount of beta-cell-derived INS DNA can significantly improve specificity compared to other PCR-based approaches, allowing for more accurate measurement of beta-cell loss, even at early stages of disease. Building upon our previously published research describing our novel approach2,3, this is the first demonstration of a quantitative tool for assessing disease progression in type 1 diabetes, and we are encouraged by its potential impact for patients in optimizing their diabetes treatment."
Therapies designed to prevent or reverse type 1 diabetes generally focus on preserving beta-cell function by preventing cell death or replacing lost beta-cells. However, by the time symptoms such as hyperglycemia begin, approximately 80% of the beta-cells have already been destroyed and it can often be too late for these treatments to be effective. An accurate method to detect beta-cell loss at an early stage, such as ddPCR, may permit medical intervention at a time when these therapies would have the greatest benefit. Furthermore, the study also suggests that ddPCR may hold even greater value in uncovering beta-cell loss in normoglycemic, "at-risk" individuals, enabling potential treatment before symptoms appear.
James Green, Chairman and Chief Executive Officer of Islet Sciences, stated, "Publication of this study in a peer-reviewed journal provides additional validation for our novel approach to detecting beta-cell loss early in the progression of diabetes. With this significant improvement in our beta-cell diagnostic technology, we are closer to a marketed product for type 1 diabetes, and though preliminary, we are very encouraged by the potential implication that the increased sensitivity may enable detection of early beta-cell loss in patients with type 2 diabetes as well."
About Islet Sciences
Islet Sciences, Inc., a biopharmaceutical company based in Raleigh, NC, is developing new medicines and technologies for the treatment and diagnosis of metabolic disease. On March 13, 2014, the Company announced the execution of a binding letter of intent to acquire BHV Pharma. The combined pipeline includes remogliflozin etabonate for the treatment of type II diabetes and NASH, a cell-based transplantation therapy for insulin-dependent diabetes; first-in-class immune-modulating small molecule IL-12 inhibitors targeting beta-cell preservation, and a PCR-based molecular diagnostic measuring beta-cell loss for the diagnosis of type 1 diabetes or onset of insulin dependent type 2 diabetes. For more information, please visit http://www.isletsciences.com.
1Usmani-Brown et al. Analysis of beta-cell death in Type 1 diabetes by droplet digital PCR. Endocrinology 2014 Jul 8; ahead of print: http://dx.doi.org/10.1210/en.2014-1150
2Akirav et al. Detection of cell death in diabetes using differentially methylated circulating DNA. Proc Natl Acad Sci U S A. 2011 Nov 22;108(47):19018-23
3Lebatschi et al. Immune therapy and beta cell death in type 1 diabetes. Diabetes 2013 May; 62(5):1676-80
This press release contains forward-looking statements. Forward-looking statements for Islet Sciences, Inc. reflect current expectations, as of the date of this press release, and involve certain risks and uncertainties. Actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the risks described in the Islet Science, Inc.'s reports filed with the Securities and Exchange Commission. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside of the Company's control.
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