This will make it possible to detect damage caused by drugs at an early stage and stop their development. Sabera plans to start commercialization in the first half of 2009
Compugen announces today the discovery and experimental proof of four biological markers for the early detection of drug-induced kidney damage in rats. The data show that this group of markers allows for the early detection of drug-induced kidney toxicity during preclinical experiments in rats, compared to existing diagnostic methods, such as pathological analysis of the kidney or chemical tests.
"New markers that enable early diagnosis of kidney damage caused by a drug that is in preclinical trials, will dramatically reduce the time and cost required to prioritize and select molecules that will be promoted in the pharmaceutical companies' development chain" said Dr. Anat Cohen-Deig, VP of Markers Diagnostic and medicinal targets in compugen.
The biomarkers were discovered while using Compugen's computational discovery platform called Nucleic Acid Testing (NAT). An important element in the discovery process was the integration of Compugen's unique data with the clinical data obtained from biological samples provided by Teva Industries Ltd. These samples were the product of a pre-clinical trial conducted by the Teva company especially for this project in accordance with a research cooperation agreement between the companies. The use of a wide variety of data consisting of different expression profiles together with tools that combine statistics and computer learning, led to the discovery of a combination of four innovative biomarkers showing a sensitivity of 80% and a specificity of more than 85%.
After the discovery process of the four markers, their performance was tested on samples obtained from another experiment conducted by Teva, in which Compugen was not exposed to the identity of the samples. In this experiment, rats were treated with control compounds against drugs that had previously failed in preclinical trials due to kidney damage effects. The combination of the four markers accurately identified the drugs that caused kidney toxicity after a short period of 1-5 days of using these drugs, compared to the other diagnostic methods that require up to 28 days of drug use before testing. In addition, these markers also indicated the relative level of toxicity of the tested molecules.
The cooperation agreement with Teva announced in January 2007 grants Teva a license to use any biomarker that is discovered, for internal research and development purposes. The commercialization rights of the markers to other companies remained with Compugen as well as the rights for internal use. Compugen plans to commercialize these biomarkers by licensing them for use during the first half of 2009.
"The increasing frequency and expanding variety of our discoveries, clearly demonstrates the great value inherent in our long-standing commitment to be pioneers in prediction based on the understanding of life at the molecular level," noted Compugen Chairman Martin Gerstel "Our discovery capabilities, which stem from this commitment and rely on insights and predictive models , on mathematical algorithms and biological calculation tools together with a unique research and development team, create the basis for the development and use of the expanding pool of discovery platforms, which are demonstrated in this announcement as well as in previous announcements and produce a significant increase in the intellectual property of drug candidates and diagnostic products" added Mr. Gerstel.
Regarding drug-induced kidney poisoning:
The tools that exist today to diagnose kidney functions, such as testing Blood Urea Nitrogen and Serum Creatinine levels in the blood, show significant results only after major kidney damage has occurred. The pharmaceutical industry invests a lot of money, time and effort in trying to identify the drugs that cause kidney damage as early as possible, in order to avoid continuing to carry out more advanced and more expensive experiments in the development chain of a drug. Since the kidney is among the main areas that can be affected, early diagnosis of kidney poisoning in the initial stages of drug development is a very important need.
בRegarding Compugen's Nucleic Acid Testing (NAT) discovery platform:
The Compugen Nucleic Acid Testing (NAT) computational discovery platform is based on two unique Compugen databases, LEADS and MED, and the integration of other unique and public biological databases. Discovery of new RNA molecules that can be used as diagnostic markers is done using algorithms, different statistical tools and by computer learning. The platform allows the detection of single markers or as a combination and can be used for the detection of markers for damage in a wide variety of other organs and the detection of unique markers for diseases such as atherosclerosis and various epithelial cancers.
