Berlin, Germany and Montréal, Québec, October 30th, 2001 lll Epigenomics AG, a transatlantic biotech company pioneering the applications of DNA methylation, and MethylGene, Inc., a Canadian biopharmaceutical company, today announced the signing of a collaboration to investigate gene (DNA) methylation changes of patients enrolled in Phase II trials of MG98. MG98 is a second-generation antisense oligonucleotide that inhibits DNA methyltransferase mRNA. Changes to DNA methylation patterns may indicate, in advance, which patients could respond to treatment by MG98. MethylGene is currently conducting multiple Phase II trials for MG98 for several cancer indications with its North American partner, MGI PHARMA, Inc..
The Epigenomics-MethylGene alliance initially covers ongoing or scheduled Phase II trials of MG98 in several tumor types including head and neck cancer and renal cell cancer. Under the terms of the agreement, Epigenomics will receive DNA-samples obtained from patients before and after MG98 treatment and identify changes in DNA methylation patterns. DNA methylation is a naturally occurring mechanism in cells to regulate gene activity. If genes are methylated incorrectly, disease may occur and may be reflected in a different methylation pattern when compared to the normally functioning cell. Financial details were not disclosed.
\"This study is an important step in our strategy of introducing DNA methylation technology into one of our primary markets, clinical pharmacogenetics, and not only into the discovery and research areas,\" Alexander Olek, CEO of Epigenomics commented. \"It is Epigenomics\' first clinical phase alliance with a biopharmaceutical partner which we hope will validate our technology platform as well as our pharmacoepigenomic approach. Our long term goal is to have this application used in clinical routine.\"
MG98 targets the mRNA of the nuclear enzyme DNA methyltransferase, which is responsible for silencing tumor suppressor genes. MethylGene\'s compound aims to reduce hypermethylation of tumor suppressor genes by inhibiting DNA methyltransferase and thereby potentially treat tumors. Epigenomics examines the methylation pattern of different kinds of disease, including cancers, in order to detect and classify these diseases at an early stage. \"Hypermethylation of tumor suppressor genes is common in many cancers,\" noted Dr. Jeffrey Besterman, Senior Vice President, Research and Development , of MethylGene. \"We previously detected encouraging changes in DNA Methyltransferase mRNA in patients who appeared to benefit from our compound during Phase I trials. We hope to investigate not only the DNA methyltransferase mRNA levels of patients but a large sample of key genes for alterations in DNA methylation , which may occur due to MG98 treatment.This collaboration is a natural addition to our clinical evaluation and development of pharmacogenetics for MG98.\"
Epigenomics is a transatlantic biotechnology company, with headquarters in Berlin, Germany and its wholly owned subsidiary in Seattle, Washington, USA, pioneering tomorrow\'s personalized medicines. By detecting DNA methylation patterns, the \"on\" and \"off\" signs for genes, Epigenomics can create a digitized readout (Digital Phenotype®) for each tissue. The comparison of healthy and sick tissue enables an exact diagnosis of disease at a very early stage and reveals new therapeutic opportunities. The combination of diagnosis and therapy, based on this epigenetic information and our robust proprietary technology, is leading the way to improving patients\' quality of life. Epigenomics is the world\'s first and only company focusing exclusively on DNA methylation and its importance in the post-genomic age, and is supported by the world\'s premier network of academic researchers and clinicians with expertise in the field of cancer and DNA methylation. For further information, please visit our website at www.epigenomics.com.
MethylGene Inc. is a privately held, Canadian biopharmaceutical and chemistry-driven rational drug design company focused on the inhibition of quality enzyme targets associated with disease. MethylGene combines functional genomic technologies with the application of mechanism-based small molecules and mRNA inhibitors to discover, patent, develop and commercialize novel therapeutics for cancer and infectious disease. MethylGene\'s , MG98, which is partnered for North America with MGI PHARMA, Inc., is currently in multiple Phase 2 clinical trials. The Company has other research and development programs to develop small molecule inhibitors of DNA methyltransferases, histone deacetylases, beta-lactamases and other enzyme targets. For more information about MethylGene, please visit www.methylgene.com.
This press release may contain forward-looking statements. Such statements are subject to certain risk factors and uncertainties, particularly those inherent in the process of discovering, researching, developing and commercializing drugs that can be proven to be safe and effective for use as human therapeutics and the endeavor of building a business around such potential products. As a result, the reader is cautioned that actual results could differ materially from those projected or assumed around this release.
