PARIS, France, Sept. 5, 2002 (PRIMEZONE) -- GenOdyssee S.A., a biotherapeutics company specializing in discovering and developing drugs from functional genomics, today announced preclinical results for its proprietary interferon (IFN) alpha variants for the treatment of hepatitis C (HCV) and cancer. In the studies conducted by independent French laboratories, GenOdyssee's variants demonstrated up to one hundred times greater efficacy compared to IFN alpha molecules currently on the market.
Professor Michael TOVEY, Director of the Viral Oncology Laboratory at CNRS Research Institute (French National Center for Scientific Research) commented, "GenOdyssee's interferons display excellent toxicity profiles and are much more specific and active than interferons 2a and 2b that are currently on the market for HCV and cancer. Such a significant improvement could herald a major advancement in patient treatment for both conditions. Undoubtedly, GenOdyssee's unique approach has significantly contributed to our understanding of the underlying mechanisms behind interferon activity, which are currently not well documented."
The studies compared GenOdyssee's nine IFN alpha variants to the currently marketed IFN alpha 2a and 2b variants in viral infectious disease models for HCV and immunotherapy models for cancer. Certain IFN alpha variants demonstrated up to one hundred times greater antiviral, immunomodulatory and antiproliferative activities than IFN alpha 2a and 2b. Other variants exhibited differential activities, for example, having greater antiproliferative but reduced antiviral and immunomodulatory properties. Initial in vivo toxicology studies reveal few side effects and suggest the company's IFN alpha variants are better tolerated than those currently on the market. Hence, these variants could provide a more specific and efficient therapeutic, with reduced adverse side effects, significantly increasing treatment efficacy. The company believes that the most potent IFN immunostimulating and antiproliferative variants will enable the development of novel immunotherapy treatments for common forms of cancer, including lung, breast and prostate.
"Genodyssee's variants could act as a stand-alone cancer therapy or act as an adjunct to therapeutic vaccines, providing greater efficacy than currently available treatments; they make promising candidates for the treatment of cancer and HCV," commented Professor Herve FRIDMAN, from the Paris Pierre & Marie Curie Medical School and Director of INSERM (French institute for Health and Medical research) unit 255. Professor Patrick MAUREL, director of INSERM unit 128, who coordinated the in-vitro preclinical studies on hepatocyte culture, confirmed that "GenOdyssee's variants, showing unprecedented activity on human hepatocyte HCV infection, make very promising candidates to significantly improve HCV treatment."
"With these promising results in hand, GenOdyssee now has a proof of concept for our innovative approach to drug discovery and development. By combining our expertise in genetic variability with our understanding of proteins, we hope to be able to select naturally occurring variants of existing therapeutic proteins which demonstrate a higher therapeutic index and fewer side effects," said Dr Jean-Louis Escary, GenOdyssee's Founder, President & Chief Executive Officer.
"The exciting results from the studies of our IFN alpha variants should enable GenOdyssee to start clinical development of the most promising variants in both hepatitis C and cancer in 2003. The HCV market is currently valued at more than $2 billion, with ten percent annual growth, and the cancer therapeutic vaccines and direct immunotherapy markets are estimated at several hundred million U.S. dollars. Hence, given the poor efficacy and high toxicity of current treatments, our proprietary IFN alpha variants represent exceptional commercial opportunities."
About GenOdyssee S.A.
GenOdyssee S.A. is a French biotherapeutics company founded in October 1999. The company pursues a dual business model: if offers genetic analysis services through its division GenOdyssee Genetics and aims to develop its own therapeutics through its division GenOdyssee Pharmaceuticals. GenOdyssee Genetics has developed a fully integrated high throughput (HT) screening platform that provides a unique set of post-genomic services including genetic polymorphism HT detection and identification, HT genotyping, bioinformatics and functional proteomics. Through its division GenOdyssee Pharmaceuticals, the company has developed a unique approach to human genetic variability and applied it to more than 100 genes coding for therapeutic proteins, to their receptors and to the tyrosine kinases involved in the corresponding biological pathways.
This program has reaped successful results. As a result of its original product R&D approach, the company started its second year of existence with a portfolio of 84 lead candidates. The company has an ongoing functional proteomics program to study the biological effects of these molecules, and 32 of them have already shown therapeutic potential. In 2001, GenOdyssee filed 30 patent applications and launched preclinical studies with its first ten lead candidates.
Notes for Editors
Infectious-disease models used in the studies Viral infectious-disease models for HCV included a novel in vitro HCV-infected primary human hepatocyte culture, mice infected with encephalomyocarditis virus (EMCV), in vitro cell cultures infected with vesicular stomatitis virus (VSV).
Hepatitis C
180 million people worldwide are infected with Hepatitis C. This virus is the leading cause of liver cancer worldwide and the tenth leading cause of death among adults in the United States, accounting for approximately 25,000 deaths annually. Hepatitis C is currently treated with a combination therapy of interferon (IFN and Peg IFN a-2a et a-2b) and Ribavirin. These treatments are not sufficiently effective; they have a high level of toxicity (causing severe side effects such as flu-like symptoms, loss of weight, hair loss, fatigue, neuropsychiatric effects, hemolytic anemia) and a response rate of less than 50%.
Immunotherapy for Cancers
Immunomodulatory and antiproliferative cancer models included ex-vivo human dendritic cell maturation, mice grafted with IFN resistant erythroleukemia and in vitro Daudi cell cultures. Certain cancers are sensitive to specific immunotherapy, others respond to monoclonal antibody therapy (anti CD 20 in lymphoma, anti ERB2 in breast cancer), and some to non-specific immunotherapy (IL2 or GM-CSF as immunostimulators or adjuvants). IFN alpha has proven to be a clinically effective drug in cancer for more than 16 years.
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