Vitro Expands HemoGenix Alliance to Include Cell-based Testing for Liver Toxicity
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Vitro Diagnostics, Inc. has announced that it signed an amendment to its contract to jointly manufacture and distribute stem cell analysis tools with HemoGenix®, Inc., a firm known for its pioneering HALO® analysis platform for stem cells. The previous agreement with HemoGenix® led to the launch of LUMENESC-Hu™ & LumiSTEM™ assays for high performance analysis of certain types of adult stem cells.
The new amendment expands the original agreement to include development of stem cell culture media and high performance toxicity assays to provide new cell-based tools for drug discovery and development. The partners also agreed to align their respective quality programs to assure consistency.
An initial target of the expanded alliance is the development of a highly sensitive test for liver toxicity combining Vitro's VITROGROW™ cell culture medium, human hepatocytes and the industrially-adopted bioluminescent readout system that has been developed and perfected by HemoGenix®. The resultant product is anticipated to provide testing for detecting liver toxicity and drug-induced liver injury, which are major obstacles in the development of safe drugs and biologics. The partners plan immediate validation studies followed by a series of bioluminescent-based products incorporating hepatocellular viability measurements together with detection of indicative biomarkers to support safe and effective new drugs and biologics.
Liver toxicity is a common problem of approved drugs that has led to recalls of high profile drugs such as troglitazone (Rezulin®) at extensive costs. The new products will be oriented towards early in vitro detection of liver toxicity, with an overall reduction in drug development cost for drug candidates. The partners also intend to expand the LumiSTEM™ platform for other cell-specific toxicity assays such as heart, kidney and neuronal cells.
Dr. Ivan Rich, CEO of HemoGenix®, Inc., said, "We are very pleased to expand our collaboration with Vitro to include advanced toxicity testing. Our HALO®, LUMENESC™ and LumiSTEM™ assay platforms have validated applications to high throughput toxicity screening and testing and we look forward to advanced hepatocellular toxicity testing through the expansion of our agreement with Vitro. I am very well aware of the complex issues associated with liver toxicity and look forward to our launch and development of a series of products that address this critical issue in drug and biologics development. This has been a persistent problem in drug development and discovery and we anticipate that our new products will advance heptotoxicity testing and thus reduce drug development costs, with an overall impact of reduction in healthcare costs."
The new amendment expands the original agreement to include development of stem cell culture media and high performance toxicity assays to provide new cell-based tools for drug discovery and development. The partners also agreed to align their respective quality programs to assure consistency.
An initial target of the expanded alliance is the development of a highly sensitive test for liver toxicity combining Vitro's VITROGROW™ cell culture medium, human hepatocytes and the industrially-adopted bioluminescent readout system that has been developed and perfected by HemoGenix®. The resultant product is anticipated to provide testing for detecting liver toxicity and drug-induced liver injury, which are major obstacles in the development of safe drugs and biologics. The partners plan immediate validation studies followed by a series of bioluminescent-based products incorporating hepatocellular viability measurements together with detection of indicative biomarkers to support safe and effective new drugs and biologics.
Liver toxicity is a common problem of approved drugs that has led to recalls of high profile drugs such as troglitazone (Rezulin®) at extensive costs. The new products will be oriented towards early in vitro detection of liver toxicity, with an overall reduction in drug development cost for drug candidates. The partners also intend to expand the LumiSTEM™ platform for other cell-specific toxicity assays such as heart, kidney and neuronal cells.
Dr. Ivan Rich, CEO of HemoGenix®, Inc., said, "We are very pleased to expand our collaboration with Vitro to include advanced toxicity testing. Our HALO®, LUMENESC™ and LumiSTEM™ assay platforms have validated applications to high throughput toxicity screening and testing and we look forward to advanced hepatocellular toxicity testing through the expansion of our agreement with Vitro. I am very well aware of the complex issues associated with liver toxicity and look forward to our launch and development of a series of products that address this critical issue in drug and biologics development. This has been a persistent problem in drug development and discovery and we anticipate that our new products will advance heptotoxicity testing and thus reduce drug development costs, with an overall impact of reduction in healthcare costs."