Until HemoGenix® launched its HALO® Platform for in vitro hemotoxicity testing in March 2002, drug development had to rely on either conventional hemotoxicity performed during regular pre-clinical animal studies or on the use of transformed cell lines which have little resemblance to fresh, primary cells.
Conventional hemotoxicity testing is performed as part of a list of toxicities that are required according to the guidelines of the regulatory agencies. Conventional hemotoxicity detects changes in circulating blood cell parameters and in morphology of the hematopoietic organs, e.g. bone marrow and spleen. Because many changes seen in the circulation are the result of actions that have occurred at the stem and progenitor cell levels of the blood-forming system at a much earlier time point, conventional hemotoxicity has no predictive value. If the same studies had been performed using HALO®, the effects found in the circulation could have been predicted without the use of animal testing, thereby saving considerable time and money.
Now it may be argued that in vitro assays are surrogate assays and do not provide the same information as a whole animal model or even a human patient. However, at HemoGenix®, our HALO® Platform was initially designed to use fresh, primary human bone marrow, peripheral blood or umbilical cord blood. The HALO® Platform has also been validated against the Registry of Cytotoxicity Prediction Model using fresh, primary human hematopoietic tissue and is therefore a validated cytotoxicity assay. We have also designed predictive paradigms of hemotoxicity that can be used for human, non-human primate, dog, rat and mouse. The HALO® Platform is the best assay available for predicting human hemotoxicity.
HemoGenix® has also recently launched the HALO®-DDI (Drug-Drug Interaction) Platform, the only cell-based hemotoxicity assay available. This 384-well plate, high throughput assay is only available as a contract research service.
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