Newswise — Discovering new chemotherapy agents is one of the most difficult tasks in medicinal chemistry, and, given the deepening recession, resources are threatening to hit all-time lows. Of the thousands of active compounds synthesized, very few have progressed beyond early clinical development. Many more might have progressed to provide human benefit, but for the lack of an appropriate preclinical testing platform capable of predicting clinical results and therefore identifying the compounds' optimal applications before clinical trials are begun. These molecules, with their unlocked potential, languish unrecognized on shelves, in freezers, and in compound libraries.
According to Dr. Douglas D. Burkett, Principal Executive Officer of Baltimore, MD-based Champions Biotechnology, Inc. (CSBR.OB), however, "These dormant compounds might actually be of great value, and should not necessarily be abandoned." Champions has developed a novel preclinical platform derived from their propriety Biomerk Tumorgraftâ„¢ models that have been shown to be predictive of how drugs perform in clinical settings and are useful in determining the compounds' optimal applications and appropriately designing Phase I/II clinical trials.
This alternative approach utilizes the implantation of primary human tumors in immune deficient mice within hours after the sample is taken from the patient; Biomerk Tumorgrafts are then propagated only as tissue fragments in a unique manner that preserves the biological properties of the original human tumor. These Tumorgrafts are also passaged only a few times, never in tissue culture, and are very different from traditional xenograft models. Champions has demonstrated that Biomerk Tumorgrafts closely reflect human cancer biology and their response to drugs is predictive of clinical outcomes in cancer patients.
"The current financial climate is taking a dramatic toll on many biotechnology companies," says Dr. Burkett. "Venture funding, which is always difficult to obtain, is scarce. Drug companies and academic research laboratories are scaling back spending levels. Our mission is to improve oncology drug development efficiency and clinical success rates. We believe this is made possible by testing new and dormant drug compounds in our predictive animal models. Since traditional animal models are not predictive, expensive human clinical trials are often initiated and fail because the optimal application of the drug was never discovered. Our Biomerk Tumorgrafts mimic human cancers and provide an affordable means to determine a drug's best application, if any, prior to beginning expensive clinical trials in humans. This ultimately lowers development costs while improving the likelihood of clinical and market success.
"Biomerk Tumorgrafts are the ideal platform for resurrecting compounds that failed due to an apparent lack of effectiveness," continues Dr. Burkettt. "Compounds that sit dormant in the portfolios of all major pharmaceutical companies could represent a potential treasure trove of new treatment drugs. Biomerk Tumorgrafts also add significant value to discovery-stage drugs by determining the optimal target population for the compound so that human clinical trials are more efficient and patients benefit. We believe that Biomerk Tumorgrafts will eventually become an industry standard as the predictor of clinical outcomes for oncology drugs."
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