Biomodels’ Oral Mucositis Expertise Speeds Up FDA Approval for ActoGeniX’s Phase 1b Trial of AGO13 in Cancer Patients

16th February 2010

Pre-clinical research organisation Biomodels has announced that it has successfully collaborated with ActoGeniX, a development stage biopharmaceutical company, in obtaining FDA approval for an Investigational New Drug (IND) application for AGO13, a novel therapeutic product for the treatment of oral mucositis in cancer patients.

The FDA approval permits ActoGenix to initiate a phase 1b clinical trial in six major oncology centres in the US. AGO13 could become the first approved therapy for oral mucositis in patients undergoing treatment of solid tumours or head/neck cancers, according to ActonGeniX.

Biomodels is internationally recognised for its clinical expertise in oral mucositis, a debilitating disease which makes essential daily activities such as eating, drinking, and talking difficult, if not impossible, for cancer patients. Oral mucositis can affect up to 100% of cancer patients undergoing high dose chemotherapy.

AGO13 ready for clinical trials

“The speedy approval of our drug application for AGO13 from the FDA was clearly the result of our successful collaborative efforts with Biomodels’ scientists who worked closely with us in a complex process involving the development of innovative, high quality platforms,” says Dr Mark Vaeck, CEO of ActoGeniX. “The pre-clinical data package that was developed enabled us to identify how AGO13 could be used clinically. We can now seamlessly translate Biomodels’ research into our clinical trials, thus speeding up the drug development process.”

Edward Fey, PhD, managing partner of Biomodels, says: “We are delighted that a new model for collaboration with ActoGenix that bridged the preclinical-clinical divide may speed up the development of an effective therapy for cancer patients suffering the ravages of oral mucositis.”

Biomodels, a preclinical drug research organisation founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy and inflammatory diseases.

The company, based in Watertown, MA, specialises in (non-GLP) efficacy studies that optimise dose, schedule and define mechanism of action. Biomodels also has expertise in modelling inflammatory diseases, including those conditions affecting the gastrointestinal tract. Biomodels’ studies enable organisations to more readily identify lead compounds, decrease the time to a clinical trial and increase the chance of clinical success.

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