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Biomodels' Oral Mucositis Expertise Speeds FDA Approval for ActoGeniX's Phase 1b Trial of AGO13 in Cancer Patients
Date:6/22/2009

ActoGeniX taps Biomodels CRO expertise in $1 billion market for cancer support care to relieve side effects of cancer treatments

WATERTOWN, Mass., June 22 /PRNewswire/ -- Biomodels LLC, a preclinical research organization specializing in cancer support care, today announced that its customized research program allowed ActoGeniX NV, a development stage biopharmaceutical company, to rapidly attain Food and Drug Administration (FDA) approval for Phase 1b clinical trials of AGO13 in cancer patients with oral mucositis.

There is currently no effective cure for the severely painful and debilitating inflammation and ulceration of the mucous membranes lining the mouth that makes eating, drinking and speaking difficult or impossible.

Oral mucositis, can affect up to 100 percent of cancer patients undergoing high dose chemotherapy.

The FDA approval permits ActoGeniX to initiate a phase 1b clinical trial in six major oncology centers in the United States. AGO13 could become the first approved therapy for oral mucositis in patients undergoing treatment of solid tumors or head/neck cancers, according to ActoGeniX.

"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," said Dr. Mark Vaeck, CEO of ActoGeniX.

The preclinical data package that was developed enabled us to identify how AGO13 could be used clinically, " he said. "We can now seamlessly translate Biomodels' research into our clinical trials, thus speeding up the drug development process."

Edward Fey, CEO of Biomodels said, "We are delighted that our collaboration with ActoGeniX will speed the development of an effective therapy for cancer patients suffering from the ravages of or
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SOURCE Biomodels LLC
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