Biomodels' Oral Mucositis Expertise Speeds FDA Approval for ActoGeniX's Phase 1b Trial of AGO13 in Cancer Patients
Posted on: Monday, 22 June 2009, 10:10 CDT
ActoGeniX taps Biomodels CRO expertise in
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 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.
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."
About Biomodels
Biomodels (www.biomodels.com), a preclinical contract research organization founded in 1997, has developed and conducted more than 1000 preclinical trials for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation, therapy, and inflammatory diseases.
The company specializes in (non-GLP) predictive studies that evaluate efficacy and define mechanism of action, enabling clients to expedite the drug discovery process. Biomodels' preclinical studies anticipate clinical objectives and enable organizations to rapidly achieve preclinical milestones.
About ActoGeniX
ActoGeniX is a biopharmaceutical company focused on the development and commercialization of ActoBiotics(TM), a novel class of orally available biopharmaceuticals for the targeted treatment of severe diseases with high medical needs. ActoBiotics(TM) represent a novel concept for oral administration of therapeutic proteins, and are designed to be safer and more effective than injectable biopharmaceuticals.
ActoGeniX was founded in 2006 as a spin-off from VIB and Ghent University in
SOURCE Biomodels LLC
Source: PR Newswire
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