Biomodels' Oral Mucositis Expertise Speeds FDA Approval For ActoGeniX's Phase 1b Trial Of AGO13 In Cancer Patients

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 23 Jun 2009 - 1:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Biomodels LLC, a preclinical research organization specializing in cancer support care, 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 oral mucositis. Biomodels was able to provide an innovative and customized program to ActoGeniX. This close collaboration resulted in a very successful outcome."

About Biomodels

Biomodels, 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 Belgium. The company is headquartered in Ghent and has approximately 40 employees, half of whom are PhD's, MD's, or PharmD's.

Source: Biomodels LLC