Biomodels has announced that its customized research program allowed ActoGeniX to get FDA approval for phase 1b clinical trials of AGO13, in cancer patients with oral mucositis.
The FDA approval allows ActoGeniX to initiate a phase-1b clinical trial in six major oncology centers in the US.
Dr. Mark Vaeck, CEO of ActoGeniX, said: 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.
“The preclinical 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, he added.
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.