Subject to FDA acceptance, Avalon plans to begin its first US phase I clinical trial of AVN944 in patients with hematologic malignancies.
“We believe the results of the preclinical research on AVN944 combined with the results of the initial non-US clinical trial on normal human volunteers conducted by Vertex Pharmaceuticals demonstrate that AVN944 has the potential to have clinical benefit for cancer patients,” commented Dr Ken Carter, CEO of Avalon.
“Additional preclinical studies and clinical testing will be necessary to establish efficacy and safety of AVN944 in cancer patients before we can expect to file a new drug application (NDA) with the FDA and market a commercial product,” he continued.
AVN944 was in-licensed by Avalon from Vertex Pharmaceuticals in February 2005. Vertex Pharmaceuticals conducted a phase I trial in the UK in human volunteers not suffering from cancer. In this trial, AVN944 was shown to be orally bio-available and well-tolerated.