Bexion Pharmaceuticals, LLC today announced that its application to begin a First-in-Human Phase 1 clinical trial with BXQ-350 has been accepted by the U..S Food and Drug Administration (FDA).
The trial will focus on BXQ-350 as a cancer treatment.
"We are very pleased to begin clinical development of BXQ-350 in patients with cancer," Bexion Pharmaceuticals Founder and CEO Dr. Ray Takigiku said. "This major milestone validates the many years of tireless work by the Bexion team and its partners and the invaluable support of its investors. We look forward to working with FDA, patients and our clinical trial partners in progressing this important trial."
The clinical trial, which is open-label, will be conducted using adult patients that are suffering from solid tumors, which will include a form of brain cancer called glioma. The trial will revolve around discovering the maximum tolerated dosage of BXQ-350 while determining its safety and pharmacokinetics. When BXQ-350 was used in pre-clinical trials involving animals, the drug proved effective in inducing tumor cell death in many different forms of cancer while having no negative effects on healthy cells.
More information on the upcoming Phase 1 trial can be found on www.clinicaltrials.gov as well as www.bexionpharma.com.