Bexion receives FDA clearance for Phase I trial of BXQ-350 to treat cancer - Clinical Trials Arena
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Bexion receives FDA clearance for Phase I trial of BXQ-350 to treat cancer

19 Jul 2016

Bexion Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) to begin the first in-human Phase I clinical trial of BXQ-350 to treat cancer.

Bexion Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) to begin the first in-human Phase I clinical trial of BXQ-350 to treat cancer.

Bexion’s BXQ-350 is a patented nanovesicle formulation comprised of Saposin C (sphingolipid activator protein, or SapC) and the phospholipid dioleoylphosphatidylserine (DOPS).

It is composed of a synthetically produced, human lysosomal protein.

The open-label, Phase I clinical trial has been designed to determine the maximum tolerated dose of BXQ-350.

"This major milestone validates the many years of tireless work by the Bexion team, its partners and the invaluable support of its investors."

The trial is planning to include adult patients with advanced solid tumours including glioma, a type of brain cancer.

It is also aimed at evaluating the safety and pharmacokinetics profile of BXQ-350.

Bexion founder and CEO Dr Ray Takigiku said: "We are very pleased to begin clinical development of BXQ-350 in patients with cancer.

"This major milestone validates the many years of tireless work by the Bexion team, its partners and the invaluable support of its investors.

“We look forward to working with the FDA, patients and our clinical trial partners in progressing this important trial."

BXQ-350 is indicated to treat a wide range of cancers since it had displayed its ability in targeting and killing cancerous cells.

The pre-clinical animal studies have demonstrated Bexion's biologic, BXQ-350 triggering tumour cell death in a range of cancers.