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Vivolux gets FDA clearance for clinical study

Swedish pharmaceutical company Vivolux has received clearance from the FDA to proceed with the drug candidate VLX1570 to clinical phase I/II for treatment against relapsed and/or refractory multiple myeloma.

The clinical study will be conducted in collaboration with the Memorial Sloan-Kettering Cancer Center and the Dana-Farber Cancer Institute at Harvard Medical School. This first study is designed to determine the safety and efficacy of VLX1570 in patients with multiple myeloma who are no longer benefiting from conventional cancer treatment. The drug candidate VLX1570 acts on the proteasome through a new mechanism of action, by inhibiting the initiation process that regulates the breakdown of defective protein, the cancer cells are forced into apoptosis – programmed cell death.

The FDA decision to grant clearance for VLX1570 to proceed to the clinical phase is a new milestone for Vivolux.

“The fact that this research has attracted interest at leading cancer institutions in the USA is solid recognition of the quality for our scientists and their work. There is a considerable medical need for new cancer drugs. VLX1570 represents a first-in-class molecule within a new mechanism of action acting on a proven druggable target, the proteasome. This is a promising cancer treatment. Vivolux has a strong project pipeline and we plan to submit new applications to the FDA during 2015,” said Hans Rosén, CEO and founder of Vivolux.