Vivolux reported that it has received the green light from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1/2 trial for VLX1570 in relapsed and/or refractory multiple myeloma.
VLX1570 finds its target in the tumor cell proteasome. The drug works by stopping a key process that causes defective proteins in the malignant cells to begin breaking down. Through its mechanism of action, VLX1570 induces apoptosis or programmed cell death, in turn inhibiting tumor growth and extending survival in preclinical cancer models that are resistant to standard therapies.
The clinical study aims to determine VLX1570’s safety and efficacy in patients with multiple myeloma who have become unresponsive to existing cancer drugs. The Phase 1/2 trial will be conducted by Vivolux in collaboration with the Memorial Sloan-Kettering Cancer Center and the Dana-Farber Cancer Institute at Harvard Medical School — both of which previously worked with Karolinska Institutet to study VLX1570 in multiple myeloma, the results of which were published in December 2013 in the journal Blood.
Professor Stig Linder at Karolinska Institutet's Department of Oncology-Pathology, said at the time, “The discovery that our substance works on multiple myeloma cells resistant to conventional therapy is very promising for the future… We show that the drug candidate kills multiple myeloma cells from cancer patients. The substance is also effective against myeloma cells that have developed a resistance to the clinically used drug bortezomib."
Hans Rosén, CEO and founder, said that the go-ahead signal from the FDA marks a significant milestone for the company and its research, which has piqued interest from important cancer institutions in the U.S. “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.”