The Swedish drug discovery company has announced that the FDA has granted clearance to proceed with VLX600 into the clinical phase I/II.
VLX600 is one of the company’s drug projects, recently published in the journal Nature Communications. The drug candidate kills sleeping cell populations in regions of solid tumors that are metabolically compromised due to poor vascularization – areas that cannot be reached by conventional cancer therapeutics.
“The FDA decision to grant clearance for VLX600 to proceed into the clinical program is a sign of quality and a milestone for Vivolux. The study will be conducted at Mayo’s three sites in the USA. There is a considerable medical need for new cancer drugs. VLX600 represents a first-in-class molecule within a new mechanism of action. A promising new concept in cancer treatment. Vivolux has a strong project pipeline and we plan to submit more applications to the FDA during 2014. Development within Vivolux is very much leading edge, as demonstrated by the interest from Harvard Medical School, Mayo and other institutions, where we will commence clinical studies during 2014,” said Hans Rosén, CEO and founder.
According to Vivolux the aim with the planned study is to determine the dose for future clinical studies. VLX600 is designed to increase the efficacy of radiotherapy and to kill cancer cells that survive traditional chemotherapy.