Vivolux receives FDA clearance to proceed with phase I/II clinical trial of VLX600

Vivolux AB, a drug discovery company specialized in cancer treatment, announced today that the FDA has granted clearance to proceed with VLX600 into the clinical phase I/II. VLX600 is one of the company's promising projects, and which was recently published in the journal Nature Communications. Researchers at Vivolux have discovered a novel cancer drug target. 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 study will be conducted in collaboration with Mayo Clinic Cancer Center. The aim 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.

In solid tumors, there are areas with poor vascular supply where cancer cells divide more slowly due to a lack of oxygen and nutrients. Cancer cells in these areas enter a sleeping state. The 'sleeping cells' start proliferating after treatment with radiotherapy or conventional chemotherapy, resulting in regrowth of tumors. Such regrowth between therapy cycles is a major clinical problem. Vivolux drug candidate, VLX600, kills sleeping cancer cells by interrupting the power supply in the cells' power plants - the mitochondria.

Hans Rosén, CEO and founder, states: "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."

Stig Linder, Professor of Experimental Oncology at the Karolinska Institute and the person who has led the development work, says: "VLX600 has killed colon cancer cells found deep inside solid tumors in various in vitro and in vivo models. These tumor cells are difficult to access by conventional chemotherapy. The therapeutic effect of VLX600 relies on the vulnerability of malignant cells in the deep tumor parenchyme to disturbances of energy supplies. It is truly exciting that our research may help cancer patients in the forthcoming clinical studies".