FDA Allows Vivolux to Take VLX600 into Clinical Studies

Vivolux is taking its cancer drug candidate VLX600 into Phase I/II clinical testing after receiving permission from the FDA. The study, conducted jointly with the Mayo Clinic Cancer Center at three U.S. sites, will enroll 28 patients to evaluate dosing for use in further clinical tests, the Swedish drugmaker said Tuesday.

VLX600 is designed to increase the efficacy of radiotherapy treatments by cutting off the energy supply to “sleeping cells” in areas of solid tumors with poor vascular supply. According to Vivolux, the sleepers often proliferate after radiation and conventional chemotherapy treatments.

The company plans to conduct Phase II studies later this year with radiation and chemotherapy, respectively, to assess the effect on high-proliferating cells. Vivolux hopes to submit the results of those studies to the FDA in 2015.

In addition to VLX600, Vivolux is in early phase trials with an upstream proteasome blocker for multiple myeloma. The company also makes tissue dyes for myelin, spermatozoan and spermatogenesis and reagents for nucleic acid detection and esterase active substrate. — Lena Freund

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