On April 15, 2014 Vivolux reproted that the FDA has granted clearance to proceed with VLX600 into the clinical Phase I/II (Press release Vivolux, APR 15, 2014, View Source [SID:1234500412]). 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.

On April 11, 2014, The Regents of the University of California (“UCLA”) filed a complaint against Medivation, Inc. and its subsidiary Medivation Prostate Therapeutics, Inc. (“MPT”) in the Superior Court of the State of California, County of San Francisco (Filing 8-K , Medivation, APR 14, 2014, View Source [SID:1234500414]). The complaint arises from the parties’ 2005 Exclusive License Agreement (“ELA”), which grants to MPT rights in certain UCLA patents, including the UCLA patents covering XTANDI. The complaint centers on two allegations. The first allegation is that Medivation and MPT have failed to pay UCLA ten percent of “Operating Profits” Medivation has received (and will continue to receive) from Astellas Pharma, Inc. as a result of the 2009 Collaboration Agreement between Medivation and Astellas. UCLA alleges that such Operating Profits are “Sublicensing Income” under the ELA and that UCLA is entitled to ten percent of such payments. The second allegation is that Medivation has breached its fiduciary duties to UCLA, as a minority shareholder of MPT. UCLA owns a fraction of one percent of the outstanding shares of MPT. The complaint seeks a declaration and judgment for breach of contract related to the allegation that “Operating Profits” payments received from Astellas are “Sublicensing Income” under the ELA, a judgment that Medivation has breached its fiduciary duties and an injunction requiring Medivation to comply with its fiduciary duties. The complaint does not seek termination of the ELA.

Medivation and MPT deny UCLA’s allegations and will vigorously defend the litigation.