A midstage drug development company is hoping that a meeting with the U.S. Food and Drug Administration this summer will help it set a course for pushing a promising new targeted cancer therapeutic through commercialization, starting with a phase 2 trial in the fall.
CerRx‘s approach to treating cancer targets ceramides — waxes used by cells to make cell membranes, a process that’s essential for cell growth. But in excess, ceramides are toxic. CerRx’s founders discovered that the drug fenretinide could simulate overproduction of ceramides exclusively in cancer cells to a level of toxicity that would kill them.
In phase 1 testing, the drug has shown “some unprecedented activity” in T-cell lymphoma and high activity in adenocarcinoma of the GI tract, said chief operating officer Bill Simpson. The company is planning a meeting with the FDA later this summer to hear feedback on registration options for the compound, which it anticipates would receive orphan drug status.
“It’s an old compound that was developed years ago as an oral drug, but it failed to live up to expectations in humans because of its preparation as an oral drug,” Simpson said. “(Our) founders have worked with the National Cancer Institute with this compound to create a proprietary emulsion injectable formulation that’s overcome those issues with insolubility.”
The company is additionally working with a combination formulation of fenretinide and the drug safingol, a fenretinide modulator that increased the killing of cancer cells 1,000-fold in preclinical models. A phase 1 combination study is also in the works, Simpson said.
Most of the company’s funding thus far has been obtained from federal and state grants, but Simpson anticipates a round of fundraising to support clinical trials.
CerRx was founded in 2008 by Drs. Barry Maurer and Patrick Reynolds of the Texas Tech University Health Science Center School of Medicine along with two-time biopharmaceutical entrepreneur Richard Love and renowned oncology drug developer Dan Von Hoff. It’s located in Lubbock, Texas.