NEW YORK, Nov. 13 - Clairus Technologies has struck a licensing agreement with the University of Pennsylvania to develop a genomics-based product that may help physicians learn whether steroids prescribed to treat an inflammatory disease are having the desired effect, a company official has told GenomeWeb.
The agreement, which was signed on Nov. 9, gives Clairus an exclusive license to the university's RNA-based molecular diagnostic product that the firm will study in 100 patients with Crohn's disease, Lee Sylvers, president and chief scientific officer of Clairus, said in an interview.
Clairus, meanwhile, will fund the R&D as well as the clinical trials, and may also perform some research in its labs to fine-tune the study.
Financial terms of the deal were not disclosed.
Sylvers said he hopes to develop a diagnostic that can alert physicians when it might be time to abandon steroid therapy and begin an alternate treatment. "What the product will be able to do—and we won't know this until the trial is concluded—is [say] whether a patient is steroid-responsive or steroid-non-responsive," he said.
Clairus ultimately hopes to commercialize any product that is developed. Gregory Sullivan, Clairus' senior vice president of business development and marketing, added that the firm has a number of pharmaceutical or biotechnology companies interested in a potential product but would not offer any specifics.
The technology enables researchers to quantitate RNA expression from a pair of undisclosed genes believed to modulate inflammation, said Sylvers, who stressed that it is not specific to Crohn's disease and may also be applied to a wide array of diseases for which steroids are used.
When given chronically, steroids place patients at risk for a host of cumulative and long-term adverse events. In addition, it is known that between 10 percent and 15 percent of patients treated with steroids will stop responding to the therapy.
Still, some physicians are wary of discontinuing steroid therapy in patients who may not be eliciting a clinical response because they believe that the therapy has helped and that the outcome would have been worse had steroids not been prescribed, Sylvers said.
The study, which is an investigator-initiated trial, is set to begin in January and will examine blood and buccal tissue from 100 patients with Crohn's disease enrolled in the University of Pennsylvania Health System, in Philadelphia. Although Clairus will not perform any hands-on research, Sylvers said he will be managing the effort.