Clinical research
Although the weekend was filled with news out of the American Society of Clinical Oncology Annual Meeting, here’s a roundup of some of the top clinical trial news from earlier last week.
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During the full presentation of the abstract on Friday, Janssen will show that treatment with Erleada significantly improved rPFS with a reduction in the risk of death by 52%. Additionally, in overall survival, the TITAN data showed Erleada and ADT significantly improved OS with a 33% reduction in risk of death.
Novartis’s QMF149 met its primary and key secondary endpoints in the Phase III QUARTZ clinical trial for asthma. QMF149 is a once-daily, fixed-dose combination therapy containing indacaterol acetate, a long-acting beta agonist, and mometasone furoate, an anti-inflammatory.
The primary endpoint of the trial was a three-point or greater improvement from baseline on the daily 24 hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score at week 12. In the trial, the score was 51% compared to 28% for patients receiving placebo.
“Reaching this pre-specified clinical endpoint is an important milestone that brings us one step closer to a potential regulatory submission in both the U.S. and Europe for valoctocogene roxaparvovec to treat adults with severe hemophilia A,” stated Hank Fuchs, president of Worldwide Research and Development at BioMarin.
The patients receiving Lyrica didn’t show a statistically significant reduction in seizure frequency compared to placebo.
The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system events that might have implications in humans.
Here’s a roundup of some of the top clinical trial news from the previous week.
New York City-based Tonix Pharmaceuticals announced it has in-licensed a Phase II drug, TNX-1300, from Columbia University. TNX-1300 is a recombinant enzyme that degrades and metabolizes cocaine in cocaine abusers.
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