ArQule (NASDAQ: ARQL) this morning said that the first patient has been dosed in its phase 1a/b trial with ARQ 531 in patients with B-cell malignancies that do not respond well to other approved therapies. ARQ 531 is an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK). The phase 1a portion of the trial aims to establish a recommended dose through a dose escalation study open to all refractory patients. The company’s goal for the phase 1b portion will be to establish proof of concept and early signs of activity. “Our clinical strategy is to rapidly identify a recommended dose and then begin to enroll a number of expansion cohorts including one dedicated to patients with the C481S mutation,” ArQule head of research and development and Chief Medical Officer Dr. Brian Schwartz, M.D., stated in the news release.
To view the full press release, visit: http://nnw.fm/nOPi1
ArQule is a biopharmaceutical company engaged in the research and development of targeted therapeutics to treat cancers and rare diseases. ArQule’s mission is to discover, develop and commercialize novel small molecule drugs in areas of high unmet need that will dramatically extend and improve the lives of patients. The company’s clinical-stage pipeline consists of five drug candidates, all of which are in targeted, biomarker-defined patient populations. ArQule’s proprietary pipeline includes: ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family, in phase 2 for iCCA and in phase 1b for multiple oncology indications; ARQ 092, a selective inhibitor of the AKT serine/threonine kinase, in a phase 1/2 company sponsored study for Overgrowth Diseases, in a phase 1 study for ultra-rare Proteus syndrome conducted by the National Institutes of Health (NIH), as well as in multiple oncology indications; ARQ 751, a next generation AKT inhibitor, in phase 1 for patients with AKT1 and PI3K mutations; and ARQ 761, a β-lapachone analog being evaluated as a promoter of NQO1-mediated programmed cancer cell necrosis, in phase 1/2 in multiple oncology indications in partnership with the University of Texas Southwestern Medical Center. In addition, the company has advanced ARQ 531, an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant BTK, in phase 1 for patients with B-cell malignancies refractory to other therapeutic options. ArQule’s current discovery efforts are focused on the identification and development of novel kinase inhibitors, leveraging the company’s proprietary library of compounds. For more information, visit www.arqule.com.
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