ProNAi Therapeutics (DNAI +1.7%) commences a 50-subject Phase 2 clinical trial, called Brighton, assessing lead product candidate PNT2258 in patients with Richter's transformation, a condition affecting 5 - 10% of chronic lymphocytic leukemia and hairy cell leukemia patients in which their cancer changes into a fast-growing diffuse large B cell lymphoma. The prognosis is poor with an average survival of only one year. There are no approved treatments for the disease.The primary endpoint of the single-agent, open-label trial is overall response rate. Secondary endpoints include disease control rate (complete responders + partial responders + those with stable (no progression) disease), duration of overall response, time to response, progression-free survival and overall survival. According to clinicaltrials.gov, the estimated final data collection date is October 2017 and the estimated study completion date is July 2019.PNT2258 is a proprietary formulation of a single-stranded 24-base DNAi oligonucleotide known as PNT100 that is encapsulated in a proprietary liposomal nanoparticle. Once injected, it delivers PNT100 into the nuclei of cancer cells where it is designed to target and interfere with an oncogene called BCL2, inhibiting its transcription.
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