Plus Therapeutics: 1st patient dosed in rhenium study obisbemeda to treat GBM

Plus Therapeutics announced that the first patient has been dosed in the ReSPECT-GBM Phase 2b dose expansion clinical trial evaluating rhenium obisbemeda for the treatment of recurrent glioblastoma ,GBM. This Phase 2b multi-center trial is designed to evaluate the safety, tolerability, distribution and efficacy of rhenium obisbemeda infused directly into the tumor via convection-enhanced delivery catheters in patients with recurrent GBM progressing after conventional treatment. "In the Phase 1/2a dose escalation trial, we showed that a rhenium obisbemeda radiation dose of 22.3 mCi in an infused volume of 8.8 mL can be safely administered and that there is a statistically significant correlation between overall survival and both absorbed radiation dose to the tumor and percent tumor volume in the treated volume," said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery, Kolitz/Zachry Endowed Chair Neuro-Oncology Research, and Co-Leader of the Experimental and Developmental Therapeutics Program at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-GBM clinical trial. "The strength of this correlation is unusually positive for a Phase 1/2a trial and we are optimistic that these safety and efficacy signals will be confirmed in the ongoing Phase 2b trial." The Phase 2b trial is expected to enroll up to 31 additional patients with small- to medium-sized tumors in approximately 24 months. The trial is supported by an award from the National Cancer Institute , part of the U.S. National Institutes of Health . "We have successfully completed two of our key near-term clinical development goals, specifically to manufacture cGMP rhenium or 186Re,obisbemeda and move our glioblastoma program into Phase 2b," said Norman LaFrance, M.D., Chief Medical Officer and Senior Vice President at Plus Therapeutics. "The treatment of our first patient went well with excellent targeted tumor delivery of high dose rhenium obisbemeda, similar to that seen at this same dose in our Phase 1/2a trial. Moving forward this year, our focus will be to expand the trial sites and ramp up enrollment to accelerate clinical development of this novel treatment option."