Shots:
- Relmada has reported initial P-II trial data assessing NDV-01 in 20 pts with HG-NMIBC (8 BCG-naïve, 12 BCG-unresponsive), where 2 pts had CIS & 18 had papillary disease (Ta/T1); 26 pts are enrolled, with 20 reaching 3mos. & 7 reaching 6mos. assessments
- Trial showed 85% ORR, 83.3% HGRFS in Ta/T1, & 100% CR in CIS pts at 3mos.; 90% ORR, 88.8% HGRFS in Ta/T1, & 100% CR in CIS at any time, with all 7 evaluable pts (1 CIS & 6 Ta/T1) achieving disease-free status, incl. 1 of these, who was re-treated at 3mos
- NDV-01 is an intravesical formulation of gemcitabine & docetaxel that forms a soft matrix in the bladder, allowing 10-day drug release without anesthesia or special equipment, with patent protection through 2038
Ref: GlobeNewswire | Image: Relmada Therapeutics
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