Nanospectra Biosciences, Inc., a medical device company pioneering a novel use of nanomedicine for selective thermal ablation, today announced the addition of four clinical trial sites to its ongoing AuroLase® pivotal study. T
| HOUSTON, Aug. 4, 2020 /PRNewswire/ -- Nanospectra Biosciences, Inc., a medical device company pioneering a novel use of nanomedicine for selective thermal ablation, today announced the addition of four clinical trial sites to its ongoing AuroLase® pivotal study. The extension study is designed to determine the efficacy of using MRI/ultrasound fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser ablation. Three of the four sites are open for patient screening and study accrual now while the fourth site is fully approved and will be ready to initiate study accrual by this fall.
The AuroLase pivotal study follows the successful first-in-human pilot study that enrolled 46 subjects at three U.S. sites. Pandemic related delays to the one-year end of study biopsies for the final subset of feasibility study subjects should be resolved within the next several weeks and, consequently, final results of the feasibility study are expected later this year. To date, eight patient procedures in the pivotal trial have been completed with 10 subjects enrolled at the initial two participating sites. These carryover sites from the prior study are joined by the following prestigious institutions and lead investigators:
“The high caliber of participating clinical trial sites and expert investigators is a testament to the quality of our science and the unmet clinical need for AuroLase Therapy,” said David Jorden, CEO of Nanospectra. “Tens of thousands of U.S. men with localized prostate cancer undergo traditional radical treatment each year, resulting in significant but still likely underreported negative impact to quality of life. We believe these men to be viable candidates for a truly effective and patient-centric focal therapy. As the first ultra-focal therapy, AuroLase has the potential to offer the important oncologic control and return men to their normal lifestyle more quickly and with significantly fewer side effects than surgery, radiation or alternative focal therapies.” The pivotal study is an open-label, multi-center, single-treatment study of AuroLase Therapy for the focal ablation of prostate tissue via nanoparticle directed near infrared irradiation and is approved by the FDA under the original Investigational Device Exemption. Up to sixty patients will be enrolled at up to eight clinical trial sites throughout the U.S. “End of study clinical and functional outcomes of the initial subset of subjects in the feasibility study were very encouraging with 13 of the first 15 prostate cancer patients treated showing no detectable signs of cancer upon biopsy a year after treatment,” said Dr. Ardeshir Rastinehad, Vice Chair of Lenox Hill Urology and System Director of Prostate Cancer/Northwell Health System and the overall clinical program’s national principal investigator. “This is an exciting and intrinsically novel technology that now has the ability to reach its full potential due to advancements in visualization and targeting and unlock some of the promise underlying nanomedicine.” For additional information on the pivotal study titled “An Extension Study of MRI/US Fusion Imaging and Biopsy in Combination with Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue” visit www.clinicaltrials.gov referencing NCT04240639. About AuroLase Therapy About Nanospectra Biosciences Note: AuroLase is an investigational device and not approved for sale or distribution. Contact Information
SOURCE Nanospectra Biosciences |
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