Nanospectra Biosciences Announces Enrollment Completion of Pivotal Study of AuroLase Therapy for Ablation of Prostate TissueEnd of Study Top-line Data Available Late-2022
HOUSTON, Nov. 02, 2021 (GLOBE NEWSWIRE) -- Nanospectra Biosciences, Inc., a medical device company pioneering a novel use of nanomedicine for selective photothermal ablation, today announced the completion of enrollment of its open-label, multi-center, single-treatment pivotal study of AuroLase Therapy for focal ablation of prostate tissue via nanoparticle directed near infrared irradiation. The Company expects preliminary six-month follow-up data to be available mid next year with the complete data set in 4Q 2022 concurrent with expected submission for US regulatory clearance.
“I would like to thank the investigators and their clinical research teams for their remarkable work on this study, especially given challenges navigating the Covid pandemic,” said David Jorden, CEO of Nanospectra. “Completion of trial enrollment establishes the timeline of final data availability and submission for FDA marketing clearance of our AuroLase Therapy for prostate tissue ablation.”
AuroLase®, Nanospectra’s lead product, is the first and only ultra-focal ablation therapy designed to maximize treatment efficacy while minimizing side effects typically associated with surgery, radiation, and alternative focal therapies. The pivotal study enrolled 60 patients at nine clinical trial sites throughout the U.S. and followed the successful first-in-human feasibility study that enrolled 46 subjects at three U.S. sites. The combined dataset from both studies will constitute the clinical package Nanospectra will submit to the FDA.
“I am pleased to have led such a ground-breaking trial, which is poised to have an indelible impact on patients’ lives and the continued evolution of standard of care for localized prostate cancer,” said Dr. Ardeshir Rastinehad, Vice Chair of Lenox Hill Urology and System Director of Prostate Cancer/Northwell Health System and the study’s national principal investigator. “I am strongly encouraged by the results of the feasibility study and the data that we have seen thus far in the extension study as it relates to oncologic control, maintenance of patient functional outcomes, and an absence of adverse side effects.”
Efficacy of focal ablation of prostate tissue is being assessed by MRI/Ultrasound guided target biopsy six months after the particle-mediated ablation procedure and at one year via both targeted biopsy and standard systematic biopsy. Per standard of care, patient follow up continues beyond the one-year study visit but is outside the scope of the study. However, patients have been consented for up to five years to track their disease status and progression or recurrence, if any.
“The side effects of prostate cancer treatments are well known and may lead some men to delay or not seek screenings or treatment,” said Steven E. Canfield, M.D., Professor and Chief Division of Urology, Edward J McGuire, MD Distinguished Chair, McGovern Medical School, UTHealth Houston. “To date, the AuroLase clinical trial has been very successful and I see a future pathway where this treatment will be a commonly used and accepted procedure for men with localized prostate cancer.”
Dr. Steven E. Canfield and the research effort at University of Texas Health Science Center, including Nanospectra’s AuroLase Therapy, was profiled by the American Urological Association and highlighted in a 5-minute film at this year’s virtual annual meeting as well as 2022’s planned annual conference in New Orleans. The segment covering the AuroLase clinical study begins at around the 1:30 mark and continues until the end.
“As we continue to follow these patients and evaluate the final data, we will begin preparing to evaluate additional clinical applications for our AuroLase Therapy within prostate cancer, as well as other cancer sites amenable to targeted focal therapy,” added Jorden.
About Nanospectra Biosciences
Nanospectra Biosciences is a privately-held medical device company, pioneering the patient-centric use of nanomedicine for selective thermal ablation. AuroLase®, the company’s lead product, is the first ultra-focal therapy for prostate cancer. Nanospectra’s ultra-focal approach maximizes treatment efficacy while minimizing side effects associated with current treatments, including surgery, radiation, and alternative focal therapies. Implementing a multi-prong growth strategy, Nanospectra is focusing on clinical advancements, exclusive partnering agreements and ongoing research and development. Nanospectra’s technology development has been funded to date by a series of grants, private equity investments and corporate partnerships.
For more information visit http://www.nanospectra.com.