Nanospectra Biosciences Announces PNAS Publication of Initial Results of First Clinical Trial of Gold Nanoshell-Localized Photothermal Ablation of Prostate Tissue
HOUSTON, Aug. 27, 2019 /PRNewswire/ -- Nanospectra Biosciences, Inc., a medical device company pioneering a novel use of nanomedicine for selective thermal tissue ablation, announced today publication of first in human data of the company's AuroLase® Therapy for the focal ablation of prostate tissue. Initial study outcomes were published in the prestigious Proceedings of the National Academy of Sciences (PNAS) in a paper titled, 'Gold Nanoshell-Localized Photothermal Ablation of Prostate Tumors in a Clinical Pilot Device Study.'
The overall multi-site study, sponsored by Nanospectra Biosciences, utilized laser-excited gold-silica nanoparticles (GSN or AuroShells) in combination with multiparametic MRI (mpMRI)/ultrasound (US) fusion imaging, to focally ablate low to intermediate grade tumors within the prostate. GSN are designed to absorb near-infrared light at wavelengths of high tissue transparency, converting the light energy to heat, and provide a new and highly localized light-based strategy for the treatment of prostate cancer with substantially reduced risks of harmful treatment-related side effects.
"Jennifer West, bioengineer at Duke University, and I initiated development of the gold-silica nanoshells nearly 20 years ago," said Naomi J. Halas, PhD, Professor of Biophysics at Rice University, GSN inventor and original co-founder of Nanospectra Biosciences. "By varying the thickness of the gold outer shell, we demonstrated that we could tune the nanoshells to interact with specific wavelengths of light. By tuning the resonance beyond the visible and into the near-infrared region, we opened the door to a wide range of applications in nanomedicine."
Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths in men. The trend towards overtreatment of prostate cancer with whole gland treatments has highlighted a need for better focal therapies with fewer complications.
The pilot device study reports effectiveness and safety data from Mt. Sinai's first 16 enrolled subjects diagnosed with localized, low to intermediate risk prostate cancer. After GSN infusion and targeted laser ablation, patients underwent MRI of the prostate at 48 – 72 hours, followed by post-procedure mpMRI/US targeted fusion biopsies at three and 12 months, as well as a standard 12-core systematic biopsy at 12 months. GSN-mediated focal laser ablation was successfully achieved in 94% (15 of 16) patients. At the one-year study endpoint, 87.5% (14/16 lesions) were negative for tumor as confirmed by pathology and considered successful treatment outcomes.
"This first in human pilot device study demonstrates that GSN-directed laser excitation and ablation is a safe and technically feasible procedure for the targeted thermal destruction of prostate tumors and I am very excited to be part of this new frontier in nanomedicine," said lead study author and principal investigator, Ardeshir R. Rastinehad, DO, Department of Urology, Icahn School of Medicine at Mount Sinai. "The early results are very encouraging and with feasibility study enrollment now complete we anticipate publishing results at the initial three month endpoint for mpMRI targeted fusion biopsies for the entire 45 subject population early next year."
"As the first ultra-focal therapy for prostate cancer, AuroLase has the potential to maximize treatment efficacy while minimizing side effects associated with surgery, radiation, and traditional focal therapies," said David Jorden, CEO of Nanospectra. "We are encouraged by the clinical success of our feasibility study to date and look forward to the initiation, potentially next month, of the pivotal study with an expected cumulative treatment population of 100 subjects."
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 traditional 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.
A copy of the paper is available at: https://www.pnas.org/content/early/2019/08/20/1906929116
Rice University newsroom: www.news.rice.edu
Mount Sinai newsroom: www.mountsinai.org/about/newsroom
View original content to download multimedia:http://www.prnewswire.com/news-releases/nanospectra-biosciences-announces-pnas-publication-of-initial-results-of-first-clinical-trial-of-gold-nanoshell-localized-photothermal-ablation-of-prostate-tissue-300907322.html