TORONTO, June 11, 2021 (GLOBE NEWSWIRE) — Theralase Technologies , a clinical stage pharmaceutical company dedicated to the research and development of innovative Anti-Cancer Therapytechnologies intended to safely and effectively destroy various cancers, bacteria and viruses, while preserving patient Quality Of Life announced today the launch of the seventh US-based Clinical Study Site ; specifically, the University of Chicago Medicine. UChicago Medicine has successfully received Institutional Review Boardapproval allowing them to commence enrollment and treatment of patients in Theralase’s pivotal Phase II Non-Muscle Invasive Bladder Cancer Clinical Study.
Study II is focused on the enrollment and treatment of approximately 100 to 125 patients, who have been previously diagnosed with Bacillus Calmette Guérin-Unresponsive Carcinoma In-Situ or who are intolerant to BCG therapy.
The Company has successfully launched five CSSs in Canada and 7 in the US for patient enrollment and treatment in Study II.
UChicago Medicine, with a history dating to 1927, is a not-for-profit academic medical health system based on the campus of the University of Chicago in Hyde Park, with hospitals, outpatient clinics and physician practices located throughout Chicago and its suburbs. UChicago Medicine translates fundamental scientific discoveries into better care for their patients and performs more clinical trials than any other hospital in Illinois.
Dr. Piyush Agarwal, MD, Professor of Surgery and Urology, Director, Bladder Cancer Program, Fellowship Director, Urologic Oncology, at UChicago Medicine stated, “This technology harnesses the power of near infrared light produced by a laser to destroy localized bladder cancer cells that have not responded to standard of care therapy such as BCG. It gives patients an option to consider before bladder removal.”
Dr. Agarwal’s clinical and laboratory research focuses primarily on bladder cancer, specifically BCG-Unresponsive disease, the urinary microbiome, molecular targeted therapy and immunotherapy. He has conducted several original, investigator-initiated clinical studies and has presented his research at national and international meetings. Dr. Agarwal has served on the Food and Drug Administrations oncologic drug advisory committee and has authored six book chapters and over 90 manuscripts.
The first US-based patient in Study II was recently treated at Virginia Urology.
VU has a long history of providing quality care to the Greater Richmond metro area for over 75 years. VU prides itself on its strong commitment to the community’s urological needs by recruiting highly skilled physicians and using the latest technology. VU is comprised of over 40 physicians that include urologists and urogynecologists as well as physicians specializing in the urologic aspect of anesthesiology, pathology, radiation oncology, and radiology. Because VU has such diverse medical professionals, they are able to provide the latest technologies with their mission of providing the best possible care for each patient.
To date, Study II has enrolled and provided the primary study treatment for 20 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 23 patients.
Shawn Shirazi, PhD, Chief Executive Officer of Theralase, stated, “It is exciting to see Theralase clear another hurdle by treating the first patient in the US and move one step closer to achieving its next milestone of enrolling and treating twenty-five patients in early 2021. Once completed, Theralase plans to submit the clinical assessment data on the first twenty-five patients treated in Study II to the FDA for consideration of Break Through Designatio status.”
About Theralase Technologies Inc.
Theralase is a clinical stage pharmaceutical company dedicated to the research and development of innovative Anti-Cancer Therapy technologies intended to safely and effectively destroy various cancers, bacteria and viruses, while preserving patient Quality Of Life.
Additional information is available at www.theralase.com and www.sedar.com
For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.com
Kristina Hachey, CPA
Chief Financial Officer
khachey@theralase.com
416.699.LASE (5273) x 224