On February 23, 2023 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug formulations, used to safely and effectively destroy various cancers, bacteria and viruses, reported that its Phase II clinical study ("Study II") interim data was recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Genito Urinary ("GU") Cancer Symposium via a moderated poster presentation (Press release, Theralase, FEB 23, 2023, View Source [SID1234628197]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Study II has been designed to treat patients diagnosed with Bacillus Calmette-Guérin ("BCG")-Unresponsive, Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary Ta/T1 disease) with a patented investigational study drug (TLD-1433) (Trade Name: Ruvidar), a ruthenium based PDC intravesically instilled into a patient’s bladder, then subsequently activated by a proprietary investigational study device (TLC-3200), a green (520 nm) laser system equipped with fiber-optic light emitters and detectors.
Girish Kulkarni M.D., Ph.D., FRCSC, Divisions of Urology and Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre, University Health Network, Professor, University of Toronto, (Toronto, Ontario, Canada), lead principal investigator of Study II stated, "Patients with BCG-Unresponsive CIS NMIBC have historically had limited treatment options other than bladder removal surgery to deal with this disease. I am encouraged by the positive interim results of the light-activated, intravesical study drug TLD-1433 (Trade Name: Ruvidar) currently under investigation by Theralase in Study II. The interim analysis of the clinical data collected from Study II to date supports that early results show complete response rates in 53% of patients evaluated at 90 days and 28 % of patients evaluated at 450 days. Based on the clinical data presented to date, Rudivar could represent a viable treatment option with an acceptable safety profile.
I look forward to enrolling and treating additional patients, alongside the other clinical study sites involved in Study II, to complete this study’s enrollment."
Arkady Mandel MD, Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase stated, "The high complete response rates and duration of this complete response without serious adverse events, directly related to the study drug or study device, indicates that intravesical Ruvidar is a promising alternative to existing therapies and compares favorably to other approved therapies; including: valrubicin, pembrolizumab and Adstiladrin. Ruvidar, as an intravesical monotherapy, has the potential to be introduced into mainstream medical practice, subject to regulatory approval, based on its one to two treatment methodology, high efficacy and high safety profile. One day we hope that Ruvidar will become the organ-sparing solution that is a game-changer for both patients and physicians."
The poster presented at the ASCO (Free ASCO Whitepaper) GU Cancer Symposium can be found on the Company’s website at www.theralase.com/ASCO_Poster.
About ASCO (Free ASCO Whitepaper)
Founded in 1964, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer.
About Study II
Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 (90 J/cm2) medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the United States.
About TLD-1433 (Ruvidar TM)
TLD-1433 is a patented PDC with 12 years of published peer reviewed preclinical research and is currently under investigation in Study II.
The trade name Ruvidar was selected by the Company, as Ru is the element symbol for Ruthenium, a rare transition metal belonging to the platinum group, which the Theralase PDC is based upon, vita is Latin for life and dar is Russian for gift; hence, roughly translated, "Ruthenium, the gift of life".