Studie II

Theralase® Releases FY2022 Audited Financial Statements

Retrieved on: 
Wednesday, April 26, 2023
ACT, Advertising, Phipps Institute for the Study, Treatment and Prevention of Tuberculosis, Clinical trial, COVID-19, Lead, BTD, Unit, Research, Trial of the century, Corporation, PDC, Patient, Cystoscopy, Principal, Biostatistics, Phase, FDA, Total, Pharmaceutical industry, Security (finance), Medical device, Studie II, Ruthenium, Mining

Selling expenses for the year ended 2022, decreased to $301,359, from $363,886 in 2021 (17% decrease).

Key Points: 
  • Selling expenses for the year ended 2022, decreased to $301,359, from $363,886 in 2021 (17% decrease).
  • The decrease in selling expenses is primarily attributed to the COVID-19 pandemic, resulting in reduced advertising (51%) and salaries (17%).
  • Administrative expenses for the year ended 2022, decreased to $1,277,253 from $1,562,867 in 2021, (18% decrease).
  • Net research and development expenses for the year ended 2022, increased to $4,281,106 from $2,924,733 in 2021 (46% increase).

Theralase® Phase II NMIBC Clinical Study (Interim) Data Presented at the ASCO GU Cancer Symposium

Retrieved on: 
Thursday, February 23, 2023
Bacteria, University of Toronto, Princess Margaret Cancer Centre, Pembrolizumab, University, Trade, FRCSC, CIS, Disease, MAK Technologies, Inc., Interim, Virus, University Health Network, Research, Patient, Trial of the century, TLT, Surgical oncology, Cancer, Urinary bladder, American Society of Clinical Oncology, PDC, Poster, Ruthenium, Society, Pharmaceutical industry, Urology, Studie II

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.

Key Points: 
  • 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.
  • One day we hope that Ruvidar™ will become the organ-sparing solution that is a game-changer for both patients and physicians.”

Theralase® Phase II NMIBC Clinical Study (Interim) Data to be Presented at the AUA Annual Meeting

Retrieved on: 
Thursday, February 2, 2023
TLT, Virus, NMIBC, Safety, Patient, Studie II, Trial of the century, Cancer, PDT, Poster, University of Toronto, Metabolic Technologies, Inc., FRCSC, University Health Network, University, American Urological Association, Interim, Princess Margaret Cancer Centre, Bacteria, Surgical oncology, Research, AUA, Pharmaceutical industry, Urology

The AUA annual meeting will take place between April 28th to May 1st, 2023 in Chicago, Illinois with the poster presented for general viewing and discussion within one of the moderated poster sessions, during the AUA annual meeting.

Key Points: 
  • The AUA annual meeting will take place between April 28th to May 1st, 2023 in Chicago, Illinois with the poster presented for general viewing and discussion within one of the moderated poster sessions, during the AUA annual meeting.
  • The poster will include interim clinical data and analysis collected through the enrollment and treatment of patients at all Canadian and US clinical study site by their respective principal investigators for Study II.
  • Arkady Mandel MD, Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase® stated, “I am delighted that Theralase® will have the opportunity to showcase its latest reported interim clinical data and analysis for Study II at the AUA annual meeting to leading uro-oncologists from around the world.
  • Based on the clinical data collected to date, PDT could represent a viable treatment option with an acceptable safety profile.”

Theralase® Phase II NMIBC Clinical Study (Interim) Data to be Presented at the ASCO GU Cancer Symposium

Retrieved on: 
Wednesday, January 25, 2023
TLT, Virus, Society, NMIBC, Studie II, American Society of Clinical Oncology, Trial of the century, Cancer, Poster, Prostate cancer, University of Toronto, Metabolic Technologies, Inc., Squamous cell carcinoma, FRCSC, University Health Network, University, ASCO, Interim, Princess Margaret Cancer Centre, Bacteria, Surgical oncology, Research, Pharmaceutical industry, Patient, Urology

The GU-ASCO cancer symposium will take place between February 16th to 18th, 2023 in San Francisco, California with the poster presented for general viewing and discussion within Poster Session B: Prostate Cancer and Urothelial Carcinoma on February 17, 2023 at 12:30 PM to 2:00 PM and 5:15 PM to 6:15 PM.

Key Points: 
  • The GU-ASCO cancer symposium will take place between February 16th to 18th, 2023 in San Francisco, California with the poster presented for general viewing and discussion within Poster Session B: Prostate Cancer and Urothelial Carcinoma on February 17, 2023 at 12:30 PM to 2:00 PM and 5:15 PM to 6:15 PM.
  • The poster titled: “A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Patients with BCG-Unresponsive NMIBC (interim analysis)” will be presented by the lead author, 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).
  • The poster will include interim clinical data and analysis collected through the enrollment and treatment of patients at all Canadian and US clinical study site by their respective principal investigators for Study II.
  • Arkady Mandel MD, Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase® stated, “I am delighted that Theralase® will have the opportunity to showcase its latest reported interim clinical data and analysis for Study II at the coveted ASCO GU Cancer Symposium to leading uro-oncologists from around the world.”

Theralase Releases Q322 Interim Financial Statements

Retrieved on: 
Tuesday, November 29, 2022
Toxicology, COVID-19, PHAC, CR, NRC, Studie II, TSX, CRA, Cancer, Health Canada, Risk, PDC, Safety, Bacteria, TSX Venture Exchange, Patient, Trial of the century, Non, Public Health Agency of Canada, GLP, TTSA, Good laboratory practice, News, CT scan, Biopsy, Virus, Research, Technical Service Council, National Research Council, Squamous cell carcinoma, Data analysis, Coronavirus, Animal, Severe acute respiratory syndrome coronavirus 2, UCC, FDA, Pharmaceutical industry, Vaccine

Theralase plans to commence GLP toxicology studies in animals in 4Q2022.

Key Points: 
  • Theralase plans to commence GLP toxicology studies in animals in 4Q2022.
  • Such statements include, but are not limited to, statements regarding the Company's proposed development plans with respect to Photo Dynamic Compounds and their drug formulations and a COVID-19 vaccine.
  • All forward-looking statements are made as of the date hereof and are subject to change.
  • Except as required by law, the Company assumes no obligation to update such statements.

Theralase Releases Q222 Interim Financial Statements

Retrieved on: 
Tuesday, August 30, 2022
GLP, COVID-19, CRA, Safety, PHAC, Research, Good laboratory practice, Coronavirus, Virus, Interim, Phase, TSX Venture Exchange, TSX, Animal, Severe acute respiratory syndrome coronavirus 2, Public Health Agency of Canada, National Microbiology Laboratory, Company, PDC, News, Cancer, Non, Toxicology, Studie II, Risk, Bacteria, Trial of the century, Patient, Vaccine, Pharmaceutical industry

Theralase plans to commence GLP toxicology studies in animals in 4Q2022.

Key Points: 
  • Theralase plans to commence GLP toxicology studies in animals in 4Q2022.
  • Such statements include, but are not limited to, statements regarding the Company's proposed development plans with respect to Photo Dynamic Compounds and their drug formulations and a COVID-19 vaccine.
  • All forward-looking statements are made as of the date hereof and are subject to change.
  • Except as required by law, the Company assumes no obligation to update such statements.

Theralase Expands Intellectual Property Portfolio

Retrieved on: 
Tuesday, June 28, 2022
TSX Venture Exchange, Patient, PDC, Research, TSX, Trial of the century, MAK Technologies, Inc., Non-small-cell lung carcinoma, Studie II, GLOBE, Mechanism of action, COVID-19, Cancer, Company, AES, Health Canada, Bacteria, Risk, IP, Reactive oxygen species, Technology, Singlet oxygen, Virus, Safety, Incidence, CR, TLT, Time, Intellectual property, Patent, News, Glioblastoma, Recurrence, NMIBC, Interim, Christian democracy, Pharmaceutical industry

Theralase has recently been granted a Brazilian patent for, Metal-Based Thiopene Photodynamic Compounds and their Use (Patent).

Key Points: 
  • Theralase has recently been granted a Brazilian patent for, Metal-Based Thiopene Photodynamic Compounds and their Use (Patent).
  • The patent advances Theralases intellectual property portfolio internationally strengthening the patent portfolio around the Anti-Cancer Technology (ACT) platform.
  • This patent further strengthens the extensive portfolio of patents already held by Theralase.
  • Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive Officer (CEO) and Chief Scientific Officer (CSO), Theralase stated that, This patent is strategic to opening up new international opportunities for Theralase by expanding its IP portfolio of medical laser and oncology focused technologies internationally.

Theralase® Phase Ib NMIBC Clinical Study Published

Retrieved on: 
Tuesday, June 21, 2022
Population, Department, PDC, University of Toronto, Surgical oncology, Princess Margaret Cancer Centre, University, Incidence, GLOBE, Medicine, University Health Network, Time, Cancer, Division, Studie II, Coronavirus Scientific Advisory Board (Turkey), UHN, PDT, Interim, News, Bacteria, Urinary bladder, TSX Venture Exchange, COVID-19, TSX, BCG, Decision-making, Trial of the century, Virus, CR, Professional, TLT, AES, Daou Technology Inc., Risk, Safety, Particle-size distribution, Company, Pharmacokinetics, Research, Standard of care, NMIBC, Pharmaceutical industry, Medical device, Patient, Study, Urology

As a result, the Medical and Scientific Advisory Board (MSAB) unanimously agreed that Theralase should further investigate PDT in a multi-site, pivotal Phase II NMIBC Clinical Study (Study II).

Key Points: 
  • As a result, the Medical and Scientific Advisory Board (MSAB) unanimously agreed that Theralase should further investigate PDT in a multi-site, pivotal Phase II NMIBC Clinical Study (Study II).
  • Study II is currently underway at 5 Clinical Study Sites (CSS) in Canada and 7 CSSs in the United States, with 41 patients treated to date.
  • I am fully supportive of the multi-site Phase II NMIBC clinical study, currently in progress, to further investigate the role of PDT in BCG-Unresponsive NMIBC.
  • Indeed, the publication of clinical results in a peer reviewed journal like EUOS validates the quality of the Theralase research and the professionalism of the clinical study team, who conducted it.

Theralase Releases Q122 Interim Financial Statements

Retrieved on: 
Monday, May 30, 2022
Cancer, Severe acute respiratory syndrome coronavirus 2, Data analysis, Risk, Company, National Microbiology Laboratory, Toxicology, News, Patient, TSX Venture Exchange, Bacteria, Good laboratory practice, Coronavirus, GLP, COVID-19, Trial of the century, TSX, Research, PDC, CRA, Studie II, Virus, Safety, Public Health Agency of Canada, PHAC, Animal, Non, CR, Pharmaceutical industry, Vaccine

For a more comprehensive analysis of the interim data please refer to Managements Discussion and Analysis (MD&A) for the three-month period ended March 31, 2022.

Key Points: 
  • For a more comprehensive analysis of the interim data please refer to Managements Discussion and Analysis (MD&A) for the three-month period ended March 31, 2022.
  • Such statements include, but are not limited to, statements regarding the Company's proposed development plans with respect to Photo Dynamic Compounds and their drug formulations and a COVID-19 vaccine.
  • All forward-looking statements are made as of the date hereof and are subject to change.
  • Except as required by law, the Company assumes no obligation to update such statements.

Theralase Release FY2021 Audited Financial Statements

Retrieved on: 
Saturday, April 30, 2022
National Microbiology Laboratory, Studie II, Virus, TSX, Public Health Agency of Canada, Cancer, Patient, CRA, PHAC, Data analysis, TSX Venture Exchange, COVID-19, Bacteria, Good laboratory practice, Toxicology, PDC, Animal, Company, GLP, News, Research, Coronavirus, Trial of the century, Risk, Severe acute respiratory syndrome coronavirus 2, Non, Safety, Medical device, Pharmaceutical industry, Audit, Vaccine

Such statements include, but are not limited to, statements regarding the Companys proposed development plans with respect to Photo Dynamic Compounds and their drug formulations and a COVID-19 vaccine.

Key Points: 
  • Such statements include, but are not limited to, statements regarding the Companys proposed development plans with respect to Photo Dynamic Compounds and their drug formulations and a COVID-19 vaccine.
  • Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.
  • All forward-looking statements are made as of the date hereof and are subject to change.
  • Except as required by law, the Company assumes no obligation to update such statements.