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Cancer-fighting pharma stock eyes 2027 regulatory approval

Trevor Abes , The Market Online
0 Comments| May 2, 2024

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  • Theralase Technologies (TSXV:TLT), a cancer-fighting pharma stock, has expanded its team with two clinical research associates
  • Bhavya Bajantri and Sonia Keshwani are tasked with completing the ongoing Phase II bladder cancer clinical study testing Ruvidar (TLD-1433), Theralase’s drug candidate to destroy solid tumors using its photo dynamic compound technology
  • Theralase is a clinical-stage pharmaceutical stock focused on safely and thoroughly destroying various cancers, bacteria and viruses
  • Theralase stock has given back 28.26 per cent year-over-year, and 64.89 per cent since 2019

Theralase Technologies (TSXV:TLT), a cancer-fighting pharma stock, has expanded its team with two clinical research associates.

Bhavya Bajantri M.Sc., CCRP, and Sonia Keshwani B.Sc., CCRP, were onboarded effective March 4 and May 1, 2024, respectively, to help to complete the ongoing Phase II bladder cancer clinical study of Ruvidar (TLD-1433), Theralase’s drug candidate to destroy solid tumors using photo dynamic compounds, which can be activated by laser light to produce a form of oxygen, known as singlet oxygen, that kills cancer cells upon absorption. The new hires’ responsibilities include:

  • Launching new clinical study sites in Canada and the United States.
  • Enrolling all patients into the clinical study in 2024.
  • Reviewing and analyzing existing clinical data.
  • Securing review ethics board approval and patient consent to obtain clinical data for up to three years after the primary study procedure.
  • Providing training and support on pathology analysis for urine cytology and bladder biopsy samples.
  • Supporting Breakthrough Designation approval from the U.S. Food and Drug Administration (FDA) in Q3 2024, which requires clinical assessment data for efficacy, duration of efficacy and safety for 20-25 patients. The FDA granted Ruvidar the Fast Track Designation in November 2020.

Theralase intends to enroll and treat 100 to 125 patients in approximately 20 clinical sites across Canada and the United States, with its sights set on addressing a multi-billion-dollar unmet need in the global bladder cancer market to lower morbidity and mortality, and improve quality of life.

If all patients are enrolled by the end of 2024 or early 2025, the company believes it can complete primary patient follow-ups by mid-2026, positioning Ruvidar for potential Health Canada and FDA approval by the end of 2026 or early 2027.

Management insights

“The company looks forward to working with Bhavya and Sonia in their new roles and their participation in the successful and timely completion of Study II,” Roger DuMoulin-White, Theralase’s president and chief executive officer, said in a statement. “The ultimate goal of our ongoing Phase II clinical study is to commercialize Ruvidar in Canada, the United States and internationally to provide a safe and effective treatment for as many patients as possible who are afflicted with this deadly disease.”

About Theralase Technologies

Theralase is a clinical-stage pharmaceutical stock researching and developing light-activated compounds, their associated drug formulations and the light systems that activate them, with the goal of safely and thoroughly destroying various cancers, bacteria and viruses.

Theralase stock (TSXV:TLT) last traded at C$0.16 per share. The stock has given back 28.26 per cent year-over-year, and 64.89 per cent since 2019.

Join the discussion: Find out what everybody’s saying about this pharma stock on the Theralase Technologies Inc. Bullboard, and check out the rest of Stockhouse’s stock forums and message boards.

The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here.




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