In 2019, it is estimated that 80,470 adults (61,700 men and 18,770 women) were given a bladder cancer diagnosis in the United States.
This is the fourth most common cancer among men (also the eighth most common cause of cancer death among men) and it is estimated will be the cause behind 17,670 deaths (12,870 men and 4,800 women) this year.
The bladder cancer market is expected to grow to around $1.1 billion in 2025, triple the size it is now.
This is a market targeted by anti-cancer drug pioneers Theralase Technologies Inc. (TSX: V.TLT, OTCQB: TLTFF, Forum). This clinical-stage pharmaceutical and medical device company is researching and developing light-activated Photo Dynamic Compounds and their associated drug formulations with the intent to target and safely and effectively destroy various cancer cells
In 2018, the Company successfully completed the first phase of its clinical study titled: “A Phase Ib Trial of Intravesical Photodynamic Therapy in Patient with Non-Muscle Invasive Bladder Cancer (“NMIBC”) at High Risk of Progression Who are Refractory to Therapy with Bacillus Calmette-Guérin (“BCG”) and Who are Medically Unfit for or Refuse a Cystectomy”. The results demonstrated that Theralase’s therapy was generally safe and well tolerated at 180 days post treatment – neither phototoxicity (commonly associated with PDT) nor kidney muscle damage (associated with red laser light-based PDT such as Photofrin) was reported. In terms of efficacy, two patients on the therapeutic dose cohort achieved durable complete responses (“CR”) on Day 360 – representing a 67% CR rate at 1 year post treatment.
In August 2019, the Company officially launched the second phase of its clinical study titled: “A Phase II Clinical Study of Intravesical Photodynamic Therapy in Patients with BCG Unresponsive NMIBCor Patients who are Intolerant to BCG Therapy” (aka “Study II”). The first patient has been treated at the University Health Network in Toronto.
Study II will focus on the treatment of approximately 100 BCG-Unresponsive NMIBC patients presenting with Carcinoma In-Situ in around 20 clinical study sites around Canada and the US. The study checks on patients by observing three distinct end points.
The primary endpoint of efficacy with this study will be measured by Carcinoma In-Situ patients with resected papillary disease who show complete response at any time point post-treatment with a duration of CR evaluated at approximately 360 days post-treatment.
The Company defines complete response in patients as any of the following.
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Negative cystoscopy and negative (including atypical) urine cytology (no cancer detected in urine
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Positive cystoscopy (cancer detected in bladder) with biopsy-proven benign or low-grade NMIBCNegative cystoscopy with malignant urine cytology (no cancer detected in urine), if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative
(Chart via Theralase. Click to enlarge.)
The third endpoint of the study will be evaluated by any occurrence, rate, frequency and / or severity of adverse events that are life-threatening or disabling.
Theralase Chief Scientific Officer Arkady Mandel, M.D., Ph.D., D.Sc. called the initiation of patient treatment in this Phase II study a significant milestone for the Company's Photo Dynamic Therapy research and development programs.
“NMIBC is a recurrent and progressive cancer, which Theralase believes it’s TLD-1433 therapy can make a significant difference in. Current standards of care for NMIBC including BCG, chemotherapy and immunotherapy, are not curative in nature and unfortunately are associated with considerable morbidity. This underscores the urgent need for new treatment options like Theralase’s TLD-1433 PDT for patients contending with this debilitating and fatal disease.”
The Company’s CEO of its Drug Division, Shawn Shirazi, added that treating this first patient in a pivotal Phase II clinical study is the beginning of an exciting journey for Theralase, that is aimed to demonstrate to both the public and the scientific community what the Company is capable of.
“Our clinical research team is working diligently on patient enrollment and on-boarding of additional Canadian and US study sites, subject to regulatory approval. If Study II can duplicate the efficacy results demonstrated in the Phase 1b NMIBC Clinical Study, Theralase will have an opportunity to be the next gold standard for patients with NMIBC, subject to regulatory approval.”
In the US alone, Bladder cancer is a multi-billion dollar cancer treatment market. NMIBC is a form of bladder cancer for which existing treatment options provide a very low success rate. In 2019, Theralase Technologies Inc. already reported in a previous news release that two patients were cancer-free after 360 days, which is a solid indication that this Company is on to something.
https://theralase.com/
FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.