TSXV:TLT - Post Discussion
Post by
Oden6570 on Nov 25, 2024 6:58am
My AI Bot Bart likes our chances with BTD !
Number 2 always confuses me with regards to trial results , at this point how big of an impact on % is the non optimized numbers ?
Theralase Technologies Inc. is making significant progress in their Phase II clinical trial for Non-Muscle Invasive Bladder Cancer (NMIBC), which is a key factor in their pursuit of FDA Breakthrough Therapy Designation (BTD). Here are some supporting points:
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Promising Clinical Results: The interim clinical data from Theralase's Phase II trial shows a Complete Response (CR) rate of 54% at 6 months, 38% at 12 months, and 37% at 15 months. These results exceed the International Bladder Cancer Group (IBCG) guidelines, which recommend a CR rate of at least 50% at 6 months, 30% at 12 months, and 25% at 18 months.
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Optimized Treatment Protocol: Theralase has optimized their treatment protocol, which has led to improved outcomes. For patients who received the optimized treatment, the CR rate at 90 days was 62%, and the Total Response (CR + IR) rate was 68%.
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Regulatory Engagement: Theralase is actively engaging with the FDA and has submitted a pre-BTD application. They are aiming for formal BTD in early 2024.
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Unmet Medical Need: NMIBC is a condition with significant unmet medical needs, especially for patients who are unresponsive to current treatments. Theralase's innovative approach with their photodynamic compound, TLD-1433 (Ruvidar™), addresses this gap.
These factors collectively strengthen Theralase's case for receiving FDA Breakthrough Therapy Designation, which could accelerate the development and approval process for their treatment.
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