A new treatment for bladder cancer could offer a higher quality of life for patients for an extended period of time compared to existing therapies.
Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF), a Canadian pharmaceutical company, is in the midst of a Phase II clinical study for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS) that so far has shown positive results.
While most oncology drugs in use are administered straightforwardly, such as through intravenous or intravesical installations, Theralase’s approach involves a unique drug-device combination. The drug, activated by light, is introduced into the bladder, selectively targeting bladder cancer cells. The bladder is then drained, refilled with sterile water, and a fiber optic is inserted to light activate the drug.
The distinctive feature of this technology lies in its ability to eradicate cancer cells while sparing healthy ones, minimizing adverse effects. Unlike conventional pharmacological approaches that often result in significant side effects due to damage to healthy cells, their method has shown no serious adverse events associated with the study drug or device.
The Theralase Anti-Cancer Therapy (ACT) technology provides superior patient efficacy, safety and is minimally invasive with a high quality of life index for the patient. In the near future, the company believes it will be the next standard of care for a number of cancer indications.
Proactive spoke with Theralase’s CEO Roger DuMoulin-White to learn how this breakthrough technology tailors treatment plans based on individual patient characteristics and what’s ahead for 2024.
Proactive: As the first company globally to introduce personalized Anti-Cancer Therapy (ACT) based on individual tissue characteristics, can you explain how Theralase's innovations set it apart in the healthcare technology field?
Roger DuMoulin-White (RDW): ACT was designed to address the uniqueness of each patient and their respective cancer by optimizing the amount of drug delivered to the patient and the activation time of that drug on a per person basis. For example, in our Phase II clinical study, we are treating patients diagnosed with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ.
The clinical study sites that we work with collect the patient’s urinary voiding diary (when they urinate and the volume of each urination) and analyze it to determine the urine voiding patterns for that patient. This helps determine the maximum amount of urine that a patient’s bladder can hold before they need to urinate.
A calculation is then completed to determine the exact volume of drug to be instilled, which is critical for absorption by their bladder cancer cells and a computer program is then used to determine the exact amount of time to light activate the drug for optimal cancer destruction.
Theralase CEO Roger DuMoulin-White
The recent update on Theralase's Phase II study shows promising results. How does this breakthrough affect bladder cancer treatment, and what benefits does it offer compared to standard pharmaceutical approaches?
The standard of care for BCG-Unresponsive NMIBC CIS is radical cystectomy or the complete removal of the bladder and associated organs. This is clearly not the first choice for many patients, so the medical industry has been working to develop new technologies to address the unmet need of this patient population. Currently approved Health Canada and FDA treatments for BCG-Unresponsive NMIBC CIS patients are not very effective for this disease condition, with the most recently approved and highest performing drug demonstrating a complete response in approximately 1 out of 2 patients and a duration of that response at 15 months of 1 out of 4. This means that 3 out of 4 patients will have cancer recurrence in a little over a year and will again be facing radical cystectomy.
The Theralase interim clinical data has demonstrated a significant improvement over these approved drugs, in that approximately 2 out of 3 patients will exhibit a complete response and 2 out of 5 will maintain this response for 15 months. These numbers represent a significant improvement over what is currently approved and allow the patient a higher quality of life for a longer period of time.
Theralase's ACT involves a unique drug-device combination. What advantages does this approach have over traditional methods, and how does it minimize side effects for patients, as seen in the study results?
The drug is instilled in a patient’s bladder and remains inert until activated. For bladder cancer this involves light activation, and for Glio Blastoma Multiforme, a deadly form of brain cancer, Theralase is researching and developing x-ray activation. The advantage is that the drug doesn’t induce any patient toxicity as it doesn’t affect cancer cells or healthy cells until activated.
The drug is allowed to be absorbed by cancer cells selectively and not healthy cells, through what is called the transferrin receptor. When absorbed selectively by the cancer cells and not the healthy cells, it is activated destroying the cancer cells, but leaving healthy cells intact.
This has obvious advantages for a cancer treatment; specifically: high efficacy in the destruction of cancer cells with little to no destruction of healthy cells, thereby preserving a patient’s quality of life and a high patient safety profile with no serious adverse events attributed to the study drug or study device. Also, the treatment is performed in one day, allowing the patient to go home the same day and recover at home with an approximately 60% chance of being cancer free.
With the focus on pre-Breakthrough Therapy Designation (pre-BTD) from the FDA, what steps is Theralase taking to secure regulatory approval? Also, how does the company plan to expand its market presence and consider potential partnerships?
Pre-BTD is a “nice to have” approval from the FDA, but it is not a “must have” approval for marketing approval. Health Canada and FDA marketing approval will depend on the strength of the safety and efficacy clinical data of the treatment and how well it compares to the standard of care. Theralase is pursuing a pre-BTD approval and if successful, ultimately a BTD, Accelerated Approval and Priority Review from the FDA, in due time, but our ultimate goal is Health Canada and FDA marketing approval allowing commercialization of this technology for the benefit of all bladder cancer patients in Canada and the United States.
In 2024, the company’s strategic objectives are to be properly capitalized for its Phase II clinical study and to complete the enrollment and primary study treatment by the end of 2024. This would allow us to complete patient follow-up by mid 2026 and if able to achieve Priority Review by the FDA, a marketing decision by the end of 2026, if not then mid-2027.
Over the next three years, Theralase is planning to actively court larger pharmaceutical companies for potential distribution partnerships that will accelerate our growth in this field and provide geographical distribution opportunities.
Looking ahead to 2024, what are the key milestones for investors to watch? Apart from regulatory approvals, what strategies does Theralase have for financing and potential collaborations to enhance its reach and distribution channels?