Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) is developing a drug targeting non-muscle invasive bladder cancer that CEO Roger DuMoulin-White says has shown super data compared to two Big Pharma drugs already approved by the FDA.
DuMoulin-White sat down with Proactive’s Stephen Gunnion to discuss the company’s Phase II clinical trial, which is focused primarily on Bacillus Calmette-Guérin (BCG)-unresponsive cases of non-muscle invasive bladder cancer.
Gunnion: Take us through the study and what it entails
DuMoulin-White: With most drugs that are being used for oncology, the pharmaceutical company likes the straight drugs. So either an IV or an intravesical installation or an IV installation.
Ours is a drug-device combination. So it's actually a light-sensitive drug, which is instilled into the bladder, and it collects preferentially to the bladder cancer cells. Then, we drain the bladder, fill it with sterile water and insert a fiber optic into the bladder where we can light activate it.
The beauty of this type of technology is that you destroy the cancer cells without affecting the healthy cells. With a lot of pharmacology approaches, you destroy a lot of healthy cells, you run into a lot of side effects with the patients. From what we've seen, we've had no serious adverse events associated with the study drug or study device, which is quite unlike the large pharma approach.
Gunnion: Is your approach unique?
DuMoulin-White: I believe so. There are other companies that have developed drug-device combinations that have used it for technic keratosis, which is a dermal issue. There are other companies in Europe that have used it for prostate cancer, but I believe we're the only ones that use it for bladder cancer.
Gunnion: How do you leverage the positive study data that you've got so far, to move beyond your pre-breakthrough therapy designation with the FDA?
DuMoulin-White: Well, the FDA, and obviously the US market, is the largest market by far in the world. So what the company is currently doing is it's working on what's called a pre-breakthrough designation or pre-BTD. This is where we supply our data informally to the FDA, the FDA reviews it and they provide guidelines or suggestions as to how to improve it or strengthen the presentation in order to go for formal BTD.
We had a meeting with the FDA in July 2023. We're working on that clinical data. Hopefully, we're in a position to reapply to the FDA with a pre-BTD in the first quarter of 2024. Once we pass muster, and they think it looks good and give us the thumbs up, then we'll supply a formal BTD.
Gunnion: When would you expect to do that if it does pass muster?
DuMoulin-White: If it passes muster, we would expect to do that in first quarter as well. Because we're fast track approval, meaning that we have a continuous dialogue with the FDA, we would expect to have a review or an approval of the pre-BTD in probably two to three weeks.
Then, once you submit a BTD formal approval, the clock for the FDA is around 60 days. So it would be I would say the end of the first quarter, beginning of the second quarter.
Gunnion: As 2023 winds up and we enter 2024, what sorts of catalysts should your investors be looking out for?
DuMoulin-White: Obviously, the pre-BTD and BTD are exciting. The company is also going to be investigating non-dilutive forms of financing into 2024. These could take the forms of geographic partnerships, distribution partnerships, royalty partnerships, etc.
The company is also looking forward to completing at least the primary study treatment for the patients. We've treated 63 patients to date, and we're looking to a total population of about 100 patients. So we need about 37 patients.
We're laying in guidelines in the direction to treat those 37 patients in 2024. Our hope is to complete all 100 patients at least with the primary study treatment by the end of 2024.
This would put us in a position for a soft and hard data lock into around the middle of 2026. And if we're lucky enough to achieve priority review from the FDA, which cuts the review timeline from 10 months to six months, we'd be looking at an FDA decision, hopefully favorably, by the end of 2026.
—This interview has been lightly edited for style and clarity—