Theralase Technologies Inc. (TSX: V.TLT, OTCQX: TLTFF, Forum) is getting closer.
That’s the gist of the message from the Company’s July 16, 2018 news release. Additional results were released (for patient number five) from the successfully completed Phase 1b clinical trial targeting bladder cancer, specifically “non-muscle invasive bladder cancer” (NMIBC).
Regular Stockhouse readers will already be familiar with this exciting anti-cancer research that uses a chemical “Trojan Horse” (photo-dynamic compound) in order to kill cancer cells from within by activating the photo-dynamic compound using laser light. TLT was most recently covered by Stockhouse in a full-length feature article from June 21, 2018.
Theralase’s proprietary research effectively tricks cancer cells into absorbing these photo-dynamic compounds (PDC’s), and once the Trojan Horse has passed through the tough walls of these cancer cells, activation of the PDC kills the cancer cell while leaving surrounding tissue virtually undamaged.
Does it work? This is the question that is currently being answered via the Company’s clinical studies – meaning direct studies on human patients. The PDC for bladder cancer (TLD-1433) has already been proven safe and well-tolerated in previous work. Now TLT is seeking to establish efficacy.
Previous data here showed that the application of TLD-1433 at half the dose, had eliminated the cancer cells in patients. Preliminary data on efficacy showed no recurrence of the cancer in the bladders at 90 days. However, with a further follow-up at 180 days, recurrence was observed in these patients.
The recurrence of cancer cells was a concern to the Theralase research team, but the Company suspected that they knew the reason for the recurrence. Further refinement of the clinical study was undertaken, delivering the full dose of the PDC and optimizing the clinical procedure used in the Study – starting with patient number five.
Demonstrating the absence of recurrence at the 180-day mark represents a breakthrough achievement for this research. CEO Arkady Mandel was happy to frame this news for investors.
This is just another example of the power of Theralase’s Anti-Cancer Technology and the enormous opportunity that awaits this young biopharma company. If these same results are confirmed in a well-designed Phase II NMIBC clinical study, then the Theralase Anti-Cancer Technology may very well be the next gold standard in the treatment of NMIBC. The "big picture" here is that the Theralase Anti-Cancer Technology is not restricted to any particular type of cancer; therefore, pending successful regulatory approval for the treatment of NMIBC, Theralase intends to bring this technology on board in the treatment of numerous cancer targets. [emphasis mine]
What makes this news all the more exciting for investors is that (at this stage of clinical studies), the efficacy of TLD-1433 wasn’t even a primary objective of the Phase 1b clinical study, which was dedicated to showing safety and tolerance at different dosage levels. Measuring efficacy was just an exploratory objective.
Next: a Phase 2 clinical study – squarely focused on establishing the efficacy of TLD-1433 as a primary treatment for NMIBC. This is of great significance to investors for two reasons.
The new standard that has been set in demonstrating that a patient is recurrence-free (of cancer) at the 180-day mark is a very encouraging data point as the clinical studies move to Phase 2. Secondly, successful completion of Phase 2 (clinical demonstration of efficacy) is not merely a research milestone. It makes the drug (and drug company) immediately attractive to Big Pharma as an acquisition candidate.
Thanks to the Patent Cliff, Big Pharma has huge holes to fill in its R&D pipeline, to minimize revenue loss due to patent expiry. Increasingly, Big Pharma is seeking to fill these holes via acquisitions.
In the case of NMIBC (non-muscle invasive bladder cancer) this is both a common and deadly form of cancer. Current treatment options are poor unless the cancer is diagnosed at a very early stage. TLD-1433 is (potentially) an enormous leap forward in a cancer treatment market with an estimated size of US$3.9 billion, in the United States alone.
As noted by CEO Mandel, using laser-activated PDC’s for the treatment of cancer can (potentially) be extended to numerous other forms of this dreaded killer and TLT already has several related initiatives in its own R&D pipeline. Next most-advanced is its treatment for a particularly aggressive form of brain cancer, GBM – another cancer market with billion-dollar potential.
As investors contemplate the addition of Theralase Technologies to their portfolio, here is perhaps the most important number to consider. As TLT moves ever closer to fully proving this amazing anti-cancer technology, the Company is still sitting with a market cap of (as of this writing) only $52 million.
theralase.com
FULL DISCLOSURE: Theralase Technoligies Inc. is a paid client of Stockhouse Publishing.