By now, much of the Stockhouse audience is thoroughly familiar with Theralase Technologies Inc (TSX: V.TLT, OTCQX: TLTFF, Forum). Since being originally introduced in a full-length feature article from April 13, 2017; Stockhouse has produced several additional feature articles detailing TLT’s amazing research into treating (curing?) Non-Muscle Invasive Bladder Cancer (NMIBC).
For new investors to this Company, it’s important to understand that Theralase’s “Trojan Horse” technology for treating cancer is well beyond the theoretical stage. This has already progressed to the completion of a Phase Ib clinical study, meaning treatment of human patients.
As TLT successfully completed its Phase 1b clinical study and is now preparing to advance to a Phase 2 clinical study, momentum is continuing to build with respect to the progress of this clinical development and commercialization research. In news released on August 13, 2018, the Company reported “exploratory efficacy” after 180 days for the last two patients using the therapeutic dose of their anti-cancer drug in the Phase Ib clinical study.
Further explanation is required. Exploratory efficacy (after six months) means not only the successful elimination of tumors from the treatment area - for NMIBC - but also no recurrence of cancer at the end of the 180-day study or what is known as a Complete Reponse.
Of note, these superior outcomes were produced via an “optimized clinical treatment procedure”, which includes the therapeutic dose of TLD-1433, the patented “photo-dynamic compound” (PDC) that is at the heart of this research. It is this PDC that allows Theralase’s laser therapy to become a cancer-killer - even with respect to patients who have been told that their cancer is unresponsive to the standard of care.
The key to this technology is the selective uptake of TLD-1433 by cancer cells, allowing the eradication of tumors, with virtually zero effect on surrounding tissue. This makes this ground-breaking technology, both a safe and potentially effective treatment for cancer.
- Theralase’s Study Drug, TLD-1433, is a photodynamic compound that is soluble and stable in water for at least 72 hours1
- TLD-1433 is able to bind with endogenous transferrin, a human glycoprotein 2
- This combined molecule is able to localize to cancer cells, which generally have more transferrin receptors versus healthy cells.3
- When the combined molecule is laser light activated, it is able to destroy cancer cells through the production of singlet oxygen and/or reactive oxygen species. 4, 5, 6
Investors also need to be aware that testing the efficacy of TLD-1433 was not even the primary objective of this Phase Ib clinical study. This stage of the clinical study process was primarily focused on demonstrating both the safety and tolerability of the drug in human patients.
Theralase has already achieved its study objectives on these fronts. This is why the demonstration of no recurrence of cancer after 180 days is deemed an “exploratory” outcome.
Coming up next for the Company (and its shareholders) is a Phase 2 study. Here the primary focus is the efficacy of the treatment itself. This is what makes the most recent news especially encouraging. Arkady Mandel, M.D., PhD., D.Sc. (and Interim CEO) expressed the delight of Theralase’s management and research team with this latest result.
“This is an exciting milestone for our Company, which further solidifies the power of Theralase’s Anti-Cancer Technology. We look forward to advancing the optimized treatment procedure throughout our planned Phase II study and eventually commercialization, if these same results are confirmed in the Phase II NMIBC clinical study. The Theralase Anti-Cancer Technology may very well be the next gold standard in the treatment of NMIBC.”
NMIBC is the initial cancer treatment (and cancer market) being targeted by this research. As noted in the most recent Stockhouse news feature on TLT, bladder cancer represents a $3.9 billion market in the United States alone.
Bladder cancer is the 4th most common form of cancer in men and 8th most common for women, according to the most recent U.S. statistics. In 2016 alone; there were 76,960 new cases diagnosed and 16,390 American deaths.
As many healthcare/tech investors already know, the commercialization of new drugs has never been more lucrative for the junior pharma companies who are pioneering many of these new therapies. Thanks to the Patent Cliff, Big Pharma has never been hungrier for new discoveries to replenish its depleted pipeline of drug patents.
Beyond NMIBC and the bladder cancer market, Theralase’s research is already being adapted as a therapy for other forms of cancer. Gliobastoma multiforme (GBM) is the focus of the next most-advanced research in the Company’s pipeline.
This is a particularly aggressive form of brain cancer. What both NMIBC and GBM share in common are poor current treatment options and high mortality rates. This means (equally) that such research is badly needed as a new healthcare treatment option and itimplies a high adoption rate when (if) this treatment is successfully commercialized.
Devising a successful (and benign) treatment for cancer remains near the very top of our healthcare priorities. For this reason, success also represents a tremendous investment opportunity for shareholders.
Despite its success to date, TLT sits with a current market cap of only $51 million. With the latest results representing a potential preview of Phase 2 success, investors looking to capitalize on this opportunity still have a very attractive window for entry.
FULL DISCLOSURE: Theralase Technologies Inc. is a paid client of Stockhouse Publishing.