Theralase Technologies Inc. (TSX: V.TLT, OTCQX: TLTFF, Forum) is a Company with a strong following in the Stockhouse Community – and for good reason. Partnering with world-renowned doctors, scientists and institutions, TLT’s ground-breaking research is moving closer and closer towards clinical approval and global acceptance for some of the deadliest forms of cancer.
Stockhouse published our own introduction to Theralase in a full-length feature article from April 12, 2017. That article asked an important question: Is a Trojan Horse the Key to Curing Cancer?
Trojan Horse? Curing cancer? Some might wonder if that earlier title was a non sequitur. It’s not. The Theralase research teams have pioneered technology that is capable of selectivelyinfiltrating and killing cancer – at the cellular level. And the best way to characterize this “infiltration” is with the metaphor of the Trojan Horse.
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Readers wanting a more thorough explanation of this technology should refer to the earlier article. To summarize this ingenious research, TLT first instills a photo-dynamic compound (PDC) directly in contact with bladder cancer tumours (intravesically) or injects the PDC directly into the bloodstream (intravenously), for other forms of cancer being targeted.
These uniquely engineered PDC molecules can be used alone or combined with transferrin depending on the cancer to be treated. Transferrin is a naturally occurring protein that performs an important function in the human body: it transports iron to our cells to ensure they have enough of this critical nutrient. Theralase’s unique twist is that they can substitute their PDC for iron on the transferrin train, tricking the cancer cell to absorb the PDC instead.
Why is this of significance? It’s because cancer cells consume much more iron than healthy cells. They hunger for transferrin – and the iron (or in this case PDC) payload it carries. These cancer cells allow the PDC to pass through the incredibly secure walls of these cells and the Trojan Horse is now within the walls.
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In the eyes of the Theralase research team, this is the key to devising an effective treatment for some forms of cancer, perhaps even the most deadly forms of this killer disease. Cancer cells are almost indestructible to external attack. That’s why the current therapies for treating cancer are simple brute force methods: chemotherapy and radiation (or surgery). Try to kill off the cancer before the “therapy” kills the patient.
Fighting cancer from the inside out
Attacking the cancer cells from within is an entirely different proposition, but again requiring considerable ingenuity. The Company’s PDC (known officially as TLD-1433) is effectively a time-bomb cleverly smuggled inside the cancer cells. Once inside, to detonate these time-bombs, Theralase employs one of its custom-designed lasers.
This laser light, causing virtually zero damage to healthy tissue, is capable of activating the PDCs below the tissue surface. Light is one of the few mediums for which these cancer cells have no defense.
The laser light enters the cancer cell, and ka-boom! The PDC inside the cancer cell is activated by this laser light, with the subsequent photo-chemical reaction eradicating the cancer cell while leaving surrounding tissue unharmed.
In a conference call with Stockhouse Editorial, Interim CEO and CSO Arkady Mandel added some additional details.
This revolutionary technology has also been proven to target cancer stem cells, which are known as immortal cells, cells within a tumour that can both self-renew by dividing and give rise to many cell types that form the tumour. Cancer stem cells have been found in various types of human tumours and are considered today by medical experts as the “key” target for cancer treatment.
This technology has progressed beyond the laboratory (pre-clinical trials) all the way to full clinical trials on human patients. For one form of cancer, bladder cancer, this research has now advanced to completion of a Phase Ib clinical study and is on its way to Phase II. Tech investors fully appreciate the significance of this.
Phase I clinical trials are concerned primarily with the safety and tolerability of a particular therapy. Phase II trials are where the actual efficacy of a particular therapy is established. Here it is important to understand that such research generally does not advance in a straight-line progression.
This has been true with TLT’s research into a cancer treatment. To date, six patients have been enrolled and treated in this Phase Ib trial.
More specifically, this is research into “non-muscle invasive bladder cancer” (NMIBC). The first three patients were treated at the maximum recommended starting dosage (½ the therapeutic dose). The second three patients have been treated using the therapeutic dosage.
On November 8, 2017; Theralase reported interim results for its first four patients. At ½ the drug dose the “primary” (safety and tolerability) and “secondary” (pharmacokinetics) results were achieved. The Company was successful with its “exploratory objective” at preventing recurrence temporarily, but did not demonstrate this same success longer term . The market treated this temporary success as “a failure”. TLT was punished, with its share price roughly cut in half.
Now flash forward to two more recent news releases from this Phase Ib clinical study. These releases (April 16, 2018 and May 17, 2018) provided an update on the fifth and sixth patients, who were given the therapeutic dosage to treat their NMIBC.
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Some of the investors who had jumped off the Theralase bandwagon climbed back aboard. The share price leaped from $0.20 to $0.32.
Then on May 30, 2018; the Company had more important news. Theralase declared the study an overall success. On that basis, it’s Medical and Scientific Advisory Board, comprised of world-class uro-oncology experts, voted for the early termination of the Phase Ib clinical study so that TLT could focus on the next phase of clinical studies as soon as possible: Phase II.
More investors jumped back onto the bandwagon. TLT made another move higher – back up to 39 cents. The recovery was essentially complete. CEO Mandel framed the next phase of this ground-breaking research.
The upcoming Phase II NMIBC clinical study will be focused on proving the clinical efficacy of TLD-1433 in the destruction of NMIBC. Success here represents a demonstration of the full commercial potential of Theralase’s cancer-fighting Trojan Horse. If successful, the Company should be granted the ability to commercialize the technology in Canada and the United States, markets that represent over $USD 4 billion dollars of market potential for this deadly disease.
Success in a Phase II clinical study would immediately attract the attention of the pharmaceutical industry.
Investors who are new to the pharmaceutical industry need to quickly learn a three-word phrase: the Patent Cliff. The gist of this is that the “value of small-molecule products facing loss of patent expiry in developed markets from 2014 to 2018 is estimated at $121 billion”.
Losing patent protection can mean the loss of up to 90% of revenues for the (former) patent-holder. This has created huge holes in the drug pipelines of Big Pharma. Even worse, this comes at a time when the cost (and time) to develop new drugs has never been greater.
The result of these two dynamics is that Big Pharma is now electing to buy new drugs for its depleted pipelines versus organic development. These drugs don’t come cheaply. Acquiring even a single new drug can mean a price-tag in the $100’s of millions of dollars.
This is the payoff that the Company is pursuing, for itself and shareholders. And its NMIBC treatment is just the first anti-cancer initiative in TLT’s own R&D pipeline. This is fruitful research, having already generated 7 issued patents, with 33 patents pending at various phases for this exciting technology. But Theralase has an additional facet of operations.
The second (and original) branch of operations is the Company’s Cool Laser Division. Indeed, this is how some investors may have first become acquainted with Theralase. Using “super-pulsed lasers”, TLT’s cool laser therapy is used to eliminate pain, reduce inflammation, and accelerate healing. The efficacy of this form of therapy is highlighted by the Company’s client list, that includes some of North America’s leading professional sports teams and associations.
Optimizing this laser therapy for TLT’s elite client list of professional athletes requires considerable expertise in laser design and engineering. Theralase is tapping into this same in-house expertise in creating the ideal laser light for its anti-cancer technology.
Large cancer markets with a poor standard of care
The success of Theralase’s clinical development is one component of the Company’s valuation. Another important component is the individual cancer markets that are being targeted.
As already noted, Theralase’s lead anti-cancer drug (PDC) is for the treatment of NMIBC. While this particular type of cancer is not as high-profile as some, this is a particularly devastating form of disease.
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According to U.S. statistics, bladder cancer is the 4th most common cancer in men and 8th most common for women, making it the 5th most common form, overall. In the U.S.; there were 76,960 new cases diagnosed in 2016, with an average of 16,390 American deaths each year.
Part of the reason for the high mortality rate is that the current standard of care provides poor treatment options (and outcomes) for patients unless caught at an early stage. This is a US$3.9 billion cancer market in the U.S. alone, based on 2016 numbers.
Next in TLT’s pipeline is a PDC that has been devised for the treatment of glioblastoma multiforme (GBM), an especially aggressive and deadly form of brain cancer. As that description implies, this variation of cancer spreads rapidly, with a very high mortality rate due to the poor (current) treatment options. A November 2017 report predicts this will become a $1.15 billion global market by 2024.
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This form of therapy requires a somewhat different approach: intravenous injection versus intravesical instillation. In turn, this requires a different PDC “cocktail” that Theralase has dubbed Rutherrin®.
The Company has progressed through its pre-clinical trials (on rats) and is now preparing to commence a Phase Ib clinical trial on human patients, with dual authorization from Health Canada and the U.S. Food and Drug Administration.
At a similar stage of development is Theralase’s PDC research into a variation of lung cancer, non-small cell lung cancer (NSCLC). Theralase is ready to advance to human clinical studies with its NSCLC program, but is currently focusing on its first two initiatives.
The war against cancer rages on. The human and economic costs of this dreaded disease are terribly high. Equally, the rewards for defeating even one form of this disease are potentially enormous.
Cancer has shown itself to be extremely resilient to any form of head-on attack. However, the Achilles’ Heel of this formidable foe may be its vulnerability to an ancient infiltration strategy: the Trojan Horse.
Appendix: Theralase’s Medical and Scientific Advisory Board
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theralase.com
FULL DISCLOSURE: Theralase Technologies Inc. is a paid client of Stockhouse Publishing.