There are many different approaches to treating cancer, ranging from Roche Holding Ltd.’s (OTC: RHHBY) monoclonal antibody Perjeta to Merck & Co. Inc.’s (NYSE: MRK) immunotherapy Keytruda. While both of these drugs have made great strides over the past couple years, some companies are looking beyond the standard ways of combatting cancer and pioneering entirely new approaches to treatment.
Theralase Technologies Inc. (“Theralase”) (OTC: TLTFF) (TSX-V: TLT), a leader in super-pulsed laser technology, has shifted its focus from tissue healing to cancer treatment. In pre-clinical studies, the company’s laser technology has shown a remarkable ability to destroy cancer cells using Photo Dynamic Compounds – or PDCs – in conjunction with the targeted light from its super-pulsed laser technology.
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Theralase began pre-clinical studies back in March of 2012 when it injected mice with 350,000 colon cancer cells to produce cancerous tumors reaching about 5mm in size. After injecting these tumors with its lead PDCs and illuminating them with near-infrared (“NIR”) light to activate them, the vast majority of the tumors were completely destroyed with no cancer returning through November of 2013.
In May of 2014, the company repeated the same study to confirm their findings and look at additional end points. Approximately 60% of the mice did not see tumor regrowth after 10 to 23 days later, while 40% had small tumor regrowth that was quickly destroyed by additional treatments. These dynamics suggest a potential immune-mediated “memory response” that destroys cancer cells.
Theralase recently confirmed this “memory response” through additional studies in November 2014. In effect, the studies show the ability to destroy a primary tumor and initiate a modification to the immune system to target the cells of the primary tumor beyond the Photo Dynamic Therapy (“PDT”) treatment – which could eradicate micro metastasis and open the opportunity to long-term cancer control.
“Theralase continues to make great strides in the refinement of their PDT technology,” said Dr. Michael Jewett MD, clinical investigator and uro-oncologist at University Health Network (“UHN”). “I remain excited about the possibilities of this discovery. If research can be replicated in humans and demonstrate the same efficacy that it has in small animals, then the implications are clearly immense.”
Theralase plans to begin a Phase I/II clinical trial targeting bladder cancer next year in order to validate the effects of its PDTs in humans. In September 2014, the company announced a partnership with JSS Medical Research Inc. to consult and provide guidance for the completion of a FDA/Health Canada Phase I/IIa clinical study evaluating its PDT platform for treatment of Non Muscle Invasive Bladder Cancer (“NMIBC”).
Bladder cancer is the fifth most common cancer and the most expensive to treat, with costs averaging between $100,000 and $200,000 per patient. In addition, bladder cancer has the highest recurrence rate among cancers at 80%. The U.S. sees approximately 75,000 new cases per year with about 15,000 deaths per year, while global figures are even higher, particularly in countries with many smokers.
On December 9, 2014, Theralase announced that the University of Toledo conducted in-vitro PDC experimentation that replicates preclinical results obtained earlier by Princess Margaret Cancer Center at UHN. The validation of the technology at the second world renowned institution marks an important step in the road to commercialization for the innovation.
On December 23, the Company reported the preclinical in-vivo orthotopic animal results from University of Toledo.
The results were preliminary, but extremely successful, proving that:
- One of Theralase’s lead PDCs was able to localize in bladder cancer in quantities 180 times greater than in healthy bladder wall tissue demonstrating a clear localization to cancerous tissue.
- When light activated, the PDC destroyed the bladder cancer via necrosis demonstrating clear efficacy.
- Healthy bladder wall tissue was unaffected by the treatment.
- The amount of PDC that entered the blood stream post treatment was negligible supporting a very strong safety profile.
This data served as a key catalyst for the stock with significant trading in the days leading up to Christmas. In addition, the results may encourage other parties to take a closer look at the technology sooner rather than later, which could lead to long-term partnership opportunities. These dynamics make the stock worth watching over the coming quarters for biotech investors.
Theralase trades with a market capitalization of less than $50 million, despite its significant potential in treating cancer. In addition to this potential, the company continues to generate over $1 million in annual revenue from its existing super-pulsed laser business. Management also plans to launch its new next generation TLC-2000 in Canada at the beginning of the year, which could help significantly drive these sales higher in 2015 and beyond.
With clinical trials commencing in mid 2015 for its anti-cancer technology and a new product release on the near horizon in its laser business, the Company has numerous near-term catalysts that could send shares higher. Investors may want to take a closer look at the stock given these dynamics, particularly given its modest market capitalization of less than $50 million.
For more information, visit the company’s website at www.theralase.com.
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Matters discussed in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this press release, the words “anticipate,” “believe,” “estimate,” “may,” “intend,” “expect” and similar expressions identify such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These include, but are not limited to, risks and uncertainties associated with: the sales of the company’s identity protection software products into various channels and market sectors, the issuance of the company’s pending patent application, and the impact of economic, competitive and other factors affecting the Company and its operations, markets, product, and distributor performance, the impact on the national and local economies resulting from terrorist actions, and U.S. actions subsequently; and other factors detailed in reports filed by the Company.
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