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Without aggressive research and regulatory approval, cancer could soon overtake heart disease as the leading cause of disease-related death in the United States. In Canada, cancer is already the number one killer, far and away outpacing heart disease. Small molecule drugs remain the standard of care, but the problem is that most are systemic and highly toxic or have dose-limiting qualities that minimize their efficacy and support the development of resistance. While the small molecule sector certainly still has upside, investors should be attentive to companies that are developing therapies with different mechanisms of action as the industry undergoes a dynamic shift towards accelerated approvals of innovative technologies.
The often-overlooked Canadian biotech space has grown into a $53-billion sector that offers a robust growth opportunity for investors. To that point, Tekmira Pharmaceuticals and Theralase Technologies are two dually-listed companies with large upside potential that have little competition to their pipelines, which are focused on RNA interference and photodynamic therapy, respectively.
RNA interference, or RNAi, was discovered essentially by accident just over a decade ago when Richard Jorgensen and colleagues found that by adding genes to petunias (in a bid to make them deeper purple), other native genes in the flower were silenced (turning the petunia white). This discovery of "switching off" genes via other cells has already led to promising research in viral conditions, such as hepatitis C and AIDS, and is taking root with new treatments for cancer on the horizon.
It's discoveries like this and growing body of evidence for other treatments that makes the "Holy Grail" cure for cancer through new approaches, such as those of Tekmira and Theralase, even more attainable than ever before.
Tekmira has a pipeline of novel RNAi therapeutics as well as a lipid nanoparticle (LNP) drug delivery technology. The Burnaby, BC-based company has reached commercialization by licensing Marqibo, an FDA-approved liposomal formulation of vincristine for the treatment of certain acute lymphoblastic leukemia (ALL) patients, to Talon Therapeutics, which was subsequently acquired by Spectrum Pharmaceuticals last July.
On its own or through partner Alnylam Pharmaceuticals, which uses Tekmira's LNP technology in three trials, Tekmira has five drug candidates in the clinic, including Alnylam's ALN-VSP for liver cancer and its own lead therapy TKM-PLK1 for solid tumors. PLK1 (short for polo-like kinase 1) is a protein known to be overexpressed is specific cancers. Tekmira hypothesizes -- and data to date supports -- that using the RNAi approach of TKM-PLK1 can inhibit the protein, disrupting tumor cell division and leading to apoptosis in the cancerous cells.
In August, Tekmira built upon encouraging data collected in a Phase 1 trial of TKM-PLK1 to initiate a Phase 1/2 trial enrolling patients with either advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC). Interim data from this trial, which is scheduled to enroll about 20 patients, is expected in the second half of this year.
GI-NET carries a terrible prognosis, with one-quarter of those diagnosed with advanced neuroendocrine tumors dying within one year. With no FDA-approved drugs to treat, it is a prime candidate for accelerated pathways for development.
Tekmira also plans to soon initiate another Phase 1/2 trial of TKM-PLK1 for patients with primary liver cancer. This is a compelling part of Tekmira as it is strengthening its own cornerstones by sponsoring clinical trials focused on therapies, rather than being dependent on milestone and royalties payments centered on partners using its LNP technology.
Theralase Technologies is generating revenue already with its highly effective TLC-1000 system and building out additional products based on patented superpulse laser technologies for biostimulative and biodestructive clinical applications.
On the biostimulative front, the Toronto-based company sells its TLC-1000 cold laser system that can penetrate up to 4 inches of tissue to deliver subcutaneous light pulses that years of clinical research have proven to eliminate pain, reduce inflammation and promote cellular regeneration. In the simplest sense, the scaffolding of this technology is built upon the ability of cytochromes to absorb light energy and convert it to chemical energy to heal tissue without side effects.
The TLC-1000 system delivers efficacy in the range of 80% to 90% and Theralase is preparing to take that to the next level with the planned fourth-quarter launch of an enhanced version, dubbed TLC-2000. This system, according to Theralase CEO Roger Dumoulin-White, can increase efficacy up to 100% by using state-of-the-art technologies to define and deliver the precise amount and intensity of light energy necessary to treat patients on an individual basis. In the $100-billion pain management industry in the U.S. alone, for which traditional drug therapies and surgeries comprise only about $50 billion, Theralase could establish itself as a significant player in the business.
To date, Theralase has sold about 1,200 of the TLC-1000 systems (800 in Canada and 400 in the U.S.) that have successfully treated more than one million patients. Sales tallied $1.17 million through the first three quarters of 2013 and are projected to increase to about $6 million going forward as it launches the new product and transitions into an annuity-based model, as opposed to a one-time-sale model.
This steady revenue stream helps mitigate risk as Theralase moves strategically ahead with its true value proposition utilizing its expert photodynamic skill set to develop new treatments for cancer and bacterial infections.
Theralase has introduced a new method for selectively targeting cancer cells through the use of patented Photo Dynamic Compounds (PDCs), small molecules that are activated into tumor-killing form when exposed to very specific light sources. In order to provide the appropriate light energy, Theralase has custom designed the TLC-3000 medical laser system. In vitro and animal model studies, in part conducted at the world renowned Ontario Cancer Institute located at Princess Margaret Hospital, University Health Network, have demonstrated the unique potential and powerful results of the treatment across a broad array of cancer lines, including breast, brain, colon, pancreatic, prostate and bladder. In the research, low concentration doses have demonstrated up to 100% tumor destruction with no adverse side effects.
One particular mouse model study best exemplifies the potential of this novel therapy. In the study, about 350,000 cells from a bladder cancer line were injected into mice and tumors were allowed to grow to 5 millimeters in size. At that point, the mice underwent a single treatment of the PDCs and light therapy. In short, this process involves using a catheter to insert the PDCs into the bladder where they enter the cancer cell and lock onto the cell nucleus. The bladder is then drained and filled with distilled water to give it shape and a fiber optic bundle is inserted. The light activates the PDCs, which induces apoptosis, destroying the tumor from the inside out. The dead cells exit the body through urine. The single treatment eradicated 100% of the cancerous cells and had no side effects, according to the company. Follow-up 20 months after treatment showed the mouse models remained cancer-free, with no scar tissue. Considering 20 months is the life expectancy of a mouse, it seems fair to say that they were "cured" of cancer.
A one-treatment cure for cancer is almost unimaginable, yet this study showed it to be possible.
Of course, this is only one animal study and there is no guarantee that the robust efficacy will translate to humans, but it certainly offers hope and provides scientific evidence that is worthy of clinical trials. One of the best parts is that this Theralase process for bladder cancer takes less than three hours from start-to-finish, meaning that it holds the potential to be conducted on an outpatient basis should the therapy eventually garner regulatory approval.
Theralase is planning to commence clinical trials for bladder cancer in the first quarter of 2015. Bladder cancer is the fifth most common cancer in the U.S., with about 72,000 new diagnoses annually and 15,000 deaths attributed to the disease that carries a stark recurrence rate in the area of 80 percent. The indication represents an area of great unmet medical need, qualifying it for a potential FDA "Breakthrough Therapy" designation, a regulatory pathway passed into law in 2012 as a means to expedite development of innovative technologies for hard-to-treat diseases where patients have little to no options. Theralase has stated that this is a path that they intend to pursue should the Phase 1 clinical trial meet its endpoints.
Realistically, this only scratches the surface of Theralase. The company plans to expand its clinical pipeline by building on preclinical data targeting other localized cancer lines, such as breast and lung cancer. Further, a newly published scientific report showed that the company's PDCs have been shown to destroy Staphylococcus aureus (s. aureus) and Methicillin Resistant Staphylococcus aureus (MRSA) in low oxygen atmospheres. This new discovery supports the intrinsic value of the Theralase platform technology, as cancerous and bacterial cells are aggressive and express strong drug resistance in hypoxic conditions.
Because Theralase is still preclinical with its cancer and bacterial therapies, the markets haven't given any real valuation to these key components of Theralase's business, holding the market capitalization around $25 million. It's arguable that this valuation is low based solely upon Theralase's commercialized product. Consider that generic drug giant Sun Pharma spent $230 million to acquire Dusa Pharmaceuticals in November 2008 to gain control of Dusa's approved photodynamic treatment for a few skin conditions. The markets that Theralase is pursuing with its TLC-1000 and TLC-2000 are much larger. While the TLC biostimulative series is formidable and fair for comparatives, the real beauty of biotechs is the speculative nature of pipelines and the tremendous market opportunities that accompany novel therapeutics for large indications. It doesn't get much bigger than the cancer and bacteria arenas and the markets have not yet baked-in this potential into Theralase's valuation.
The life sciences equities on Bay and Wall Streets have been on fire for the past year, with U.S. biotechs essentially doubling in 2013, only to be topped by the 111% gain that Canadian stocks delivered. Both Tekmira and Theralase have been strong performers in the past four months and both have revenue streams to support further clinical research. It is companies like these that have assumed leadership positions with innovative approaches that are likely to continue to attract the attention of investors and other bigger pharmas in the future as they deliver this clinical data to validate their drug candidates.
Written by Robert James.
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