Toronto, Ontario / ACCESSWIRE / September 11, 2014 / To take advantage of the vastly improved business climate in Quebec, Theralase Technologies Inc. (“Theralase”) (TLT.V) (TLTFF: OTC Link(R)) announced today that it is partnering with JSS Medical Research Inc. (“JSS”), a Montreal based Contract Research Organization (“CRO”), to consult and provide guidance in the completion of a FDA / Health Canada Phase I/IIa clinical study. The clinical study planned for early 2015 will evaluate the safety and efficacy of Theralase’s innovative Photo Dynamic Therapy (“PDT”) platform in the destruction of bladder cancer. Theralase anticipates executing further agreements in the Quebec biotech sector worth several million dollars over the next 12 to 18 months.
Bladder cancer is the fifth most common cancer (fourth for men, eighth for women), the most expensive cancer to treat, costing between $100k and $200k per patient and has the highest recurrence rate at 80%. In the US alone, bladder cancer costs an estimated $4B to treat and there are approximately 75,000 new cases per year with 15,000 deaths. Internationally, there are 386,000 new cases a year. Risk factors for bladder cancer increasingly are being linked to smoking, as countries with a higher prevalence of smoking have demonstrated higher rates of bladder cancer. Theralase has discovered a treatment that destroys cancer cells and prevents their reoccurrence during preclinical testing and is quickly advancing to human clinical trials.
The Globe and Mail reported on September 8, 2014 that Canada is experiencing a serious shortage of an essential drug for the treatment of bladder cancer. The shortfall, which is due to manufacturing problems at plants operated by two different pharmaceutical companies, could have major consequences for patients. Without the drug, bacillus Calmette-Guerin (“BCG”) to control their symptoms, some patients might require surgery to remove their bladders. If Theralase is successful in its human clinical trials in bladder cancer, this may help to alleviate the reliance on BCG.
Theralase chose to partner with JSS for several reasons. First and foremost, JSS has built its reputation on the successful design, execution, analysis and publication of FDA and Health Canada-approved human clinical trials. During the last five years and in response to its client’s demands, JSS has dramatically expanded its operations and currently conducts clinical studies in North America, Latin America, Europe and Asia. The recent merger with Integrated Research Inc., in 2014, a Montreal-based CRO, consolidated its position as the largest Canadian owned CRO and significantly enhanced its capabilities in the conduct of phase I, II and III clinical studies.
Secondly, the recent positive changes in stability in business climate in Quebec, coupled with the election of a new premier, Philippe Couillard, a former neurosurgeon, who is both pro-business and pro-biotech in Quebec have all been factors in the selection.
Theralase intends to continue to invest in the Quebec biotech market as the research and development progresses and if this research is successful, Theralase plans to invest millions of dollars into the
infrastructure of Quebec providing numerous high paying, white collar jobs for the province, as it commercializes this ground breaking technology.
Theralase is completing its preclinical development work on its PDT platform in 2014 and plans to test its lead Photo Dynamic Compound (PDC) in bladder cancer in early 2015. Theralase’s leading PDCs are currently being evaluated for safety and preclinical efficacy by Princess Margaret Cancer Centre, University Health Network (“UHN”) and the University of Toledo under separate research agreements. The results of these research agreements will determine which lead Theralase PDC will be evaluated in human application in a FDA / Health Canada Phase I/IIa clinical study for bladder cancer in early 2015.
Dr. John S. Sampalis, President and CEO of JSS Medical Research stated, “As a CRO that is itself entrepreneurial and committed to innovative research, we are genuinely thrilled to have met an experienced group like Theralase who are also committed to the same principles of innovation and excellence. We look forward to working as a team and supporting Theralase to bring their novel therapy to Canadian and international markets.”
Joanne Watson, Chief Business Officer of JSS Medical Research stated, “With our previous clinical research experience in the area of Photo Dynamic Therapy, and our ongoing collaborations within the research community, our team is a logical fit for Theralase.”
Roger Dumoulin-White, President and CEO of Theralase Inc. stated that, “Theralase spent considerable time to conduct detailed due diligence in the selection of a CRO, as we wanted to ensure that we were partnering with the best organization able to provide us the expert guidance we require to be successful. We found that partner in Dr. Sampalis and JSS.”
Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated, “I look forward to championing the PDC anti-cancer project and working side by side with JSS and their team of experts in the successful completion of a FDA / Health Canada Phase I/IIa clinical study for bladder cancer.”
About Theralase Technologies Inc.
Founded in 1994, Theralase Technologies Inc. (“Theralase”) (TLT.V) (TLTFF: OTC Link(R)) designs, manufactures and markets patented super-pulsed laser technology used for the elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing. Theralase has sold over 1,200 systems to licensed healthcare practitioners such as: medical doctors, chiropractors, physical therapists and athletic therapists. Theralase has been very successful in healing nerve, muscle and joint conditions in clinical practice and now Theralase’s scientists are investigating the application of its lasers in the destruction of cancer using specially designed molecules called Photo Dynamic Compounds (PDCs) which localize to the DNA of cancer cells and then, when activated by light, destroy the cancer cells.
Additional information is available at www.theralase.com and www.sedar.com .
About JSS Medical Research:
JSS Medical Research is a full-service Contract Research Organization with its corporate office in Montreal, Canada and a regional office in Bogota, Colombia. The company offers comprehensive clinical
trial management services, from study design to publication of results, in Phase I-IV trials across a broad range of therapeutic areas. Biotechnology companies rely on the company’s knowledgeable project teams, and its customer-centric and flexible approach to successfully conduct their critical early phase trials, while pharmaceutical companies can leverage its niche post-marketing service offerings. With science and clinical epidemiological expertise at its core, JSS Medical Research is a leader in Post-Approval Clinical Epidemiology Studies (PACES) including Post-Marketing Observational Studies, Health Outcomes Research and Health Economics. Currently JSS Medical Research is conducting research studies in over 20 countries around the world for its clients, which include the top 25 global pharmaceutical companies and biotechnology/device companies, worldwide.
For more information, visit www.jssresearch.com
This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
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President & CEO, Theralase Technologies Inc.
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
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SOURCE: Theralase Technologies Inc.