Toronto, ON -- March 14, 2013 -- Theralase Technologies Inc. (TLT.V) announced that its proprietary Photo Dynamic Compound (PDC) technology has been approved for use in a live animal bladder cancer model by the University Health Network (UHN) Research Ethics Board. This approval expedites the Company's progress towards commercializing its advanced bladder cancer therapy.
Theralase's leading proprietary oncology PDC has repeatedly demonstrated that it is:
-toxic to bladder cancer cells when light activated (100% kill rate)
-exceeds potency of FDA approved PDCs
-highly stable ensuring optimal tumour destruction
Theralase will validate its PDC technology in this animal cancer model to support an Investigational New Drug (IND) application to be filed with the FDA later this year. This IND application will allow Theralase to commence a Phase 1/2a human clinical trial to prove the safety and efficacy of its PDC technology on a 30 subject population with scheduled completion in 2014. Based on recent pharmaceutical acquisitions for oncology drugs and market statistics, the estimated value of the PDC upon successful completion of a FDA Phase 1/2a clinical trial ranges from $84 million to $360 million in upfront payments followed by a double digit revenue royalty stream. (Source:BIO statistics)
Arkady Mandel MD, PhD, DSc, Chief Scientific Officer of Theralase Technologies Inc. stated, "Protocols and standard operating procedures are in place to ensure adherence to the highest scientific and ethical standards. In addition, the program has been fully accredited by the Canadian Council for Animal Care. This critical research is a vital progressive step that will greatly advance our innovative bladder cancer therapy."
Michael Jewett, FRCSC, MD, an eminent urologist and a member of the Department of Surgical Oncology at UHN's Princess Margaret Cancer Centre, as well as a member of Theralase's Medical and Scientific Advisory Board said, "The elements of Theralase's PDC development plan are in place and I believe they will lead to a successful FDA Phase 1/2a human clinical bladder cancer trial to commence early next year. With a recurrence rate of nearly 80%, bladder cancer is the most expensive cancer to treat on a per patient basis and raises many issues affecting the quality of life because of its persistence."
Roger Dumoulin-White, President and CEO of Theralase Inc. stated, "Our leading PDC drug candidate has been proven to be superior to any currently approved FDA PDC on the market. As we continue to achieve our critical research milestones, Theralase's leading PDC provides indisputable proof of its efficacy in the destruction of cancer in live animal models. Subject to a successful FDA Phase 1/2a human clinical bladder cancer trial of the PDC technology, Theralase will apply for "breakthrough status" with the FDA, which if granted, would allow Theralase the unique opportunity of commercializing its technology without the need for further FDA clinical trials, thus allowing the bladder cancer technology the most direct route to fulfill an unmet medical need and aid in the destruction of a deadly disease."
About Theralase Technologies Inc.:
Theralase Technologies Inc., founded in 1995, designs, develops, manufactures and markets patented, superpulsed laser technology utilized in biostimulation and biodestruction applications. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing. Theralase is currently developing patented Photo Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when light activated by Theralase's proprietary and patented laser technology.
For further information please visit www.theralase.com , regulatory filings may be viewed by visiting www.sedar.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.
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