Theralase achieves commercialization milestone for its bladder cancer therapy

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Theralase Technologies Inc. (TSXV: TLT) 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.

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Theralase achieves commercialization milestone for its bladder cancer therapy

  1. 1. Press Release Theralase Achieves Commercialization Milestone For Its Bladder Cancer TherapyToronto, ON -- March 14, 2013 -- Theralase Technologies Inc. (TSXV: TLT) announced that its proprietaryPhoto Dynamic Compound (PDC) technology has been approved for use in a live animal bladder cancermodel by the University Health Network (UHN) Research Ethics Board. This approval expedites theCompany’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 destructionTheralase will validate its PDC technology in this animal cancer model to support an Investigational NewDrug (IND) application to be filed with the FDA later this year. This IND application will allow Theralase tocommence a Phase 1/2a human clinical trial to prove the safety and efficacy of its PDC technology on a30 subject population with scheduled completion in 2014. Based on recent pharmaceutical acquisitionsfor oncology drugs and market statistics, the estimated value of the PDC upon successful completion of aFDA Phase 1/2a clinical trial ranges from $84 million to $360 million in upfront payments followed by adouble digit revenue royalty stream. (Source: BIO statistics)Arkady Mandel MD, PhD, DSc, Chief Scientific Officer of Theralase Technologies Inc. stated, “Protocolsand standard operating procedures are in place to ensure adherence to the highest scientific and ethicalstandards. 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 cancertherapy.”Michael Jewett, FRCSC, MD, an eminent urologist and a member of the Department of Surgical Oncologyat UHN’s Princess Margaret Cancer Centre, as well as a member of Theralase’s Medical and ScientificAdvisory Board said, “The elements of Theralase’s PDC development plan are in place and I believe theywill lead to a successful FDA Phase 1/2a human clinical bladder cancer trial to commence early nextyear. With a recurrence rate of nearly 80%, bladder cancer is the most expensive cancer to treat on a perpatient 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 hasbeen proven to be superior to any currently approved FDA PDC on the market. As we continue toachieve our critical research milestones, Theralase’s leading PDC provides indisputable proof of itsefficacy in the destruction of cancer in live animal models. Subject to a successful FDA Phase 1/2ahuman 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 itstechnology without the need for further FDA clinical trials, thus allowing the bladder cancer technologythe most direct route to fulfill an unmet medical need and aid in the destruction of a deadly disease.”
  2. 2. Press ReleaseAbout Theralase Technologies Inc.:Theralase Technologies Inc., founded in 1995, designs, develops, manufactures and markets patented,superpulsed laser technology utilized in biostimulation and biodestruction applications. Theralasetechnology is safe and effective in treating pain, inflammation and for tissue regeneration of neuralmuscular skeletal conditions and wound healing. Theralase is currently developing patented PhotoDynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when lightactivated by Theralase’s proprietary and patented laser technology.For further information please visit www.theralase.com , regulatory filings may be viewed by visitingwww.sedar.com.This press release contains forward-looking statements, which reflect the Companys current expectations regarding future events. The forward-lookingstatements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to updatethese 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 responsibilityfor the adequacy or accuracy of this release.For More Information:Roger Dumoulin-WhitePresident & CEO416-699-5273 ext. 225rwhite@theralase.comKristina HacheyChief Financial Officer416-699-5273 ext. 224khachey@theralase.comArkady MandelChief Scientific Officer416-699-5273 ext. 242amandel@theralase.comGreg BewshDirector of Investor Relations416-699-5273 ext. 258gbewsh@theralase.com

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