Pivotal Milestone Achieved – Theralase Advances Towards FDA Clinical Approval
Toronto, ON – March 14, 2012 - Theralase Technologies Inc. (TSXV: TLT) announced today that it is pursuing FDA Phase 1 approval for its patented Photo Dynamic Compounds (PDCs).
Theralase has successfully identified the leading drug candidate, which will be used for safety and efficacy clinical testing in human cancer patients. In multiple preclinical studies, the leading drug candidate has been selected from Theralase’s library of PDCs and has repeatedly demonstrated:
- extremely high efficacy, virtually 100% kill rate, in various cancer cell lines including brain and colorectal cancers
- robust destruction of sub cutaneous (under the skin) cancerous tumours in animals
- extremely low toxicity
- high stability, allowing for a long shelf life
The preclinical results have been reviewed by SPIE (The International Society for Optics and Photonics) and were accepted by the Conference Chairs for presentation at the SPIE Photonics Europe conference slated for April, 2012 in Brussels, Belgium.
Theralase will validate its extensive data with additional cancer animal models and toxicology analyses. This will provide the results required by the FDA to design a FDA Phase 1 clinical human study to commence in 2013 with scheduled completion in 2014.
Roger Dumoulin-White, President and CEO of Theralase Inc. stated, "Achievement of this critical milestone represents irrefutable proof that the Theralase leading drug PDC candidate is effective in the destruction of cancer in live animal models. The treatment was well tolerated by the animals, eliminating their cancer without any adverse effects. The Theralase leading drug candidate has been proven to be superior to any currently approved FDA PDC drug on the market, tested in our lab.”
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. The technology is safe and effective in the treatment of chronic pain, neural muscular-skeletal conditions and wound healing. When combined with its patented, light-sensitive Photo Dynamic Compounds (PDCs), Theralase laser technology is able to specifically target and destroy cancers, bacteria and viruses, as well as microbial pathogens associated with food contamination. 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.
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.
For More Information
Roger Dumoulin-White
President & Chief Executive Officer
416-447-8455 ext. 225
Kristina Hachey
Chief Financial Officer
416-447-8455 ext. 224
Dr. Arkady Mandel
Chief Scientific Officer
416-447-8455 ext. 242
Greg Bewsh
Director of Investor Relations,
416-447-8455 ext. 262
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