Theralase Granted US Patent for Lead Anti-Cancer Drug
Toronto, Ontario – June 20, 2016, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that it has been granted a US patent for its lead anti-cancer drug, TLD-1433, by the United States Patent and Trademark Office (“USPTO”).
US patent number 9,345,769 (filed on April 15, 2013 and issued on May 24, 2016) provides patent protection for tens of thousands of metal based PDCs; including, Theralase’s lead anti-cancer drug, TLD-1433, currently under investigation by the Company for the destruction of Non-Muscle Invasive Bladder Cancer (“NMIBC”).
The US patent provides patent protection for Theralase’s second major platform of anti-cancer PDCs for twenty years from date of filing, plus an allowable extension of 433 days, providing a minimum patent protection in the US of TLD-1433 and tens of thousands of more compounds until June 22, 2034.
Theralase’s first major platform of PDCs is protected by four issued US patents, under worldwide exclusive licence from Virginia Tech Intellectual Property.
Under worldwide exclusive licence agreement with the inventor of the latest patent, Dr. Sherri McFarland has agreed to maintain strict confidentiality on any trade secrets associated with the synthesis or manufacture of TLD-1433 for a period of twenty (20) additional years following the expiry of the last patent covering inventions or improvements in compounds or their methods of use; thereby, increasing minimum proprietary protection of TLD-1433 in the US until June 22, 2054.
Theralase appreciating the value in the metal based compound technology, invented by Dr. McFarland, has vigorously pursued international protection of the patent, with patent applications currently pending in Canada, the major economies of Europe, Brazil, Russia, India and China.
Now that the precedent has been established with the issuance of a US patent by the USPTO, Theralase is optimistic that additional international patents will issue in due course.
Roger Dumoulin-White, President and CEO of Theralase stated that, “The Company is emboldened by the recent USPTO decision to issue a US patent for the second major platform of PDCs, which, include the lead PDC, TLD-1433. If TLD-1433, when light activated by Theralase’s patent pending laser system, is proven successful in clinical studies for NMIBC over the next few years, this should allow the Company the opportunity to dramatically increase shareholder value. The primary outcome measures of a Phase Ib clinical study will be safety and tolerability, with a secondary outcome measure of pharmacokinetics (where the drug accumulates in tissue and how it exits the body) and an exploratory outcome measure of efficacy. The primary outcome measures of a Phase II clinical study will be safety, tolerability and efficacy.”
Dr. Sherri McFarland, Professor of Chemistry, Acadia University stated that, “I am delighted that the PDCs that I originally invented have been given the recognition of a US patent by the USPTO. I have had a strong positive relationship with Theralase in the development of these PDCs and look forward to assisting wherever I can in the commercialization of this technology to aid patients inflicted with this life threatening disease.”
Dr. Arkady Mandel, Chief Scientific Officer at Theralase stated that, “Dr. McFarland, Theralase and University Health Network’s pre-clinical and clinical research teams have all worked extremely hard to develop and commercialize the Theralase anti-cancer, Photo Dynamic Therapy (“PDT”) technology; including, achieving Good Manufacturing Practice (“GMP”) manufacturing approval and Clinical Trial Application (“CTA”) approval by Health Canada. With Phase Ib clinical studies set to commence in July 2016, pending Investigational Testing Authorization (“ITA”) by Health Canada, Theralase is well on its way to making this technology a reality.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures, markets and distributes patented super-pulsed laser technology indicated for the: elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy (“PDT”) Division researches and develops specially designed molecules called Photo
Dynamic Compounds (“PDCs”), which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
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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