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ANTI-CANCER DRUGS INDEPENDENTLY VERIFIED AND VALIDATED

Theralase Technologies Inc.'s (TLT.V) patented, lead anti-cancer drug, TLD-1433, and associated family of compounds have been independently verified and validated in a peer-reviewed publication.

A detailed computational investigation by Marta Alberto and co-workers, entitled "Theoretical Exploration of Type I/Type II Dual Photoreactivity of Promising Ru(II) Dyads for PDT Approach," appearing in the peer-reviewed American Chemical Society (ACS) journal Inorganic Chemistry, has independently verified and validated the unique photophysical properties of Theralase's lead photodynamic compound (PDC), TLD-1433 and associated family of compounds. The study can be found on-line.

The study details how Dr. Sherri McFarland has pioneered the use of specialized excited states for dual-mode type I (oxygen independent)/II (oxygen dependent) photoreactivity as a means of creating novel classes of PDCs with potencies that are orders of magnitude greater than those of traditional photosensitizers used for photodynamic therapy (PDT).

The most advanced PDC, TLD-1433, developed by Dr. McFarland and Theralase, has successfully achieved the primary, secondary and exploratory end points in the first part of a phase 1b human clinical trial, at the maximum recommended starting dose (0.35 milligram/square centimetre) (MRSD) in the first three patients treated, for non-muscle invasive bladder cancer (NMIBC), evaluated at 90 days posttreatment.

The elegant computational study on the family of PDCs, which includes TLD-1433, has used the orthogonal approach of time-dependent density functional theory (TDDFT) to quantum mechanically validate Dr. McFarland's experimental findings with regard to type I/II dual-mode PDT effects and highly specialized excited states.

The study highlights the ability of TLD-1433, and its associated family of PDCs, to invoke PDT effects even at low oxygen concentrations by exploiting multiple PDT pathways and further validates, on a very sophisticated level, the criteria Dr. McFarland previously outlined for producing these unique effects. The unprecedented PDT potencies and unique dual-mode mechanisms of the Dr. McFarland-Theralase PDCs are well positioned to finally bring PDT to the forefront of cancer therapy.

Currently, Dr. McFarland and Theralase continue to push the boundaries of PDC development by introducing PDC supercatalysts. These so-called supercatalysts maintain dual-mode type I/II photoreactivity and produce femtomolar PDT effects with no sacrificial co-catalysts. These first-of-their-kind PDCs exploit the fundamental principles of photophysics and supercatalysis to achieve extraordinarily large therapeutic effects.

In comparative analysis evaluations completed by Dr. McFarland, the Theralase PDCs are approximately a billion times more potent than a commonly used anti-cancer chemotherapy drug, Cisplatin, when laser light activated.

The clinical utility of PDC supercatalysts cannot be understated, having the potential to overcome variations in light dosimetry and other issues that have prohibited the application of PDT to most cancers.

Theralase and Dr. McFarland firmly believe that these PDCs and the laser light systems used to activate them are the future of PDT in the destruction of cancer.

Theralase and Dr. McFarland are continuing their highly productive collaboration that has already resulted in one PDC in a human clinical trial for NMIBC, by building a pipeline of PDCs and associated laser light systems, specifically designed to activate the PDCs, for various clinical applications.

Theralase and Dr. McFarland are developing PDCs from a tumour-centred approach for personalized medicine, with a focus on brain and lung cancer as the most logical next-generation targets.

Dr. Sherri McFarland, PhD, professor, department of chemistry and biochemistry, University of North Carolina at Greensboro, stated that, "The orthogonal third party study on TLD-1433 and related PDCs computationally validates the structure-activity relationships that we have already determined experimentally, providing theoretical support for the potent type I/II dual-mode PDT effects that are now being realized with success in patients with NMIBC as part of the phase Ib clinical trial."

Dr. Arkady Mandel, MD, PhD, DSc, chief scientific officer of Theralase, stated that: "The latest computational investigation authored and researched independently, provides further support for what we already know, TLD-1433, and its associated family of PDCs, are world-class anti-cancer drugs that have been proven in the first three patients treated in a phase Ib clinical trial, at the MRSD, to be safe and effective in preventing the recurrence of NMIBC, evaluated at 90 days posttreatment."

Roger Dumoulin-White, president and chief executive officer of Theralase, stated that: "The PDCs that Theralase and McFarland have researched and developed have proven to be very strong anti-cancer drugs in initial clinical studies. We look forward to successfully expanding the platform of PDCs, and the laser light systems that activate them, for various clinical oncology applications, as our clinical program matures."

About Theralase Technologies Inc.

Theralase Technologies in its therapeutic laser technology (TLT) division designs, manufactures, markets and distributes patented superpulsed laser technology indicated for the treatment of chronic knee pain, and in off-label use, the elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions.