Theralase Discovers Theralase® Cold Laser Therapy Enhances Cancer Destruction for Standard Cancer Treatments

Toronto, Ontario – November 30, 2017

Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a leading biotech company focused on the commercialization of medical lasers to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer has discovered that its Theralase® Cold Laser Therapy (“Theralase® CLT”) has been proven effective, preclinically, to enhance cancer cell destruction by standard cancer treatments.

It was previously disclosed that one of the hallmarks of cancer cells is a change in cellular metabolism from an oxygenated process (mitochondrial respiration through the production of Adenosine Triphosphate (“ATP”) that relies on oxygen consumption) to an non-oxygenated process (glycolysis, an oxygen independent process), known as the “Warburg Effect”.

Cancer cells modify their cellular metabolism to ensure their survival and proliferation, thus making them difficult to destroy by standard cancer treatments.

Theralase has demonstrated, in previous research, preclinically, that its Theralase® CLT, using specific laser energy dosages, is able to reverse the Warburg Effect in cancer cells making them more susceptible to destruction from other forms of therapy.

Building upon these findings, Theralase has discovered that its Theralase® CLT, due to its ability to stimulate cancer cells to reverse the Warburg Effect, has now been demonstrated effective, preclinically, to enhance cancer destruction by several standard cancer treatments; including: ionizing radiation (X-rays) and chemotherapy (anti-cancer drugs Cisplatin and Temozolomide (“TMZ”)), as well as Photo Dynamic Therapy (“PDT”), increasing the efficacy of these treatments, while potentially decreasing their associated toxic side effects.

Theralase® CLT is cleared by Health Canada and the Food and Drug Administration for the treatment of chronic knee pain and in off label use, the treatment of numerous nerve, muscle and joint conditions by: reducing/eliminating pain, reducing inflammation and accelerating healing.

Theralase® CLT accomplishes these clinical results by increasing mitochondrial membrane potential and ATP synthesis.

In cancer cells, a high level of ATP release is required for their efficient destruction by anti-cancer treatments, such as: PDT, ionizing radiation or chemotherapy, a level which is not available due to their change in cellular metabolism.

In the Theralase conducted experiments, Theralase® CLT was used to pre-treat Glioblastoma Multiforme (“GBM”) Rat Glioma (“RG2”) brain cancer cells, in vitro. Six hours post treatment, GBM RG2 cells were then treated with PDT using a Sub Lethal Dose 50 (“LD50”) (dose of drug and light that normally kills 50% of the cells).

In other Theralase conducted experiments, Theralase® CLT was used to pre-treat human bladder cancer cells, in vitro, which were then treated with a LD50 PDT dose, achieving similar results as the GBM RG2 experiment (data not shown).

Post-treatment analysis of the GBM RG2 cancer cells, revealed that cancer cells that were pre-treated with Theralase® CLT and then treated with a PDT LD50 dose were destroyed 25% greater than cancer cells treated by PDT alone.

This data strongly suggests that Theralase® CLT technology reverses the Warburg Effect, changing the cellular metabolism of the cancer cells, and making them more susceptible to destruction by PDT.

Therefore, Theralase® CLT could be used to increase the efficacy of PDT anti-cancer treatments, while potentially decreasing the dose of PDC drug and / or light energy required, increasing safety and tolerability, while reducing treatment toxicity.

Some cancerous tumours are difficult to treat with ionizing radiation (X-rays), because they are prone to developing a natural immunity to this form of treatment.

Theralase® CLT has been proven effective, preclinically, to overcome this resistance to X-rays and increasing cancer cell death by X-ray treatment.

GBM RG2 cells were pre-treated in vitro with Theralase® CLT. Six hours post treatment, these same cancer cells were irradiated with X-rays. Post-treatment analysis demonstrated that GBM RG2 cancer cells pre-treated with Theralase® CLT then subjected to X-ray had a 20% greater cell kill versus cancer cells treated with X-ray alone, strongly suggesting that the reversal of the Warburg Effect is essential to overcoming resistance to X-rays and improving overall cancer cell kill.

Standard cancer treatments may involve:

1) Cancerous tumour removal by surgical means

2) Multiple treatment sessions of ionizing radiation (X-rays)

3) Multiple treatment sessions of chemotherapy.

Chemotherapy may involve using one or more anti-cancer drugs, as part of a standardized chemotherapy regimen. These drugs are non-specific intracellular poisons that inhibit cell division and thus induce many side effects to normal cells or healthy tissue.

In addition, many cancer cells develop a resistance to these chemotherapy drugs, which in turn creates an ever-increasing spiral of higher and higher doses of the chemotherapy drugs to obtain an effect; however, at a significant cost, leading to increasing side effects and decreasing patient Quality Of Life (“QOL”).

Cisplatin and temozolomide (“TMZ”) are two such chemotherapy drugs used in the treatment of solid tumors, such as GBM brain cancer.

They are administered systemically to the patient and as a result induce significant side effects that can dramatically affect the patient’s QOL.

Theralase® CLT has been demonstrated to decrease the resistance of GBM RG2 brain cancer cells, preclinically, to both cisplatin and TMZ and thus increase the efficacy of these drugs at killing GBM RG2 cells, in vitro.

GBM RG2 brain cancer cells were pre-treated with Theralase® CLT. Six hours post treatment, the cancer cells were treated with either cisplatin or temozolomide. Post-treatment analysis demonstrated that Theralase ® CLT combined with either drug led to a greater cell kill compared to either drug alone (Cisplatin – 25% increased cell kill, Temozolomide – 22% increased cell kill when pre-treated with Theralase® CLT).

This discovery allows an increase in cancer cell destruction and lower chemotherapy drug doses to be used, which could potentially lead to a significant decrease in the associated side effects and an increase in the patient’s QOL, without affecting the desired effect of the cancer treatment.

Based on the latest data, the Theralase scientific research team has discovered, preclinically, that Theralase® CLT is able to:

1) Increase the efficacy of PDT

2) Overcome radio-resistance in cancerous tumour cells, allowing X-rays to be more effective in killing cancer cells.

3) Increase the efficacy of chemotherapy drugs, which can be used to lower the doses of chemotherapy drugs administered and potentially decrease their associated side effects.

Mark Roufaiel, Ph.D., Research Scientist, Theralase stated that, “CLT has been previously used successfully in cancer patients for the prevention and management of complications after surgery, chemotherapy and radiation therapy, but in general, it has been withheld by healthcare practitioners for fear that CLT might result in the stimulation or progression of cancerous tumors. The latest data discovered by our scientific team; however, strongly suggests that Theralase® CLT, at predefined scientifically determined doses is: safe, tolerable, effective and does not promote tumour growth, but on the contrary, delays tumour growth and increases overall patient survival. The latest data presented here further supports the potential for using Theralase® CLT, in combination with various standard cancer treatments to enhance cancer destruction and reduce their associated side effects. The fact that Theralase® CLT enhanced cancer cell death was demonstrated preclinically by using not one, but numerous anti-cancer treatments (i.e.: PDT, X-ray, Cisplatin or Temozolomide) strengthens the claim and supports the potential use of Theralase® CLT in numerous anti-cancer treatment programs. Theralase® CLT, and its reversal of the Warburg Effect, provides a powerful tool to be used by healthcare practitioners in the war on cancer, to pre-treat a patient, prior to anti-cancer treatment, to enhance the effectiveness of the treatment.”

Arkady Mandel, MD, Ph.D., D.Sc., Chief Scientific Officer, Theralase stated that, “One of the key strategies of our scientific team’s Theralase® CLT preclinical development program is to break down preconceived notions pertaining to CLT with new scientific, preclinical and clinical knowledge of how Theralase® CLT works so effectively on tissues: including, discoveries of previously unknown therapeutic pathways, such as mitochondria independent cellular signalling mechanisms. This enables our scientific team to build strategies to re-shape the use of Theralase® CLT from its existing therapeutic market and launch it into the oncology market, as a stand-alone therapy or to be used in conjunction with other anti-cancer treatments. A significant number of in vitro and animal cancer models have been evaluated with Theralase® CLT, such as: cisplatin, temozolomide, PDT and X-rays, building a body of evidence that significant and transferable anti-tumour effects of Theralase® CLT is applicable across a number of diverse tumour cell lines. The preclinical data of our research demonstrates the Theralase® CLT potential for the treatment of different type of cancers. The development of the Theralase® CLT technology may introduce new applications of this technology allowing new patient populations to benefit from Theralase® CLT treatment.

Roger Dumoulin-White, P.Eng., President and CEO, Theralase stated, “The latest research from Dr. Mandel and his scientific team opens up new potential distribution possibilities for both the Therapeutic Laser Therapy (“TLT”) division and the Photo Dynamic Therapy (“PDT”) division. Theralase will focus on translating this preclinical research into clinical protocols that could be readily deployed in the clinic by healthcare practitioners to pre-treat patients suffering with various cancer conditions with a goal of increasing the efficacy of their present anti-cancer treatments, lowering any associated side effects and increasing their overall QOL.”

About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures, markets and distributes patented super-pulsed 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. Theralase’s Photo Dynamic Therapy (“PDT”) Division researches and develops specially designed molecules called Photo Dynamic Compounds (“PDCs”), which have demonstrated an ability to localize to cancer cells and then when laser light activated, effectively destroy them.

Additional information is available at www.theralase.com and www.sedar.com .

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For More Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
rwhite@theralase.com
www.theralase.com