Toronto, Ontario – January 17, 2018
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a biotech company focused on the commercialization of medical lasers to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer has announced an optimization to the delivery schedule of its proprietary anti-cancer vaccine, increasing its efficacy in the destruction of brain cancer.
The anti-cancer vaccine was evaluated in a rat glioma (“RG2”) animal model, an established model of Glioblastoma Multiforme (“GBM”), a deadly form of human brain cancer.
As originally disclosed, the anti-cancer vaccine was created by exposing RG2 cells to patented stressors extracorporeally (outside the body) and then injecting this anti-cancer vaccine into rats to delay the progression of brain glioma tumours.
The previous data obtained in this model demonstrated an increase of 35% in the survival of animals that have been vaccinated twice versus control (non-vaccinated rats).
In the latest research, rats were vaccinated twice and then subjected to glioma (brain tumour) induction. Post brain tumour induction, as an optimization, four additional maintenance vaccinations were completed.
The latest data obtained on the optimized delivery timetable (six vaccinations versus two vaccinations) demonstrated a material increase in the survival of animals from 35% to 87.5%.
In order to transfer this research from the lab (animals) to the clinic (humans), potentially helping the patients in most need of the treatment, Theralase is in the process of developing two separate clinical treatment paths for patients diagnosed with GBM, with the aim of safely and effectively destroying their cancers with minimal side effects.
It is expected that the first Phase Ib GBM clinical study would generally involve the patient:
- receiving primary treatment, such as: surgical debridement, temozolomide (oral chemotherapy drug) and / or radiation therapy
- receiving the Theralase anti-cancer vaccine (created from the patient’s own tumour cells), post primary treatment, via subcutaneous or intramuscular injections, to stimulate the body’s immune system to destroy residual GBM cancer cells.
It is expected that the second Phase Ib GBM clinical study would generally involve the patient:
- receiving an intravenous injection of Rutherrin®, a patented PDC (TLD-1433) drug formulation combined with transferrin
- having the drug activated by laser light (via surgically inserted optical fibers) and/or ionizing radiation (using conventional trans-cranial (non-invasive) X-ray treatment), at 8 to 24 hours post-injection (allowing Rutherrin® to cross the blood brain barrier and be selectively absorbed into the GBM cancer cells).
- receiving additional PDT and/or radiation treatments (Step 1 and 2) to destroy any residual tumours, as required.
- receiving the Theralase anti-cancer vaccine (created from the patient’s own tumour cells), post treatment, via subcutaneous or intramuscular injections, to stimulate the body’s immune system to destroy residual GBM cancer cells.
- There are an estimated 24,000 new cases of malignant gliomas diagnosed in the US annually, with more than 14,000 deaths.
In the majority of cases, they recur following initial treatment, especially for GBM, the most common and lethal form of brain cancer.
Most patients do not survive beyond 2 years, post diagnosis.
Next steps planned by the Company to develop this technology are expected to include: manufacturing and scale-up of the anti-cancer personalized vaccine, regulatory approval to use an anti-cancer vaccine in human application, the recruitment of neurological oncology specialists to the Theralase Medical and Scientific Advisory Board and with their assistance the design and commencement of a Phase Ib GBM clinical study.
Manjunatha Ankathatti Munegowda, Ph.D., DVM, Research Scientist, Theralase, stated that, “In previous research, we demonstrated that the newly developed anti-cancer vaccine increased survival in an aggressive brain cancer model by 35%. Optimization of the delivery timetable, by repeatedly stimulating the immune response with multiple vaccinations, has increased survival by 87.5%. This anti-cancer vaccine could be used to target and eliminate any recurrences, post primary treatment, by delivering vaccinations to the patient from a stored bank of their own patient specific anti-cancer vaccines.”
Arkady Mandel M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase stated, “Theralase has designed and put into development a specific autologous (prepared from the patient’s own cancer cells) anti-cancer vaccine. In the latest research, utilizing the RG2 cell line as a model of human GBM, Theralase has demonstrated that its anti-cancer vaccine is effective. The anti-cancer vaccine is personalized and designed to train the patient’s immune system to develop a specific immune response creating anti-cancer immune cells that remember, hunt, recognize and kill a patient’s brain cancer cells regardless of where they may be located in the body.”
Dr. Mandel went on to say, “The latest optimized results confirm the efficacy of the vaccine via multiple vaccinations. The anti-cancer vaccine is non-toxic and has no noticeable adverse effects, when tested in an established animal model. Theralase is currently investigating the GMP scale-up of the anti-cancer vaccine with a cell based drug manufacturer to produce patient specific anti-cancer vaccines and maintain their ongoing storage, preservation and delivery to patients, as required. This latest research supports Theralase’s belief that teaching the immune system to destroy cancer cells throughout the body is one of the keys to conquering cancer.”
Potential risks to the development and commercialization of this technology include:
- Successful transfer of the anti-cancer vaccine technology from lab (animals) to clinic (humans)
- Successful manufacture and scale-up of the anti-cancer vaccine
- Sufficient capitalization to execute human clinical trials
- Health Canada and FDA regulatory approval to commence human clinical trials
- Successful regulatory approval of the human clinical trials upon completion
- Demonstrated safety and efficacy benefits over current standard of care treatments
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