‘Our Primary Objective is on Commercializing the Next Gold-Standard Treatment for NMIBC, Using our ACT technology’: Dr. Shawn Shirazi, CEO of Theralase® Technologies

“Theralase^®’s mandate is the research and development of new technologies or the improvement of existing technologies, which border on medical excellence for the betterment of all men and women.”

Theralase^® Technologies is a clinical-stage pharmaceutical company dedicated to the research and development of light-activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers. The company is focused on discovering, developing, and commercializing anti-cancer therapies using light-activated PhotoDynamic Compounds and their associated drug formulations to safely and effectively treat patients afflicted with the disease.

Theralase^® was incorporated in 1994 and is headquartered in Toronto, Ontario.

Dr. Shawn Shirazi (CEO) spoke exclusively to The Silicon Review. Below is an excerpt.

Q. 'Destroying cancer at the speed of light^®' and 'Healing at the speed of light^®'? Would you like to elaborate on these concepts a bit more?

In the first tagline, Theralase^® utilizes patented Anti-Cancer Therapy (ACT) medical laser technology to activate a light-sensitive drug known as TLD-1433 that has localized inside cancer cells preferentially versus healthy cells to safely and effectively destroy these cancer cells. This state-of-the-art technology is currently under investigation in phase II clinical study in Canada and the United States for the destruction of Non-Muscle Invasive Bladder Cancer (NMIBC), the fourth most common type of cancer in men and the ninth most common cancer in women.

In the second tagline, Theralase^® uses proprietary Cool Laser Therapy (CLT), which has been proven to safely and effectively eliminate a patient's chronic knee pain. It is used off-label by healthcare practitioners to treat various nerve, muscle, and joint conditions.

Q. How efficiently do you address cancer patients' concerns, given that Theralase^® focuses on the R&D of laser-based technologies to destroy cancer cells and other such diseases?

Theralase^® is indeed involved in the research and development of various medical laser technologies for the destruction of cancer; however, we are laser-focused on bringing our ACT technology to commercialization, as evidenced by our phase II NMIBC clinical study currently underway. This study is a pivotal clinical study, meaning that if proven successful, Theralase^® would commercialize this technology in Canada, the United States, and across the world.

The current standard of care for treating all cancers involves some combination of surgery, radiation, chemotherapy, and pharmaceutical drugs. All of these treatments have varying degrees of efficacy, meaning that they are effective for some patients, but not for others, but more importantly; they all are capable of introducing some fairly significant side effects to the patient, which can affect the patient’s Quality Of Life (QOL), morbidity, and unfortunately, their mortality. We are working towards our objective of providing the world with a cancer treatment, which is effective, but does not introduce any significant side effects to the patient; thus, preserving their QOL.

Q. What are your focus areas? Please share an overview.

Our primary objective is on commercializing the next ‘gold-standard’ treatment for NMIBC, using our ACT technology, as previously discussed. Our secondary objective is the research and development of an injectable form of our patented light-sensitive drug, TLD-1433, named Rutherrin^® (TLD-1433, a ruthenium-based drug combined with an endogenous glycoprotein, known as transferrin), which has been demonstrated preclinically to allow it to localize precisely to cancer cells versus healthy cells, and can be injected intravenously into patients. Once injected, it “hunts” and localizes to various cancer cells; wherever they may be located in the body, it effectively destroys them when activated by external radiation. This secondary objective is currently focused on the destruction of GlioBlastoma Multiforme (GBM), a deadly form of brain cancer, and Non-Small Cell Lung Cancer (NSCLC), the second most common cancer for men and women. Our tertiary objective is to research and develop a COVID-19 vaccine to prevent contracting the SARS-CoV-2 virus, in conjunction with the University of Manitoba and the National Microbiology Laboratory, both based in Canada. Lastly, our quaternary objective is the promulgation of our proprietary CLT technology across Canada and the United States.

Q. How effective is photodynamic therapy compared to traditional treatments such as surgery, chemotherapy, and radiotherapy?

As mentioned earlier, Theralase^® ACT technology can selectively target cancer cells versus healthy cells; thus, significantly increasing efficacy while at the same time minimizing side effects. The Theralase^® ACT technology thus has the potential for higher safety and efficacy versus surgery, chemotherapy, or radiation.

Q. You must be decisive and persistent to succeed in this competitive industry. That said, how do you plan to stay at the forefront of technological innovations?

Theralase^® believes that "a strong offense is the best defense" (George Washington circa 1799); therefore, we are constantly researching and developing the next generation technologies able to safely and effectively treat various medical conditions, to remain at the cutting-edge of development, as we concurrently strive to commercialize our existing pipeline of technologies.

Q. How do you plan to transform your company into a future that is unfolding before you?

By never "resting on our laurels" (2nd Century Greece), Theralase^®'s mandate is to research and develop new technologies or improve existing technologies, which border on medical excellence for the betterment of all men and women. By staying focused on what is in front of us and producing strong preclinical and clinical data that supports the safety and efficacy of our technologies, we will succeed in our objectives.

Leadership | Theralase^® Technologies

Dr. Shawn Shirazi (Ph.D., M.Sc., B.Sc.) CEO: Dr. Shawn Shirazi is the CEO of Theralase^® Technologies. He brings over 20 years of hands-on experience in pharmaceutical drug formulation and development, clinical trial management, Good Manufacturing Practices (GMP), international drug manufacture, international regulatory guidelines, and quality assurance in GMP drug manufacture. He has held senior roles with both start-ups and large pharmaceutical organizations, including Executive Director and Vice President of Research and Development for Torpharm Inc (Division of Apotex), Senior Director Global Research and Development of Perrigo Company (NYSE: PRGO), and Chief Operating Officer – North America for Daxinganling Lingonberry Boreal Biotech Co. Ltd. (a leading manufacturer of high-quality plant extracts, based in China). During his career, Dr. Shirazi has led the generic drug development programs for numerous pharmaceutical organizations, resulting in multiple "First To File" drug applications, allowing product exclusivity and global leadership of research and development and merger and acquisition portfolios. He obtained his B.Sc. in Chemistry from York University (Toronto, Ontario, Canada) and a M.Sc. and Ph.D. in Pharmacology from the University of Ottawa (Ottawa, Ontario, Canada).

Dr. Arkady Mandel (M.D., Ph.D., DSc.) CSO and Director: Dr. Arkady Mandel earned his designation as a medical doctor from the Moscow State Medical University in 1978. His medical residency included dermatology, infectious diseases, urology, and venereal diseases at the Central Research Institute of Dermatology and Venerology in 1980, followed by a Ph.D. from the same institution in 1982. He was then awarded, in recognition of his scientific knowledge, original research, publications, and extensive contributions to the field of clinical medicine, the highest academic research degree in science, that of a Doctor of Science. Dr. Mandel's Doctor of Science accreditation majored in biochemistry, microbiology, immunology, biophysics, and photobiology, and was awarded jointly from the Academy of Sciences and the U.S.S.R. Ministry of Public Health in 1989. Dr. Mandel is one of the key founders of the therapeutic use of lasers in dermatology and other areas of clinical medicine and the originator and developer of phototherapy methods that offer numerous benefits to patients throughout the world.

Kristina Hachey, CPA & CFO: Kristina Hachey earned her designation as a CPA in 2002. She graduated from Ryerson University with a bachelor’s degree in business management and Administration, majoring in Accounting and Finance, minoring in International Business. Ms. Hachey has been employed as Theralase’s Chief Financial Officer since May 2004. Prior to joining Theralase, she served as VP Finance of Kensington Capital Partners from April 1998 to May 2004.

"Theralase^® ACT technology can selectively target cancer cells versus healthy cells; thus, significantly increasing efficacy while at the same time minimizing side effects. The Theralase^® ACT technology thus has the potential for higher safety and efficacy versus surgery, chemotherapy, or radiation."