Theralase destroys 98% of cancer cells in animal model

2015-07-22 07:27 ET - News Release

Mr. Roger Dumoulin-White reports
THERALASE ACHIEVES 98% DESTRUCTION OF BLADDER CANCER
Theralase Technologies Inc. has achieved near-complete destruction (approximately 98 per cent) of bladder cancer in an animal model.

The company previously announced on Dec. 9 and 23, 2014, respectively, its success in destroying bladder cancer cells both in a Petri dish and in a preliminary orthotopic rat model in research performed at the University of Toledo. Theralase, in order to optimize the model, relocated it to Princess Margaret Cancer Center, University Health Network, under the direction of Dr. Lothar Lilge, senior scientist, UHN, and Dr. Arkady Mandel, chief scientific officer of the company. Optimization of both the formulation and purity of the lead drug, TLD-1433, by Sigma Aldridge Fine Chemicals and the wavelength of laser light used to activate the drug by Theralase resulted in achieving the highest cell kill to date.

Bladder cancer is the fifth most prevalent cancer in the world (fourth in men, eighth in women), resulting in 430,000 new cases worldwide and an estimated 91,000 deaths annually. There has been no new treatment developed for this disease in the last 16 years. The cost to treat a patient with this disease ranges from $100,000 (U.S.) to $200,000 (U.S.). The disease has an 80-per-cent recurrence rate. Of new bladder cancer cases, 70 per cent are early-stage disease affecting the inner lining of the bladder (urothelium) and are known as non-muscle-invasive bladder cancer. According to the latest clinical research, 25 per cent of these patients will have a recurrence of the disease within six months and a total of 50 per cent recur within two years. The standard of care currently is to surgically resect the bladder tumour followed by installation of a bacteria, known as bacillus Calmette-Guerin, into the bladder for high-risk patients. The next course of action for these patients, where the standard of care was not effective, is to either repeat the same treatment (surgery and BCG therapy) or to surgically remove the bladder in its entirety with any associated lymph nodes and nearby organs.

Theralase is developing an alternative therapy, known as photodynamic therapy, applicable for 50 per cent of patients or those who have relapsed within two years of treatment. In this form of treatment, Theralase's lead water-soluble PDT drug, TLD-1433, is instilled into the bladder through a plastic tube known as a catheter, allowed to be absorbed into the bladder cancer cells for approximately one hour, and then subsequently laser light activated over a period of 30 minutes. The entire procedure could be performed in a surgical suite in less than three hours. Theralase is researching the destruction of the entire bladder tumour with only one treatment; however, subsequent treatments could be performed in the future if there ever was a recurrence. The worldwide market for bladder cancer treatment is estimated to be worth more than $20-billion annually, with half of this population having a need for an alternative to their standard of care within two years.

Dr. Lothar Lilge, UHN, stated: "In the latest preclinical study, animals with bladder cancer tumours were treated via PDT. All orthotopic grown tumours in the bladders of these animals showed a strong response to PDT, with large areas of hemorrhage, necrosis (destruction) and inflammation present throughout the entire depth of the tumour, leading to a near-complete (approximately 98-per-cent) destruction of the tumour. Blood vessels of the submucosa and muscle layers (underlying structures) and healthy urothelium (bladder wall lining) did not show damage associated with the treatment. One of the major causes of failure of a previous photodynamic compound, Photofrin, to destroy bladder cancer was irreparable damage to the muscle layer of the bladder, post PDT treatment, rendering the bladder non-functional. The Theralase technology presents none of these issues in all experiments completed to date. I look forward in assisting Theralase in commencing clinical studies with their PDT technology later this year."

Dr. Arkady Mandel, chief scientific officer, stated, "Theralase, in conjunction with our partners SAFC and UHN, is continuing to fine-tune our PDT technology with the goal of commencing a Health Canada phase Ib clinical study for NMIBC in Q4 2015." Dr. Michael Jewett, a senior uro-oncologist at UHN and clinical principal investigator for the proposed clinical studies, stated: "The results obtained from this orthotopic rat model are extremely strong. Greater than 98-per-cent destruction of the bladder tumours with no impact to healthy urothelium or the underlying structure of the bladder, including the submucosa and muscle layers, is exactly what the doctor ordered. It will be a pleasure to lead the clinical studies at UHN to prove the safety, tolerability and efficacy of this technology on human patients later this year. If this is able to work in humans, the PDT technology is a game changer for anyone inflicted with this deadly disease."

Roger Dumoulin-White, president and chief executive officer, Theralase, stated: "We continue to make significant strides forward in the pursuit of commercialization of this technology in the destruction of NMIBC and, in the not-too-distant future, other equally devastating forms of cancer. We join all of our employees, directors, consultants, supporters, partners and shareholders in celebrating this latest success of hard work, tenacity and commitment to succeed in what will prove to be one of many more successes to come in the not-too-distant future."
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