Toronto, Ontario – October 13, 2016, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that it has successfully demonstrated the ability of its lead Photo Dynamic Therapy (“PDT”) technology to increase survival by 575% for a very aggressive form of brain cancer, known as Glioblastoma Multiforme (“GBM”), in a rat model.
GBM, also known as glioblastoma and grade IV astrocytoma (malignant brain tumor made up of star-shaped cells), is the most common and most aggressive cancer that begins within the brain. GBM kills > 85% of those diagnosed within 5 years.
The National Cancer Institute (“NCI”) estimates that 22,850 adults (12,630 men and 10,280 women) were diagnosed with brain and other nervous system cancer in 2015. It also estimates that in 2015, 15,320 of these diagnoses resulted in death (67% mortality rate).
NCI estimates that GBM accounts for 52 percent of all primary brain tumors and occurs primarily in adults between the ages of 45 and 70.
Experiment Details:
A very aggressive GBM tumor cell model (“RG2”) was used, which typically only allows survival of untreated animals to approximately 4 days, once the GBM has commenced growth to a Magnetic Resonance Imaging (“MRI”) detectable size.
In this same model, Amino Levulinic Acid (“ALA”), a competitive PDC has demonstrated an ability for the animal to survive 8 days post treatment, based on historical data.
As of October 12, 2016, the rat treated by the Theralase PDC Rutherrin® is alive and has managed to survive 31 days post treatment without any observed side effects.
All findings have been confirmed by MRI.
Chronology:
August 30th, 2016: A five month old Fischer 344 rat was injected in the cerebral cortex with 5,000 rat glioblastoma tumor cells
September 10, 2016: Rutherrin® comprised of TLD-1433 PDC (5 mg/kg) + transferrin is injected intravenously via the rat’s saphenous tail vein
September 11, 2016: 24 hours post injection, the Rutherrin® infused animal brain is exposed to 200 mW/cm2, 808 nanometer laser light with a total delivered energy of 600 J/cm2.
October 7, 2016 (26 days post PDT): Tumor diameter is 3.8 mm (Volume = 28.74 mm3) (111% daily growth rate)
October 12, 2016 (31 days post PDT): Rat still alive and functioning well.
Conclusions:
A 2 day increase in median survival in rats with this aggressive model would be equivalent to a 3 month survival in humans. Based on calculations, the current survival rate for untreated animals is 4 days (equivalent to 6 months survival in humans).
The animal has survived for 31 days post treatment (27 days longer than an untreated animal) resulting in an estimated increase in survival of 81 months in humans (6.75 years) or 575 % increase in survival.
The current median survival in humans with extensive treatment (maximal surgical resection, radiotherapy and concomitant and adjuvant chemotherapy with temozolomide) is approximately 14.1 months or 1.2 years1.
Discussion:
The RG2 model has not been optimized and was completed only on one animal suggesting that further optimizations could significantly increase the efficacy of this treatment.
Future experiments are planned that will increase:
- the dose of the PDC injected
- the dose of laser light used to activate the PDC
- the wavelength of laser light used for non-invasive application (i.e.: X-ray activation – our newest patent pending technology)
- dwell time after injection to activate the PDC
- multiple treatment approach
to investigate whether further increases in efficacy are attainable.
Arkady Mandel, MD, Ph.D., D.Sc., Chief Scientific Officer at Theralase stated that, “Glioblastoma multiforme is the most frequent primary brain tumor, it has poor prognosis, and it remains refractory to
current treatment. Because brain tumours are located at the control centre for thought, emotion, and movement, they can dramatically affect an individual’s physical and cognitive abilities and quality of life.
The data presented clearly demonstrates that the PDC Rutherrin® (TLD-1433 + transferrin) is able to cross the blood brain barrier, an immune privileged site, and be absorbed preferentially by tumor tissue through the transferrin receptor (15.7 times higher uptake in GBM versus healthy brain tissue). The data also indicates a significantly higher concentration of drug in tumor compared to normal tissue at between 4 hours and 24 hours post injection, suggesting that an optimal time to activate the PDC would be between these two time points. This latest research will allow us the ability to plan additional experiments to optimize the treatment methodology, prior to designing a Phase Ib human clinical study for patients inflicted with GBM.
Roger Dumoulin-White, President and CEO of Theralase stated that, “The PDT technology never ceases to impress us as to how effective the technology can be in the destruction of a wide range of cancer targets. We have shown a very high kill rate of Non-Muscle Invasive Bladder Cancer (“NMIBC”) pre-clinically, and now we have demonstrated a similar response in brain cancer. It is interesting to note that Theralase has employed different PDC installation methods (intravenous versus intravesical) and different activation wavelengths (NIR versus green) in the two cancers demonstrating the versatility of this technology to be applied across a wide range of cancers. Human clinical trials for NMIBC are around the corner and with some optimization steps, it seems that brain cancer clinical trials are not far behind. I look forward to introducing this technology to the world commercially in the not too distant future.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures, markets and distributes patented super-pulsed
laser technology indicated for 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 are able 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 .
This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
1 Stupp R, Hegi ME, Gilbert MR, Chakravarti A (2007) Chemoradiotherapy in malignant glioma: standard of care and future directions. Journal of Clinical Oncology 25(26):4127–4136