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Let’s get this train rolling!!
Theralase Enrolls First Patient into Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
Toronto, Ontario – July 26, 2019, Theralase® Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTCQB), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds (“PDC”) and their associated drug formulations, intended to safely and effectively destroy various cancers, announced today that the first patient has been enrolled into its Phase II clinical study titled “Patients with Non-Muscle Invasive Bladder Cancer (“NMIBC”), who present with Carcinoma In-Situ (“CIS”), who are considered Bacillus Calmette Guérin (“BCG”) Unresponsive or are intolerant to BCG Therapy (“Phase II”)” at University Health Network (“UHN”) in Toronto.
Phase II has been designed in compliance with FDA industry guidelines for BCG-unresponsive NMIBC (issued: February 2018) and defined by the FDA in a Pre-Investigational New Drug (“IND”) conference call in late June 2019. The study will utilize the Therapeutic Dose (0.70 mg/cm2) of the Company’s lead PDC TLD-1433 and will focus on the treatment of approximately 100 BCG-unresponsive NMIBC patients who present with CIS in approximately 20 clinical sites located in Canada and the US, with a primary endpoint of efficacy and a secondary endpoint of safety. The Company is no longer pursuing European study sites due to the exorbitant costs of regulatory approval.
The primary endpoint of the Study will be:
Efficacy – Evaluated by Complete Response (“CR”) at any time in patients with CIS with or without papillary disease post-initial treatment duration response.
The secondary endpoint of the Study will be:
Duration of CR evaluated at 360 days post-initial treatment.
The tertiary endpoint of the Study will be:
Safety – Evaluated by the incidence and severity of Adverse Events (“AEs”) Grade 4 or higher that do not resolve within 360 days post-treatment; whereby:
Grade 1 = Mild
Grade 2 = Moderate
Grade 3 = Severe
Grade 4 = Life-threatening or disabling
Grade 5 = Death
Shawn Shirazi, Ph.D., CEO - Drug Division, Theralase stated that, “The enrollment of the first patient at UHN represents a major milestone for Theralase. I am pleased that the Phase II ACT-NMIBC clinical study has enrolled and will be treating its first patient. Our primary focus has been to onboard sites in Canada followed by the US and Europe; however, as we have been successful in signing an agreement with a Trial Management Organization (“TMO”) in the US, we no longer will be proceeding with European study site onboarding at this time. The addition of the TMO has increased the anticipated number of US clinical sites, thereby negating the need to open up European sites and ultimately a significant cost savings for the Company.”
This was my favorite part of the PR:
“We hope that these optimizations translate into a successful completion of the Phase II clinical study for the Company and potentially in the future allow patient treatments to be performed in a non-operating room environment."
That would be a game changer!
Agreed!!!
Patient Five Cancer-Free Twelve Months After Single Anti-Cancer Treatment
Toronto, Ontario – January 31, 2019, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers reports that patient five, enrolled and treated in the recently completed Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”), has demonstrated no tumour recurrence or presence of disease at the 360 day clinical and cystoscopy assessment.
The Study’s purpose was to evaluate TLD-1433, Theralase’s lead PDC, for the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy, primarily at 90 days and secondarily at 180 days post treatment.
The Study was successfully completed with patient five and six demonstrating achievement of the primary, secondary and exploratory endpoints.
Patient five has demonstrated no tumour recurrence or presence of disease at the 90, 180, 270 and now 360 days post treatment clinical and cystoscopy assessment, marking a new achievement for the Company.
Patient five and six were enrolled and treated in the Study at the Therapeutic Dose (0.70 mg/cm2). Theralase’s Anti-Cancer Treatment involved the intravesical instillation of a water-based solution of Theralase’s lead anti-cancer PDC, TLD-1433, via a catheter inserted through the urethra into the bladder of the patient, to allow the PDC to be preferentially absorbed by NMIBC tumours. The bladder was then drained of the solution, flushed with sterile water to remove non-absorbed solution and refilled with sterile water via a cystoscope. A fibre optic assembly, comprising a Laser Emitter used to emit laser light and a proprietary Dosimetry System used to detect laser light, were then used to activate TLD-1433 resident in the NMIBC tumours.
Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase stated, “Today, we received additional evidence that even a single treatment with Theralase’s Photo Dynamic Therapy (“PDT”) is able to lead to a Complete Response (“CR”) at 360 days post treatment for patients presenting with Bacillus Calmete Guérin (“BCG”)-Unresponsive NMIBC. This provides further support of the enormous opportunity that awaits Theralase in the treatment of NMIBC. For NMIBC, a CR is defined by the FDA as the definitive endpoint for single-arm intravesical studies of patients who present with BCG-Unresponsive Carcinoma In-Situ (“CIS”) disease, with or without resected papillary tumours. In the Health Canada approved Phase II NMIBC clinical study, the Company is providing two treatment procedures (therapeutic procedure at Day 0 and maintenance procedure at Day 180). The latest data on patient five is extremely encouraging, in that it demonstrates after only one anti-cancer treatment procedure, CR at 90, 180, 270 and now 360 days post-treatment is possible. If the efficacy results obtained to date are able to be replicated, demonstrating a CR at 360 days post-treatment, in a larger patient population, via a well-designed Phase II NMIBC clinical study, then the Theralase Anti-Cancer Technology has the potential to be the next gold standard in the treatment of NMIBC. We are highly encouraged by this recent data demonstrating that BCG-Unresponsive NMIBC patients, who refused or were ineligible to undergo a radical cystectomy (bladder removal surgery) have remained cancer free at 270 and now up to 360 days post anti-cancer treatment, achieving developmental milestones beyond their previous clinical experience and their history living with this devastating disease. Theralase’s TLD-1433-PDT may provide sustainable and comprehensive benefit to people diagnosed with NMIBC and I look forward to providing updates on the Phase II NMIBC clinical study when it commences. The Theralase Anti-Cancer Technology is also multi-faceted, in that the technology is able to be adapted to the treatment of additional cancer indications, if successfully validated in independent clinical studies. Pending successful commencement of the Phase II NMIBC clinical study, the Company plans to investigate the commencement of an additional Phase Ib clinical study for a new cancer indication.”
Definitely some interesting times with this science. That would be a game changer!
We learned from Phase 1 that whatever timeline they give us can pretty much be doubled. These clinical trials meet a lot of bumps along the way. Enrolling 20 sites with IRB approval will take time for sure.
The results, so far, are excellent though! Hopefully Phase 2 kicks off soon ????
Patient Six Cancer-Free at Nine Months After Single Anti-Cancer Treatment
Toronto, Ontario – January 30, 2019, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers reports that patient six, enrolled and treated in the recently completed Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”), has demonstrated no tumour recurrence or presence of disease at the 270 day clinical and cystoscopy assessment.
The Study’s purpose was to evaluate TLD-1433, Theralase’s lead PDC, for the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy, primarily at 90 days and secondarily at 180 days post treatment.
The Study was successfully completed with patient five and six demonstrating achievement of the primary, secondary and exploratory endpoints.
Patient five and six have demonstrated no tumour recurrence or presence of disease at the 90, 180 and now 270 days post treatment clinical and cystoscopy assessment, marking a new achievement for the Company.
Patient five and six were enrolled and treated in the Study at the Therapeutic Dose (0.70 mg/cm2). Theralase’s Anti-Cancer Treatment involved the intravesical instillation of a water-based solution of Theralase’s lead anti-cancer PDC, TLD-1433, via a catheter inserted through the urethra into the bladder of the patient, to allow the PDC to be preferentially absorbed by NMIBC tumours. The bladder was then drained of the solution, flushed with sterile water to remove non-absorbed solution and refilled with sterile water via a cystoscope. A fibre optic assembly, comprising a Laser Emitter used to emit laser light and a proprietary Dosimetry System used to detect laser light, were then used to activate TLD-1433 resident in the NMIBC tumours.
Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase stated, “This new data from patient six mirrors the 270 days Complete Response (“CR”) efficacy data observed in patient five at the same time interval. This evidence further bolsters our understanding that even a single treatment of Theralase’s Photo Dynamic Therapy (“PDT”) is able to lead to CR at 270 days post treatment for patients presenting with Bacillus Calmete Guérin (“BCG”)-Unresponsive NMIBC. This illustrates the enormous opportunity that awaits Theralase in the treatment of NMIBC. For NMIBC, a CR post treatment has recently been defined by the FDA as the definitive endpoint for a single-arm intravesical study for patients who present with BCG-Unresponsive Carcinoma In-Situ (“CIS”) disease, with or without resected papillary tumours. In the Health Canada approved Phase II NMIBC clinical study, the Company is providing two treatment procedures (therapeutic procedure at Day 0 and maintenance procedure at Day 180). The latest data on patient five and six is extremely encouraging, demonstrating that CR at 270 days post-treatment is achievable in the elimination of NMIBC after only one PDT treatment procedure. If the efficacy results are able to be demonstrated at 12 months post-treatment, in a larger patient population, conducted in a well-designed Phase II NMIBC clinical study, then the Theralase Anti-Cancer Technology has the potential to be the next gold standard in the treatment of NMIBC. The Theralase Anti-Cancer Technology is also multi-faceted, in that the technology is able to be adapted to the treatment of additional cancer indications, if successfully validated in independent clinical studies. Pending successful commencement of the Phase II NMIBC clinical study, the Company plans to investigate the commencement of an additional Phase Ib clinical study for a new cancer indication.”
The Phase II NMIBC Clinical Study, entitled, “A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer or Patients Who are Intolerant to BCG Therapy” will utilize the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and will focus on the enrollment and treatment of approximately 100 BCG-Unresponsive NMIBC patients in approximately 20 clinical sites located in Canada, the US and internationally, with a primary endpoint of efficacy and a secondary endpoint of safety.
The endpoints of the Phase II NMIBC Clinical Study will be:
Primary (Efficacy) – Evaluated by CR in patients with CIS with or without resected papillary disease at 90 days post-treatment with duration of CR evaluated at 360 days post-treatment.
Patient CR is defined as at least one of the following:
1) Negative cystoscopy and negative (including atypical) urine cytology
2) Positive cystoscopy with biopsy-proven benign or low-grade NMIBC
3) Negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative
Secondary (Safety) – Evaluated by the incidence and severity of Adverse Events (“AEs”) Grade 4 or higher that do not resolve within 360 days post-treatment; whereby:
Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening or disabling and Grade 5 = Death
One step closer!!
Health Canada Grants ITA Approval to Commence Phase II Clinical Study
Toronto, Ontario - December 10, 2018, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations, intended to safely and effectively destroy various cancers, announced today that Health Canada has granted the Company Investigational Testing Authorization (“ITA”) approval to utilize its patent pending TLC-3000 Photo Dynamic Therapy (“PDT”) Laser System, in conjunction with its Clinical Trial Application (“CTA”) approved lead PDC, TLD-1433, to commence enrolling and treating patients in a Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”), subject to submitting a Clinical Trial Site Information Form and receipt of their respective Research Ethics Board (“REB”) approval for each Canadian oncology location that will conduct Study II.
The TLC-3000 PDT Laser System delivers green laser light (525 nm), while simultaneously monitoring the laser light to achieve the target dosage at the bladder wall surface, safely and effectively destroying the NMIBC.
Study II titled, “A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer or Patients Who are Intolerant to BCG Therapy” will utilize the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and will focus on the treatment of approximately 100 NMIBC patients in approximately 20 clinical sites located in Canada, the US and internationally, with a primary endpoint of efficacy.
Oncology sites will be launched first in Canada, followed by the US, pending Food and Drug Administration approval, and then internationally, pending international regulatory approval.
The primary endpoint of the Study II design will be:
Efficacy – Evaluated by Complete Response (“CR”) in patients with Carcinoma In-Situ (“CIS”) with or without resected papillary disease at 90 days post-treatment with duration of CR evaluated at 360 days post-treatment.
Patient CR is defined as at least one of the following:
Negative cystoscopy and negative (including atypical) urine cytology
Positive cystoscopy with biopsy-proven benign or low-grade NMIBC
Negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative
The secondary outcome endpoint of the Study design will be:
Safety – Evaluated by the incidence and severity of Adverse Events (“AEs”) Grade 4 or higher that do not resolve within 360 days post-treatment; whereby: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening or disabling, Grade 5 = Death
Arkady Mandel, MD, PhD, DSc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase said that “Theralase is proud of the hard work delivered by our clinical, technical, scientific, regulatory and administrative teams that have resulted in Health Canada’s decision to grant the Company CTA and ITA approval to commence a Phase II NMIBC clinical study, subject to REB approval. The clinical data collected from the Phase Ib NMIBC clinical study supports our belief that Theralase’s PDT technology offers a new and advanced treatment option for NMIBC BCG-Unresponsive patients, who have exhausted all other available treatment options. TLD-1433 PDT represents a unique approach, using a targeted and patient specific drug and light delivery system. Theralase is currently in discussions with a number of world-class uro-oncology centers interested in enrolling and treating patients in a Phase II NMIBC clinical study, subject to final regulatory and REB approvals for the countries in question. Theralase looks forward to demonstrating to the world what this technology is truly capable of. Theralase believes that its anti-cancer PDT technology will provide patients, who present with various cancers, and who have failed to respond to standard of care treatment, with new hope and a strong alternative therapy”.
In light of the statement in this PR about early commercial adoption if early Phase 2 results are positive, how many patients do you think they will have to get through before supplying “early” results? How is it possible to have early commercial adoption without full FDA, Canadian, or international approvals after a full phase 2 study is completed?
Does this come back to the new law passed in the US that allows the use of non-approved treatments for terminal patients with no other choices, or is there something else I’m missing?
Theralase® Provides Corporate Update
Theralase® Provides Update on Upcoming Initiatives for Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
Toronto, Ontario – August 27, 2018, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers has provided a corporate update on the Phase II for the Non-Muscle Invasive Bladder Cancer (“NMIBC”) Clinical Study.
Photo Dynamic Therapy (“PDT”) utilizing the Company’s lead drug, TLD-1433, has met all expectations of the Company in the successfully completed Phase Ib NMIBC Clinical Study.
In the Phase Ib study all 6 patients enrolled and treated (3 at the Maximum Recommended Starting Dose (“MRSD”) (0.35 mg/cm2) and 3 at the Therapeutic Dose (0.70 mg/cm2)) achieved both the primary (safety and tolerability as measured by Adverse Events (“AE”)) and secondary (pharmacokinetics, as measured by PDC remaining in urine and blood) endpoints.
All 3 patients (patients 4, 5 and 6) treated with the Therapeutic Dose achieved a Complete Response (“CR”) at 90 days after PDT. Patients 5 and 6 achieved a CR at 180 days and continue to exhibit a CR. Patient 4 was found to have progressed to metastatic disease after 90 days and was removed from the follow up evaluation. This metastatic progression of disease in patient 4 was unrelated to TLD-1433 PDT.
These results compelled the independent Medical and Scientific Advisory Board (“MSAB”) to recommend to the Company, the early termination of the Study due to achievement of the primary and secondary endpoints. The MSAB also recommended that the clinical data collected from the first three patients treated at the MRSD and the three patients treated at the Therapeutic Dose were sufficient to support the conclusion that the Study had successfully achieved the Study’s primary and secondary endpoints and had adequately addressed the Study’s scientific, technical and clinical questions, as per the approved Study design and clinical protocol. The MSAB recommendation to the Company was to terminate the Study based on the six patients treated to date and suggested that the Company pursue a pivotal Phase II NMIBC clinical study approval with Health Canada and the FDA with efficacy as the primary endpoint.
Patient 5 and 6 in the Phase Ib study, presented with stage T1 High Grade and Carcinoma-In-Situ (“CIS”) NMIBC, respectively, prior to the PDT treatment and regardless of the treatment procedure performed (i.e.: Trans-Urethral Resection of the Bladder Tumour (“TURBT”) and/or Bacillus Calmette Guérin (“BCG”)) had done so for the last 4 and 5 years, respectively).
The 180 day CR of their disease to Theralase’s PDT marks a significant event for both the Company and the patients.
The Phase II NMIBC Clinical Study is currently under Health Canada review and is expected to be submitted to the Food and Drug Administration for review in September 2018.
The Company will work with both Canadian and US regulatory authorities to address any questions they may have about the Phase II clinical study design and expect to receive the requisite approvals to commence the Phase II clinical study in both countries in late 2018 / early 2019.
The Phase II clinical study is anticipated to involve the recruitment, treatment and follow-up of 100 patients providing them two Theralase PDT treatments, one at Day 0 and one at Day 180.
The enrollment, treatment and follow-up of these 100 patients is expected to involve 15 to 25 clinical sites in Canada, the US, and internationally, and is expected to take 3 years to complete.
If the initial data in the Phase II clinical study is favourable compared to standard of care, then early adoption of the technology for commercial application is possible, subject to approval by the requisite
regulatory authority.
Michael Jewett, MD, FRCSC, FACS, Professor of Surgery (Urology) at the University of Toronto and the Chairman of Theralase’s MSAB stated that, “The lack of significant adverse events and early efficacy signal with the six month CR data from the Phase Ib clinical study is encouraging and reinforces our strong support for conducting the Phase II NMIBC clinical study. Theralase’s PDT technology platform may offer a new treatment option for NMIBC patients, who have exhausted all other available treatment options. In contrast to most other areas in cancer therapy, there has not been a significant treatment advance for CIS and/or high-grade NMIBC in decades. TLD-1433 PDT is a unique and innovative approach, using a targeted, patient specific drug and light delivery system. I believe the Theralase PDT treatment will provide NMIBC BCG-Unresponsive patients (patients who have failed the standard of care treatment of TURBT and BCG) with new hope and an alternative for staving off life-altering bladder removal surgery.”
Theralase Submits Phase II Bladder Cancer Clinical Study Application to Health Canada for Review and Approval
Toronto, Ontario – August 20, 2018, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers has submitted a Clinical Trial Application (“CTA”) and Investigational Testing Authorization (“ITA”) for its TLD-1433 anti-cancer technology to Health Canada for review and approval.
Pending Health Canada and the individual Canadian oncology location(s) Research Ethics Board’s (“REB”) approvals, and subject to securing the requisite financing, Theralase plans to commence a Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study, entitled, “Photo Dynamic Therapy Using Laser Light Activated TLD-1433 in BCG-Unresponsive Patient Population” (“Study”) with select Canadian oncology locations.
Theralase’s anti-cancer technology utilizes the proprietary Theralase TLC-3200 Medical Laser System to light activate the Company’s lead, patented PDC, TLD-1433, intended to treat NMIBC.
In the proposed Study design, approximately 100 patients will be enrolled and treated at the Therapeutic Dose (0.70 mg / cm2) of TLD-1433. Oncology sites will be launched in Canada pending Health Canada Approval, in the US, pending Food and Drug Administration approval, and internationally pending international regulatory approval.
The primary outcome endpoint of the Study design is proposed to be:
Efficacy - Evaluated by Complete Response (“CR”) in patients with Carcinoma In-Situ (“CIS”) with or without resected papillary disease at 90 days post-treatment with duration of CR evaluated at 360 days post-treatment.
Patient CR is defined as at least one of the following:
1) Negative cystoscopy and negative (including atypical) urine cytology
2) Positive cystoscopy with biopsy-proven benign or low-grade NMIBC
3) Negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative
The secondary outcome endpoint of the Study design is proposed to be:
Safety - Evaluated by the incidence and severity of Adverse Events (“AEs”) Grade 4 or higher that do not resolve within 360 days post-treatment; whereby:
Grade 1 = Mild
Grade 2 = Moderate
Grade 3 = Severe
Grade 4 = Life-threatening or disabling
Grade 5
Arkady Mandel, MD, PhD, DSc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase stated, “The submission of a CTA and ITA to Health Canada for the Study marks completion of another major milestone for the Company on our way to proving the efficacy of our anti-cancer technology in the destruction of NMIBC. Pending approval of the CTA, ITA and REB, along with securing the required financing, Theralase plans to authorize select Canadian oncology location(s) and their respective Principal Investigator(s) to commence enrolling and treating NMIBC patients using our approved clinical treatment procedure.”
I know! It’s infuriating! I guess we’ll have to be showing good, consistent results through Phase 2 before we get any traction. It’s weird the way this stock behaves being that it’s a possible life altering treatment.
Part of the problem is we are still on the OTC. We won’t get any of that institutional money until we’re uplisted, but we have a ways to go before we can qualify for that. I only want to do that organically though. I pray they don’t decide to do a reverse split to get there. I don’t think our outstanding share count is high enough to warrant it though. ????
Very exciting times! Looking forward to commencement of Phase 2! Hopefully soon ????
Well deserved! So is this $4.5 million we won’t have to put in towards furthering the research? That would be really helpful!
My favorite part of this PR:
“The exploratory endpoint of efficacy is extremely encouraging as the fifth and sixth patients are clinically cancer free as of the ninety day cystoscopy examination."
Joint venture with cannabis company? Hmmmmm.....interesting
Theralase Discovers Cannabinoid Increases Efficacy of Patented Anti-Cancer Technology in Destruction of Brain Cancer
Toronto, Ontario – March 27, 2018, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations to safely and effectively destroy various cancers, announced the filing of a US patent application detailing the discovery of a significant increase in the destruction of cancer cells, when Theralase’s patented anti-cancer technology is combined with cannabinoids.
In preclinical experiments, Theralase scientific researchers combined a specific cannabinoid with their patented anti-cancer Photo Dynamic Therapy (“PDT”) technology to produce an unexpected synergistic effect in the destruction of rat glioma brain cancer cells (“RG2”).
In the study, RG2 brain cancer cells were preconditioned, in-vitro, with a specific cannabinoid and then subjected to Theralase’s anti-cancer technology. The researchers discovered that the efficacy of this combined treatment increased 250%, compared to treatment with Theralase’s anti-cancer technology or the specific cannabinoid alone.
Mark Roufaiel, Ph.D., research scientist at Theralase stated, “The latest data demonstrates that the use of a selected and non-toxic cannabinoid is able to increase the killing effect of Theralase’s anti-cancer PDT in a synergistic manner, leading to an effect greater than the sum of their individual effects. These results strongly suggest that a specific cannabinoid could be used to increase tumour destruction and improve therapeutic outcomes.”
Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer at Theralase stated that, “The anti-inflammatory and anti-proliferative properties of cannabinoids may provide additional benefits to our patented anti-cancer technology. Our scientific research team undertook experiments to combine PDT and a cannabinoid to assess if there were any perceived benefits. In order to observe the effects of the specific cannabinoid, the PDT drug and light doses were reduced and hence the efficacy of the anti-cancer technology at these levels. Lo and behold, we discovered that the combination of these two technologies produced a greater than anticipated synergistic effect.”
Dr. Mandel went on to say, “We had expected the pairing of the two technologies to produce an additive effect, that is, the efficacy of one technology would “add” to the efficacy of the other technology, as in a one plus one equals two scenario. Instead, we were pleasantly surprised to discover that these two technologies, when used in combination, produced a much higher kill rate than expected, delivering results where one plus one now equals three and one half.”
The graph below depicts the preclinical results obtained:
1) Control - no treatment, no effect
2) Theralase® PDT alone (10%)
3) Specific cannabinoid alone (10%)
4) Hypothetical expected additive effect of the specific cannabinoid + PDT (20%)
5) Actual observed synergistic effect of the specific cannabinoid, when combined with Theralase’s PDT (35%)
Dr. Mandel stated, “I am very pleased with these preclinical results and if we are able to translate this technology successfully to humans, it strongly suggests that specific cannabinoids could be used to increase the efficacy of Theralase’s anti-cancer PDT technology in the destruction of deadly cancers, such as Glioblastoma Multiforme (“GBM”) brain cancer. The initial results reported are the first of a set of experiments planned by our scientific research team in the field of combining cannabinoids with Theralase’s PDT technology and also our anti-cancer vaccine, RuVaCare, in the destruction of human cancers. We believe this research will provide a strong foundation for a “first-in-man” clinical study, where the Company’s patented anti-cancer technology and / or anti-cancer vaccine will be combined with cannabinoid(s) in the treatment of cancer.
Dr. Mandel concluded by saying that, “This latest preclinical research lays the groundwork for the Company to actively seek strategic partnerships in the co-development of this combined technology for the treatment of specific human cancers, such as GBM. The Company plans to explore these avenues in the immediate future, with the hopes of securing a joint venture with a company interested in the development of this combination technology, such as a Canadian cannabis producer.”
A lot!
Research seems to be going really well so far. Time will tell what the Phase 1 and 2 trials bare out. Time is the operative word. I feel like we’re going to be waiting awhile before even the NMIBC Phase 2 is complete, much less these other indications. It’s exciting to see a possible cancer cure out there or, at the least, a strong adjunct to preexisting therapies!
Theralase Anti-Cancer Technology Effective in Destroying Brain Cancer Stem Cells
Toronto, Ontario – March 15, 2018, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations to safely and effectively destroy various cancers, announced today that its lead PDC, TLD-1433, combined with transferrin to form Rutherrin®, has been demonstrated to effectively destroy human brain cancer stem cells.
Despite tremendous advances in cancer therapy over the last ten years, resistance to treatment and high rates of recurrence remain stubbornly common.
In fact, even patients who experience a complete clinical response to frontline therapy (i.e.: surgery, radiation or chemotherapy), often suffer a relapse with the emergence of lethal, drug-resistant disease—stemming in large part from microscopic deposits of surviving cancer cells that escaped treatment by various mechanisms. This is commonplace for malignancies of the bladder and brain.
The contribution of cancer stem cells to the formation of cancers has been previously established in the clinical literature and has been described for several solid tumours.
Although a combination of surgery, radiation and chemotherapy may destroy most of cancer cells in a tumour, it is believed that the cancer cells left alive may in fact be cancer stem cells, capable of reforming the tumour. If able to be destroyed, the destruction of these cancer stem cells may represent an extremely important discovery in defeating cancer’s resistance to treatment and more importantly, recurrence.
GlioBlastoma Multiforme (“GBM”) is the most common and aggressive primary brain tumour and unfortunately has one of the worst survival rates of all types of cancer.
Despite aggressive surgery, radiation and chemotherapy, these tumours, virtually all become resistant to therapy and as a result recur.
There are an estimated 24,000 new cases of malignant gliomas diagnosed in the US annually, with more than 14,000 deaths. Most patients do not survive beyond 2 years, post diagnosis.
The cancer stem cells within these aggressive tumours are hypothesized in the latest clinical research to be responsible for the observed resistance to treatment and recurrence.
In the Company’s latest research, Theralase research scientists have tested the effect of Rutherrin® Photo Dynamic Therapy (“PDT”) on GSC-118 cancer cells, an established human GBM cancer stem cell line.
In previous research, TLD-1433 has been shown to successfully kill human GBM brain cancer cells in-vitro (U87 cell line).
In the latest research, Theralase has demonstrated the ability of Rutherrin® PDT to destroy GSC-818 brain cancer stem cells in the 300 to 600 nM range, when activated by green laser light (520 nm / 20 J/cm2).
Pavel Kaspler, Ph.D., Research Scientist at Theralase stated that, “GSC-818 GBM cancer stem cells have been completely destroyed by Rutherrin® PDT at concentrations that are up to ten times lower (300 to 600 nM) than those levels detected by mass spectrometry in previously reported Theralase research for the treatment of orthotopic rat GBM tumours utilising the RG2 animal model (3 uM). Another important observation is that the destruction of these GBM brain cancer cells was completed at light doses 4.5 times less than that used for PDT in animals and clinically (20 J/cm2 versus 90 J/cm2). These important discoveries are allowing our team to optimize GBM treatments preclinically to allow translation of this technology to a Phase Ib GBM clinical study using Rutherrin® PDT and our latest discovery, the cancer vaccine.”
Arkady Mandel, MD, Ph.D, D.Sc., Interim Chief Executive Officer and Chief Scientific Officer stated that, "I believe that the presence of glioma stem cells within various types and grades of gliomas is one of the main reasons that they are so difficult to destroy. The Theralase research presented here today supports the efficacy of Rutherrin® PDT in the destruction of human GBM cancer stem cells and is of significant clinical and scientific interest. GBM is the most common and unfortunately most aggressive primary brain cancers. The current initial standard of care consists of surgical resection followed by radical radiotherapy and adjuvant temozolomide chemotherapy. Despite optimal therapy, median survival is approximately 14 months from diagnosis and less than 6 months for patients with recurrent disease; therefore, today’s clinical treatments remain palliative in nature and not curative. The latest scientific and clinical published research suggests that continued GBM tumour growth and recurrence is due in a large part to the presence of resistant glioma stem cells, which display self-renewal and hence the highest probability of transforming themselves into an aggressive GBM. Moreover, recurrent GBM disease may be a consequence of the enhancement and/or gain of stem cell-like characteristics during disease progression, signifying that the cancer stem cells phenotype is a crucial therapeutic target. Our
success in the destruction of GSC-818 GBM human cancer stem cells achieved today is a major accomplishment that the Company plans to exploit to optimise this technology preclinically with the aim of effectively translating this information clinically in the form of a Phase Ib GBM clinical study focused on improved patient survival and / or development of an effective frontline treatment for this deadly disease.”
Wow! Theralase is really churning out some impressive research lately!
Theralase Discovers New Anti-Cancer Vaccine
Toronto, Ontario – November 20, 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 announced the discovery of a new anti-cancer vaccine.
This new anti-cancer vaccine was created by exposing Rat Glioma (RG2) cancer cells, representative of GlioBlastoma Multiforme (“GBM”), a deadly form of human brain cancer, to proprietary and patented stressors extracorporeally (outside the body) and then injecting this anti-cancer vaccine into rats to delay the progression of brain gliomas, utilizing a well-established animal model of GBM.
The data obtained in this model by Theralase researchers demonstrated a significant increase of 35% in the survival of animals versus control (no vaccination).
In previous research, Theralase reported that Rutherrin® (TLD-1433 + transferrin) injected intravenously (“IV”) into an animal diagnosed with GBM was able to effectively cross the Blood Brain Barrier (“BBB”) and localize preferentially to GBM tumors. Once localized, the drug is able to be activated by laser light, and / or potentially X-ray, to safely and effectively destroy the GBM tumours.
In light of the new discovery, Theralase is currently developing a comprehensive, multi-pronged Photo Dynamic Therapy (“PDT”) clinical procedure; whereby, a patient diagnosed with GBM would:
1) receive an IV injection of Rutherrin®.
2) receive laser light activation (via surgically inserted optical fiber and/or using conventional trans-cranial X-ray treatment, at levels at or below standard of care), at a specified number of hours post-injection (allowing Rutherrin® to cross the BBB and selectively be absorbed into their GBM cancer cells) to activate the drug.
3) be provided a precise treatment to safely and effectively destroy their GBM cancer, with minimum side effects.
4) receive repeat PDT treatments to induce an immune-mediated response.
5) receive the new anti-cancer vaccine, created from their own tumour cells (or alternatively cancer cells from another patient, which tumour(s) have a similar genetic profile), to stimulate the body’s immune cells to hunt, recognise and destroy residual GBM cancer cells.
Malignant gliomas are not uncommon in patients, with an estimated 24,000 new cases and more than 14,000 deaths in the US, annually. In the majority of cases, they recur following initial treatment, especially for GBM, the most common and most lethal form of brain cancer.
Most patients do not survive beyond 2 years, post diagnosis.
For GBM patients treated with the current standard of care (i.e.: surgical removal of brain tissue, radiation and chemotherapy (temozolomide), the National Cancer Institute of Canada’s randomized clinical study reported that the five year Progression Free Survival (“PFS”) rate was determined to be 4%, with less than 10% of patients surviving more than five years, post diagnosis.
In Theralase conducted research, it was demonstrated that the anti-cancer vaccine, increases well-established biomarkers of the immunological destruction of GBM cancer cells, such as Adenosine TriPhosphate (“ATP”) and calreticulin.
Extracellular ATP quantification:
Cell surface expression of calreticulin was increased 85% over control:
Proinflammatory genes: IL-1b (key regulatory cytokine), Heat Shock Protein 70 (“HSP 70”) (important cellular stressor proven to enhance Antigen Presenting Cells (“APCs”)), Interferon-a (“IFN-a”) (cytokine important for inducing protective anti-tumour responses) and Granulocyte Macrophage Colony-Stimulated Factor (“GMC-SF”) (essential cytokine for processing and presenting tumor antigens for the priming of anti-tumour cytotoxic T lymphocytes) all play a major role in the immunological response of the body to cancer cells.
The Theralase conducted research has demonstrated that the new anti-cancer vaccine increases expression of:
1) IL-1b by 10 times
2) HSP 70 by 10 times
3) IFN-a by 2 times
4) GMC-SF by 3 times
To evaluate the new anti-cancer vaccine in animals, rats were vaccinated and then subjected to GBM induction.
Vaccinated rats were able to survive 35% longer on average than non-vaccinated rats.
Post mortem evaluation detected a 700% increase in anti-cancer CD8+ T cells (“cancer-killer” cells) in the anti-cancer vaccine GBM tissue samples.
Based upon the collected data, Theralase researchers have established that the new anti-cancer vaccine, in a GBM RG2 cancer model is able to:
1) demonstrate a source of tumor antigens for an immunologic, tumour specific, anti-cancer response
2) potentially target micro-metastases of GBM in the brain unable to be removed by surgical intervention
3) restore the body’s own complex immune and defense mechanisms to recognize and destroy GBM cancer cells.
Next steps planned by the Company to commercialize this technology include: optimization of the pre-clinical animal models, followed by a Phase Ib clinical study in a patient population presenting with GBM disease and pre-existing tolerance mechanisms, which are actively retarding the immune recognition and destruction of tumours in these cancer patients.
Manjunatha Ankathatti Munegowda, Ph.D., DVM, Research Scientist, Theralase, stated that, “In order to be effective, an anti-cancer vaccine must have an ample supply of antigens and be able to provide secondary responses required to stimulate the body to elicit an effective immune response. The Theralase anti-cancer vaccine has both, possessing multiple tumour antigens and adjuvants such as: TNFa and IL-1b. This anti-cancer vaccine could be used along with current debulking strategies, to help eliminate any residual disease. It is also able to serve as a protective vaccine to target and eliminate any possible relapses.”
Mark Roufaiel, Ph.D., Research Scientist, Theralase stated, “The data supports that the anti-cancer vaccine induces immunogenic changes in the highly aggressive GBM RG2 model. Our results demonstrate that the anti-cancer vaccine treated GBM RG2 cancer cells may be a source of tumor related antigens for induction of an immunologic, tumour specific, anti-cancer, therapeutic response. This advanced vaccination approach induces a potent anti-tumour effect with significant delay in tumour progression, and significant increase in animal survival; therefore, this new anti-cancer vaccine may be an ideal treatment to improve the clinical outcomes of standard of care treatments of various cancers; including, highly recurrent and/or treatment resistant tumours.”
Arkady Mandel M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase and the originator of Theralase’s vaccine technology stated, “As tumour cells frequently undergo high rates of mutation, resulting in the loss of single or multiple antigens, it would be ideal to choose a source of an antigen that can elicit a broad tumour-specific response. Theralase’s anti-cancer vaccine was designed to offer this distinct advantage, allowing APCs to process and present numerous patient specific tumour antigens to stimulate a strong T cell immunological response to prevent tumour escape. The stimulated CD4+ Th cells could also provide assistance to CD8+ T cells to generate a more direct and robust anti-tumour immunity and long-term memory. Moreover, the Theralase anti-cancer vaccine has been created to be suitable for all cancer patients, regardless of their diagnosis and / or human leukocyte antigen type. The Theralase anti-cancer vaccine based immunotherapy offers an exciting opportunity to target specific cancers, by becoming the “master regulator of immune responses” via activation of the most potent APC population for priming and activating naïve T cells to recognize and combat tumours.
Roger Dumoulin-White, P.Eng., President and CEO of Theralase stated that, “In the international scientific and medical community, it has long been understood that the immune system is the key to conquering cancer. We’re now at a point in the Company’s research and development phase, where this knowledge can be effectively translated into treatment solutions, such as this new anti-cancer vaccine, used in conjunction with our existing anti-cancer technology, to help cancer patients combat and defeat this deadly disease.”
PDC technology and Dr. McFarland continue to amaze me. Being able to use molecules vs milligrams is mind blowing. The real game changer will be the ability for this to be used systemically through an IV! It’s like all of those sci-fi movies I’ve seen over the years are coming to life!
Theralase Researcher Discovers Super Potent Anti-Cancer Drugs
Toronto, Ontario – November 13, 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 recently identified a new platform of super potent anti-cancer drugs, or PDCs, discovered by Dr. Sherri McFarland, Ph.D., Professor, Department of Chemistry and Biochemistry, University of North Carolina at Greensboro, the original inventor of the Theralase licenced ruthenium-based PDCs.
Dr. McFarland has discovered a new generation of PDCs, that are 10 billion times more potent in killing cancer cells than other tested PDCs. It only takes a few molecules of the new PDCs to kill cancer cells, in vitro, when activated by visible light.
The new PDCs also exhibit very low, in vitro, dark cytotoxicity (cancer cell kill in the absence of light), providing a very low toxicity to cells.
This photocytotoxicity (cancer cell kill in the presence of light) activity has been optimized, without increasing the dark cytotoxicity (see figure below).
These next generation PDCs are thus able to increase in vitro therapeutic margins (ability to kill cancer cells when light activated versus when not light activated) by ten orders of magnitude over tested PDCs and were conceived by Dr. McFarland by designing the most potent PDCs for systemic (IntraVenous or (“IV”)) patient administration at the lowest possible dose.
The preliminary data, obtained to date, demonstrates that the new PDCs exhibit preferential properties for IV delivery and are thus able to greatly expand the scope of cancers that can be targeted by this new platform PDT technology.
Dr. McFarland stated that, “I am delighted that we have discovered new PDCs that are able to increase the Photo Dynamic Therapy (“PDT”) potency over other tested PDCs by ten orders of magnitude (10,000,000,000 times), using highly specialized methodologies and formulations. The very large and unprecedented therapeutic margins make safe, IV systemic delivery of these new PDCs that much more possible, vastly increasing the number of cancers that can be targeted with this PDT technology. With our PDC TLD-1433 showing promise in a Phase Ib clinical trial for treating Non-Muscle Invasive Bladder Cancer (“NMIBC”) with PDT, it is an exciting time to be working closely with the Theralase team on the development of the next generation PDCs for hard-to-treat cancers such as GlioBlastoma Multiforme (“GBM”), a deadly form of brain cancer.”
Dr. Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase stated that, “The ability to increase the light toxicity of the PDC by ten orders of magnitude without affecting the dark toxicity of the PDC, is a dramatic discovery. The in vitro results presented by Dr. McFarland opens up a tremendous opportunity to develop and clinically evaluate a new PDT technology platform that may mitigate the risk of systemic toxicity, while offering an exceptional potency in the destruction of cancer cells; hence, safely and effectively, destroying a greater quantity of cancer cells per single treatment. This provides the Company with an opportunity to establish a new realm in the types of cancers that can safely and effectively be treated with this cutting-edge PDT technology.”
Roger Dumoulin-White, P.Eng, President and CEO of Theralase stated that, “Theralase, in its collaborative research partnership with Dr. McFarland, continues to push the envelope on what these PDCs are capable of in the destruction of cancer cells. I look forward to scaling up the manufacture of these new PDCs to allow use in a new Phase Ib clinical study.”
Titan Medical Reports Third Quarter 2017 Financial Results
November 9, 2017
Company to hold business update conference call November 13 at 4:30 p.m. Eastern time
TORONTO (November 9, 2017) – Titan Medical Inc. (TSX: TMD) (OTCQB: TITXF) (“Titan” or “the Company), a medical device company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (“MIS”), announces financial results for the three and nine months ended September 30, 2017.
All financial results are reported in U.S. dollars, unless otherwise stated. The unaudited condensed interim financial statements and management’s discussion and analysis for the period ended September 30, 2017 may be viewed on SEDAR at www.sedar.com.
David McNally, President and CEO of Titan Medical, said, “The third quarter of 2017 and recent weeks were exciting and productive, and built upon the work we have done to advance the development of our single-port robotic surgical system. We installed our first advanced prototype SPORT Surgical Systems at the Florida Hospital Nicholson Center and at Columbia University Medical Center, and commenced preclinical feasibility and validation studies. We are encouraged by the enthusiastic feedback we are receiving from the surgeons testing the SPORT Surgical System. We plan to commence additional studies with Columbia University Medical Center and our European center of excellence, Institut Hospitalo-Universitaire de Strasbourg, in the fourth quarter of 2017 and to continue with all three sites into 2018.
“Having successfully completed all our published milestones for the third quarter, we are confident we are on track to meet our fourth quarter milestones and will continue to execute as we enter 2018,” Mr. McNally concluded.
Operational highlights for the third quarter of 2017 and recent weeks include:
On July 10, 2017 Titan announced a collaboration with Florida Hospital Nicholson Center in Celebration, Florida for feasibility and validation studies to support Titan’s regulatory application for its SPORT Surgical System.
On August 22, 2017 Titan announced the signing of an agreement with Institut Hospitalo-Universitaire de Strasbourg in France for feasibility and validation studies to support Titan’s regulatory applications for the SPORT Surgical System.
On September 18, 2017 Titan and Florida Hospital Nicholson Center announced the installation of Titan’s SPORT Surgical System at the hospital’s training facility. This was the first installation in the world for preclinical feasibility and validation studies of the SPORT Surgical System, a single-port robotic system.
On September 25, 2017 Titan announced the successful completion of the world’s first gynecologic, colorectal and urologic single-port procedures using its advanced prototype SPORT Surgical System at the Florida Hospital Nicholson Center. The first procedure performed by Dr. Ricardo Estape may be viewed via the Company’s Website at here.
On October 23, 2017 Titan and Columbia University Medical Center announced the installation of a SPORT Surgical System at Columbia’s simulation training facility in New York City. This was the second U.S. installation of the SPORT Surgical System for preclinical feasibility and validation studies and the first at an academic medical center.
On November 2, 2017 Titan posted a video of a colorectal procedure in an animal model at Florida Hospital Nicholson Center. The procedure was performed by Dr. Eduardo Parra-Davila and may be viewed via the Company’s Website at https://titanmedicalinc.com/technology/#videos.
Financial highlights for the third quarter of 2017 include (all comparisons are with the third quarter of 2016, unless otherwise stated):
Research and development expenses for the third quarter of 2017 were $4,061,695, compared with $3,429,550.
Including adjustment for warrant liability, net and comprehensive loss for the third quarter of 2017 was $13,902,817, compared with a net and comprehensive loss of $1,659,863.
The Company completed a public offering on June 29, for gross proceeds of $5,576,357, followed by a second closing on July 21, for gross proceeds of $1,328,871.
On August 24, 2017 Titan announced that it has completed the equity conversion of Longtai Medical Inc.’s $2.0 million deposit that was previously scheduled to be refunded to Longtai.
On October 26, 2017 Titan announced that since September 26, 2017 the Company had received $7.1 million in proceeds from the exercise of share purchase and broker warrants.
On October 31, 2017 Titan completed a $2,677,732 million private placement involving more than a dozen U.S. robotic surgeons, as well as other investors.
Cash, cash equivalents and deposits with suppliers as of September 30, 2017 were $7,268,903, compared with $6,356,559 as of December 31, 2016.
Conference call and webcast
Management will host a business update conference call on November 13, 2017 at 4:30 p.m. Eastern time to discuss the Company’s progress with developing the SPORT Surgical System and upcoming milestones, and to answer questions. To access the conference call, the dial-in numbers are (866) 595-8403 (U.S. and Canada toll free), and (706) 758-9979 (International). All listeners should provide the operator with conference ID 4898477.
Following the conclusion of the conference call, a replay will be available through November 19, 2017 and can be accessed by dialing (855) 859-2056 (U.S. and Canada toll free) or (404) 537-3406 (International). All listeners should provide conference ID 4898477. The call will also be archived on the Company's website for a period of time at www.titanmedicalinc.com.
Agreed Salix. I’m happy to see some semblance of sanity from a few here. I just don’t understand why they decided to release this now? I would have released this in a broader PR once the other 5 patients are treated
I’m quite shocked at the markets initial reaction to this! It wasn’t a great PR today but it wasn’t bad either. The 1st 3 patients were treated with a lower dose therapy. It would have been great if all of them were still cancer free but Phase 1’s purpose is to gather data to fine tune a treatment protocol for Phase 2 that will have maximal efficacy for treatment of NMIBC. They will take this lackluster data and the data from the next 6 patients to create a more robust protocol for Phase 2 next year. Am I missing something?!
Simply amazing technology! These guys impress me every day with their cutting edge research
I talked to Roger last Wednesday about the progress of patient enrollment. He said they released a PR outlining that but I informed him that they had not.
He said that their plan all along has been to complete treating the other patients by December 2017. I told him that a lot of us believed from their previous PR's that they would be treated by August or at the latest September. He seemed shocked by that and stated that they have never given a date like that for completion. He staunchly held to the December date but would always finish with "if not sooner." So he said that IF the last patient was treated in December that Phase 1 data would be complete in June/July 2018. If they finish treating them sooner then the data will be available sooner.
He also told me that they have no say when or which patients are enrolled in the study. That is all left up to Princess Margaret and the hospital will let them know once a patient is treated. He said they never expected any patients to be treated over the summer because of doctors and potential patients going on vacation, but now that schools are back in session their enrollment is in full swing.
I finished the phone call asking whether they would PR each time a patient is treated, like they have done in the past, and he said no, they have decided to release a PR once ALL 5 patients have been treated.
Very nice guy to talk to but not quite the positive information I was looking for. He seems very confident in their product and the way the process is rolling out. We'll just have to hope they continue to execute in a timely manner.
Hope this helps everyone. Hang in there! Little longer to wait but it sounds like next year might be a wild ride!
Exciting stuff! It's really exciting that they're getting positive results with glioblastoma. Right now there are no good treatments to prolong someone's life with glio. This treatment could potentially be life changing for those people affected.
Anxiously awaiting news that they've treated the other 5 patients for the NMIBC Phase 1 trial!
Theralase Demonstrates Increased Efficacy for Latest Anti-Cancer Drug
Toronto, Ontario – September 12, 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, announced today that it has demonstrated increased efficacy with its latest, patented, licensed, anti-cancer drug, TLD-1633, when compared to its lead anti-cancer drug, TLD-1433.
The latest PDC, known as TLD-1633, has recently been shown to be approximately 15% more effective than TLD-1433 in the destruction of a human Glioblastoma Multiforme (“GBM”) cell line (U87), a deadly form of brain cancer.
In preclinical research, TLD-1633 has also demonstrated a lower dark toxicity, supporting an even higher safety profile than TLD-1433.
Pavel Kaspler, Ph.D., a research scientist at Theralase stated that, “Research on Theralase’s latest licensed anti-cancer drug, TLD-1633, is showing even stronger data preclinically than Theralase’s top performing anti-cancer drug TLD-1433. I look forward to expanding my research to assess the performance of TLD-1633 in various cancer lines, with and without the use of transferrin, as a transport system.”
Sherri McFarland, Ph.D., Professor, Department of Chemistry and Biochemistry, The University of North Carolina at Greensboro stated that, “TLD-1633 is a natural progression of the research work completed by our research labs in the development of TLD-1433. TLD-1633 has shown even stronger safety and efficacy in our labs than TLD-1433, and I am delighted to work with Theralase to optimize and expand their licenced PDC program, as we embark on additional cancer indications.”
Arkady Mandel, MD, Ph.D., D.Sc., Chief Scientific Officer of Theralase stated that, “I am delighted that TLD-1633 has been added to our growing list of compounds, identified by Dr. McFarland’s research program, in conjunction with our own, as potent anti-cancer agents. TLD-1433 was originally chosen as the lead anti-cancer PDC in our fight against Non-Muscle Invasive Bladder Cancer (“NMIBC”), because of its strong characteristics, but it seems an even more potent PDC, TLD-1633, may be better suited to be utilized for other cancers of the body, such as GBM, especially when combined with transferrin. This is truly ground-breaking research that myself and the entire Theralase research team are delighted to be involved with.”
Roger Dumoulin-White, President and CEO of Theralase stated that, “Theralase continues to expand our preclinical research and development, both in bringing new PDCs on-line and investigating new clinical applications, that we hope to translate into new clinical programs, in the not too distant future, via Phase Ib clinical studies.”
I liked the section that stated the Theralase PDC therapy is a BILLION times stronger than Cisplatin when activated. That's just hard to fathom! Great stuff!
We've only treated 1 of the next 6 patients so far. So the 180 day clock won't actually begin until all of the 6 patients have been treated. It's just a waiting game now
Agreed! I'm very happy with the momentum of TLTFF. I think we'll need to get the 180 day results back, with efficacy data, before we get some big price moves
Theralase Anti-Cancer Drugs Independently Verified and Validated
Toronto, Ontario – August 22, 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, announced today that its patented, lead anti-cancer drug, TLD-1433, and associated family of compounds, have been independently verified and validated in a peer-reviewed publication.
A detailed computational investigation (“Study”) by Marta Alberto and coworkers entitled “ Theoretical Exploration of Type I/Type II Dual Photoreactivity of Promising Ru(II) Dyads for PDT Approach”, appearing in the peer-reviewed American Chemical Society (“ACS”) journal Inorganic Chemistry, has independently verified and validated the unique photophysical properties of Theralase’s lead Photo Dynamic Compound (“PDC”), TLD-1433 and associated family of compounds.
The Study can be found at the following link.
http://pubs.acs.org/doi/abs/10.1021/acs.inorgchem.6b01782
The Study details how Dr. Sherri McFarland (“McFarland”) has pioneered the use of specialized excited states for dual-mode Type I (oxygen independent) / II (oxygen dependent) photoreactivity as a means of creating novel classes of PDCs with potencies that are orders of magnitude greater than those of traditional photosensitizers used for Photo Dynamic Therapy (“PDT”).
The most advanced PDC, TLD-1433, developed by McFarland and Theralase, has successfully achieved the primary, secondary and exploratory endpoints in the first part of a Phase 1b human clinical trial, at the Maximum Recommended Starting Dose (0.35 mg/cm2) (“MRSD”) in the first 3 patients treated, for Non-Muscle Invasive Bladder Cancer (“NMIBC”), evaluated at 90 days post treatment.
The elegant computational Study on the family of PDCs, which includes TLD-1433, has used the orthogonal approach of Time-Dependent Density Functional Theory (“TDDFT”) to quantum-mechanically validate McFarland’s experimental findings with regard to Type I/II dual-mode PDT effects and highly specialized excited states.
The Study highlights the ability of TLD-1433, and its associated family of PDCs to invoke PDT effects even at low oxygen concentrations by exploiting multiple PDT pathways and further validates, on a very sophisticated level, the criteria McFarland previously outlined for producing these unique effects.
The unprecedented PDT potencies and unique dual-mode mechanisms of the McFarland-Theralase PDCs are well positioned to finally bring PDT to the forefront of cancer therapy.
Currently, McFarland and Theralase continue to push the boundaries of PDC development by introducing PDC supercatalysts. These so-called supercatalysts maintain dual-mode Type I/II photoreactivity and produce femtomolar PDT effects with no sacrificial co-catalysts. These first-of-their-kind PDCs exploit the fundamental principles of photophysics and supercatalysis to achieve extraordinarily large therapeutic effects.
In comparative analysis evaluations completed by McFarland, the Theralase PDCs are approximately a billion times more potent than a commonly used anti-cancer chemotherapy drug, Cisplatin, when laser light activated.
The clinical utility of PDC supercatalysts cannot be understated, having the potential to overcome variations in light dosimetry and other issues that have prohibited the application of PDT to most cancers.
Theralase and McFarland firmly believe that these PDCs and the laser light systems used to activate them are the future of PDT in the destruction of cancer.
Theralase and McFarland are continuing their highly productive collaboration that has already resulted in one PDC in a human clinical trial for NMIBC, by building a pipeline of PDCs and associated laser light systems, specifically designed to activate the PDCs, for various clinical applications.
Theralase and McFarland are developing PDCs from a tumour-centered approach for personalized medicine, with a focus on brain and lung cancer as the most logical next-generation targets.
Sherri McFarland, PhD, Professor, Department of Chemistry and Biochemistry, The University of North Carolina at Greensboro stated that, “The orthogonal third-party study on TLD-1433 and related PDCs computationally validates the structure-activity relationships that we have already determined experimentally, providing theoretical support for the potent Type I/II dual-mode PDT effects that are now being realized with success in patients with NMIBC as part of the Phase Ib clinical trial.”
Arkady Mandel, MD, PhD, D.Sc., Chief Scientific Officer of Theralase stated that, “The latest computational investigation authored and researched independently, provides further support for what we already know, TLD-1433, and its associated family of PDCs, are world-class anti-cancer drugs that have been proven in the first three patients treated in a Phase Ib clinical trial, at the MRSD, to be safe and effective in preventing the recurrence of NMIBC, evaluated at 90 days post treatment.”
Roger Dumoulin-White, President and CEO of Theralase stated that, “The PDCs that Theralase and McFarland have researched and developed have proven to be very strong anti-cancer drugs in initial clinical studies. We look forward to successfully expanding the platform of PDCs, and the laser light systems that activate them, for various clinical oncology applications, as our clinical program matures.”
That PR was released on Accesswire but I don't actually think it has been released by Theralase yet. At least it hasn't been posted on their website yet. So...maybe it's not getting a widespread audience yet. Hopefully they'll release an official PR tomorrow?
Great PR find by the way!
Was this our highest volume day ever? Next closest I can find is 1,004,544 on February 25, 2015
Small sample size but this is huge news! Congratulations everyone! Cheers
Theralase Presents Phosphorescent Photosensitizers at International World Congress
Toronto, Ontario – June 15, 2017, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a leading biotechnology 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 its latest research on phosphorescent photosensitizers was recently presented on June 12th, at the 16th International Photodynamic Association (“IPA”) World Congress held from June 8th to 13th, 2017 in Coimbra, Portugal.
The IPA was founded in 1986 and its membership consists of some of the most prominent international clinicians and scientists involved in performing and researching Photo Dynamic Therapy (“PDT”) and Photo Diagnosis (“PD”). The IPA promotes the study of diagnosis and clinical treatment using light and Photo Sensitizers (“PSs”), and disseminates this knowledge to IPA members, the medical community and the general public. The IPA World Congress is held every two years and is quickly becoming known as the premier forum to communicate outstanding advances in the clinical and research aspects of PDT and PD.
Angelika Rueck, Ph.D, University of Ulm, presented, “New phosphorescent Photo Sensitizers (“PS”) to follow up PDT response by Fluorescence Lifetime Imaging (“FLIM”) and PS Phosphorescence Lifetime Imaging (“PLIM”).”
Dr. Rueck presented how the Theralase patented PDC, TLD-1433, has demonstrated pre-clinically that:
• It is able to localize to the mitochondria of T-24 human bladder cancer cells and not the nucleus (Effective way to kill cancer cells without nuclear damage)
• Under simultaneous FLIM and PLIM activation the cell’s metabolism and oxygenation during PDT can be measured (By measuring oxygenation levels during PDT, the efficacy of PDT treatment can be optimized)
TLD-1433 PLIM and NADH FLIM can determine oxygenation and cellular metabolism during PDT and hence optimize efficacy of the treatment for various cancer cell types.
Angelika Ruelck, Ph.D. stated that, “FLIM/PLIM allows deep insight into the light induced mechanisms during PDT, allowing Theralase the opportunity to overcome the difficulty of treating under hypoxic (low oxygen) conditions or hypoxic tumour areas, common to cancer cells. The combination of PLIM with PDT treatment planning using TLD-1433, opens new avenues towards increasing patient outcomes during PDT treatment.”
Roger Dumoulin-White, President and CEO of Theralase stated that, “Theralase is delighted that Dr. Rueck presented the latest research on phosphorescent photosensitizers to such a respected group of international researchers and clinicians at the 16th IPA World Congress. This research will allow Theralase the ability to successfully commercialize this next generation PDT technology for NMIBC and various other cancers.”
Theralase Presents X-Ray Activation at International World Congress
Toronto, Ontario – June 14, 2017, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a leading biotechnology 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 its latest research on X-ray activation of PDCs was recently presented on June 12th, at the 16th International Photodynamic Association (“IPA”) World Congress held from June 8th to 13th, 2017 in Coimbra, Portugal.
The IPA was founded in 1986 and its membership consists of some of the most prominent international clinicians and scientists involved in performing and researching Photo Dynamic Therapy (“PDT”) and Photo Diagnosis (“PD”). The IPA promotes the study of diagnosis and clinical treatment using light and Photo Sensitizers (“PSs”), and disseminates this knowledge to IPA members, the medical community and the general public. The IPA World Congress is held every two years and is quickly becoming known as the premier forum to communicate outstanding advances in the clinical and research aspects of PDT and PD.
Pavel Kaspler, Ph.D, Theralase presented, “X-ray and Photon Mediated in-vitro and in-vivo Activity of Ruthenium(II)-Based Compounds.”
Dr. Kaspler presented how the Theralase patented PDC, TLD-1433, has demonstrated pre-clinically that it has a(n):
• Small mass of approximately 1kiloDalton (small enough in molecular weight to cross a cell’s membrane barrier)
• High Reactive Oxygen Species (“ROS”) quantum yield (close to unity for 1O2) (the higher the conversion of delivered photons of light to production of ROS, the higher the PDC’s efficacy in the destruction of cellular targets)
• High PDT efficacy (destroying cancer cells while leaving healthy tissue intact)
• Ability to absorb energy in the X-ray range (X-rays are able to pass directly through human tissue allowing significant depth of penetration)
Dr. Kaspler presented how the TLD-1433 injected intratumorally in a Balb/C mouse animal model has a greater than 90% cell kill in human GlioBlastoma Multiforme (“GBM”) cancer treated pre-clinically with a low dose of X-ray (1 Gy, 75 keV) and then activated by Near Infrared (“NIR”) laser light (808 nm, 200 J/cm2), four hours after injection.
Dr. Kaspler stated that, “X-ray followed by NIR laser light activation of TLD-1433 is a new and unexpected discovery by the members of our research team under the leadership of Dr. Arkady Mandel and Dr. Lothar Lilge. This discovery has far reaching implications, including: targeting cancers that are difficult, if not impossible to reach with conventional laser light sources, such as GBM brain tumours or deep tissue related cancers.”
Dr. Kaspler concluded in his presentation that TLD-1433 is:
• Stable under X-ray activation and remains able to produce ROS via subsequent NIR laser light activation
• Able to be activated by X-ray eliciting a PDT-like cell kill
• Able to be dually activated (X-ray followed by NIR laser) delivering a cell kill greater than the two wavelengths applied separately
• Able to destroy cancer cells predominantly via necrosis at 24 hours post treatment.
• Able to deliver noticeable damage to tumors when X-ray activated
• Able to deliver significant tumour damage when dually activated (X-ray followed by NIR laser) in the presence of transferrin
Roger Dumoulin-White, President and CEO of Theralase stated that, “Theralase is delighted that Dr. Kaspler presented the latest PDC X-ray activation results to such a respected group of international researchers and clinicians at the 16th IPA World Congress. This initial research will allow Theralase the ability to successfully complete a Phase Ib GBM clinical study for this next generation PDT technology, demonstrating: a primary outcome of safety and tolerability and a secondary outcome of pharmacokinetics.”
I agree! Hopefully we'll see some PR's in rapid succession showing that the 6 patients have been treated. They'll have to be treated this month in order for Phase 1 to be complete in December
I thought this PR was much more informative about the results of the first half of Phase 1 vs the PR actually announcing the successful 1st half of Phase 1. I'm glad to see this information is being disseminated to an international audience.
Do you think they've enrolled or treated any of the other 6 patients for the 2nd half of the trial?