Replies to post #3530 on Theralase Technologies Inc (TLTFF)

[JMoriarty]

I like your breakdown, very accurate.

Ill divide by 3 again though. Because I'm interested in the first 'statistically significant' number between 10 and 15 patients.

32/3 is about 12 patients. Say 3 UHN hospitals start and treat 1/week for a month.. thats 12.

Cost for 12 patients steps 1,2,3 = 6.59*.3= $2.6


Terry Fox Grant winner is May 31st.

Honestly Id roll 12 this year to get the pps up to $4++

Roll out GBM Phase 1b

Uplist to Nasdaq then go USA and International with a full investment community behind us.

JMHO Never do more than you have to for maximum results



Let's consider the cost of the trial for the three locations, Canada, United States and Europe are equal. We can divide the projection by 3 representing each location. Now we look at Canada first.
Canadian Phase 2 trial costs ($CDN M)
Phase II NMIBC Study Drug Manufacture and Packaging 1.00 (3.0 /3=1)
Phase II NMIBC Study Device Manufacture and Packaging 1.00 (3.0/3=1)
Clinical Research Organization / Regulatory Approval 0.83 (2.5/3=.83)No credit given for Canadian approvals already complete.
Phase II NMIBC Clinical Study 2.16 (6.5/3=2.16)
WorkingCapital 1.60 (5.0/3=1.6)
Complete Canadian Trial Total 6.59 ($CDN M)

6.59($CDN M) divided by 3 represents 3 separate values to each of the three phases of the Canadian Phase 2 trial.

1. Intial 32 patient treatments ( 1st treatmet) 2.6 (6.59x.4)
2. 2nd patient treatment (6month from 1st treatment)1.97 (6.59x.3)
3. Study completion after 2nd treatment 1.97 (6.59x.3)

2.6 Million required for initial Roll out in Canada treating 32 patients with the 1st treatment.

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Theralase’s 5th Annual Medical and Scientific Advisory Board Meeting Advances Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
TORONTO, ON / ACCESSWIRE / May 13, 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 PhotoDynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers announced that Theralase recently met with its Medical and Scientific Advisory Board ("MSAB"), as well as potential Principal Investigators ("PIs"), who are interested in participating in the Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("ACT-NMIBC").
The meeting focused primarily on the presentation of the clinical endpoints achieved in the successfully completed Phase Ib NMIBC clinical study, as well as a discussion on the design and FDA regulatory requirements pertaining to the ACT-NMIBC.
The FDA provided guidance to the industry in February 2018, entitled, "BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry".
In the guidance, the FDA stated that, "In BCG-unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application." 1
Theralase's primary question to be discussed with the FDA during a pre-Investigational New Drug ("pre-IND") conference call to be held in early 3Q2019 will be "If Theralase's ACT-NMIBC demonstrates a Complete Response ("CR") at 90 days and a duration of that CR of 30% or more at 360 days post primary treatment, would this be sufficient to support a marketing application in the opinion of the FDA?"
The PIs at the meeting consisting of leading Canadian, US and international uro-oncologists, were presented with the opportunity to learn more about Theralase's TLD-1433-based PhotoDynamic Therapy ("PDT") and its application to BCG-Unresponsive NMIBC.
Dr. Shawn Shirazi, CEO-Drug Division, Theralase stated, "Theralase stakeholders should be excited about the ability of the Company to execute on its strategic objectives, from successfully completing the Phase Ib NMIBC clinical study to the commencement of the ACT-NMIBC study. The Company is focusing on opening Canadian, US and international study sites throughout Q2 2019 and Q1 2020 with the PIs that attended the 5th annual MSAB meeting. The overall response of the PIs was extremely encouraging, with the MSAB and PIs recognizing the hard work and dedication of the Theralase team in the execution of its clinical development strategy to advance a viable treatment to potential commercialization for BCG-Unresponsive NMIBC."
About Phase Ib Study
Theralase's Phase Ib NMIBC clinical study successfully achieved the: primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of TLD-1433 within the body) and exploratory endpoint of efficacy. The study results have shown a strong efficacy signal with a 66% CR in the Therapeutic Dose Group (0.70 mg/cm2) after only a single PDT treatment, with patients 5 and 6 demonstrating no presence, recurrence or progression of the disease, 360 days post treatment.
About Phase II Study
The ACT-NMIBC clinical study will utilize the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and will focus on the treatment of approximately 100 to 125 BCG-Unresponsive NMIBC patients in approximately 20 clinical study sites located in Canada, the US and internationally, with a primary endpoint of efficacy and a secondary endpoint of safety.
The primary endpoint will be evaluated by:
CR in patients with Carcinoma In-Situ ("CIS") with or without resected papillary disease at 90 days post-treatment with a 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 endpoint will be evaluated by:
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
Proposed Clinical Treatment Plan:



About Theralase's MSAB
The MSAB is comprised of scientific and clinical professionals in PDT and bladder cancer and have been retained by the Company to provide strategic guidance on the research, development and commercialization of the Company's TLD-1433-based PDT technology in the treatment of patients inflicted with BCG-Unresponsive NMIBC.
About Theralase® Technologies Inc.
Theralase® 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.
https://app.quotemedia.com/quotetools/newsStoryPopup.go?storyId=8230579700456805&topic=TLTFF&symbology=null&cp=null&webmasterId=90338

[123414]

Arkady Mandel, M.D., Ph.D., D.Sc. Interim Chief Executive Officer and Chief Scientific Officer of Theralase stated that, “Theralase is pleased to support world-class research aimed at optimizing our patented PDCs in a clinical setting. The peered-reviewed recognition of our technology, as well as the financial and technical support, from the Ontario government and world-class industry players, such as IBM and Altera (Intel) will fast-track the commercialization of Theralase’s PDC technology, which will ultimately directly benefit cancer patients. The ORF project will provide even greater insight and knowledge as to how our patented PDCs localize in tissue and how to optimize both the dose of the PDC and laser light to activate them to provide the highest safety and efficacy for individual patients stricken with this deadly disease. Scientific, medical, engineering, business and computational collaboration, combined with government support, will help not only the Company to commercialize our Anti-Cancer PDT technology, but also help to establish the use of PDT worldwide as an effective and impactful anti-cancer therapy. With so few treatments available and even fewer on the near-term horizon for various cancers, combined with an increase of cancer incidence, the medical community needs to fully embrace the cutting-edge technological advantages that have been developed by Theralase and now with the support of a world-class, multi-disciplinary team of esteemed researchers, scientists and clinicians. Through the ORF grant, the Company is leveraging resources to create value for both cancer patients and shareholders, while advancing our innovative technology through the various clinical stages with an end-game of commercialization. We strongly believe that our innovative PDCs and ground-breaking technologies, as well as the focus and strong work ethic of our teams, will support Theralase on our journey to commercial success."

UHN and UT researchers will specifically focus on developing algorithms focused on optimizing and predicting patient response to PDT when treated for a range of cancers, including: bladder, brain, lung, esophagus, head and neck and female reproductive organs. The safety and efficacy of the PDT will be tested and validated initially in animals and with that knowledge, the optimized procedures will be subsequently transferred into various human clinical studies.