2.6 Million required for initial treatmentof Canadian patients Cost reduced further by Canadian $4.5 Million Grant Money. How much is Phase 2 NMIBC going to cost?
Let's begin by looking at total cost estimate. This estimate includes, Canada, United States and Europe. Description Cost Total 20.0($CDN M) Phase II NMIBC Study Drug Manufacture and Packaging 3.0 Phase II NMIBC Study Device Manufacture and Packaging 3.0 Clinical Research Organization / Regulatory Approval 2.5 Phase II NMIBC Clinical Study 6.5 Working Capital 5.0 Complete Canada, United States and Europe Trial Total 20.0 http://theralase.com/wp-content/uploads/2019/03/Theralase-Corporate-Power-Point-Presentation-03-25-2019.pdf pg19
Canada: 6 sites with 5 or 6 patients at each site.
The ACT-NMIBC study has been designed in compliance with FDA industry guidelines issued February, 2018 for BCG-unresponsive NMIBC. The Study will consist of 100 patients in approximately 20 clinical study sites in Canada, the US and internationally. The breakdown of sites for Canada the US and international may be respectfully 6, 7 and 7. Canada, United States and Europe potentially each get 1/3 of the 100 patients, so respectfully 32+34+34 patients for each location. Patients then are divided by the sites for each location. Aproxamently 6 sites in Canada treating 5 or 6 patients at each site. https://clinicaltrials.gov/ct2/show/NCT03945162?term=theralase&rank=4 bief summary 100 patient http://theralase.com/pressrelease/theralase-commences-phase-ii-nmibc-clinical-study/ 2nd paragraph 20 sites total _________________________ 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.
Canadian Grant Money-grant valued at $CAN 4.5 million Theralase Researchers Receive Government Grant /June 28, 2018- UHN and UT were successfully awarded an ORF-RE grant valued at $CAN 4.5 million, with financial and technical support provided by world-class industrial and institutional partners, such as: IBM Canada, Altera (Intel), Theralase... Arkady Mandel, "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"... Through the ORF grant, the Company is leveraging resources to create value for both cancer patients and shareholders, 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. https://www.fscwire.com/newsrelease/theralase-researchers-receive-government-grant -------------------------------- ACT NMIBC PH2 -Recruiting!! Recruitment Status : Recruiting First Posted : May 10, 2019 Last Update Posted : May 10, 2019 Estimated Study Start Date : May 2019 https://clinicaltrials.gov/ct2/show/NCT03945162?term=theralase&rank=4
Patient Six Cancer-Free Twelve Months After Single Anti-Cancer Treatment Results of Phase Ib Non-Muscle Invasive Bladder Cancer ("NMIBC") Clinical Study Demonstrate a 66% Complete Response ("CR") at the Therapeutic Dose (0.70 mg/cm2) 360 Days Post Treatment https://app.quotemedia.com/quotetools/newsStoryPopup.go?storyId=4947968130766865&topic=TLTFF&symbology=null&cp=null&webmasterId=90338 With a strong 66% CR rating at 12 months proven from our NMIBC Phase 1b study, TLT ACT may become the treatment of choice. Further ensuring success the Phase 2 study is having 2 treatments as opposed to the one treatment in the NMIBC phase 1b study. This alone should slam dunk the data points.
Here is why the 66% CR/360D is so significant...
2018 Review of available published clinical studies and US FDA information by Theralase
Doxorubicin / Epirubicin Complete Response ("CR") = 35% at 14 to 31 days Yes Unknown Approved / Not used in clinical practice 2007 No Gemcitabine and Cisplatin 10% CR at 12 months Yes Unknown Approved / Not used in clinical practice 2011 No Mitomycin CR = 31% at 6 months Yes $USD 4,000 Approved / Not used in clinical practice 2012 No Thiotepa CR = 52% at 4.2 months Yes Unknown Approved / Not used in clinical practice 2014 No Mycobacterium phlei cell wall-nucleic acid complex ("MCNA") Disease Free Survival ("DFS") = 26.5% at 12 months Yes Unknown Not Approved 2015 No Valrubicin 10 to 13% CR at 12 months Yes Unknown Approved / Not used in clinical practice 2017 No Oncolytic adenovirus (CG0070 virus) 27% CR at 12 months No Unknown Phase II study underway 2019 No Vicinium (VB4-845) 16% CR at 12 months No Unknown Phase III study underway 2019 No Theralase (TLD-1433) Clinical Study Demonstrate a 66% Complete Response (“CR”) at the Therapeutic Dose (0.70 mg/cm2) 360 Days Post TreatmentNo Yes Phase II study to commence 2Q2019 2021 Maybe [url]http://theralase.com/pressrelease/patient-six-cancer-free-twelve-months-after-single-anti-cancer-treatment/ [/url][tag]66% CR AT 360 DAYS[/tag] PD-L1 checkpoint inhibitors (atezolizumab, durvalumab, avelumab, nivolumab, and pembrolizumab) Overall Response Rate ("ORR") = 28% in patients who have PDL1 expression Yes Up to $USD 300,000 Approved for patients with metastatic and locally-advanced bladder cancer. Not approved for NMIBC. FDA halted 2 studies for decreased patient survival with low expression levels of PD-L1 versus platinumbased chemotherapy. 2023 No Recombinant adenovirus (Interferona2b (rAd-IFN)) 35% Relapse-Free Survival ("RFS") at 12 months for high grade tumours (CIS population ?) Yes Unknown Phase III study to commence Unknown Maybe Source: http://theralase.com/wp-content/uploads/2019/03/Theralase-Corporate-Power-Point-Presentation-03-25-2019.pdf page9
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