Phase 1 (completed study) patients 5 and 6 will be hitting 24 month treatment anniversary's. Both of these patients were cancer free 18 months after single treatment.
If both patients remain cancer free after 24 months from a single treatment, the company will have unprecedented data points.
Phase 1 patients 5 and 6 were respectfully initially treated on Jan 10 and Feb 7, 2018.
Study II progress. Theralase is conducting a Study II with 3 Canadian study sites open for patient enrollment and treatment, specifically, University Health Network (“UHN“), London Health Science Centre (“LHSC“), and McGill University Health Centre (“MUHC“). To date, 4 patients have been treated at UHN and 1 patient treated at MUHC. (20 sites planned with the majority in the US).
Phase 2 study: 6 patients treated. The company is fully financed to finish StudyII. As per 1Q2020 Company Quarterly Newsletter.
Phase II NMIBC Clinical Study Status
In 4Q2019, Theralase filed an Investigational New Drug ("IND") application to the Food and Drug Administration ("FDA") for a pivotal Phase II NonMuscle Invasive Bladder Cancer ("NMIBC") clinical study. The IND is currently on Full Clinical Hold pending a response by Theralase, which is expected in 1Q2020.
Pending FDA acceptance of Theralase's response, Theralase will commence onboarding clincial study sites in the United States.
In the mean time, Theralase is proceeding with patient enrollment and study site onboarding in Canada. University Health Network ("UHN") The Phase II NMIBC clinical study ("Study II") has successfully launched in Canada, with 3 Canadian centres open for enrollment and treatment of patients.
1.(Toronto, ON) - 5 patients treated 2. McGill University Health Centre ("MUHC")(Montreal, QC) - 1 patient treated 3. London Health Sciences Centre ("LHSC") (London, ON) - 0 patient treated
To date, 6 patients have been treated.
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Financial Highlights: As per 1Q2020 Company Quarterly Newsletter.
As of November 29, 2019, Theralase has 14.98M in cash and zero debt, except for trade payables. The company is fully financed to finish StudyII.
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Phase 1 (completed study) patients 5 and 6 will be hitting 24 month treatment anniversary's. Both of these patients were cancer free 18 months after single treatment.
If both patients remain cancer free after 24 months from a single treatment, the company will have unprecedented data points.
Phase 1 patients 5 and 6 were respectfully initially treated on Jan 10 and Feb 7, 2018.
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