Is there a reason why you are referring to "Ph. 2B data"? i.e. why the B
My understanding is that we are currently on a Phase 2 (II) Study? Are they synonymous?
Phase II NMIBC Clinical Study
As the frontrunner in personalized Anti-Cancer Therapy (“ACT”) treatments for patients diagnosed with Non-Muscle Invasive Bladder Cancer (“NMIBC”), the pivotal Phase II NMIBC clinical study (“Study II”) has the potential to become the next gold standard for NMIBC treatment.
Study II utilizes the therapeutic dose (0.70 mg/cm2) of the study drug (TLD-1433) and focuses on the enrolment and treatment of approximately 125 Bacillus Calmette Gurin (“BCG”)-Unresponsive NMIBC patients presenting with Carcinoma In-Situ (“CIS”) in approximately 15 clinical sites located in Canada and the US, with a primary endpoint of efficacy at any point in time, a secondary endpoint of duration of Complete Response ("CR") and a tertiary endpoint of safety.
In Study II, all patients will receive two study treatments (Day 0 and Day 187).
To date, 24 patients have been enrolled and treated in Study II.
Fast Track Designation (“FTD”) was granted by the US Food and Drug Administration (“FDA”) to Theralase® in November 2020. In order to potentially qualify for Breakthrough Therapy Designation (“BTD”) the Company has been advised by the FDA, to provide clinical assessment data for the primary, secondary and tertiary objective for approximately 20-25 patients treated at the therapeutic dose level.
Theralase® may also be eligible for Accelerated Approval (“AA”) by the FDA should the clinical results of Study II support a clinically meaningful improvement in safety and/or efficacy over current NMIBC treatment therapy.