ON Topic Shawn Shirazi, Ph.D., CEO of Theralase stated, "Theralase is pleased that we have enrolled and successfully treated 12 patients in Study II and look forward to analyzing and reporting out on the clinical data, when clinically relevant. The Company's immediate goal is to successfully enroll and treat 20 to 25 patients, who have received two treatment procedures, to provide clinical evidence to Health Canada and the FDA on the primary, secondary and tertiary clinical outcome objectives; which may then be used to support Breakthrough Therapy Designation ("BTD") approval from the FDA. The Company is strategically targeting clinical sites across Canada and the US (subject to IND approval) that serve large urban populations to maximize enrollment in Study II."
About Study II
The Phase II NMIBC Clinical Study utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and is focused on the enrollment and treatment of approximately 100 Bacillus Calmete Gurin ("BCG")-Unresponsive NMIBC patients presenting with Carcinoma In-Situ ("CIS") in approximately 20 clinical study sites located in Canada and the US.
Study II has a:
- Primary endpoint of efficacy (defined by Complete Response ("CR")) at any point in time
- Secondary endpoint of duration of CR at 360 days post-initial CR
- Tertiary endpoint of safety measured by incidence and severity of Adverse Events ("AEs") grade 4 or higher that do not resolve within 360 days post-initial CR
For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a CR 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 and negative cytology
- For intravesical therapies without systemic toxicity, the FDA includes, in the definition of a CR, negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
Intravesical instillation does not deliver the investigational drug to the upper tract or prostatic urethra; therefore, the development of disease in these areas cannot be attributed to a lack of activity of the investigational drug. Thus, sponsors can consider patients with new malignant lesions of the upper tract or prostatic urethra, who have received intravesical therapy to have achieved a CR in the primary analysis; however, sponsors should record these lesions and conduct sensitivity analyses in which these patients are not considered to have achieved a CR.
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and develop