The phase II NMIBC (bladder cancer) study has enrolled 14 patients at two of Canada's five selected sites. Others will be enrolled at all those Canadian sites and a number of U.S. sites recently selected. (The pandemic slowed this whole thing up, unfortunately - but it's moving along better, now, it seems.) From the quarterly newsletter...
Discussion:
Study II, in an interim clinical data analysis has achieved all primary, secondary and tertiary objectives at 180 days post initial Study II Treatment, demonstrating a strong efficacy, duration and safety profile. Theralase® will continue to enroll and treat patients in Study II with an aim to enroll and treat 100 patients in 2021/2022, to provide clinical data on all endpoints, with an aim at achieving marketing approval for Study in Canada and the US by 2023.
In addition to patient CR responses, there are two patients who are demonstrating Partial Responses (“PRs”) (negative cystoscopy and positive urine cytology). If Upper Tract Urothelial Cell Carcinoma (“UTUCC”) or urothelial carcinoma of the prostatic urethra can be identified, then these patients have the potential to be classified as CRs, in accordance with the FDA’s 2018 guidance to industry.
Final clinical data from the completed Phase Ib clinical study (for patients treated at the Therapeutic Dose) and interim clinical data from Study II for patients with BCG-Unresponsive, NMIBC CIS strongly support Theralase’s® contention that the Study Treatment offers a new and advanced treatment option for patients, who have exhausted all other available treatment options, with 5/15 (33%) of these patients demonstrating NMIBC cancer free status.
