Theralase Signs Agreement with Urology Organization to Provide US Clinical Study Sites for its Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
Theralase® Technologies Inc. (“Theralase” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical-stage pharmaceutical company dedicated to the research and development of light-activated PhotoDynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers, is pleased to announce that the Company has signed an agreement with a Trial Management Organization (“TMO”) to provide 4 to 6 US-based urology study sites that will be able to commence enrolling and treating patients, subject to Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) approval for its Phase II Non Muscle Invasive Bladder Cancer (“NMIBC”) Clinical Study (“Study II”).
Interestingly, Theralase is not naming the organization, possibly for competitive intelligence purposes.
Clinical Investigator Sites Offer Sponsor Advantages
The TMO is in discussions with approximately 14 potential US-based clinical study sites that are large integrated clinical urology practices. The TMO’s mandate is to expeditiously complete clinical studies in uro-oncology. Each of these individual clinical study sites has a dedicated and robust clinical infrastructure that is lead by experienced principal investigators and clinical research coordinators. The TMO has a highly structured approach to executing and managing clinical studies, which allows a rapid enrolment and treatment of patients according to clinical protocols.
Shawn Shirazi, Ph.D., CEO – Drug Division, Theralase stated that “This is an important step in our onboarding of US-Based clinical study sites. In conjunction with this TMO and its network of clinical study sites, Theralase will select 4 to 6 clinical study sites that could potentially enroll and treat between 25 to 50 of the approximately 100 patients the Company is expecting to recruit and treat in its Phase II Clinical Study, subject to US FDA IND approval. This agreement greatly assists our US study site onboarding and patient enrollment as the Company prepares to file the IND application and negotiate onboarding additional study sites with other organizations in the US”.
Dr. Shirazi further stated that, “Through the lengthy process of identification and selection of clinical study sites, I am pleased to mention that our clinical study co-ordinators and myself are diligently working on finalizing 4 additional sites in Canada, 5 in the US (in addition to the TMO study sites) and 5 in Europe. Although enrolling and treating patients at the US and European sites is subject to the approval of the FDA and the European Medicines Agency, the Company is able to negotiate clinical research agreements, budgetary requirements and other non-regulatory related activities for each US and European study site prior to obtaining regulatory approval, thus potentially expediting patient enrollment and treatment in Study II. Overall, very exciting times ahead for the Company as it continues moving forward with providing a viable treatment option to patients inflicted from Bacillus Calmette Guerin (“BCG”) unresponsive NMIBC.”
About Theralase® Technologies Inc.
Theralase® is a clinical-stage pharmaceutical company dedicated to the research and development of light-activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers.Source: Yahoo! Finance