All systems are go... Patients, sites, FDA submission, funds - Study II Launch.The commencement of Study II is underway with the first patient enrolled and ready to be treated at the Company’s lead study site, University Health Network (“UHN”). Additionally, McGill University Health Centre (“MUHC”) is added as another study site, subject to a Site Initiation Visit (“SIV”) tentatively scheduled for early September, 2019. Through the agreement with the US uro-oncology Trial Management Organization (“TMO”), the Company is planning to onboard up to 6 US based clinical study sites and is diligently working to bring approximately 20 clinical sites on board.
- FDA compliance.In June 2019, FDA confirmed in the Pre-Investigational New Drug (“IND”) conference call, that Theralase’s protocol design for Study II is aligned with the industry guidelines (February, 2018) for Bacillus Calmette Guerin (“BCG”)-unresponsive NMIBC.
Shawn Shirazi, Ph.D., CEO of Theralase - Drug Division stated that, “With the first patient soon to be treated, we are very excited to advance our Phase II NMIBC Clinical Study, as it allows the Company to potentially commercialize this groundbreaking technology for patients afflicted with this devastating disease. The Company now has all the characteristics of other successful biotech companies such as: cutting-edge technology, an experienced management team, and sufficient capitalization to successfully execute on the Company’s strategic initiatives.”
Kipton Lade, CEO of Theralase - Device Division stated that, “With the completion of this most recent round of financing, Theralase is poised to accelerate execution on the Company’s key strategic objectives, such as successful completion of Study II and commercialization of our NMIBC anti-cancer technology."