|TLTFF - Operational Highlights: |
Oversubscribed Prospectus Offering. The Company has successfully completed an oversubscribed marketed public offering (“Offering”) on August 22, 2019, raising gross proceeds of CAD $17,250,000. Use of proceeds of the Offering are intended for: advancing the NMIBC Study II, optimization of the TLC-2000 therapeutic laser system, working capital and general business purposes.
Successful Phase Ib NMIBC Clinical Study. Theralase’s Phase Ib NMIBC clinical study successfully achieved the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics, and exploratory endpoint of efficacy. The study results have shown a strong efficacy signal with a 66% Complete Response (“CR”) in the Therapeutic Dose Group (0.70 mg/cm2) after only a single PhotoDynamic Therapy (“PDT”) treatment, with patients five and six demonstrating cancer-free status with no presence, recurrence or progression of the disease, 360 days post treatment. Further, patient five has demonstrated an extended cancer-free status for 18 months post treatment.
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."
About Study II:
The Phase II NMIBC Clinical Study will utilize the Therapeutic Dose (0.70 mg/cm2) of TLD-1433, focusing on the treatment of approximately 100 BCG-Unresponsive NMIBC patients presenting with Carcinoma In-Situ (“CIS”) in approximately 20 clinical study sites located in Canada and the US, with a primary endpoint of efficacy (measured by CR) and a secondary endpoint of duration of CR and a tertiary endpoint of safety.
The primary and secondary endpoint will be evaluated by:
CR in patients with CIS with resected papillary disease at any time point post-treatment with a duration of CR evaluated at approximately 360 days post-treatment.
Patient CR is defined as one of the following (no cancer detected in bladder):
Negative cystoscopy and negative (including atypical) urine cytology (no cancer detected in urine)
Positive cystoscopy (cancer detected in bladder) with biopsy-proven benign or low-grade NMIBC
Negative cystoscopy with malignant urine cytology (no cancer detected in urine), if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative