Fast-Tracks are a dime a dozen...OR is it $10/shre? ; - )20 cents USD EH?? wink wink..."PITY" ; - )
Theralase receives fast-track status for NMIBC study
2020-11-23 08:26 ET - News Release
Ms. Kristina Hachey reports
THERALASE GRANTED FDA FAST TRACK DESIGNATION FOR NMIBC PHASE II CLINICAL STUDY
The U.S. Food and Drug Administration has granted Theralase Technologies Inc. fast-track designation (FTD) for its phase II bacillus calmete guerin-(BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) clinical study.
As a fast-track designee, Theralase will have access to early and frequent communications with the FDA to discuss Theralase's development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows TLD-1433, in combination with the TLC-3200 medical laser system (TLC-3200), to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with BCG-unresponsive NMIBC CIS, with or without papillary Ta or T1 tumours. FTD can lead to an accelerated approval and priority review, if certain criteria are met, which the FDA has previously defined to the company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.
Michael Jewett, MD, FRCSC, FACS, inaugural Farquharson clinical research chair in oncology, departments of surgery (urology) and surgical oncology, Princess Margaret Cancer Centre, University Health Network (UHN), stated: "By awarding fast-track designation to the photosensitizer drug TLD-1433 activated by the laser TLC-3200, currently being assessed in a phase II clinical study for the treatment of NMIBC, the FDA has recognized Theralase's potential to meaningfully improve patient outcomes for this life-threatening disease. This is a significant accomplishment for the company. This latest milestone complements the clinical development strategy to provide urologists, uro-oncologists and patients with the tools to combat BCG-unresponsive NMIBC, safely and effectively."
Shawn Shirazi, PhD, chief executive officer, Theralase, stated: "FDA's FTD for our lead drug candidate, TLD-1433, activated by the TLC-3200, is another important milestone for Theralase, as it can potentially speed the development of this drug-device combination for NMIBC patients. The TLD-1433 -- TLC-3200 technology represents a paradigm shift in medical technology and an advanced approach to treat NMIBC. We are excited by the progress the company has delivered in study II, as we continue to enroll and successfully treat patients. The company continues to work towards launching new clinical study sites in Canada and the U.S. with a mandate to enroll and treat all patients for their first study II treatment in 2021."
About fast-track designation
FTD is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical needs. Filling an unmet need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapies. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses.
About study II
Study II utilizes the therapeutic dose (0.70 milligram per square centimetre) of TLD-1433, activated by the TLC-3200, and is focused on the enrolment and treatment of approximately 100 BCG-unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the U.S.
Study II has a:
- Primary end point of efficacy (defined by complete response (CR) at any point in time;
- Secondary end point of duration of CR at 360 days postinitial CR (approximately 450 days postinitial study treatment, assuming CR is achieved at the 90 day assessment);
- Tertiary end point of safety measured by incidence and severity of adverse events (AEs) grade 4 or higher that do not resolve within 450 days postinitial treatment.
The FDA, in its 2018 guidance to industry, stated that:
"For single-arm trials of patients with BCG-unresponsive disease, CR is defined 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, negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative."
The FDA further states that: "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. (1)"
About Theralase Technologies Inc.
Theralase is 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, bacteria and viruses.
(1) "BCG-unresponsive non-muscle invasive bladder cancer: developing drugs and biologics for treatment -- guidance for industry" dated: February, 2018.