Theralase’s TLD-1433 patient meets primary end point
Theralase Technologies Inc. has provided an update on patient five in the TLD-1433 study on non-muscle invasive bladder cancer clinical study.
THERALASE TECHNOLOGIES Inc. has provided an update on patient five, enrolled and treated in the recently completed phase 1b non-muscle invasive bladder cancer clinical study.
The study’s purpose was to evaluate TLD-1433, Theralase’s lead PDC, for the primary end point of safety and tolerability, with a secondary end point of pharmacokinetics (movement and exit of drug within tissue) and an exploratory end point of efficacy.
Theralase’s anti-cancer treatment involves the installation of a water-based solution of Theralase’s lead anti-cancer PDC, TLD-1433 at the therapeutic dose (0.70 milligram/square centimetre), via a catheter inserted through the urethra into the bladder of the patient, to allow the PDC to be preferentially absorbed by NMIBC tumours. The bladder is then drained of the solution, flushed with sterile water to remove non-absorbed solution and refilled with sterile water via a cystoscope. A fibre optic assembly, known as a laser emitter emits laser light to activate TLD-1433, while a proprietary dosimetry system detects the emitted laser light, used for patient safety and efficacy. Both devices are inserted through the cystoscope, with the sole purpose of activating the absorbed PDC to destroy the
The treatment was well tolerated by the patient, who demonstrated no tumour recurrence or presence of disease at the 90-day or 180-day clinical and cystoscopy assessment.
The patient has met study end points demonstrating achievement of the primary, se c ond ary and exploratory end points at 90 and 180 days and now, at 270 days posttreatment, that marks a new achievement for the company.
Dr. Arkady Mandel, MD, PhD, DSc, interim chief executive officer and chief scientific officer of Theralase, stated: “This is an example of the enormous opportunity that awaits this young company in the treatment of cancer. For NMIBC, a complete response is defined by the FDA as the definitive end point for single-arm intravesical studies of patients who present with BCG-unresponsive carcinoma in-situ disease, with or without resected papillary tumours. In the proposed phase 2 NMIBC clinical study, the company is providing two treatment procedures (therapeutic at day zero and maintenance at day 180). The latest data on patient five are extremely encouraging, in that they demonstrates after only one treatment procedure, CR at three, six and now nine months posttreatment has been obtained. If the efficacy results are able to be demonstrated at 12 months posttreatment, in a larger patient population, conducted in a well-designed phase 2 NMIBC clinical study, then the Theralase anti-cancer technology has the potential to be the next gold standard in the treatment of NMIBC. The Theralase Anti-cancer technology is also multifaceted, in that the technology is able to be adapted to the treatment of additional cancer indications if successfully validated in independent clinical studies. Pending successful commencement of the phase 2 NMIBC clinical study, the company plans to investigate the commencement of an additional phase 1b clinical study for a new cancer indication.”
“A phase 2 clinical study of intravesical photo dynamic therapy in patients with BCG-unresponsive non-muscle invasive bladder cancer or patients who are intolerant to BCG therapy” will utilize the therapeutic dose (0.70 mg/cm2) of TLD-1433 and will focus on the treatment of approximately 100 NMIBC patients in approximately 20 clinical sites located in Canada, the United States and internationally, with a primary end point of efficacy.
We seek Safe Harbor.
Erika Flores condensed this news release (email@example.com).
Guy John Anderson, Randall Bruder, Roger John Dumoulin-White, Matthew Thomas Perraton
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