|Patient#6/Patient Enrolled PH2/Onboarding US sites/FDA-IND |
$TLTFF ACT 33%CR 1.5years-33% of patients (p#6) unreported.
Patient Five Cancer-Free Eighteen Months After Single Anti-Cancer Treatment
Toronto, Ontario – July 31, 2019, 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 Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers reports that patient five, enrolled and treated in the Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”), has demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 540 day clinical and cystoscopy assessment.
Patient 6 was treated 7 FEB 2018. Patient six verified 12 month CR April 2, 2019
Patient Six Cancer-Free Twelve Months After Single Anti-Cancer Treatment
Results of Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”)
Clinical Study Demonstrate a 66% Complete Response (“CR”) at the Therapeutic Dose (0.70 mg/cm2) 360 Days Post Treatment
Toronto, Ontario –April 2, 2019
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 Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers is pleased to report that patient six, enrolled and treated in the recently completed Phase Ib NMIBC Clinical Study (“Study”), has demonstrated a CR with no tumour recurrence, progression or presence of NMIBC disease at the 360 day clinical and cystoscopy assessment.
Theralase® Anti-Cancer Technology Treats Sixth Patient
Phase 2 NMIBC Patient Currently enrolled.
Theralase Enrolls First Patient into Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
TORONTO, ON / ACCESSWIRE / July 29, 2019 / Theralase® Technologies Inc. (“Theralase” or the “Company”) (TLT: TSXV) (TLTFF: OTCQB), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds (“PDC”) and their associated drug formulations, intended to safely and effectively destroy various cancers, announced today that the first patient has been enrolled into its Phase II clinical study titled “Patients with Non-Muscle Invasive Bladder Cancer (“NMIBC”), who present with Carcinoma In-Situ (“CIS”), who are considered Bacillus Calmette Gurin (“BCG”) Unresponsive or are intolerant to BCG Therapy (“Phase II”)” at University Health Network (“UHN”) in Toronto.
US clinical sites currently in progress...
Theralase is raising funds for the FDA submission. In advance of The FDA IND submission they are working out the details of clinical sites for the US.
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”).
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 co-ordinators. 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”.
I don't base the PPS as my gouge of the company's progress. I gage the company progress in terms of how close they are in completing milestones. I have been buying this stock since 2014. I see the milestone of the FDA submission as very near term. In my opinion the science has grown stronger through the years as more milestones are met. The goal of them raising the money is for the FDA submission/progression of the Phase 2. They had a Phone conversation with the FDA in June and are on the right track for the submission and design of the Phase 2 study.
The Company completed a Pre-IND meeting with the FDA and it was confirmed that the Company’s design of the Phase II ACT-NMIBC clinical study met FDA Guidance for Industry dated February 2018 on “BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment”. The guideline states that “In BCG-unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application.”1
Shawn Shirazi, Ph.D., CEO – Drug Division, Theralase stated that “We can now proceed with completing and filing an IND application with request for fast track designation, which pending approval, would allow the Company to expeditiously and effectively extend our clinical study into the US, to qualify and onboard clinical sites. In addition, the Company is continuing to qualify Canadian sites and working towards the European Medicines Agency approval, to qualify and onboard European clinical sites for a total of approximately 20 clinical sites.
The Company is no longer pursuing European study sites due to the exorbitant costs of regulatory approval.