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Destroying Cancer at the Speed of Light®

Clinical Study Underway (75 of 100 Patients Treated)
Expected to complete enrollment in 2025
Expected to complete study at the end of 2026


Bullboard - Investor Discussion Forum Theralase Technologies Inc. V.TLT

Alternate Symbol(s):  TLTFF

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called... see more

TSXV:TLT - Post Discussion

Theralase Technologies Inc. > FDA Approval for TLD1433 pdt almost certain IMHO
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Post by Eoganacht on Jan 26, 2023 6:51pm

FDA Approval for TLD1433 pdt almost certain IMHO

In December 2022 Ferring received FDA approval for Adstiladrin for high-risk, BCG-unresponsive NMIBC based on a CR rate at 12 months of 23.5%. We have already achieved a CR rate of 28% at 450 days with 12 patients undertreated. Our CR rate is bound to improve as the trial progresses. So it is a question of "when" not "if".

Case closed. The current stock price of 35 cents is the bargain of a lifetime.

https://www.ferring.com/ferring-receives-approval-from-u-s-fda-for-adstiladrin-for-high-risk-bcg-unresponsive-non-muscle-invasive-bladder-cancer/

Ferring Receives Approval from U.S. FDA for Adstiladrin for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
 
Ferring’s novel adenovirus vector-based gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) is the first gene therapy approved for bladder cancer
 
Efficacy and safety of Adstiladrin supported by Phase 3 results demonstrating that more than half of patients (51% of CIS ± Ta/T1 cohort) achieved a complete response (CR) at three months and of these, 46% continued to remain free of high-grade recurrence at 12 months
 
Bladder cancer is the sixth most common cancer in the U.S.; Adstiladrin provides NMIBC patients a valuable alternative compared to an invasive bladder removal surgery
 
Saint-Prex, Switzerland – 16 December 2022 – Ferring Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approved Adstiladrin® (nadofaragene firadenovec-vncg), a novel adenovirus vector-based gene therapy, for the treatment of adult patients with high-risk, Bacillus Calmette-Gurin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
 
“Patients with BCG-unresponsive NMIBC have historically had limited treatment options other than bladder removal surgery,” said Steven A. Boorjian, M.D., Carl Rosen Professor and Chair of the Department of Urology at Mayo Clinic, and lead investigator on the recent clinical trial of Adstiladrin. “The approval of Adstiladrin is therefore a significant advance in the current treatment landscape and provides a novel treatment option for patients.”
 
Bladder cancer is the sixth most common cancer in the U.S., with NMIBC representing approximately 75% of all new bladder cancer cases.1,2 BCG remains the first-line standard of care for people living with high-grade NMIBC. However, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.3
 
Adstiladrin, an intravesical therapy administered every three months, targets the patient’s own bladder wall cells to enhance the body’s natural defenses to fight cancer. The FDA approval was based on results of the Phase 3 clinical trial, which met its primary endpoint with more than half (51%, n=50 of 98; 95% CI 41 to 61) of patients with carcinoma in situ with or without concomitant high-grade Ta or T1 disease (CIS ± Ta/T1) achieving a complete response (CR) by three months. Of the patients who achieved an initial CR, 46% (n=23 of 50) continued to remain free of high-grade recurrence at 12 months.
 
“The approval of Adstiladrin showcases the power of private industry-academia partnerships in bringing novel treatments to market,” said Colin Dinney, M.D., Chairman, Department of Urology, Division of Surgery, University of Texas MD Anderson Cancer Center. “The Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) defined the clinical trial design required to address this patient population and has been a proud collaborator in the research of Adstiladrin, and we are delighted that such a transformative treatment is now approved by the FDA.”
 
“Ferring has been working diligently to realize the potential of gene therapy for bladder cancer patients, where there has long been a critical unmet need for additional treatment options,” said Armin Metzger, Executive Vice President and Chief Science Officer, Ferring Pharmaceuticals. “We are proud to have achieved this critical milestone towards fulfilling the potential of Adstiladrin, a first-of-its-kind therapy, for bladder cancer patients. Adstiladrin is the culmination of a complex research, development, and production process, and we are grateful to the teams, physicians and patients who have helped us reach this approval.”
 
Ferring expects that Adstiladrin will be commercially available in the United States in the second half of 2023, following manufacturing capacity expansion which will see the company pioneering commercial scale vector production for oncology.
 
For full prescribing information, please visit: https://www.ferringusa.com/wp-content/uploads/sites/12/2022/12/ADSTILADRIN_pi.pdf
 
About ADSTILADRIN
 
Adstiladrin® (nadofaragene firadenovec-vncg) is a gene therapy developed as a treatment for adult patients with BCG-unresponsive NMIBC. It is a non-replicating adenovirus vector-based gene therapy containing the gene interferon alfa-2b, administered by catheter into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene to do its work. The internal gene/DNA machinery of the cells “picks up” the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach thereby turns the patient’s own bladder wall cells into interferon microfactories, enhancing the body’s natural defenses against the cancer. Nadofaragene firadenovec-vncg has been studied in a clinical trial program that includes 221 patients with high-grade, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849)6.
 
About Non-Muscle Invasive Bladder Cancer (NMIBC)
 
NMIBC is a form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.3 Bladder cancer is the sixth most common cancer in the U.S., and it is estimated that there were approximately 81,180 new cases of bladder cancer in the U.S. in 20224, 75% of which present as NMIBC.2 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard of care. However, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.3 Current treatment options for BCG-unresponsive patients are very limited, and often result in a highly invasive life-changing procedure of radical cystectomy (complete removal of the bladder).5
 
About the Phase 3 Study
 
The Phase 3 study of nadofaragene firadenovec-vncg in 157 patients from 33 U.S. sites met its primary endpoint with more than half (51%) of the 98 patients (95% CI 41 to 61) with carcinoma in situ with or without concomitant high-grade Ta or T1 disease (CIS ± Ta/T1) achieving a complete response (CR), all by three months. Of the patients who achieved an initial CR, 46% (n=23 of 50) continued to remain free of high-grade recurrence at 12 months. In the study, nadofaragene firadenovec-vncg was administered directly into the patient’s bladder by instillation once every three months by a healthcare professional.
 
The most common adverse events (AEs) observed in the study that occurred in patients in order of decreasing frequency were: instillation site discharge (33%), fatigue (24%), bladder spasm (20%), micturition urgency (19%), and hematuria (17%). The discontinuation rate due to AEs was 1.9%.
 
The long-term follow-up phase of the four-year study is ongoing, and patients are continuing to be monitored for a total of five years.
Comment by Kingpin68 on Jan 26, 2023 7:57pm
Eog, what do you make of the wording here : 'Of the patients who achieved an initial CR, 46% (n=23 of 50) continued to remain free of high-grade recurrence at 12 months.' Why ' high grade recurrence '. Is low grade recurrence acceptable. And how does that compare to TLD's partial response numbers. Isn't a partial response the same or similar to being free of high-grade ...more  
Comment by Eoganacht on Jan 26, 2023 9:12pm
Hi Kingpin - this was a trial for high risk NMIBC which would presumably mean the patients had high grade tumours. So I just took being free of high grade recurrence as another way of saying CR. Maybe someone else reading this may know better.
Comment by enriquesuave on Jan 26, 2023 10:30pm
Presence of low grade ( LG) still constitutes a CR because TURBT can be done on LG with good success.  It's all in the FDA document on NMIBC trials.  Obviously if a treatment also destroys LG tumors without need for TURBT then all the better.   "The goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy. The development of low-risk/low-grade ...more  
Comment by CancerSlayer on Jan 27, 2023 12:42am
  To put it simply, low-grade recurrence is acceptable per FDA guidance.  A partial response reflects either a low-grade cancer within the bladder or it simply represents a "yet to be determined" status wherein confirmation of cancer existing outside of the bladder is still pending. More technically, a PR is defined as a patient who either displays a positive cystoscopy ...more  
Comment by Rumpl3StiltSkin on Jan 26, 2023 10:42pm
Well said Eoga and Enrique
Comment by CancerSlayer on Jan 27, 2023 1:03am
I have presented these lackluster CR%s, & if you look closely, patients now have 3 FDA approved single-drug treatments that all fall below 24% CR after 12 months...and these current options cover a broad spectrum of treatment types, including chemotherapy, immunotherapy & gene therapy.  It is obvious to me that another approach is much needed.  Our CRs already exceed the above ...more  
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The Road to Saving Lives: Clinical Study Underway

  • Clinical Study with 75 of 100 Patients Treated (Enrollment to be completed in 2025, with study completed by end of 2026)
     
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