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Destroying Cancer at the Speed of Light®

Clinical Study Underway (68 of 100 Patients Treated)
Expected to complete enrollment at the end of 2024
Expected to complete study at the end of 2026


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

Alternate Symbol(s):  V.TLT.WT | 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. > Update on Phase II Bladder Cancer
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Post by knoxt on Jan 15, 2024 7:21am

Update on Phase II Bladder Cancer

TORONTO, ON / ACCESSWIRE / January 15, 2024 / Theralase® Technologies Inc. (" Theralase® " or the " Company ") ( TSXV:TLT )( OTCQB:TLTFF ), a clinical stage pharmaceutical company dedicated to the research and development of light and/or radiation activated Photo Dynamic Compounds (" PDCs ") for the safe and effective destruction of various cancers, bacteria and viruses is providing an update regarding its Phase II Non-Muscle Invasive Bladder Cancer (" NMIBC ") clinical study (" Study II ").

To date, Study II has provided the primary study treatment for 63 patients.

In 2016, Kamat et al. stated in the Journal of Clinical Oncology that the International Bladder Cancer Group (" IBCG ") recommended that, " Single-arm designs may be relevant for the BCG-unresponsive population. Here, a clinically meaningful initial complete response rate (for carcinoma in situ) or recurrence-free rate (for papillary tumors) of at least 50% at 6 months, 30% at 12 months and 25% at 18 months is recommended. " [1]

Based on the 63 patients treated to date, the interim clinical data for Study II is presented below:

Assessment

Primary Objective Performance

Secondary Objective Performance

Tertiary Objective Performance

#

%

#

%

#

%

Complete Response ("CR")

38

64%

17

37%

59

100%

Indeterminate Response ("IR")

6

10%

2

4%

0

0%

Total Response (CR and IR)

44

75%

19

41%

59

100%

Evaluable Patients

59

 

46

 

59

 

Assessment

Patient Assessment Visit

90 Days

180 Days

270 Days

360 Days

450 Days

#

%

#

%

#

%

#

%

#

%

Complete Response ("CR")

33

56%

31

54%

23

43%

20

38%

17

37%

Indeterminate Response ("IR")

4

7%

10

18%

7

13%

3

6%

2

4%

Total Response (CR and IR)

37

63%

41

72%

30

56%

23

44%

19

41%

Evaluable Patients

59

 

57

 

54

 

52

 

46

 

The Study II interim clinical data demonstrates a Complete Response (" CR ") of 54% at 6 months, 38% at 12 months and 37% at 15 months, which exceeds the IBCG guidelines.

In addition, the Study II interim clinical data demonstrates that at the 90 Day Assessment Visit, 56% of Evaluable Patients achieved a CR and 63% achieved a Total Response (CR + IR), while at 450 days, 37% achieved a CR and 41% achieved a TR.

 
 
 
 

For evaluable patients in Study II, who received the optimized Study II Treatment (Post August 1, 2020), the interim clinical data is presented below:

Assessment

Patient Assessment Visit (Optimized Treatment - Post August 1, 2020)

90 Day

180 Day

270 Day

360 Day

450 Day

#

%

#

%

#

%

#

%

#

%

Complete Response ("CR")

29

62%

28

60%

20

45%

17

40%

14

39%

Indeterminate Response ("IR")

3

6%

9

19%

6

14%

3

7%

2

6%

Total Response (CR and IR)

32

68%

37

79%

26

59%

20

48%

16

44%

The interim clinical data for patients who received the optimized Study II Treatment demonstrates that at the 90 Day Assessment Visit, 62% of Evaluable Patients achieved a CR and 68% achieved a Total Response (CR + IR), while at 450 days, 39% achieved a CR and 44% achieved a TR.

 
 
 
 

Notes:

  • Indeterminate Response (" IR ") is defined as negative cystoscopy (no evidence of Urothelial Cell Carcinoma (" UCC ") in the bladder) and positive urine cytology (detection of cancer in the urine, without a negative confirmatory bladder biopsy, suggesting UCC in the renal system other than the bladder)
  • For patients to be included in the statistical clinical analysis they must be enrolled in Study II, provided the primary Study II Treatment and evaluated by a PI at the 90 day assessment visit (cystoscopy and urine cytology)
  • One patient passed away prior to their 90 day assessment and is therefore not included in the statistical analysis; therefore, there are 63 patients in the statistical analysis.
  • Evaluable Patients are defined as patients who have been evaluated by a PI and thus the statistical analysis excludes a patient's clinical data at specific assessment days, if that clinical data is pending.
  • Four patients have been enrolled and provided the primary Study II Treatment, but have not been evaluated at their 90 day assessment; therefore, 59 patients are considered Evaluable Patients at 90 days and 46 patients considered Evaluable Patients at 450 days.
  • The data analysis presented above, should be read with caution, as the clinical data is interim in its presentation, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with clinical data still pending.
  • For patients who have been removed from Study II by the PI or have elected to discontinue from Study II their Last Observation Carried Forward (" LOCF ") has been used in this statistical analysis.
  • A SAE is defined as any untoward medical occurrence that at any dose: Is serious or life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or results in death.

The Swimmer's plot below is a graphical representation of the interim clinical results (n=63) graphically demonstrating a patient's response to a treatment over time. As can be seen in the plot, clinical data is still pending for patients, who have demonstrated an initial CR at 90 days and continue to demonstrate a duration of that response.

 
 
 
 

The Swimmer's Plot illustrates:

  • 38 Evaluable Patients achieved CR on at least one assessment date and thus achieved the primary objective of Study II (38/59 = 64%)
  • 17 Evaluable Patients achieved CR at each assessment date (with one patient under review for their 270 and 360 day response) and thus achieved the primary and secondary objectives of Study II for all patients assessed up to 450 days (17/46 = 37%).

The Kaplan-Meier (" KM ") Curve below represents the interim cumulative incidence of clinical events; including, the treatment efficacy occurring over a prespecified time in Study II.

 
 
 
 

According to the interim clinical data in the KM curve:

  • > 80% of patients remained in Study II after 90 days, following the initial Study II Treatment.
  • For all evaluable patients, 41% of Total Response (" TR ") have a duration of response ≥ 450 days, while 37% of Complete Response (" CR ") evaluable patients have a duration of response ≥ 450 days.
  • For optimized evaluable patients, 44% of TR patients have a duration of response ≥ 450 days and 39% of CR have a duration of response ≥ 450 days.

For 63 patients treated in Study II, there have been 13 Serious Adverse Events (" SAEs ") reported:

  • 2 - Grade 2 (resolved within 1 and 1 days, respectively)
  • 7 - Grade 3 (resolved within 1, 2, 3, 4, 4, 82 and unknown days, respectively)
  • 3 - Grade 4 (resolved within 3, 6 and 8 days, respectively)
  • 1 - Grade 5

Theralase® believes all SAEs reported to date are unrelated to the Study II Drug or Study II Device.

In 2020, the FDA granted Theralase® Fast Track Designation (" FTD ") for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®'s development plans and ensure the timely collection of clinical data to support the approval process. The accelerated communication with the FDA potentially allows, the Study II Treatment, to be the first intravesical, patient-specific, light-activated, Ruthenium-based PDC for the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS, (with or without recurrent / resected papillary T a /T 1 tumours). FTD can lead to Break Through Designation (" BTD "), Accelerated Approval (" AA ") and/or Priority Review, if certain criteria are met.

In mid-2023, the Company submitted a pre-BTD submission to the FDA and based on the FDA's feedback, the Company is currently working with the Clinical Study Sites (" CSSs "), a central pathology organization, a biostatistics organization and a regulatory consulting organization to update the pre-BTD with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in 1Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company plans to compile a BTD submission for review by the FDA in support of the grant of a BTD approval.

Theralase® is working to complete enrollment and delivery of the primary Study II Treatment for all patients in 2024. If successful, this would allow clinical data lock in mid-2026 with a potential Health Canada and FDA approval by 2026 / 2027.

About Study II:

Study II utilizes the therapeutic dose of the patented Study II Drug (" Ruvidar TM " or " TLD-1433 ") (0.70 mg/cm 2 ) activated by the proprietary Study II Device (" TLC-3200 Medical Laser System "). Study II is focused on enrolling and treating approximately 100 BCG-Unresponsive NMIBC Carcinoma In-Situ (" CIS ") patients in up to 15 CSSs located in Canada and the United States.

About Ruvidar TM :

Ruvidar TM is a patented PDC with 12 years of published peer reviewed preclinical research and is currently under investigation in Study II.

Comment by Oilminerdeluxe on Jan 15, 2024 7:35am
No commentary given? 
Comment by Oden6570 on Jan 15, 2024 8:24am
I assume the update now includes the 6 patients they spoke of in recent email ! With the enrolment stage of our NMIBC only approximately 37 patients away and our results improving with every patient, we are very excited for the potential value of our share price.   Our clinical results are best in class and we are optimistic that this will be reflected in our future share price ...more  
Comment by Kingpin68 on Jan 15, 2024 8:37am
It looks like two patients were added to the 90-day numbers, and there are still four pending according to the swimmers plot. But overall the numbers still look very good across the board.
Comment by riverrrow on Jan 15, 2024 9:36am
Overpromise and under deliver.  That's the best strategy for any management.  In his January 2 email M Perraton talked about "waiting on 6 recently treated patients to be added to our results."   This update only includes 2 new patients at 90 days and three new patients have reached the 450 day mark.  The good news that almost everybody has probably missed is ...more  
Comment by Longholder99 on Jan 15, 2024 9:41am
US markets closed today.  All good news for TLT takes a few days to digest in my observation. Nice to see regular communication which some of our local naysayers whine about regularly.  Incremental moves forward are a good thing.  
Comment by socksnblonds642 on Jan 15, 2024 10:51am
This release is pretty much irrelevant to us. Likely for PP purposes only. All good info. The numbers look great. We're all here and excited because of the results like this.  I am wondering where the BTD submission is. Results are more than good enough to submit. There are enough evaluable patients for the FDA to review. I'd like to see an update telling us where they are with BTD. I ...more  
Comment by Beano349 on Jan 15, 2024 10:25am
All this good news and still waiting on the pre btd to be resent. They are gonna need more cash again. 
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The Road to Saving Lives: Clinical Study Underway

  • Clinical Study with 68 of 100 Patients Treated (Enrollment to be completed by end of 2024, with study completed by end of 2026)
     
  • Ground Floor Investment Opportunity in Multi-Billion Dollar Industry
     
  • Best-in-class treatment for NMIBC (according to interim clinical data)
     
  • NMIBC (Non-Muscle-Invasive Bladder Cancer)
     

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Address:
41 Hollinger Road
Toronto, ON M4B 3G4
Canada

Toll Free:
1-866-THE-LASE (843-5273)
Local Phone:
416-699-LASE (5273)

Email:
info@theralase.com

Fax:
416-699-5250