Theralase® Technologies Inc. (“
Theralase” or the
“
Company”) (
TSXV: TLT)
(
OTCQB: TLTFF), a clinical stage pharmaceutical
company focused on the research and development of light activated
Photo Dynamic Compounds (“
PDC”) 1 and their
associated drug formulations, intended for the safe and effective
destruction of various cancers, bacteria and viruses, has provided
an update on the Phase II Non-Muscle Invasive Bladder Cancer
(“
NMIBC“) Clinical Study (“
Study
II”).
As previously announced, Theralase® successfully
completed a Phase Ib NMIBC Clinical Study (“Study
I”), which enrolled and provided the primary study
treatment, at the therapeutic dose, for 3 patients. To date, Study
II has enrolled and provided the primary study treatment for 35
patients, which when combined with the Study I data, leads to a
total of 38 patients, who have received at a minimum, the primary
study treatment.
Study II Clinical Study
Data:
Assessment (Days) |
Complete Response (“CR”) 2 |
Partial Response (“PR”) 3 |
Pending 4 |
CR (Evaluable Patients) 5 |
Total Responders (CR + PR) 6 |
Potential Responders (CR + PR + Pending)
7 |
90 |
44.7% |
15.8% |
10.5% |
50.0% |
60.5% |
71.1% |
180 |
31.6% |
15.8% |
28.9% |
44.4% |
47.4% |
76.3% |
270 |
23.7% |
5.3% |
42.1% |
40.9% |
28.9% |
71.1% |
360 |
13.2% |
7.9% |
47.4% |
25.0% |
21.1% |
68.4% |
450 |
13.2% |
5.3% |
47.4% |
25.0% |
18.4% |
65.8% |
On July 30, 2020, the Company optimized the Study II treatment,
specifically:
a) Bladder volume calculation for administration of the study
drug and study device volume b) Study device treatment time
The Study II optimized treatment patients, who
received either an optimized primary study treatment or optimized
maintenance study treatment consisted of: 23 patients at 90 days,
26 patients at 180 days and 27 patients at each of 270, 360 and 450
days.
Study II Clinical Study Data (Optimized:
Post August 1, 2020):
Assessment (Days) |
Complete Response (“CR”)2 |
Partial Response (“PR”)3 |
Pending4 |
CR (Evaluable Patients)5 |
Total Responders (CR + PR)6 |
Potential Responders (CR + PR +
Pending)7 |
90 |
52.2% |
17.4% |
13.0% |
60.0% |
69.6% |
82.6% |
180 |
22.2% |
18.5% |
40.7% |
40.0% |
42.3% |
83.0% |
270 |
14.8% |
3.7% |
59.3% |
36.4% |
18.5% |
77.8% |
360 |
3.7% |
7.4% |
66.7% |
11.1% |
11.1% |
77.8% |
450 |
3.7% |
3.7% |
66.7% |
11.1% |
7.4% |
74.1% |
Note: The interim analyses
presented above, should be read and interpreted with caution, as
the reported clinical data is early in its presentation. Study II
is presently ongoing and new clinical data collected may or may not
continue to support the current reported trends.
Study II Objectives:
- Primary - Efficacy (defined by CR) at any
point in time.
- Secondary - Duration of CR (defined by
duration of CR lasting a minimum 360 days post-initial CR).
- Tertiary - Safety measured by incidence and
severity of Adverse Events ("AEs") grade 4 or
higher that do not resolve within 450 days post primary study
treatment. (Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Serious,
Grade 4 = Life Threatening and Grade 5 = Death)
Performance to Objectives:
Primary:For 38 patients
enrolled and treated in Study II:44.7% achieved CR at 90 days, with
50% achieving CR with evaluable patients and a potential of 71.1%,
if all PR and Pending patients achieved CR
For 23 patients enrolled and treated in Study II
(who received an optimized primary study treatment):52.2% achieved
CR at 90 days, with 60% achieving CR with evaluable patients and a
potential of 82.6%, if all PR and Pending patients achieved CR
Secondary:For 38 patients
enrolled and treated in Study II:13.2% achieved CR at 450 days,
with 25% achieving CR with evaluable patients and a potential of
65.8%, if all PR and Pending patients achieved CR
For 27 patients enrolled and treated in Study II
(who received an optimized primary or maintenance study
treatment):3.7% achieved CR at 450 days, with 11.1% achieving CR
with evaluable patients and a potential of 74.1%, if all PR and
Pending patients achieved CR
Tertiary:For 38 patients
enrolled and treated in Study II, there have been 7 Serious Adverse
Events (“SAEs”) reported:
- 1 – Grade 2 (resolved within 1
day)
- 3 – Grade 3 (resolved within 5, 80
and 107 days, respectively)
- 2 – Grade 4 (resolved within 6 and
6 days, respectively)
- 1 – Grade 5 (not resolved))
Theralase® believes all SAEs reported to date
are unrelated to the Study Drug or Study Device, subject to final
review and confirmation by the independent Data Safety Monitoring
Board (“DSMB”).
Conclusion:
Study II has delivered significant clinical
results to date for the primary, secondary and tertiary
objectives.
Dr. Vera Madzarevic, Ph.D., Director of Clinical
Development and Quality Assurance at Theralase® stated, “From the
38 patients treated to date in Study II, those evaluable patients,
have achieved 50.0% CR at 90 days and 25.0% have maintained this CR
for at least 450 days, since primary study treatment. Additionally,
total responders (CR +PR) at 90 days is 60.5% and 18.4% at 450
days; however, there is significant data still pending. This
provides clinical support for achieving the primary and secondary
objectives of Study II. The tertiary objective clinical data is
promising, as only 7 SAEs were reported to date. Theralase®
believes these 7 SAEs are unrelated to the Study Drug or Study
Device. In conclusion, it is encouraging to see, from the
preliminary clinical data that the Company has accumulated to date,
that if the trends continue, then Theralase® is on track to
achieving the primary, secondary and tertiary Study II
objectives.”
Dr. Arkady Mandel M.D. Ph.D. D.Sc., Interim
Chief Executive Officer and Chief Scientific Officer, Theralase®
stated, “I am encouraged by the clinical results to date, which
demonstrate the potential to fill an unmet need for patients
diagnosed with BCG-Unresponsive NMIBC. These patients are facing
bladder removal and by delivering them a complete response with a
durability lasting up to 15 months post primary study treatment,
Theralase® is providing them an opportunity to retain their bladder
and the quality of life associated with it.”
Definitions:
1 PDCs are light sensitive molecules that are
able to produce highly volatile singlet oxygen and Reactive Oxygen
Species (“ROS”), that can induce inactivation of
cancer cells, bacteria or viruses through oxidative stress, when
activated by light at a particular wavelength.
2 Complete Response (“CR”) is
defined according to the FDA Guideline “BCG-Unresponsive Nonmuscle
Invasive Bladder Cancer: Developing Drugs and Biologics for
Treatment Guidance for Industry” (U.S. Department of Health and
Human Services Food and Drug Administration Center for Drug
Evaluation and Research (“CDER”) Center for
Biologics Evaluation and Research (“CBER”) -
February 2018):
“For single-arm trials of patients with
BCG-Unresponsive disease using intravesical therapies without
systemic toxicity, the FDA defines a Complete Response
(“CR”) 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
- Negative cystoscopy with malignant
urine cytology, if cancer is found in the upper tract or prostatic
urethra and random bladder biopsies are negative”
3 Partial Response (“PR”) is
defined as patients who display either positive cystoscopy and
negative urine cytology or negative cystoscopy and positive urine
cytology during an assessment visit. According to the FDA guidance,
patients participating in Study II, who are currently diagnosed as
PR, may be re-classified as CR, if the cystoscopy is positive, low
grade NMIBC is detected and the urine cytology is negative or if
urine cytology is positive, cystoscopy is negative and upper tract
or prostatic urethra urothelial cell carcinoma is detected.
4 Pending is defined as patients, who have not
been assessed at a specific time point; hence, their clinical data
is currently awaiting assessment.
5 CR (Evaluable Patients) is defined as patients
who have demonstrated CR with evaluable data; hence, excluding
patients who have clinical data Pending.
6 Total Responders (CR + PR) is defined as
patients who have demonstrated either a CR or PR.
7 Potential Responders (CR + PR + Pending) is
defined as patients who have demonstrated a CR, PR or have clinical
data Pending.
About Study IIStudy II utilizes
the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the
proprietary TLC-3200 medical laser system. Study II is focused on
enrolling and treating approximately 100 to 125 BCG-Unresponsive
NMIBC Carcinoma In-Situ (“CIS”) patients in up to
15 Clinical Study Sites (“CSS”) located in Canada
and the United States.
About TLD-1433TLD-1433 is a patented PDC with
over 10 years of published peer reviewed preclinical research and
is currently under investigation in Study II.
About Theralase® Technologies
Inc.Theralase® is a clinical stage pharmaceutical company
dedicated to the research and development of light activated
compounds and their associated drug formulations with a primary
objective of efficacy and a secondary objective of safety in the
destruction of various cancers, bacteria and viruses.
Additional information is available
at www.theralase.com and www.sedar.com
Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Forward Looking Statements
This news release contains "forward-looking
statements" within the meaning of applicable Canadian securities
laws. Such statements include, but are not limited to, statements
regarding the Company's proposed development plans with respect to
Photo Dynamic Compounds and their drug formulations. Forward
looking statements may be identified by the use of the words
"may, "should",
"will", "anticipates",
"believes", "plans",
"expects", "estimate",
"potential for" and similar expressions including
statements related to the current expectations of Company's
management for future research, development and commercialization
of the Company’s Photo Dynamic Compounds and their drug
formulations, including preclinical research, clinical studies and
regulatory approvals.
These statements involve significant risks,
uncertainties and assumptions; including, the ability of the
Company to: adequately fund, and secure the requisite regulatory
approvals to successfully complete a Phase II NMIBC clinical study
in a timely fashion and implement its development plans. Other
risks include: the ability of the Company to successfully
commercialize its drug formulations, the risk that access to
sufficient capital to fund the Company’s operations may not be
available or may not be available on terms that are commercially
favorable to the Company, the risk that the Company’s drug
formulations may not be effective against the diseases tested in
its clinical studies, the risk that the Company’s fails to comply
with the term of license agreements with third parties and as a
result loses the right to use key intellectual property in its
business, the Company’s ability to protect its intellectual
property, the timing and success of submission, acceptance and
approval of regulatory filings, and the impacts of public health
crises, such as COVID-19. Many of these factors that will determine
actual results are beyond the Company's ability to control or
predict.
Readers should not unduly rely on these forward-
looking statements which are not a guarantee of future performance.
There can be no assurance that forward looking statements will
prove to be accurate as such forward looking statements involve
known and unknown risks, uncertainties and other factors which may
cause actual results or future events to differ materially from the
forward-looking statements.
Although the forward-looking statements
contained in the press release are based upon what management
currently believes to be reasonable assumptions, the Company cannot
assure prospective investors that actual results, performance or
achievements will be consistent with these forward-looking
statements.
All forward-looking statements are made as of
the date hereof and are subject to change. Except as required by
law, the Company assumes no obligation to update such
statements.
For More Information:
1.866.THE.LASE (843.5273)416.699.LASE
(5273)www.theralase.com
Kristina Hachey, CPAChief Financial
Officerkhachey@theralase.com416.699.LASE (5273) x 224
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