Toronto, Ontario (FSCwire) -
Theralase Technologies Inc. (“Theralase®” or the
“Company”) (TLT:TSXV)
(TLTFF:OTC), a leading biotech company focused on
the commercialization of medical devices to eliminate pain and the
development of Photo Dynamic Compounds (“PDCs”) to
destroy cancer, announced today that it has demonstrated 18 month
long term stability of it lead anti-cancer Photo Dynamic Compound
(“PDC”), TLD-1433.
Stability studies are an essential
component of pharmaceutical development, allowing evaluation of a
drug’s stability under the influence of a variety of environmental
factors such as: temperature, humidity and light. Data from these
studies enable recommended storage conditions, retest intervals and
shelf lives to be established.
Demonstrating long term stability
of a drug to be used in human clinical testing is essential to
prove that the potency and/or efficacy of the drug is not affected
during prolonged shelf life.
TLD-1433, in the most recent
testing report, demonstrated that its purity has changed less than
0.34% in 18 months of long term stability testing, indicating
extreme stability of the compound.
Under long term and accelerated
stability storage conditions, the drug is evaluated by High
Performance Liquid Chromatography (“HPLC”) to
separate, identify and quantify each chemical component to a very
high degree of resolution to assess if any change occurs in the
chemical composition over time.
Long term stability is completed
over three years, with reporting at 0, 3, 6, 9, 12, 18, 24 and 36
months.
Accelerated stability is completed
over six months, with reporting at 0, 3 and 6 months.
6 months accelerated stability and
18 months long term stability testing have now been successfully
completed.
The next long term stability
reporting period will be at 24 months.
TLD-1433 has demonstrated that it
has remained stable at these reported time periods and according to
Health Canada guidelines, accelerated and long term stability has
now been proven at 6 months and 18 months, respectively, allowing
use in treating patients in a clinical study.
Theralase is currently focused on
enrolling patients in a Phase Ib clinical trial for patients
afflicted with Non-Muscle Invasive Bladder Cancer
(“NMIBC”) utilizing its novel, next generation
light-activated, anti-cancer drug, TLD-1433.
The Phase Ib NMIBC clinical trial
will evaluate TLD-1433 for the primary endpoints of safety and
tolerability, with a secondary endpoint of pharmacokinetics
(movement and exit of drug within tissue) and an exploratory
endpoint of efficacy.
About Theralase
Technologies Inc.
Theralase Technologies Inc.
(“Theralase®” or the “Company”)
(TSXV: TLT) (TLTFF: OTC) in its
Therapeutic Laser Technology (“TLT”) Division
designs, manufactures, markets and distributes patented
super-pulsed laser technology indicated for the treatment of
chronic knee pain, and in off-label use, the elimination of pain,
reduction of inflammation and dramatic acceleration of tissue
healing for numerous nerve, muscle and joint conditions.
Theralase’s Photo Dynamic Therapy (“PDT”) Division
researches and develops specially designed molecules called Photo
Dynamic Compounds (“PDCs”), which are able to
localize to cancer cells and then when laser light activated,
effectively destroy them.
Additional information is
available at www.theralase.com and www.sedar.com .
This news release contains
"forward-looking statements" which reflect the
current expectations of management of the Corporation’s future
growth, results of operations, performance and business prospects
and opportunities. Such statements include, but are not limited to,
statements regarding the proposed use of proceeds.. Wherever
possible, words such as "may",
"would", "could",
“should”, "will",
"anticipate", "believe",
"plan", "expect",
"intend", "estimate",
"potential for" and similar expressions have been
used to identify these forward-looking statements. These statements
reflect management's current beliefs with respect to future events
and are based on information currently available to management.
Forward-looking statements involve significant risks, uncertainties
and assumptions. Many factors could cause the Corporation’s actual
results, performance or achievements to be materially different
from any future results, performance or achievements that may be
expressed or implied by such forward-looking statements; including,
without limitation, those listed in the filings made by the
Corporation with the Canadian securities regulatory authorities
(which may be viewed at www.sedar.com). Should one or more of these
risks or uncertainties materialize, or should assumptions
underlying the forward looking statements prove incorrect, actual
results, performance or achievements may vary materially from those
expressed or implied by the forward-looking statements contained in
this news release. These factors should be considered carefully and
prospective investors should not place undue reliance on the
forward-looking statements. Although the forward-looking statements
contained in the news release are based upon what management
currently believes to be reasonable assumptions, the Corporation
cannot assure prospective investors that actual results,
performance or achievements will be consistent with these
forward-looking statements. The Corporation disclaims any intention
or obligation to revise forward-looking statements whether as a
result of new information, future developments or otherwise except
as required by law. All forward-looking statements are expressly
qualified in their entirety by this cautionary statement.
Neither TSX Venture Exchange
nor its Regulation Services Provider (as that term is defined in
the policies of the TSX Venture Exchanges) accepts responsibility
for the adequacy or accuracy of this release.
For More
Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext.
225
416.699.LASE (5273) ext. 225
rwhite@theralase.com
www.theralase.com
To view this press release as a PDF file, click onto the following
link:
public://news_release_pdf/theralase03152017.pdf
Source: Theralase Technologies Inc. (TSX Venture:TLT, OTC
Pink:TLTFF)
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