Toronto, ON -- March 14, 2013 -- Theralase
Technologies Inc. (TSXV: TLT) announced that its proprietary Photo Dynamic
Compound (PDC) technology has been approved for use in a live animal bladder
cancer model by the University Health Network (UHN) Research Ethics Board. This
approval expedites the Company’s progress towards commercializing its advanced
bladder cancer therapy.
Theralase’s leading proprietary oncology PDC has
repeatedly demonstrated that it is:
- toxic to bladder
cancer cells when light activated (100% kill rate)
- exceeds potency
of FDA approved PDCs
- highly stable
ensuring optimal tumour destruction
Theralase will validate its PDC technology in this animal
cancer model to support an Investigational New Drug (IND) application to be
filed with the FDA later this year. This IND application will allow Theralase
to commence a Phase 1/2a human clinical trial to prove the safety and efficacy
of its PDC technology on a 30 subject population with scheduled completion in
2014. Based on recent pharmaceutical acquisitions for oncology drugs and market
statistics, the estimated value of the PDC upon successful completion of a FDA
Phase 1/2a clinical trial ranges from $84 million to $360 million in upfront
payments followed by a double digit revenue royalty stream. (Source: BIO
statistics)
Arkady Mandel MD, PhD, DSc, Chief Scientific
Officer of Theralase Technologies Inc. stated, “Protocols and standard operating
procedures are in place to ensure adherence to the highest scientific and
ethical standards. In addition, the program has been fully accredited by the
Canadian Council for Animal Care. This critical research is a vital progressive
step that will greatly advance our innovative bladder cancer therapy.”
Michael Jewett, FRCSC, MD, an eminent urologist and
a member of the Department of Surgical
Oncology at UHN’s Princess Margaret Cancer Centre, as well as a member of
Theralase’s Medical and Scientific Advisory Board said, “The elements of
Theralase’s PDC development plan are in place and I believe they will lead to a
successful FDA Phase 1/2a human clinical bladder cancer trial to commence early
next year. With a recurrence rate of nearly 80%, bladder cancer is the most
expensive cancer to treat on a per patient basis and raises many issues
affecting the quality of life because of its persistence.”
Roger Dumoulin-White, President and CEO of
Theralase Inc. stated, “Our leading PDC drug candidate has been proven to be
superior to any currently approved FDA PDC on the market. As we continue to achieve
our critical research milestones, Theralase’s leading PDC provides indisputable
proof of its efficacy in the destruction of cancer in live animal models.
Subject to a successful FDA Phase 1/2a human clinical bladder cancer trial of
the PDC technology, Theralase will apply for “breakthrough status” with the FDA,
which if granted, would allow Theralase the unique opportunity of
commercializing its technology without the need for further FDA clinical
trials, thus allowing the bladder cancer technology the most direct route to fulfill
an unmet medical need and aid in the destruction of a deadly disease.”
About
Theralase Technologies Inc.:
Theralase Technologies Inc., founded in 1995, designs, develops,
manufactures and markets patented, superpulsed laser technology utilized in
biostimulation and biodestruction applications. Theralase technology is safe
and effective in treating pain, inflammation and for tissue regeneration of
neural muscular skeletal conditions and wound healing. Theralase is currently
developing patented Photo Dynamic Compounds (PDCs) that are able to target and
destroy cancers, bacteria and viruses when light activated by Theralase’s
proprietary and patented laser technology.
This press release contains forward-looking statements, which reflect
the Company's current expectations regarding future events. The forward-looking
statements involve risks and uncertainties. Actual results could differ
materially from those projected herein. The Company disclaims any obligation to
update these forward-looking statements.
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
416-699-5273 ext. 225
rwhite@theralase.com
