Theralase Achieves Commercialization Milestone For Its Bladder Cancer Therapy
March 14 2013 - 7:00AM
Access Wire
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.
For further information please visit www.theralase.com ,
regulatory filings may be viewed by visiting www.sedar.com.
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
Kristina Hachey
Chief Financial Officer
416-699-5273 ext. 224
khachey@theralase.com
Arkady Mandel
Chief Scientific Officer
416-699-5273 ext. 242
amandel@theralase.com
Greg Bewsh
Director of Investor Relations
416-699-5273 ext. 258
gbewsh@theralase.com
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