VANCOUVER, April 10, 2019 /CNW/ - Sirona Biochem Corp.
(TSX-V: SBM) (FSE: ZSB) (the "Company") is pleased to
announce the results of its clinical trial performed by Dr.
Zoe Draelos of Dermatology
Consulting Services, conducted in North
Carolina, USA. Sirona's TFC-1067 demonstrates superiority to
the gold standard, hydroquinone, for the treatment of dyschromia
(hyperpigmentation or "dark spots" of the skin).
In the 12-week double blinded study involving 48 participants,
TFC-1067 successfully achieved the endpoint of lightening
dyschromic areas on the skin. With application of TFC-1067, areas
of hyperpigmentation were significantly lightened and blended into
surrounding skin, evening skin tone while preserving overall tone.
TFC-1067, achieved this goal, while the hydroquinone comparator did
not.
No clinical safety issues were observed with TFC-1067 during the
trial. Combined with extensive preclinical safety testing, there is
now strong evidence that TFC-1067 is a safe and superior
replacement to hydroquinone for the treatment of facial
hyperpigmentation.
Hydroquinone has remained the gold standard for skin lightening
despite known toxicity which is an ongoing concern for the FDA and
the dermatology community. Hydroquinone is banned or has restricted
dosing in an increasing number of countries. Although many
non-hydroquinone alternative lightening compounds are either toxic
or ineffective, unfortunately, millions of people still resort to
toxic treatments for hyperpigmentation despite poor aesthetic
results. There is a clear unmet need for a safe and effective
treatments in this 20-Billion-USD
skin lightening market.1
The Company is currently pursuing publication of these results
in a peer reviewed scientific journal. A detailed report of the
clinical trial will then be made available to the scientific
community including the dermatological and cosmetic community.
"Having demonstrated clinically in our human trial what we
predicted in preclinical testing is further validation of the
commercial value of our proprietary technology," reports Dr.
Howard Verrico, CEO Sirona Biochem.
"These results were achieved with a very basic formulation. The
full potential of TFC-1067 is yet to be demonstrated. Having
validated the commercial value of TFC-1067 with the clinical
trial's success we have greatly improved our licensing
opportunities and value globally. Currently we are in discussions
for licensing TFC-1067 in specific markets. An update will be
released when these discussions conclude."
"TFC-1067 performed remarkably well in comparison to 2%
hydroquinone, which traditionally has been challenging to
approximate. Hydroquinone alternatives are needed," said Dr.
Zoe Draelos. "Most consumers desire
lightening of dark spots to blend into surrounding skin. The
study product achieved this goal."
About Dr. Zoe Draelos
Zoe Diana Draelos, MD, is a
practicing board-certified dermatologist and a Fellow of the
American Academy of Dermatology with a research interest in
cosmetics, toiletries, and biologically active skin medications.
She is a researcher in High Point, North
Carolina, and a Consulting Professor of Dermatology at
Duke University. In 1988, she founded
Dermatology Consulting Services to provide education, develop
formulations, and conduct clinical studies in association with
industry. Prior to pursuing a medical career, Dr. Draelos completed
an undergraduate degree in Mechanical Engineering and was elected a
Rhodes Scholar. A member of Sigma Xi research honorary and
Alpha Omega Alpha medical honorary,
she is author of 12 textbooks, including Cosmetics in
Dermatology, now in its second edition after having been translated
into 4 languages, Hair Cosmetics, as well as the editor
of Cosmeceuticals, now in its third edition and translated
into 5 languages. She has experience conducting FDA phase I, II,
III, and IV studies and also specializes in OTC drug and cosmetic
studies. Dermatology Consulting Services can develop protocols,
write consents, organize case report forms, obtain IRB approval,
recruit and administer the study, perform data entry, prepare the
statistical analysis, and write the final report. She has
successfully completed over 545 clinical studies as the primary
investigator. This diversity of services offered by Dr. Draelos
provides a unique start to finish approach to clinical research for
drugs, OTC drugs, and cosmetic formulations.
For further information, please
visit http://www.zoedraelos.com/.
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery
company with a proprietary platform technology. Sirona specializes
in stabilizing carbohydrate molecules with the goal of improving
efficacy and safety. New compounds are patented for maximum revenue
potential.
Sirona's compounds are licensed to leading companies around the
world in return for licensing fees, milestone fees and ongoing
royalty payments. Sirona's laboratory, TFChem, is in France and is the recipient of multiple French
national scientific awards and European Union and French government
grants. For more information, please
visit www.sironabiochem.com.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this press release.
Sirona Biochem cautions you that statements included in this
press release that are not a description of historical facts may be
forward-looking statements. Forward-looking statements are only
predictions based upon current expectations and involve known and
unknown risks and uncertainties. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of release of the relevant information, unless
explicitly stated otherwise. Actual results, performance or
achievement could differ materially from those expressed in, or
implied by, Sirona Biochem's forward-looking statements due to the
risks and uncertainties inherent in Sirona Biochem's business
including, without limitation, statements about: the progress and
timing of its clinical trials; difficulties or delays in
development, testing, obtaining regulatory approval, producing and
marketing its products; unexpected adverse side effects or
inadequate therapeutic efficacy of its products that could delay or
prevent product development or commercialization; the scope and
validity of patent protection for its products; competition from
other pharmaceutical or biotechnology companies; and its ability to
obtain additional financing to support its operations. Sirona
Biochem does not assume any obligation to update any
forward-looking statements except as required by law.
___________________________
|
1
|
Fact.MR retrieved
from:
https://www.factmr.com/report/309/skin-lightening-products-market
|
SOURCE Sirona Biochem Corp.