New AC-1 data from extension trial for acne sufferers provides further
support that the system is a safe, highly effective, novel solution
with long-lasting efficacy results
Strong alignment with European registration trial results announced in
Submission filed for marketing approval for AC-1 in Europe and Canadian
filing planned in Q3:2013
KLOX's proprietary platform found to be promising in other skin
Company successfully raised $5 million private placement financing
LAVAL, QC, July 11, 2013 /CNW Telbec/ - KLOX Technologies Inc. ("KLOX"
or the "Company") released results from its most recent extension trial
in Europe for its innovative AC-1 BioPhotonic platform for the
treatment of moderate to severe acne vulgaris. Of the 140 million
people worldwide who suffer from this chronic and often debilitating
dermatological condition, over 20% suffer from moderate to severe
forms. The multi-billion dollar global acne market currently lacks
non-systemic and non-invasive treatments with strong efficacy and good
safety profiles; KLOX is confident that its system will be able to fill
this significant void and with these strong results plans to introduce
the system on the market as the Lumigel Cleanse™ and Lumiderm™ Light.
The data being released today was obtained from the KLOX acne extension
trial that began shortly after the closing of its registration trial
which treated a randomly selected hemiface (trial completed in December
2012). Patients were invited to roll into the extension trial to treat
the previously non-treated hemiface and to document the persistence of
effect on the first treated hemiface. The results obtained in the
extension trial confirmed the efficacy originally demonstrated in the
previously completed 12-week registration trial in which all primary
and secondary endpoints were met.
Extension trial highlights related to patients having completed the
study as per protocol:
Treatment results from the registration trial were maintained over the
additional 3-month follow-up period.
The clinical benefit observed in patients who entered the extension
trial and had previously met the primary endpoint in the registration
trial, defined as a 2-grade or better improvement on the Investigator's
Global Assessment (IGA)1 scale, was maintained in 75% of that cohort.
46% of moderate and severe patients who participated in the extension
trial and received treatment on their second hemiface improved by at
least 2 grades on the IGA scale. These results are comparable to the
51.7% announced in the registration study.
All endpoints were met, as in registration trial.
The safety profile continued to be very good with the treatment being
Patients in treated group experienced a significant improvement in their
acne, demonstrating a visible difference, including an important
reduction in their inflammatory lesion counts.
"The extension trial was an important opportunity for us to examine the
persistence of the treatment's efficacy and safety over a 6-month
period and to treat the other hemiface of patients enrolled in our
original registration trial. These latest results are consistent with
our original findings and further underline the strong efficacy and
remarkable safety profile of the KLOX Lumigel Cleanse™ and Lumiderm™
Light System in the treatment of moderate to severe acne. Not only is
this non-invasive treatment well-tolerated by patients but it works and
its effects are long lasting," stated Dr. Christina Antoniou, Professor
of Dermatovenerology, A. Sygros Hospital, University of Athens School
of Medicine and principal investigator of the KLOX AC-1 trial.
For more details on the extensial trial click HERE.
Market registration expected shortly in Europe
KLOX filed its regulatory submission for its acne system in June 2013
for Europe and is preparing to submit for Canada shortly with the goal
to receive market approval in those two geographies by Q4: 2013.
"We are pleased to see once again data that further confirms the vast
potential of our innovative and proprietary platform - one that can be
applied not only for the treatment of acne but also in tissue repair
including chronic wounds and post-surgical scarring and skin
rejuvenation. This data supports our current efforts to globally
partner our acne and skin rejuvenation programs and to continue
creating significant value for our shareholders," stated Dr. Lise
Hébert, President and CEO of KLOX.
Recent data presented at 9th World Congress of Cosmetic Dermatology
While at the 9th World Congress of Cosmetic Dermatology in Athens
(Greece), Dr. Andreas Nikolis, Plastic, Reconstructive and Aesthetic
Surgeon, Associate Professor of Plastic Surgery, Division of Plastic
Surgery, University of Montreal presented scientific information
regarding the potential of the impact of the KLOX BioPhotonic platform
in facial rejuvenation destined for the cosmetic market.
Dr. Nikolis presented the results of an investigational trial evaluating
KLOX's proprietary and innovative light-based technology in facial
aesthetics. Results indicated that the combination of light with the
gel in a non-interacting carbomer improves facial aesthetics in
multiple facial subunits and significantly increases the density of
collagen fascicles. This investigational trial demonstrates that the
KLOX Lumigel Tone™ and Lumiderm™ Light offers a promising non-invasive
alternative in the management of the aging face and facial rejuvenation
For more details on the investigational trial click HERE.
The company successfully raised a private placement financing amounting
to $5 million, which provides a healthy financial position to advance
1 The Investigator's Global Assessment (IGA) scale, an U.S. Food and Drug
Administration recognized scale, is composed of 5 severity grades
reported from 0 (clear skin) to 4 (severe acne) which describe
morphological changes associated with acne vulgaris.
About KLOX Technologies: Leveraging light-based bioPhotonic technologies
KLOX is a privately-owned company focused on the development and
commercialization of a unique, non-invasive BioPhotonic technology
using a primary device consisting of a multiple LED lighting system
that interacts with an oxygen-rich gel containing light-trapping
molecules. KLOX's cosmetics and medical devices are destined for the
rapidly growing aesthetics, dental, dermatological and medical markets.
Currently, KLOX is also developing the WH-1 BioPhotonic System, an
innovative light-based treatment for the multi-billion dollar advanced
wound care market. The WH-1 BioPhotonic System is being investigated to
treat pressure ulcers, diabetic and venous leg ulcers with the goal to
significantly accelerate healing in an optimal environment. Four
Investigational Testing Authorization trials are currently advancing in
Canada to evaluate the safety and preliminary efficacy of the WH-1
BioPhotonic System in the treatment of Stage II pressure ulcers,
venous leg and ulcers.
Forward Looking Statements
Certain statements contained in this presentation, other than statements
of fact that are independently verifiable at the date hereof, may
constitute forward-looking statements. Examples of such forward-looking
statements include those regarding cosmetics and medical devices and
medical applications and clinical trials and the status and related
results thereto, as well those regarding continuing and further
development efforts. Such statements, based as they are on the current
analysis and expectations of management, inherently involve numerous
risks and uncertainties, known and unknown, many of which are beyond
KLOX Technologies Inc.'s control. Such risks include but are not
limited to: the impact of general economic conditions, general
conditions in the medical, cosmetics and/or consumer goods industries,
changes in the regulatory environment in the jurisdictions in which
KLOX Technologies Inc. does business, financial and commercial markets
volatility, fluctuations in costs, and changes to the competitive
environment, as well as other risks. Consequently, actual future
results may differ materially from the anticipated results expressed in
the forward-looking statements. In the case of forward-looking
statements regarding investigational product candidates and continuing
and further development efforts, specific risks which could cause
actual results to differ materially from KLOX Technologies Inc.'s
current analysis and expectations include: failure to demonstrate the
safety, tolerability and efficacy of our products, final and quality
controlled verification of data and the related analyses, and the
expense and uncertainty of obtaining regulatory approval.
SOURCE: KLOX Technologies Inc.
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