Highly statistically significant top-line results; KLOX to pursue filing
for European regulatory approval
LAVAL, QC, Feb. 25, 2013 /CNW Telbec/ - KLOX Technologies Inc. ("KLOX"
or the "Company") is pleased to report top-line efficacy and safety
data from its multi-center, randomized, split-face European
registration trial for the KLOX AC-1 Biophotonic System. The AC-1
Biophotonic System has completed a clinical investigation for the
treatment of patients with moderate to severe acne vulgaris, a chronic
dermatological condition characterized by persistent lesions and/or
scars. This condition affects over 140 million patients worldwide, of
which approximately 20% are suffering from moderate to severe forms.
The current acne therapeutic market has high unmet needs in terms of
safety and efficacy particularly for severe cases. Data released today
qualifies KLOX's AC-1 Biophotonic system for acne sufferers as a
first-in-class solution and a true clinical advancement in the
treatment of moderate and severe acne.
"Acne can have devastating effects on the physical, psychological and
social aspects of acne sufferers' lives. While diagnosis is easy, many
current treatment avenues remain a challenge as they are frequently
associated with important safety concerns. In this context, the
significant clinical impact of KLOX's AC-1 Biophotonic System as
demonstrated in this trial is extremely encouraging and further
validates the broad potential of our biophotonic platform," stated Dr.
Lise Hébert, President and CEO of KLOX. "On the basis of these strong
results and this excellent safety profile, we are now more committed
than ever to quickly advancing this proprietary, innovative and
non-invasive light-based medical device to market as well as pursuing a
commercial partnership in the near future," she added.
Clinically and statistically significant results
The primary endpoint used for the assessment was an U.S. Food and Drug
Administration recognized scale, namely the Investigator's Global
Assessment (IGA). Patients treated with the AC-1 Biophotonic System
twice a week for six weeks on a randomly selected hemiface demonstrated
a clinically and highly statistically significant improvement, as
measured by the reduction of at least 2 grades in IGA from baseline to
Week 12. The treated hemiface group demonstrated a 51.7% responder rate
versus an 18.0% responder rate for the untreated group (p < 0.0001).
Significant, visible clinical difference in responders suffering from
moderate to severe acne
All secondary endpoints were met, including the reduction in
inflammatory lesion counts. The prospective trial reported a highly
statistically significant reduction in inflammatory lesion counts at
Week 12: 81.6% of the treated hemiface group had a reduction of at
least 40% reduction in inflammatory lesion counts compared to 46.0% in
the untreated hemiface group (p < 0.0001). Results were also
statistically significant at Week 6 (p < 0.0001). The magnitude of the
difference was noticeably maintained throughout the study. Each of the
groups had a comparable mean baseline count of 23 inflammatory lesions
Further analyses on secondary endpoints are ongoing, together with an
evaluation of the effect of the AC-1 Biophotonic System on scarring.
Excellent safety profile
No serious adverse events were reported throughout the study. The AC-1
Biophotonic System was very well tolerated throughout the entire
12-week trial, and most of the reported adverse events were categorized
as mild and transient.
"With the successful completion of this registration trial and today's
release of positive results on efficacy and safety, KLOX's biophotonic
system has met the challenge of an emerging treatment for acne for our
clinical practices. The high completion rate of approximately 90%
reflects high patients' adherence to the treatment schedule and high
patients' satisfaction. With an early response as soon as after 6 weeks
of treatment, this "patient friendly" therapy, is a safe, well
tolerated option that allows patients to avoid the need for systemic
acne treatments", said Dr. Christina Antoniu, Professor in
Dermatovenerology, Dermatology Department, A. Sygros Hospital,
University of Athens School of Medicine (Athens, Greece) and Principal
Investigator of the KLOX registration acne trial.
"This is a very significant advance in the treatment of moderate to
severe acne, a true paradigm shift in the array of available
treatments. In fact, this new non-invasive biophotonic treatment is a
true innovation that is poised to be used first line by
dermatologists," commented Dr. Steven Bernstein, Chief of Dermatology
Surgery at Centre hospitalier de l'Université de Montréal (CHUM).
"The results of the present study demonstrate a successful alternative
to the current treatment strategies available for moderate and severe
acne vulgaris. The multi-center randomized clinical evaluation of the
KLOX AC-1 Biophotonic System demonstrated a significant impact on such
cases", said Dr. Andreas Nikolis, Plastic, Reconstructive and Aesthetic
Surgeon, Associate Professor of Plastic Surgery, Division of Plastic
Surgery, University of Montreal. "The idea behind this treatment
regimen is multi-pronged, and involves managing the underlying problems
leading to acne and the stimulation of collagen in the traumatized
skin. Furthermore, the safety profile in this 90 patient study is
exceptional, leading to a major alternative for patients suffering from
a significant degree of acne," he concluded.
Registration trial details
The registration trial was a multi-center, randomized clinical trial of
12 weeks in duration including 6 weeks of active treatment on the
randomly selected hemiface with a subsequent 6-week follow-up.
Investigators enrolled a total of 90 patients of which 36% were
suffering from severe acne. The overall acne severity was assessed by
the investigator, using the IGA scale. The primary endpoint of this
trial was defined as at least a two-point improvement on the five-point
IGA scale and was measured at different time points through Week 12.
The study was designed to have 90% power to detect at least a 25%
difference in reaching the two-point improvement on IGA versus the
untreated group with a statistical significance defined as p < 0,05.
A 12-week open-label extension trial is currently ongoing to treat the
second hemiface of each participating individual and to evaluate the
persistence of the efficacy results from the registration study as well
as safety. Preliminary results on the first 30 patients will be
available in March 2013.
KLOX to pursue market registration in Europe
The efficacy and safety profile of the KLOX AC-1 Biophotonic System
demonstrated in the registration trial will provide the basis for
advancing this innovative treatment to the European market with a
filing for CE mark registration planned for the second quarter of 2013.
About moderate to severe acne vulgaris
Moderate to severe acne vulgaris is estimated to affect over 140 million
people worldwide. Acne has to devastating effects on the physical,
psychological and social aspects of a patient's life. It is caused by
an association of four key factors: increased sebum production,
follicular hyperkeratinization, colonization with the bacteria
Propionibacterium acnes and production of inflammation.
Moderate to severe acne that does not respond to topical agents is often
treated through orally administered antibiotics with an average 50%
efficacy rate in reducing acne lesions while however this treatment
causes significant unfortunate side effects. As a result, the acne
market has high unmet needs in terms of therapies which show both
safety and efficacy, with little innovation currently on the horizon.
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. Two
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 and
venous leg ulcers.
In view of these recent results, company representatives will be
attending the upcoming Annual Meeting of the American Academy of
Dermatology to be held from March 1-5 in Miami, Florida. For further
information on KLOX and its programs or to arrange a meeting at the
conference, please contact Mrs. Jody Engel, Director, Business
Development at (450) 680-4582 or visit the Company's website: www.kloxtechnologies.com
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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