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 per hemiface.
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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