- 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 February 2013
- 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 treatments
- 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 well tolerated.
- 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 treatments.
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 its pipeline.
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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