Strong Extension Trial Results For Innovative AC-1 BioPhotonic Platform For The Treatment Of Moderate To Severe Acne Vulgaris
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(TM) and Lumiderm(TM) 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) 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(TM) and Lumiderm(TM) 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.
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.
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(TM) and Lumiderm(TM) Light offers a promising non-invasive alternative in the management of the aging face and facial rejuvenation treatments.
Klox Technologies Inc.