KLOX Technologies reports on its interim results from its ongoing clinical studies on LumiHeal™ for the treatment of chronic wounds and postsurgical scarring

LAVAL, Quebec, Sept. 28, 2016 -- Today, clinical interim results on KLOX Technologies (Klox) LumiHeal^TM for the treatment of hard-to-heal non-responsive chronic wounds and postsurgical scarring will be reported in conjunction with the 2016 World Union of Wound Healing Societies (WUWHS) Congress in Florence, Italy.

The Klox LumiHeal^TM system is a first-in-class, proprietary, non-invasive, non-thermal treatment that harnesses the power of fluorescence in the presence of oxidants to treat serious skin and soft tissue disorders.

“We believe that LumiHeal^TM can really make a significant difference in the way we manage and treat acute and chronic wounds”, stated Dr. Marco Romanelli, MD, PhD, Associate Professor of Dermatology at the School of Medicine, University of Pisa, and Chief of the Wound Healing Research Unit, and President Elect of the World Union of Wound Healing Societies. “This is an area where an unmet need remains, and with LumiHeal’s^TM innovative approach, excellent safety profile and effectiveness, it can help bridge that gap.”

Professor Franco Bassetto, Head Clinic of Plastic Surgery Full Professor of Plastic Surgery Chair and Residency Program of Plastic Reconstructive and Aesthetic Surgery, University Hospital of Padova, Italy, will at 12:15 p.m. (CEST) unveil interim results from the EUREKA study, which evaluated the real-life use of LumiHeal^TM in chronic wounds management.

Following Professor Bassetto’s presentation, Professor Andreas Nikolis, MD, MSc, FRCSC, Plastic Reconstructive and Aesthetic Surgery, Associate Professor of Plastic Surgery, Division of plastic surgery, University of Montreal, Canada, will share interim findings comparing LumiHeal^TM to silicone sheets in the treatment of surgical wounds in the context of breast reductions.

“We are thrilled by the interim results of both studies and the high level of satisfaction from patients and investigators. Due to its ease of use and effectiveness, 95% of investigators involved in the chronic wound management study, EUREKA, stated they would recommend LumiHeal^TM to their colleagues”, said Dr. Michel Cimon, MD, Senior Vice President, Chief Medical and Science Officer of KLOX Technologies. “Furthermore, the vast majority of patients that completed the postsurgical scarring study to date, were more satisfied with the use of LumiHeal^TM with respect to ease of use and complexity of treatment.”

Clinical interim results from EUREKA study on LumiHeal^TM and chronic wounds management

Professor Franco Bassetto will report interim study results on the evaluation of real-life use of LumiHeal^TM in Chronic Wounds Management. To date, results include 33 patients who took part in the 100-patient EUREKA study. The full study will conclude by the end of the year and data will be available in the first half of 2017.

Investigators’ interim analysis indicate that the use of LumiHeal™ in the treatment of pressure ulcers (PU), diabetic foot ulcers (DFU) and venous leg ulcers (VLU) is safe, easy to administer and very well tolerated by the subjects’ population. Compliance to the study visits was excellent.

The good tolerability and compliance profiles may be due to the positive action on pain reduction observed during this study, especially in the VLU population, along with efficacy.

Interim results support the excellent efficacy profile of LumiHeal™ in promoting wound healing and wound bed preparation. These results point to the capacity of this treatment to help chronic, hard-to-heal, non-responsive wounds (PU, DFU, VLU) become responsive, as would acute wounds. Interim results show 17 patients with chronic wounds closed over the course of the treatment, while two (2) were close to closing and three (3) others were ready to skin graft. An additional six (6) patients of the 33 experienced a decrease in wound size during the study period, but without meeting the criteria of full responders.

Once closed, no wound reopened during the two-week confirmation period. The very low risk of wound breakdown or dehiscence was in line with the study treatment. Exploratory endpoints showed the potential of the system to modulate the inflammatory response during the wound healing process. Subjects’ quality of life was improved in all enumerated sub-sections (social life, well-being and physical symptoms), and Investigators also responded with a high level of satisfaction. The very low occurrence of infections during the study period, and especially the absence of infections with DFU wounds, suggests a positive control of the wound biofilm.

Preliminary results on the impact of LumiHeal^TM on postsurgical scarring

Professor Andreas Nikolis will report interim findings from a study comparing LumiHeal^TM to silicone sheets in the treatment of surgical wounds.
42 patients undergoing bilateral breast reductions were enrolled in this study. One (1) breast incision was randomized to treatment with LumiHeal^TM (treatment initiated at seven (7) or 21-days post-surgery), while the contralateral breast was treated with silicone gel sheeting alone for eight (8) weeks. 

Preliminary results from 16 patients who have completed all required treatment visits support an excellent safety profile across all patients with a significant improvement in physician and patient reported outcomes. To date, no severe adverse effects have been reported in the study, and reported adverse effects are unlikely to be linked to the LumiHeal^TM treatment. 

At the end of the treatment period, the data to date show a lower proportion of patients with red scars, as well as a greater proportion of patients reaching normal pliability. Furthermore, a significantly greater proportion of patients treated with LumiHeal^TM have reached a normal scar height when compared to silicone sheets treatment.

The full study will conclude by the end of 2016 and data will be available in the first half of 2017.

Schedule of LumiHeal^TM related events at 2016 WUWHS Congress

Today, Klox is hosting a Satellite Symposium on The Role of KLOX BioPhotonic System in Wound Healing (September 28, 2016) from 12:15 p.m. to 1:45 p.m. (CEST) in Hall RAFFAELLO. Oral presentations:

• Unmet Needs in Wound Healing 
  Chair: Prof. Luc Teot, Montpellier University Hospital FRANCE
  
  

• Wound Healing: “Very Intimate Process”. The Science Behind the LumiHeal™ System 
  Prof. Giovanni Scapagnini, Department of Medicine and Health Sciences, University of Molise 
  ITALY
  
  

• EUREKA ITALIA. The Evaluation of Real-Life Use of KLOX BioPhotonic System in Chronic Wounds Management: a Reproducibility Study. Interim Results 
  Prof. Franco Bassetto, Head Clinic of Plastic Surgery Full Professor of Plastic Surgery Chair and Residency Program of Plastic Reconstructive and Aesthetic Surgery University Hospital of Padova 
  ITALY
  
  

• Evolution of Photobiomodulation: Impact on Scarring 
  Prof. Andreas Nikolis,  MD, MSc, FRCSC, Plastic Reconstructive and Aesthetic Surgery, Associate Professor of Plastic Surgery, Division of plastic surgery, University of Montreal  
  CANADA

Other relevant presentations and posters:

• BioPhotonic Therapy Applied to Pressure Ulcers: a New Therapeutic Possibilities? 
  Author: Dr. Alessandro Corsi  
  Upper Floor at Poster Area (PO217-ID1042.45)
  
  

• A New Technology “Soft Used” in the Treatment of Chronic Injuries: BioPhotonic as Added Value in Wound Healing in Economic Evaluation 
  Authors : Dr. Sara Sandroni, Dr. Morena Mascalchi, Dr. Mirella Rossi 
  Upper Floor at Poster Area (PO496-ID10893.45)
  
  

• Photonic Treatment of Chronic Wounds 
  Authors: Dr. Elia Ricci, Dr. Monica Pittarello, Dr. Alberico Balbiano di Colcavagno, Dr. Veronica Fess 
  At Hall RENAISSANCE at 8:25 a.m. (CEST) on Monday, September 26, 2016
  
  

• Lasers and Lights in Wound Healing 
  Chair: Dr. Nicola Zerbinati (Italy) 
  Co-Chairs: Dr. Marcello Monti (Italy), Dr. Matteo Tretti Clementoni (Italy) 
  Speakers: Dr. Steven Paul Nisticò (Italy), Dr. Marco Romanelli (Italy) 
  At Hall LEONARDO from 3:45 p.m. to 5:45 p.m. (CEST) on Tuesday, September 27, 2016.

About LumiHeal^TM
The KLOX BioPhotonic LumiHeal^TM is a first-in-class, proprietary, non-thermal and non-invasive treatment solution that harnesses the power of fluorescence in the presence of oxidants to treat serious skin and soft tissue disorders. LumiHeal^TM has received the CE mark for treatment of acute and chronic wounds. It is comprised of a multi-LED light and a topical photo-converter gel comprising light-capturing molecules (chromophores), which is applied on the open wound. The illumination of the topical photo-converter gel with the multi-LED light permits the synergistic effects of oxidants and photons (fluorescence) to control biofilms, initiate healing and reduce pain, in a safe and efficient manner. The treatment duration lasts only a number of minutes and is non-abrasive, non-thermal, and has been reported to be comfortable for the patient.

About KLOX Technologies
Klox is a specialty pharmaceutical company focused on developing and commercializing products based on its proprietary BioPhotonic technology platform to address skin and soft tissue disorders. Klox is advancing its programs as part of its multiple franchises focusing on indications across Dermatology, Wound Care, and Oral Health. For more information and to consult the abstracts, please visit www.kloxtechnologies.com

Forward Looking Statements
Certain statements contained in this newswire, 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 and commercialization 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.

For more information:
Roxanne Chaudier
Hill+Knowlton Strategies
[email protected]
514-375-2725