Illumacell’s light devices are designed to provide unparalleled depth of penetration and to elicit a phototoxic effect in target tissues. Scientific literature indicated that typical red light devices emitting at 635 nm wavelengths have limited penetration to 1 cm.
Illumacell has demonstrated ex vivo that our LED red light devices can deliver light energy to penetrate multiple layers of animal tissues. A subsequent study in a mouse model of breast cancer showed that light penetrating a 4-cm barrier of swine non-lactating, mammary tissue (closely resembling human) was capable of inducing tumour regression. This observation suggested the exciting potential of Illumacell’s 5-ALA PDT for cancer therapy at depth.
To advance our clinical program in clinical applications of light therapy, Illumacell completed a pilot safety study to support a Medical Device License application, for a low optical-power hand-held light, theKPTL-10 (Kerber Applied Research Inc. of Hamilton). A Health Canada Investigational Testing Authorization was approved for a 60-person phototherapy trial in patients with diabetic and venous leg ulcers at the Chinook Regional Hospital in Lethbridge, Alberta. (www.clinicaltrials.gov NCT04300205.)
Enrollment for this clinical trial was negatively impacted by the COVID-19 pandemic. Enrollment was stopped at 30 patients to analyze and write up an interim study report. Illumacell is designing a follow-up study to treat chronic leg ulcers with the antimicrobial action of 5-ALA-PDT.
Health Canada’s Special Access Program allows physicians to use unapproved medical devices in special circumstances. Under the authority of this program, Illumacell arranged for the treatment of a late-stage breast cancer patient. Dr. Ginette Laverdiere was responsible for the weekly treatments that were conducted with Illumacell assistance. Illumacell PDT treatments significantly reduced the patient’s chronic pain and a much higher quality of life was provided. Scans were conducted at the Juravinski Cancer Centre in Hamilton ON which confirmed the elimination of several spinal metastases.
Recognizing a clinical unmet need for patients, and enthusiastic support from dental surgeons in California, Illumacell is currently focused on the treatment of aggressive oral leukoplakia which is one of many types of Oral Premalignant Disorders (OPMDs). Oral leukoplakia’s typically progress into squamous cell carcinomas and aggressive lesions respond poorly or insufficiently to antibiotics and the alternative is undesired physical resections. The Illumacell PTL-1000 light device readily shines sufficient light energy through the cheek and is an exciting PDT option for the treatment of OPMDs. This non-invasive light treatment, from outside the cheek into the oral cavity, exposes the base of the lesion; an approach that’s unattainable by current light technologies. Importantly, our PDT approach allows the patient to avoid gruesome and scarring surgical options. Illumacell’s value proposition for dental surgeons is a recurring treatment/revenue model with improved clinical outcome for the patient from a cosmetic perspective.
Dr. Joel Epstein is a leading onco-dental surgeon in Beverly Hills. He has agreed to be the Principal Investigator for an Early Feasibility Study for OPMDs as he strongly believes Illumacell addresses the unmet clinical needs of his patients. Illumacell is working closely with CDER, a division of the FDA and the study proposal approval is pending.
