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 has launched a pilot safety study to support a Medical Device License application, for a low optical-power hand-held light, the KPTL-10 (manufactured by sister company, 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.) A secondary endpoint of accelerated wound healing will also be evaluated.
Enrollment for this clinical trial was negatively impacted by the COVID-19 pandemic. We have currently stopped enrollment at 30 patients to analyze and write up an interim study report. Illumacell expects that a follow-up study incorporating oral 5-ALA in addition to light for antimicrobial will be initiated in the near future.
Illumacell has focused its clinical cancer applications of Photodynamic Therapy (PDT) in collaboration with local physicians and the Health Canada Special Access Program (SAP) for medical devices. This program allows health care professionals to obtain an unlicensed device to exclusively treat a patient on compassionate grounds, or when conventional therapies have failed, are unavailable, or are unsuitable.
Two patients, one with breast cancer and spinal metastases and the other with advanced pancreatic cancer with liver and spleen involvement are currently in the early stages of 5-ALA-photodynamic therapy using the Illumacell PTL-1000 prototype light device. Each has declined standard treatment in favour of photodynamic Therapy (PDT) with weekly and biweekly treatment regimens. No measures of clinical or biochemical response are currently available.
Encouraging results will open the door to larger clinical trials of specific cancers, necessary for North American regulatory approvals.
Illumacell intends to conduct a Photodynamic Therapy (PDT) trial with systemically-administered photosensitizer precursor drug 5-ALA for advanced skin cancers that are deeper and pose a technical challenge for current light devices. While superficial cancers can be successfully treated with topically-applied photosensitizers and PDT, successful treatments for patients suffering from deep, invasive skin tumors are severely lacking. These patients are currently treated palliatively and often remain in significant pain, have to undergo limb amputation, or battle metastatic cancer.
Alongside a network of nationally recognized dermatologists in the Toronto area and in collaboration with Health Canada, Illumacell is currently developing PDT cancer studies for advanced skin cancers that are deeper and pose a technical challenge for current light devices and therapies.