US-based biopharmaceutical company Immune Therapeutics (IMUN) has begun a clinical study of low dose Naltrexone (LDN) in collaboration with the College of Medicine, Malawi, to prevent cervical cancer.
LDN, also known as Lodonal, has been developed as an immune modulator as it enhances levels of endorphins, also known as the peptides formed in the brain and adrenal glands.
It is typically administered at bedtime and clings to opioid receptors in the brain and immune cells, temporarily inhibiting endorphins signals to increase endorphin production.
An increased endorphin production triggers the activity of stem cells, macrophages, natural killer cells, T and B-cells and other immune cells.
The open-label, multicentre study has been designed to evaluate the safety and acceptability of a single-visit approach aimed to prevent cervical cancer.
The single-visit approach involves the visual inspection of the cervix of a woman with acetic acid wash (VIA), and if the results are positive, patients will be treated with immediate cryotherapy of the pre-cancerous lesion.
The study's secondary goal is to evaluate life extension by improving the immunity system of the patients.
Queen Elizabeth Central Hospital in Blantyre OBGYN department head and principal investigator of the trial Dr Frank Taulo said: "Since the beginning of the cervical cancer prevention programme in Malawi, strides have been made regarding scaling up of the screening services and pre-malignant lesions treatment using cryotherapy.
“One of the biggest challenges has been the inadequate cryotherapy medical device.
“The timely donation of ten cryotherapy guns has alleviated this anomaly tremendously. Now several centres are able to treat these lesions."
The trial has been funded by the partnership between the Brewer Foundation and IMUN, and was donated with the Wallach LL100 Cryosurgical system to run the trial and to treat the patients.