Imagion Biosystems enters clinical development stage of HER2 breast cancer detection reagent; in vivo study in 2019
During the remainder of 2018 Imagion expects to have the nanoparticles tested for safety and toxicity, initiate production of a second batch of material for the initial human research study and seek regulatory and institutional approval for the human research study.
Cancer detection innovator Imagion Biosystems (ASX: IBX) has announced it will proceed to clinical development of a nanoparticle test reagent designed to enable early identification of HER2 cells in the lymph nodes of breast cancer patients.
The company said it had successfully optimised the formulation and its manufacturing partner would begin production of the first batch to be used in toxicology tests later this year.
The tests are a pre-requisite to Imagion’s planned first-in-human clinical study in early 2019.
Speaking at the company’s annual general meeting in May, executive chairman Robert Proulx said the HER2 reagent – used with Imagion’s MagSense bio-imaging detection technology – provides a “whole new way” of detecting tumours in breast cancer patients without the use of ionising radiation.
“It will be safer for patients and less expensive than invasive biopsy procedures,” he said.
“The business opportunity is immense.”
How MagSense works
MagSense technology employs a very low applied magnetic field when compared to traditional magnetic resonance imaging (MRI).
It is also reported to be biologically-safe and non-toxic, unlike PET (positron emission tomography) scans or xrays which expose patients to radioactivity.
Imagion said breast cancer patients would receive an intravenously-injected dose of HER2 magnetic nanoparticles, which would be left to circulate within the body and find cancer cells.
The bio-specific antibodies on the nanoparticles would cause them to stick to the specific tumour being targeted, and patients would then undergo scanning by ultra-sensitive detectors to locate and quantify the tumours.
A non-invasive alternative
Despite technical advances in science and medicine, cancer continues to be one of the leading causes of mortality worldwide.
Many cancers are asymptomatic until the later stages of development, and current imaging methods are unable to differentiate benign from malignant, nor are they sensitive enough to detect small tumours.
Breast cancer is the second-leading cause of cancer-related deaths in women and the second most common cancer diagnosed, with approximately 20% of primary tumours being identified as HER2-positive.
Breast cancer diagnosis
Mammograms also cannot differentiate benign from malignant tumors, resulting in high false positives in breast cancer diagnosis and causing unnecessary biopsy procedures.
Current methods of detecting cancer metastasis in sentinel lymph nodes near the breast are also invasive, involving biopsies for pathology testing.
MagSense technology by comparison, is non-invasive and reported to be more sensitive than current medical imaging with its ability to differentiate benign from malignant tumours.
It is tumour-specific and eliminates the need for surgeries, with residual benefits including reduced overall healthcare costs and improved quality of life for patients.
At mid-afternoon trade, shares in Imagion were steady at $0.088.