The U.S. Food and Drug Administration has approved human clinical trials to test the safety of the cancer-detection technology developed at Case Western Reserve University: a tumor-targeting contrast agent that accurately detects aggressive prostate cancer on a magnetic resonance imaging (MRI) scanner.
The molecular targeted imaging agent is sold to Molecular Theranostics LLC, a Cleveland-based startup, and its partners US Motek LLC and Jiangsu Motek Pharmaceuticals Ltd. licensed from China.
The agent will undergo a clinical trial at Ohio Clinical Trials Inc. in Columbus under a contract with US Motek. Patient enrollment is expected to begin in early May and the study later in the month.
The imaging agent known as MT218 was invented in the laboratory of Case Western Reserve researcher Zheng-Rong Lu, who has been developing the tumor-specific MRI contrast agent for nearly 15 years.
Molecular Theranostics co-founder Lu and his partners believe the compound could one day enable clinicians to diagnose malignant prostate cancer non-invasively and accurately in a joint MRI scan.
A more accurate MRI scan of prostate cancer – and possibly other cancers – could benefit patients who are sometimes unnecessarily treated with aggressive interventions or, conversely, better identify those in need of the treatments, said Lu, M. Frank Rudy, and Margaret Domiter Rudy Professor for Biomedical Engineering at the Case School of Engineering.
We are very excited about this Phase 1 clinical trial as our research product is currently in clinical development to help people. Our agent has a promise to detect the aggressive solid tumors to provide imaging guidance for precise health care for cancer patients. “
Zheng-Rong Lu, Fall Western Reserve Researcher
Key to making this more accurate diagnosis of the tumor is the use of Lu’s patented gadolinium-based MRI contrast agent, which binds to a molecular marker called extra-domain B-fibronectin, a cancer-associated subtype of fibronectin.
The gadolinium agent is a paramagnetic substance that can improve the MRI signals of aggressive tumors to improve the accuracy of cancer diagnosis.
The clinical trials at Motek are investigating whether the active ingredient can be safely administered to humans – the first step in clinical development to detect tumors in patients, as has been successfully done in animal models, said Lu. The study participants are expected to be 30 healthy black and white men between the ages of 18 and 55, he said.
A second trial is being conducted to test the drug’s effectiveness in detecting aggressive tumors and differentiating the types of tumors, Lu said.
Lu’s patented technology was jointly developed by Molecular Theranostics and its affiliates (US Motek LLC and Jiangsu Motek Pharmaceuticals Ltd). Jiangsu Motek Pharmaceuticals announced FDA approval in March.
Current prostate tests
Prostate cancer is the most common non-skin cancer in the United States: one in eight men nationwide will be diagnosed with prostate cancer at some point, according to the Prostate Cancer Foundation.
MRI provides high-resolution, three-dimensional tissue images and is often used to diagnose prostate cancer.
However, current technologies – particularly MRI contrast agents added to tissues to reveal tumors – are limited. An inaccurate diagnosis can result in a tumor being either over- or under-treated, Lu said.
Representatives from Jiangsu Motek Pharmaceuticals said “the gold standard” for the clinical diagnosis of prostate cancer is a 12-needle puncture biopsy guided by rectal ultrasound. However, sampling errors in the biopsy – and the fact that different tumor levels can coexist in the prostate – can lead to a false-negative diagnosis rate of up to 30%, according to the company.
On the other hand, extensive blood tests for prostate cancer and a subsequent biopsy can sometimes lead to overdiagnosis and overtreatment. This over-treatment can lead to serious infections, as well as reproductive and urinary side effects, Lu said.
“That’s why it’s so important,” said Lu. “Research shows that only 20% of diagnosed patients develop aggressive tumors – we could save the other 80% from aggressive over-treatment.”
Source:
Case Western Reserve University
