A clinical trial validating Telo-HL‘s usefulness in determining the risk of relapse in Hodgkin’s lymphoma (HL) is underway, Canada’s 3D Signatures announced.
This is Stage 3 of Telo-HL’s validation program. Both Stage 1, the assay development component, and Stage 2, the assay validation, were completed on schedule.
Telo-HL is powered by the Toronto-based company’s proprietary TeloView diagnostic technology platform, which analyzes changes in telomere structures within DNA to determine aspects and characteristics of deadly diseases like HL.
Telomeres are the caps at the end of each strand of DNA that protect chromosomes, and that work much like the plastic tips at the end of a shoelace. The purpose of Telo-HL is to stratify HL patients into non-relapsing and relapsing patients, so that relapsing patients can select other therapies besides standard chemotherapy when starting their treatment.
No biomarker can yet predict response to chemotherapy among these patients or help physicians in guiding treatment decisions on an individual basis.
The trial, to analyze 400 to 480 retrospective HL patient samples matching the targeted prognostic criteria for Telo-HL, should end by September. Researchers will evaluate six different TeloView parameters in order to develop a statistical scoring model from data gathered during the study. That will establish which patients are both at high positive risk and high negative risk; the aim is to determine Telo-HL’s accuracy in predicting a patient’s risk of relapse within one year.
The company hopes Telo-HL can help HL patients who seek personalized therapies, and to save money for patients and insurers who are paying for expensive treatments that may be unnecessary if patients are eligible for targeted, effective therapies.
“We are now that much closer to an effective biomarker for Hodgkin’s lymphoma,” Jason Flowerday, CEO of 3D Signatures, said in a press release. “I am particularly proud of our laboratory team. They hit the ground running at our new facility in Toronto just a few weeks ago. Their dedication to the validation program has been exceptional.”
