The clinical trial component of 3D Signatures’ (OTCQB:TDSGF; TSXV:DXD; FSE:3D0) Hodgkin's lymphoma test (Telo-HL) validation program is under way. This process is referred to as Stage 3 of the validation program.
Assay development and assay validation, Stage 1 and Stage 2 of the validation program, respectively, were completed on schedule. The clinical trial is expected to be complete by Sept 30, 2017.
Powered by the company's proprietary TeloView software platform, Telo-HL stratifies HL patients at the point of diagnosis into non-relapsing and relapsing patients. Relapsing patients may then be considered for alternative treatments at the time of diagnosis rather than waiting until they have failed multiple rounds of standard chemotherapy. There is currently no biomarker available that can predict patient response to standard chemotherapy in HL patients.
The clinical trial involves the analysis of 400-to-480 retrospective HL patient samples that match the targeted prognostic criteria for Telo-HL. The sample size is expected to provide robust data for expert statisticians to assess six different TeloView parameters relative to clinical outcome data and develop and finalize a statistical scoring model to predict patient risk profiles.
The company expects Telo-HL to benefit patients seeking personalized treatment while also providing significant cost savings to payers and insurers that are currently burdened with expensive treatments and procedures that may not be necessary if patients could be considered for more targeted and effective therapies at the outset.
"We are now that much closer to an effective biomarker for Hodgkin's lymphoma," Jason Flowerday, CEO, said in a statement.