3D Signatures Inc. is pleased to announce that a preliminary third-party analysis of the trial data for Telo-HLTM, 3DS' test in development for Hodgkin's lymphoma (HL), shows that the Company's TeloViewTM platform is able to distinguish, with a high degree of statistical significance, multiple differences between a patient group that responds to standard ABVD chemotherapy, and a group that relapses or is refractory to treatment within the first 12 months.
Telo-HLTM is intended to provide clinicians with the first biomarker to identify the 15% - 20% of new HL patients who will likely fail standard chemotherapy, and who should immediately be considered for more advanced treatment or inclusion into clinical trials to access emerging treatments such as immunotherapies.
3DS has established a clinically-compliant methodology for application of its TeloViewTM process to diagnostic Hodgkin lymphoma biopsy samples, employing more sensitive imaging technology than its previous HL trials. Specimens from over 400 HL patients (who were subsequently treated with ABVD) were processed for this trial, from four contributing hospital sites across Canada and Europe. The 3DS three-step process was applied, comprising a wet lab co-immuno-telomeres FISH assay, 3-dimensional imaging (with identification of 30 Hodgkin and 30 Reed-Sternberg cells), followed by TeloView(TM) software analysis.
The multi-parametric telomeric analysis with TeloViewTM was performed by 3DS (blinded to patient status), and the results were then shared with statistical partner BioStat Solutions Inc. ("BSSI"), who compared the TeloViewTM data with the corresponding clinical outcomes for patients, and identified highly significant group differences across multiple TeloViewTM parameters.
"BSSI is excited to be collaborating with 3DS, helping them ensure the quality of the data being used is to the highest standards, and that they are poised to deliver the best possible analysis of this predictive technology for HL treatment," said Ronald L. Bromley, CEO of BioStat Solutions, Inc.
"We believe that these results from the application of our TeloViewTM platform to Hodgkin's lymphoma are so strong, the Company will now even more confidently proceed with developing the final scoring model for its Telo-HLTM test to predict response at the individual patient level," said Jason Flowerday, CEO of 3D Signatures. "This is great news for the Telo-HLTM program, and we remain on track to complete all phases of the test development and analytical validation by April 2018."
The Company intends to submit the completed test development and validation work to a highly reputable clinical journal for publication in the latter half of 2018.
"This trial builds on the foundational work done in Dr. Sabine Mai's academic laboratory to establish 3D telomere profiling as a novel biomarker platform. We see this as a new genomic stability testing paradigm applicable broadly across clinical trial research and laboratory medicine", says Dr. Kevin Little, CSO of 3D Signatures.
Powered by 3DS' proprietary TeloView(TM) software platform, Telo-HL(TM) is intended to provide clinicians with the first set of biomarkers that will distinguish between patients that will respond to standard ABVD chemotherapy, and the 15% - 20% of patients who will fail standard chemotherapy and be refractory or relapse within the first year. The Company expects Telo-HL(TM) to benefit patients seeking personalized treatment and to provide significant cost savings to payors 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 of treatment.