Denovo Biopharma announced today that the FDA has granted DB102 the IND clearance to proceed for a phase III trial to treat Diffuse Large B Cell Lymphoma in the US (ENGINE Study).
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| [24-October-2017] |
| SAN DIEGO, Oct. 24, 2017 /PRNewswire/ -- Denovo Biopharma, a leader in precision medicine, announced today that the US Food and Drug Administration (FDA) has granted DB102 the Investigational New Drug application (IND) clearance to proceed for a phase 3 trial to treat Diffuse Large B Cell Lymphoma (DLBCL) in the US (ENGINE Study). The ENGINE study was also recently approved by China Food and Drug Administration (CFDA). DB102 (enzastaurin) had not demonstrated satisfactory efficacy in prior clinical studies, however after Denovo applied its unique biomarker platform, a novel predictive genetic biomarker, DGM1 (Denovo Genomic Marker 1), for DB102 was discovered. The DGM1 positive patients exhibited improved overall survival compared to DGM1 negative patients in the DB102 treatment group across multiple studies. In particular, DB102 demonstrated significantly improved efficacy when combined with R-CHOP in treating high risk (IPI >=3) DLBCL subjects when compared to those treated by R-CHOP alone. Based on this encouraging finding, Denovo filed IND’s in both US and China for a global Phase 3 study to evaluate the safety and efficacy of enzastaurin plus R-CHOP as the first line treatment for high risk DLBCL patients who possess DGM-1. “Despite advances in novel therapies being developed to treat lymphoma, high risk (IPI>=3) DLBCL remains an unmet medical need and there are barely any clinical trials that specifically target this group of patients as front-line therapy,” said Dr. Wen Luo, CEO of Denovo. “We are very pleased with the acceptance of our phase 3 trial in both US and China, as it allows us to evaluate this innovative biomarker guided treatment as a potential new option to treat high risk DLBCL patients who are seeking a more effective therapy.” About DB102 DB102 (Enzastaurin) is an orally available investigational small molecule, serine/threonine kinase inhibitor of the PKC beta and AKT pathways and has been studied in more than 3,000 patients across a range of solid and hematological tumor types. DB102 was originally developed by Eli Lilly and for which Denovo has acquired worldwide rights. Enzastaurin received orphan drug designation in DLBCL and (Glioblastoma) GBM from the FDA and EMA. About Denovo Biopharma LLC Denovo Biopharma is a biopharmaceutical company providing novel biomarker approaches to personalized drug development, including re-evaluating medicines that have failed in general patient populations. The company offers the first platform and algorithm for de novo genomic biomarker discovery using archived clinical samples. By identifying biomarkers correlated with patients’ responses to drug candidates retrospectively, Denovo Biopharma enables the design and execution of follow-on clinical trials in targeted patient populations while optimizing efficacy, safety and tolerability. For additional information please visit www.denovobiopharma.com. For more information on the enzastaurin Phase 3 study, visit CONTACT: info@denovobiopharma.com
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