05.03.2019 – 14:31
The expansion stage seeks to establish the overall response rate (ORR), duration of response (DR) and safety of five patient cohorts
Mundipharma EDO GmbH, part of the Mundipharma global network of independent associated companies, today announced that the first patient has been enrolled in the expansion stage of a Phase I/II clinical trial of tinostamustine in patients with relapsed/refractory (R/R) haematological malignancies in the US and Europe which they are conducting in conjunction with Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P.
Following the successful completion of the dose-escalation phase to determine the safety, tolerability and recommended Phase II dose, the expansion stage seeks to establish the ORR, DR and safety of five cohorts of patients with R/R cancer, specifically: multiple myeloma (MM), Hodgkin lymphoma (HL), peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and T-cell prolymphocytic leukaemia (T-PLL). Each study arm will run separately, with results announced as they become available.1
Tinostamustine is an alkylating deacetylase inhibiting molecule that, in preclinical studies, has been shown to improve drug access to the DNA strands within cancer cells, break them and counteract damage repair.2-4 Preclinical studies suggest that these complementary and simultaneous modes of action have the potential to overcome resistance.4,5
Lead study investigator Dr Owen O'Connor, Columbia University Medical Center, commented: "Initial results in the dose-escalation phase of the study have been promising and our aim now is to establish the efficacy and safety of the treatment in cancer types for patients with very limited treatment options, either because their cancer is rare or is not responding to other treatments."
Dr Thomas Mehrling, CEO of Mundipharma EDO added: "This is an important milestone for both Mundipharma EDO and tinostamustine. Our focus as a company is on areas where we can bring benefit to cancer patients with significant unmet need and we, in conjunction with Imbrium Therapeutics, are excited to progress this compound."
1. clinicaltrials.gov/ct2/show/NCT02576496 2. Lo?pez-Iglesias. Blood 2014;124:(21) 3. Lo?pez-Iglesias. 15th International Myeloma Workshop. 2015. Rome, Italy 4. Di Filippi, et al. ASH. 6 December 2015 5. Yan, et al. Cancer Research 2012;72(Suppl 1):Abstract 2741
Original content of: Mundipharma International, transmitted by news aktuell