On March 5, 2019 Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, reported that they have enrolled the first patient in the expansion stage of a Phase 1/2 clinical trial of tinostamustine, an investigational treatment, in patients with relapsed refractory (R/R) hematologic malignancies in the U.S. and Europe (Press release, Imbrium Therapeutics, MAR 5, 2019, View Source [SID1234533974]).
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Following a dose escalation trial to establish tolerability, this expansion phase seeks to investigate the overall response rate, duration of response and safety of five cohorts of patients with R/R cancers, including: multiple myeloma, Hodgkin lymphoma, peripheral T-cell lymphoma, cutaneous T-cell lymphoma and T-cell prolymphocytic leukemia. Each study arm will run separately, with results to be submitted for upcoming medical meetings.
"The initiation of the expansion arms of this Phase 1/2 trial is a significant step for our work in oncology as we pursue important treatment options for people living with these types of devastating cancers," said Paul Medeiros, president of Imbrium Therapeutics. "We look forward to continue building on the foundation of safety data generated in the dose-escalation portion of the trial as we advance the development of tinostamustine as a potential therapy for people with limited treatment options."
Craig Landau, MD, president and CEO, Purdue Pharma L.P., added, "This milestone underscores our continued commitment to improving the lives of patients with cancer and leveraging our capabilities in science and medicine to develop more effective therapies. We are creating a strong pipeline of potential medicines to help us achieve this mission."
In addition to tinostamustine, Imbrium’s clinical stage oncology portfolio includes etoposide toniribate, a novel prodrug with a target cell-activated topoisomerase inhibitor. Imbrium is currently collaborating in research for four drug candidates across 14 different cancer types. Research on these compounds is being advanced on behalf of Imbrium by Mundipharma EDO.
"We are excited to see the first patient enrolled in the tinostamustine expansion study in patients with hematologic malignancies, a group of difficult-to-treat cancers," said John Renger, PhD, vice president, Head of Research & Development and Regulatory Affairs, Imbrium Therapeutics. "Preclinical data suggest tinostamustine’s dual mechanisms of action may improve access to the DNA strands within cancer cells, both through breaking the strands and also counteracting the cancer cells’ attempt to repair the DNA damage."
Imbrium Therapeutics, in collaboration with Mundipharma EDO GmbH, expects to continue enrollment in the Phase 1/2 trial. To learn more about the trial, please visit clinicaltrials.gov.
About Hematologic Malignancies
Hematologic malignancies are forms of cancer in the cells of blood-forming tissue or in the cells of the immune system. Examples of hematologic cancer are acute and chronic leukemias, lymphomas, multiple myeloma and myelodysplastic syndromes. In most blood cancers, the normal blood cell development process is interrupted by uncontrolled growth of an abnormal type of blood cell. These cancerous cells prevent the blood from performing many of its functions.1
About Tinostamustine
Tinostamustine is an alkylating deacetylase inhibiting molecule (AK-DACi) in development for a range of rare or difficult-to-treat blood cancers and solid tumors. It is a multi-action therapy and is currently in Phase 1 clinical trials. Pre-clinical studies with tinostamustine as monotherapy have shown response, in myeloid and lymphoid malignancies and solid tumors.