Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, today announced 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.
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, Imbriums 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 tinostamustines 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
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.
About Imbrium Therapeutics L.P.
Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new pharmacologic and biologic therapeutics. We are pursuing oncology chemotherapeutics, treatments for disorders of the central nervous system, and non-opioid approaches to the management of pain. As an operating subsidiary of Purdue Pharma L.P., Imbrium strives to develop and bring to market new medicines that serve the unmet needs of patients, physicians and health systems worldwide. We have built a robust and diversified pipeline of investigational drug candidates, and we actively collaborate with industry and academic partners to identify and advance future impactful medicines. For more information, please visit www.imbriumthera.com.
About Mundipharma EDO
Mundipharma EDO is part of the Mundipharma global network of privately-owned independent associated companies, which operate in over 120 countries worldwide. We develop treatments for patients around the world with rare or R/R cancer, investigating smart approaches to new cancer treatments from concept through to clinical development and regulatory approval. We operate a lean, agile research and development model, empowering the team to form conclusions and make quick decisions with the aim of getting new therapies to patients as rapidly as possible. For more information please visit: www.edoncology.com.
About the Mundipharma Network
Mundipharma is a global network of privately-owned independent associated companies whose purpose is to move medicine forward. With a high performing and learning organization that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our European portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.
1 American Society of Hematology. Blood Cancers. Accessed February 28, 2019. Retrieved from https://www.hematology.org/Patients/Cancers/.
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