-- First Study of an XPO1 Inhibitor to Treat Patients with Severe Viral Infections
-- Precision for Medicine Responsible for Clinical Trial Management in Europe
BUDAPEST, Hungary, April 22, 2020 /PRNewswire/ -- Precision for Medicine, a pioneer in the design, development and execution of biomarker-informed clinical studies and complex data management, is collaborating with Karyopharm Therapeutics to help conduct the first global randomized clinical trial for low dose selinexor (XPOVIO®), an XPO1 inhibitor, in hospitalized patients with severe COVID-19.
Precision for Medicine will oversee implementation of the clinical trial in Europe. The countries planning to participate in the study and where sites will be located include the United Kingdom, Italy, France, Spain, Germany, and Austria. Precision will be responsible for ensuring site engagement, obtaining regulatory and clinical governing authority approvals, documentation preparation, as well as collecting and monitoring data. In total, 230 patients will be enrolled into the trial.
"As companies race to explore new therapeutic solutions to fight COVID-19, clinical trials will be challenged with aggressive timelines, the need to adhere to evolving protocols and guidelines, and the use of advanced technologies for data collection and monitoring," said Katerina Kaleova, MD, Medical Director, Precision for Medicine. "Karyopharm and Precision for Medicine, working with regulatory authorities, investigators, hospital sites, and local laboratories, are preparing to quickly and accurately capture the data needed to accelerate early findings that can add to the increasing evidence that XPO1 inhibitors could play an important role in treating people with life-threatening viral infections."
The COVID-19 pandemic has rapidly changed clinical and regulatory environments requiring flexibility and commitment to align on new processes in order to achieve successful outcomes. Working with Karyopharm to engage and address authorities' comments during the trial review stage, the companies were able to achieve in just days what normally takes many months for the launch of a global randomized clinical trial.
"COVID-19 has accelerated innovative strategies, remote monitoring technologies and data access in an effort to discover effective treatments to combat the coronavirus," said Chad Clark, president, Precision for Medicine. "Karyopharm's trial is a critical step toward finding treatment solutions for those most severely affected by COVID-19."
"This latest alliance with Precision for Medicine builds on the successful submission and Food and Drug Administration (FDA) approval for XPOVIO® (selinexor)," said Karyopharm Chief Development Officer Ran Frenkel. "We have also collaborated on successful phase II and phase III clinical trials in haemato-oncological malignancies, as well as trials in therapeutic areas such as multiple myeloma, diffuse large B-cell lymphoma and acute myeloid leukemia."
About Precision for Medicine Precision for Medicine is the first biomarker-driven clinical research services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Precision applies novel biomarker approaches to clinical research that take advantage of the latest advancements in science and technology, focusing predominantly on genomics, immune-response assays, specimen logistics, biomarker analytics, companion diagnostics, and global clinical trial execution. Precision for Medicine is part of Precision Medicine Group, with 2000 people in 35 locations in the U.S., Canada, and Europe. For more information, visit www.PrecisionForMedicine.com [https://c212.net/c/link/?t=0&l=en&o=2783186-1&h=1404895637&u=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fpfm&a=www.PrecisionForMedicine.com].
About Karyopharm Therapeutics Karyopharm Therapeutics Inc. is an oncology-focused pharmaceutical company dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO(®) (selinexor), received accelerated approval from the U.S. FDA in July 2019 in combination with dexamethasone as a treatment for patients with heavily pretreated multiple myeloma. A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency. A supplemental New Drug Application was recently accepted by the FDA seeking accelerated approval for selinexor as a new treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. Visit www.karyopharm.com [https://c212.net/c/link/?t=0&l=en&o=2783186-1&h=1943013202&u=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DWr4KwFc77qKOPO_wt1ceEWsV6I7ZeDBsBwBQY0-NiKtjZp0VSjAw2ynNFWbNSTdoY9SZ5DRkQF_6uEgqxGecnhQeCNQJETi9g5bbWg3pIyA%3D&a=www.karyopharm.com].
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