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 (Nasdaq: KPTI) to help conduct the first global randomized clinical trial for low dose selinexor (XPOVIO®), an XPO1 inhibitor, in hospitalized patients with severe COVID-19.
| 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 (Nasdaq: KPTI) 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 About Karyopharm Therapeutics MEDIA CONTACT:
SOURCE Precision for Medicine, Inc. | ||
Company Codes: NASDAQ-NMS:KPTI |
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