Selinexor study is the first exploration of an XPO1 inhibitor in patients with severe viral infections
MANSFIELD, MA (June 24, 2020) – eClinical Solutions LLC, a leading global provider of cloud-based enterprise software and software-driven clinical data services that accelerate drug development, is collaborating with Karyopharm Therapeutics (Nasdaq: KPTI) on randomized clinical trials for low-dose selinexor, an XPO1 inhibitor, in hospitalized patients with severe COVID-19. This is the first study of an XPO1 inhibitor in patients with severe viral infections. XPO1 inhibitors like selinexor (marketed as XPOVIO®) have previously shown preclinical activity against respiratory viruses, including SARS-CoV.
“The eClinical Solutions team is extremely motivated by the opportunity to contribute to finding new therapies that may treat COVID-19,” said Raj Indupuri, CEO of eClinical Solutions. “We are proud to partner with Karyopharm to support rapid data collection, cleaning and review for this program. The way they use modern technologies in clinical research to optimize data collection and analysis demonstrates their dedication to innovation not only in scientific research, but throughout the clinical development process.”
The eClinical Solutions Data Services team configured the data capture system for the trial using Medidata Rave EDC and the elluminate Clinical Data Platform for agile data management and review. The Karyopharm and eClinical Solutions teams collaborated closely to build a fully validated data database to collect data from physicians and patients in just 15 days—an accelerated timeline in order to meet the first patient milestone of this critical research initiative. The eClinical Solutions data management team is using elluminate Data Central to support data review activities for the study to ensure data is rapidly cleaned and available for medical and safety review.
“eClinical Solutions has been a valuable partner on other selinexor research programs. Their team’s knowledge of Karyopharm data standards and processes combined with their expertise in data collection platforms and clinical data management practices helped us meet our accelerated timelines for this important new research,” said Kristan Gallitano, SVP Development Operations at Karyopharm Therapeutics.
About eClinical Solutions
eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® platform provides life sciences companies with greater control of their clinical trial data. elluminate software and data-driven services have been used by more than 100 life sciences companies on more than 1000 trials. eClinical Solutions has worked with Karyopharm since 2015 to tech-enable a simplified data flow and help produce high quality data for more than 10 studies, including 5 database locks that provided the data for the July 2019 FDA approval of Karyopharm’s lead compound XPOVIO® (selinexor). Learn more about eClinical Solutions and Karyopharm in this Case Study. For more information visit eclinicalsol.com.
About Karyopharm Therapeutics, Inc.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is an innovation driven 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. Food and Drug Administration (FDA) in July 2019 in combination with dexamethasone as a treatment for patients with heavily pretreated multiple myeloma. In addition to single-agent and combination activity against a variety of human cancers, 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. For more information, please visit http://www.karyopharm.com.