Cambridge, MA-based clinical research organization to be responsible for Clinical Trial Site Management and On-Site Monitoring in the United States
CAMBRIDGE, Mass.--(BUSINESS WIRE)--PROMETRIKA (www.prometrika.com), a leading clinical research organization, is collaborating with Karyopharm Therapeutics (Nasdaq: KPTI) to conduct the first randomized clinical trial for low-dose selinexor (XPOVIO®), an XPO1 inhibitor, in hospitalized patients with severe COVID-19.
PROMETRIKA will be responsible for US clinical trial site management and on-site monitoring, ensuring collection of accurate and actionable high-quality data. In total, 230 patients will be enrolled into the trial worldwide.
Karyopharm and PROMETRIKA are working closely with investigators and hospital sites at unprecedented speed to accurately capture the data needed to fast-track early findings. The goal is to add to the body of evidence that XPO1 inhibitors may play an important role in treating people with this life-threatening viral infection.
“COVID-19 has accelerated implementation of innovative remote monitoring and data access strategies,” said Heather Paden, Head of Clinical Operations at PROMETRIKA. "Karyopharm's trial is a critical step toward finding effective medicines for those hospitalized due to severe COVID-19 and the PROMETRIKA team is honored to be a part of such an important study."
“We appreciate this opportunity to further contribute to the tireless and comprehensive efforts of our industry in the search for therapeutic tools to combat this horrible pandemic,” said Miganush Stepanians, Founder and CEO at PROMETRIKA.
About PROMETRIKA, LLC - www.prometrika.com
Founded in 2003 and based in Cambridge, Massachusetts, PROMETRIKA is a leading full-service clinical research organization (CRO). Unique in its industry, the company utilizes a caring and collaborative approach to clinical development and execution. They are a cohesive, highly tenured team that prides itself on senior leadership involvement in all phases of a trial. PROMETRIKA’S services include clinical operations, drug safety, medical monitoring, data management, biostatistics and programming, medical writing, and regulatory strategy and submissions. They have collaborated on thousands of studies and helped a wide range of clients achieve new drug approvals by the U.S. FDA and European regulatory authorities.
About Karyopharm Therapeutics, Inc. - www.karyopharm.com.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) 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.
Deanna Chan, 617-844-0240