The Asia-Pacific’s largest specialist biotech CRO Novotech has been engaged for a Phase 2 COVID-19 study by biotech sponsor Karyopharm Therapeutics Inc.
The Phase 2 randomized, open-label, multicenter study will evaluate the activity and safety of two regimens of low dose oral selinexor in patients with moderate or severe COVID-19 (NCT04355676). This is the second selinexor study in COVID-19 being initiated by Karyopharm and is expected to enroll 80 patients.
Novotech will manage the Asia-Pacific region for the study, which will include several sites in Australia and Malaysia.
XPOVIO(R) (selinexor), was approved by the U.S. FDA in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma.
Karyopharm Therapeutics Chief Development Officer Ran Frenkel said:
“We have quickly mobilized our team to activate clinical trial sites globally and we are pleased to be working with Novotech on this important initiative. Novotech was appointed for their local regulatory and site knowledge, extensive infectious disease clinical research experience, and outstanding track-record in the Asia-Pacific region”.
Novotech Chief Executive Officer Dr. John Moller said:
“Novotech is well positioned to partner with Karyopharm on this drug trial and we look forward to this collaboration. Novotech has exceptional relationships with sites and KOLs throughout the region, and we have processes in place to accelerate COVID-19 trials. The regulatory authorities and ethics committees in the region are fast tracking review processes, and sites have adapted quickly to the new environment.”
Demand for clinical research in the Asia-Pacific is on the rise. The number of clinical trials initiated by biotechnology companies in Asia-Pacific since the beginning of March is about 10% higher than in the United States according to GlobalData.
About Novotech – https://novotech-cro.com
Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific. Novotech has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotechnology companies. Novotech was established in 1996, with offices in 11 locations across the region, and site partnerships with major health institutions.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management.
Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
For RFP enquiries: Please fill out the form available at https://novotech-cro.com/talk-to-an-expert
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427
About Karyopharm Therapeutics
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(R) (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.