Novotech Selected As CRO For Karyopharm's COVID-19 Clinical Study

he 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 randomised, 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.

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