WPD Pharmaceuticals Inc., a clinical stage pharmaceutical company, is pleased to announce that is has engaged world-renowned Contract Research Organization (“CRO”), Worldwide Clinical Trials (“WCT”) to coordinate and supervise Phase 1 and 2 clinical trials on its Berubicin drug candidate.
Berubicin is a new drug and one of the first anthracyclines proven to cross the blood-brain barrier to reach brain tumors. The discovery and further development of Berubicin can potentially extend the clinical use of anthracyclines to brain tumors, specifically Glioblastoma, an aggressive type of cancer that can occur in the brain or spinal cord .
WCT is a global CRO providing full-service drug development services to the pharmaceutical and biotechnology industries from Early Phase and Bioanalytical Sciences through Phase II and III trials to peri-approval studies. WCT offers clients expertise in neuroscience, cardiovascular, inflammation, rare disease, oncology and other therapeutic areas. They manage clinical trials across nearly 60 countries in North America, Latin America, Europe, Asia Pacific and Middle East.
WCT will provide research services, implementation of start-up activities, organization and development for clinical trials being conducted by WPD in adult and pediatric populations with Glioblastoma, according to international standards of good clinical practice (ICH GCP) and other applicable regulatory requirements. These requirements include safety management, pharmaco-vigilancem and data management. WCT will also support WPD’s application for orphan drug designation, which if successful, has filing fee savings and other benefits.
60% of the program budget will be refunded by a grant already awarded to WPD by The National Center for Research and Development based in Poland under the European Union’s Smart Growth Operational Program.
About WPD Pharmaceuticals
WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.
WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things. The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes for most compounds 30 countries in Europe and Asia, including Russia.
On Behalf of the Board
CEO, WPD Pharmaceuticals