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09.09.2020
WPD Pharmaceuticals Engages Worldwide Clinical Trials as CRO for Phase 2 Berubicin Trials

Vancouver, British Columbia / September 9, 2020 – WPD Pharmaceuticals Inc. (“WPD” or the “Company”) (CSE: WBIO) (FSE: 8SV1), 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

 

‘Mariusz Olejniczak

 Mariusz Olejniczak

CEO, WPD Pharmaceuticals 

 

Contact

 

Investor Relations

Email: investors@wpdpharmaceuticals.com

Tel: 604-428-7050

Web: www.wpdpharmaceuticals.com

 

Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

 

This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company can develop effective drugs against cancer and possibly viruses; and that Phase II clinical trials of Berubicin will be undertaken by WCT; that we will be reimbursed 60% of the Phase II trials costs; that Berubicin may be designated as an orphan drug; and that Berubicin could be effective in treating Glioblastoma. Factors which may prevent the forward looking statement from being realized include that our supply of compounds for testing may not be sufficient for our needs; lack or funds, permits, subcontractors or other factors may delay our plans; competitors or others may successfully challenge a granted patent and the patent could be rendered void; we may be unable to raise sufficient funding for our research; we may be unable to expend sufficient funds on research to keep our sublicense rights; our grant and other applications may not be successful or if successful, we may not meet the requirements to receive the grants awarded; that our drugs don’t provide positive treatment, or if they do, the side effects are damaging; and competitors may develop better or cheaper drugs; our plans may be delayed; we may not be able to get commercial quantities of our drugs made; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com.  Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate.  Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.



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