WPD Pharmaceuticals Contracts Clinigen Clinical Supplies Management to Perform QP Certification of Berubicin for the Clinical Trials Authorization
(firmenpresse) - Vancouver, British Columbia - January 14, 2020 - WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the Company or WPD) a clinical-stage pharmaceutical company, is pleased to announce that it has signed a contract with Clinigen Clinical Supplies Management (Clinigen), a leading clinical supply management business, to provide critical services during the Berubicin phase 2 adult and phase 1 pediatric clinical trials which are scheduled to start in February 2021 and May 2021, respectively.
For nearly half a century, Clinigen has built a reputation as one of the most trusted specialty logistics company in the world through its unsurpassed knowledge, global reach and flawless supply chain execution. Clinigens global supply chain facility and depot network combines market-leading clinical trial services such as comparator sourcing, packaging and labelling with biological sample management. Clinigen delivers tailored solutions for clients globally to ensure clinical trials are a success, regardless of size or scope, from Phase I to Phase IV Trials.
For WPDs trials, Clinigen will cover Qualified Person (QP) services for ensuring and confirming that the Berubicin clinical product has been manufactured in accordance to the European Union Good Manufacturing Practice (EU GMP) standards. Clinigen will also be responsible for packaging and labeling of the Investigational Medicinal Product (IMP), storage in accordance with the product specification and release of the IMP to clinical sites in accordance to Good Distribution Practice (GDP). QP certification of the IMP is crucial to obtain approval of the Regulatory Authority and to initiate the clinical trials. WPD aims to conduct the clinical trials with the highest quality and in compliance with the applicable EU regulations and all applicable requirements including GMP. The services provided by Clinigen are expected to last up to 3 years.
Mariusz Olejniczak, CEO of WPD commented, We are very pleased to cooperate with Clinigen in the upcoming Berubicin trials. Clinigen has significant global experience in the Qualified Person services and clinical supply management and we are sure that Berubicin IMP authorized to the clinical trials and given to the patients will be of the highest quality. Clinigen is an important part of the framework and strategy we are building to execute on the successful trials for Berubicin.
About Clinigen Clinical Supply Management
Since 1997, Clinigen Clinical Supplies Management has offered a dynamic range of fully integrated services to meet the complex clinical supply challenges pharmaceutical and biotechnology companies face. Part of the Clinigen Groups global supply chain facility and depot network, it combines market-leading clinical trial services such as comparator sourcing, packaging and labelling with biological sample management. Clinigen Clinical Supplies Management delivers tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.
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, WDP Pharmaceuticals
Contact:
Investor Relations
Email: investors(at)wpdpharmaceuticals.com
Tel: 604-428-7050
Web: www.wpdpharmaceuticals.com
Cautionary Statements:
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 anticipates will or may occur in the future. Forward-looking statements in this press release include that the Berubicin phase 2 adult and phase 1 pediatric clinical trials will start in February 2021 and May 2021, respectively. and that WPDs drugs could be developed into novel treatments for cancer. These forward-looking statements reflect the Companys current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected. Factors which may prevent the forward looking statement from being realized is that our timing may be delayed for clinical trials for any number or reasons; competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs dont provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; 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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Datum: 14.01.2021 - 07:33 Uhr
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