The Company's key strategies were, and remain as follows: (i) to manufacture and deliver natural psilocybin in the form of a prescription drug known as KRN-101 to trial centres, and (ii) to initiate Real World Evidence (RWE) trials, including all necessary partnerships, to lead to a regulatory approved medication for treating anxiety and depression, initially in cancer patients.
The Company has made substantial progress, in spite of an economic environment that has presented widespread challenges to financial markets and business operations across all sectors.
Some of the most significant milestones that have been achieved by the Company over the last 6-months include:
Albert Labs International Corp. listing on Canadian Securities Exchange (CSE)- Filing US Provisional Patent for standardised and scalable manufacturing of natural pharmaceuticals, including KRN-101
Established Pre-Clinical Advisory Board , chaired by globally-renowned toxicology expert, Dr Ricardo Dinis-Oliveira
- Granted Health Canada Licence for production, sale (through the Special Access Programme) and export of Schedule 1 substances
- Successful technology transfer, procurement and implementation of pre-clinical programme at Schedule 1 analytical and toxicological laboratory in
Porto, Portugal - RWE Clinical Trial protocols written (with partners at the
University of Manchester ,Christie Hospital , andNational Cancer Research Institute ) for the study of KRN-101 as a treatment for cancer-related distress, includingAlbert Labs' psychotherapy protocols
- Ethical approval received for
Albert Labs' pre-clinical programme for KRN-101 toxicology studies at laboratory inPorto - Professor
Sara Tai appointed as Lead Clinical Researcher for RWE Clinical Trial, Senior Clinical Psychology Professor at theUniversity of Manchester
- Mike Thompson MBE, former CEO of the Association for the British Pharmaceutical Industry (ABPI) and Senior Vice-President of Commercial Strategy at GSK Global, and
Katie Shelton-Innes , experiencedUK growth company finance expert, appointed to Board of Directors
- New International PCT Patent Application (No. PCT/CA2022/051281) filed for proprietary manufacturing method, providing industry-leading levels of scalable and consistent natural Psilocybin-based pharmaceuticals
- Successful technology transfer and implementation of KRN-101 manufacturing process and quality assurance procedures ready for pre-clinical studies at laboratory in
Porto
October 2022:
- Received Good Laboratory Practice (GLP) accreditation for pre-clinical programme allowing for submission of pre-clinical data to global regulatory authorities (including MHRA, EMA and FDA)
In the near future, the Company will continue work on:
- The completion of KRN-101 toxicology studies to GLP standards, ready for CTA, and available for licensing and Special Access Programmes;
- Third-party validation (to Good Manufacturing Practice standard) of KRN-101 data for Clinical Trial Application (CTA);
- Pre-CTA MHRA Scientific Advice Meeting
- Partnership negotiations to extend clinical research into further regulatory jurisdictions
Dr.
A key differentiator for
"Developing and refining our standardised, "quality-regulated" API production process is a major accomplishment, and the additional time we took resulted in a robust production process with additional intellectual property potential," said
The Company has also been working on expanding its market access programme.
"We feel that the strategy of parallel tracking work toward both
Through collaborations with research institutions, hospital centres and government agencies,
The company's goal is to deliver effective medicines to suffers with mental health concerns in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.
You can find more details about
ON BEHALF OF THE BOARD OF DIRECTORS
Dr.
Chief Executive Officer, Chairman
This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.
The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.
Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.
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