Adelaide, Australia – Agilex Biolabs, Australia’s most advanced specialist bioanalytical laboratory for clinical trials, congratulated client Zelira Therapeutics on their Phase 2 Medicinal Cannabis Insomnia Study.
Agilex Biolabs, the only FDA-inspected lab of its type in the region, was engaged for the PK analysis work on the study.
Zelira Therapeutics Dr Deborah Cooper,Clinical Operations Director, said working with Agilex Biolabs was an excellent experience.
“Agilex Biolabs have done a great job – no hitches, deviations or delays,” said Dr Cooper.
Announcing the study outcome, Zelira Therapeutics said:
Zelira Therapeutics has achieved a world-first clinical validation demonstrating that its medicinal cannabis drug works for people suffering insomnia.
This paves the way for selling into global markets from the second half of this year including Australia, where the product has already launched and the USA.
The Perth-based company has put its patented medicinal cannabis formulation ZLT-101 (Zenivol™), ingested sublingually, through a Phase 1b/2a clinical trial against insomnia, and seen it pass with flying colours.
“We are delighted as these results have exceeded our expectations,” said Dr Richard Hopkins, Managing Director, ex-US markets, at Zelira Therapeutics.
“Globally we are the first company to take a full-spectrum cannabis product and test it for efficacy in the insomnia space.”
Not only do the results mean that Zelira can launch a product for insomnia, Dr Hopkins said the data – and the clinical validation – from the trial mean that doctors can be confident in prescribing medical cannabis.
Full release here: https://clients3.weblink.com.au/pdf/ZLD/02223052.pdf
Agilex Biolabs CEO Jason Valentine said:
The Agilex Biolabs cannabinoids assay achieves >98% of ISR (Incurred Sample Reanalysis) samples within the acceptance criteria, which demonstrates that it is robust and reproducible.
The FDA and EMA criteria is 67% of samples within 20%.
Agilex Biolabs’ world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.
The company has just expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the New Labs Walkthrough Video Here
Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).
Agilex also offers pharmacodynamics servicesthat include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
- Receptor occupancy
· Cytokine release assays (whole blood or PBMC stimulation assays) and
- PBMC assays and cellular mechanism of action assays (eg: ADCC)
Agilex Biolabs has more than 90 staff including 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year they will analyse more than 60,000 samples for pharma/biotechs companies from US, Europe and APAC.
Biotechs are particularly attracted by Agilex Biolabs’ FDA-inspected status, and the 43.5% rebate on clinical trial spend that applies in Australia.
About Agilex Biolabs https://stagexlab.agilexbiolabs.com/
Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 20 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.
We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.
Agilex Biolabs operates a fully quality-assured laboratory ensuring that, within the principles of GLP, assays are validated to the latest FDA/EMA guidance and study samples are assayed and reported to the sponsor’s desired format using WATSON LIMS. Laboratory certifications include OECD GLP and ISO/IEC17025.
Our highly experienced team consists of over 65 dedicated laboratory staff with >15 years average industry experience across senior scientists. Expertise includes development of robust compliant PK and PD assays de novo or by method transfer.
Our laboratory is fitted with 7 SCIEX tandem mass spectrometers, 6 API 4000 and 1 QTRAP 5500 as our standard platform for LC-MS/MS analysis. For immunoassay, we employ the state-of -the-art systems of Meso Scale Discovery (MSD) and Gyrolab xPlore.
Agilex Biolabs owns a suite of validated biosimilar assays that have already supported biosimilar studies executed in the region. These assays include Avastin/Bevacizumab, Lucentis/Ranibizumab, Actemra/Tocilizumab, Xolair/Omalizumab, Herceptin/Trastuzumab and Solaris/Eculizumab. We would like to discuss how we can support companies with biosimilar pipelines looking to conduct trials in the region. Our validated biosimilar assays require less setup saving time and money.
Agilex Biolabs also have a suite of biomarker assays that have been developed to support studies in the areas of endocrinology (estrone, estradiol, progesterone, testosterone and others).
Recently, Agilex Biolabs has added a comprehensive cannabinoid assay to its suite of validated assays to support clinical trials. The fully validated assay includes the five cannabinoids THC, CBD, CBN and the two THC-metabolites OHTHC and COOHTHC.
Our LC-MS/MS experience includes NCEs, sugars, nucleotides, enantiomers, steroids, prodrugs, peptides, immunosuppressants, nanoparticles, neurotransmitters, oligonucleotides and polymeric mixtures.
Our biologics experience entails PK analysis using colorimetric, fluorescence or chemiluminescence detection for recombinant or fusion proteins, monoclonal antibodies, ADCs, immunogenicity testing, biomarker analysis and PBMC blood stimulation assays.