The data are contained in the extensive Clinical Study Report (CSR) which has been approved by the Company and its providers in compliance with good clinical practice (GCP).
Following the top-level data announced in
Highlights
As reported in
No serious adverse events were observed
Total blood levels of sulforaphane (SFN) and SFN-metabolites were confirmed in the micromolar range, where efficacy is seen in vitro
Additional pharmacodynamic exploratory investigation, utilising mRNA sequencing, showed changes in gene expression after dosing with SFX-01 even in healthy volunteers
In addition to the biomarkers analysed in the study and contained within the CSR, changes in gene expression were measured by mRNA sequencing on participants' blood, for placebo and SFX-01 treated subjects that received 600mg once daily. The initial analysis identified a large number of significant differentially expressed genes in the SFX-01 treated group, between blood samples taken before the first dose was administered (baseline) and blood samples taken after the first dose timepoint (6 hours after first dose). Further analysis will be undertaken on this large and complex dataset to gain insight into the particular genes identified. Further disease-related mechanistic insight will also be provided from future clinical studies in patients.
Dr
'We are sharing this report with our partner
'With this study, we have conducted the most extensive evaluation of sulforaphane and its metabolites in man ever produced in a single study and have done this to a drug regulatory standard, consistent with our business model.'
Dr
'We are very pleased with the results and are eager to move forward to applying the new formulation to future clinical studies using SFX-01.'
Following the successful completion of this study, all further regulatory submissions and clinical trials will be conducted using the new tablet formulation of SFX-01. The new form brings additional patent protection and replaces the previous prototype capsule formulation.
A pharmacokinetic study looks at how the drug is absorbed and circulates in the body, while a pharmacodynamic study investigates how the drug exerts its effects in the body including the biochemical, molecular and physiological mechanisms relevant to disease.
Contact:
Dr
Tel: +44 1625 466591
About SFX-01
Evgen's core technology is Sulforadex, a method for synthesising and stabilising sulforaphane and novel proprietary analogues based on sulforaphane. Sulforaphanes have shown potential benefits in neurodevelopmental disorders, oncology and inflammatory conditions. SFX-01, Evgen's lead asset, is the only stabilised sulforaphane suitable for clinical research and eventual approval as a medicine.
SFX-01 is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. The Company has already completed three trials in patients, including a positive open label trial in metastatic breast cancer using the prototype capsule formulation.
About
The Company's lead asset, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin and has undergone clinical trials for oestrogen-positive (ER+) metastatic breast cancer and recently a Phase 1b study of the Company's new enteric coated tablet formulation. The FDA has granted Orphan Drug status to SFX-01 in malignant glioma. SFX-01 will be investigated initially in this indication as an investigator sponsored study in
The Company also has a wide number of collaborations with leading academic centres in the
The Company has its headquarters and registered office at
(C) 2023 Electronic News Publishing, source