Inclusion and exclusion criteria, as their names suggest, are used to determine who can and who cannot take part in a clinical study. The idea is to control for potential variables that could bias the results of the research.
Usually things like weight and genetic make-up or previous disease history and age are used to decide whether a person can take part or must be excluded, with specific criteria set out in protocols agreed before the research begins.
It is less common for a person’s willingness to eat meringue to be a deciding factor, which is why we had a few questions for TxCell when we noticed just such a requirement in the protocol for a trial of its Crohn’s disease treatment, Ovasave.
Beating Crohn's with meringue
A TxCell spokeswoman told us the insistence participants eat meringue is less about ensuring they are well nourished than about ensuring the high tech cell therapy product is delivered to the site of flare ups.
“Ovasave is composed of autologous ex-vivo expanded ovalbumin-specific Treg cells. The immuno-modulating activity of Ovasave depends on the local recognition of ovalbumin-specific Treg cells with ovalbumin within the inflamed gut lesions.”
She added that: “In order to ensure during the clinical development of Ovasave that ovalbumin will be present in an adequate and standardised quantity in patient's gut, patients are asked to eat a meringue once a day during the treatment period. The provided meringue are standardised in weight and ovalbumin content.”
The study in question – code named CATS9 – was temporarily halted last year after French regulator ANSM raised concerns about TxCell’s manufacturing facility in Besacon where trial supplies of Ovasave were made.
TxCell has since hired specialist CMOs in Belgium and the US - MaSTherCell and PCT, respectively, - and announced its intention to restart the trial this year.
Delivery tech
TxCell said that although meringue is good enough for trial stage development, it is working on a more traditional way of delivering Ovasave.
“Meringue can be standardise per manufacturing which is easier and guarantee high load of ovalbumin in the gut. Basically, any egg containing foods would be able to trigger Ovasave properties.
The spokeswoman added that: “TxCell does not anticipate the need of meringue delivery in late stage clinical trials and approval.”