Inclinix to boost recruitment for US Diamyd vacc trial

By Gareth Macdonald

- Last updated on GMT

Related tags: Clinical trial, Insulin

Diabetes focused drugmaker Diamyd Medical has called in CRO Inclinix Medical to help recruit patients for “rapidly expanding” late-stage trials of its candidate diabetes vaccine Diamyd.

The vaccine, which is designed to preserve insulin production in patients with type-1 diabetes, demonstrated statistically significant efficacy in Phase II studies in 70 children suffering from the condition.

The ongoing Phase III trial programme, which to date has recruited a total of 640 children and adolescents with recent onset type-1 diabetes, consists of parallel studies in Europe and the US.

Inclinix has been contracted to accelerate recruitment for the US study, which is currently being expanded from 13 to 43 trial sites in pediatric diabetes clinics nationwide as part of Diamyd’s “Diaprevent” programme.

North Carolina-based Inclinix which used to operate as PharmaTech Solutions, provides recruitment, qualification and retention services through its InSite Screener and Patient Tracker systems which, it claims, can accelerate the process.

Diamyd CEO Elisabeth Linder explained that the contract is performance based, with recruitment timelines being designed to enable the firm to seek US Food and Drug Administration (FDA) marketing approval sometime in 2011.

Tobin Geatz, Inclinix’ CEO, said: “We look forward to the opportunity to contribute to the development of the Diamyd vaccine and thereby make a truly global impact on the pediatric medical community​."

Seeks Industrial partner

Earlier this month Diamyd said that it will carry out a rights issue of 3.1 million new shares later this month in a bid to raise SEK220m (€21.6m) to finance the Phase III programme expansion.

The firm is also said that the funds will “strengthen [its] negotiation position in the ongoing process to find an industrial partner​” for Diamyd, but did not disclose any further information.

The US and European market for a treatment for newly diagnosed young type 1 diabetes patients is estimated to be worth more than $1bn (€686m).

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