Contract research news in brief

pharmafile | October 6, 2009 | News story | Research and Development CRO 

Pharmafocus' periodic round-up of developments in the contract research sector includes contracts awarded to Inclinix, Foranep and Phase Forward and capital investments by TFS and Pharmatek.

Sweden's Diamyd has turned to US contract research organisation (CRO) Inclinix Medical to accelerate recruitment into its phase III trial of its vaccine for patients with type 1 diabetes, with a view to being in a position to file for approval in the USA in 2011. Inclinix will help Diamyd expand its US trial from 13 to at least 43 sites. The Diamyd vaccine is designed to preserve insulin production by delaying the progressive autoimmune destruction of pancreatic beta cells that is a feature of type I diabetes.

Foranep Pharma, a French CRO specialising in the neurosciences, has won a contract from Swiss biopharmaceutical firm Anavax Life Sciences to carry out phase I trials of ANAVEX 2-73, a candidate drug for Alzheimer's disease. Foranep will perform study setup, protocol review, site monitoring, and project management for the trials. ANAVEX 2-73 is a sigma-1 receptor agonist and has been shown in preclinical testing to be neuroprotective, as well as preventing memory deterioration.

Swedish CRO TFS Trial Form Support International, which has operated a clinical research unit at the Karolinska Institute since 2003, has just signed a deal to extend the public private partnership until 2016. The agreement will also see the size of the unit extended with an additional 850 sq. m. of space and 16 overnight beds, bringing the total to 30. The unit specialises in first-in-man, proof-of-concept, microdosing and imaging studies and is now the largest facility of its type in Northern Europe.

Pharmatek International has invested in a machine that can dispense active pharmaceutical ingredients (API) directly into capsules in order to enhance its ability to supply medications for use in early-stage clinical trials. The Xcelodose unit, developed by Pfizer subsidiary Capsugel, can dispense doses as low as 100mcg into capsules, and can reduce the time-to-clinic and the cost of drug product in trials. The machine is due to be validated by the middle of this month.

Hungarian pharmaceutical company Gedeon Richter has taken out a multi-year license to Phase Forward's clinical trial management system (CTMS) Clintrial. The software is used to collect, manage and review clinical data and is used by more than 200 life sciences companies around the world.

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