Parexel issues statement regarding TeGenero clinical trial

Parexel, the medical company conducting the first human trial of TeGenero's experimental treatment TGN1412 said it believes that based on a review of data, "best practices" were followed in the Phase I trial after six healthy volunteers in the UK trial were hospitalised shortly after taking the drug, which is being developed as a treatment for chronic inflammatory diseases and leukaemia. Two of the men remain in critical condition after suffering from multiple organ failure, while the other four have regained consciousness.

The medical company added that its review found that "appropriate policies and procedures were adhered to." The company noted that it is cooperating with the MHRA, which has "not yet provided a timeline for the completion of its inquiry." In a statement, TeGenero indicated that it is "working closely" with both doctors treating the hospitalised patients and the authorities in charge of the investigation. Meanwhile, German prosecutors were considering an investigation into the biotech company. Susanne Stöcker, a spokeswoman for the Paul Ehrlich-Institut which is responsible for licensing trials in the country, remarked that the organisation "was thinking about changing the rules for the first human trials," The Times reports.

Commenting on the news, antibody researcher Professor Sir Gregory Winter said that he believes monoclonal antibody TGN1412 "super-charges" the immune response in the body, The Telegraph reports. Winter added that TeGenero's experimental treatment is "a different sort of antibody" from what is currently available on the market, and it may be a "very potent process" which makes it hard to predict ahead of time "how mild or severe the clinical response is," the same source reports.

Meanwhile, some scientists expressed concern that this trial may affect other antibody research. "It would be disaster if this one very serious incident impeded the development of new antibody therapies for serious diseases such as arthritis and cancer," remarked Professor Chris Higgins of the Medical Research Council, The Telegraph reports.

To read more Top Story articles, click here.