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Critically ill men in drug trial continue to improve

London Susan Mayor

One of the two men left critically ill by a phase I trial of a new monoclonal antibody almost two weeks ago is improving, says the latest statement released by the hospital caring for him.

The statement, from the critical care department at Northwick Park Hospital, London, said, “The two volunteers have each made improvements since last week. One is in a serious condition. The other is still critical but we are pleased with his progress since last week. However, we remain cautious as his condition is still complex.” Staff said they were unable to comment further without breaching patient confidentiality.

The hospital said that the four other men involved in the trial were continuing to make a good recovery. “They continue to receive specialist care and observation, but have been discharged from critical care. They remain in hospital and are working on regaining their strength and mobility, and are making good progress with both,” the statement said.

All six men were healthy volunteers who became seriously ill after being given the antibody TGN1412 in a phase I trial carried out at a privately run research unit on the hospital campus (BMJ 2006;332:683, 25 Mar)

A statement from the company running the trial, Parexel, said that the Medicines and Healthcare Products Regulatory Agency (MHRA) was “continuing inquiries of the various parties involved with the compound developed by TeGenero, but has found no reason to recommend the discontinuation of trials at Parexel’s phase I unit.”

Parexel added that the company’s internal quality assurance department had completed a preliminary audit “which continues to support that the protocol approved by the MHRA and the ethics committee was adhered to properly, and that best practices and policies and procedures were correctly followed.”

On 20 March, Boehringer Ingelheim confirmed that it was the manufacturer of the agent that was being studied in the clinical trial. A statement posted on the company’s website said that a review of the manufacturing documentation and the pharmaceutical release procedure had confirmed that the material supplied by them to TeGenero complied with all relevant requirements.

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