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A to Z of MS Goat serum

Product name

Aimspro

Aimspro is the brand name of an experimental product derived from the serum of goats that have been inoculated with a number of vaccines so as to develop antibodies to a range of diseases. Serum is the liquid component of blood, in which the blood cells, clotting agents and other cells are suspended.

Aimspro was initially put forward as a treatment for HIV/AIDS. Researchers thought the strong anti-inflammatory properties of the goat serum could be beneficial in MS.

Research

There is currently no peer reviewed published evidence of efficacy or long-term safety for this treatment.

Aimspro was initially given, by weekly injection, to people with MS by a GP in Kent as an experimental treatment. Data gained from these patients suggested a significant clinical improvement and this information was used to help obtain approval for two double-blind, randomised, placebo-controlled trials in the UK.

There have been two small trials of Aimspro in the UK. The first, at St George's Hospital in London, involved 40 people with secondary progressive MS who were able to walk, but who had seen a significant decline over the past year. This trial was halted at the manufacturer's request in March 2005 following a dispute with the hospital about storage of the drug.

The trial at the John Radcliffe Hospital in Oxford recruited 12 people who had some continuing loss of vision following earlier optic neuritis. Participants were on active treatment for two weeks. Researchers found that the two main outcome measures of the trial, looking at the effect on vision, were negative. A third outcome measure, the effect on visual field size, showed transient improvement in people on Aimspro. However, this effect was not significantly different from that seen in people taking a dummy placebo. The drug was well tolerated and no serious side effects were observed during the short course of the trial.

In March 2008, Daval International, the manufacturer, announced that recruitment for a double-blind placebo-controlled cross-over study of the effect of Aimspro on bladder function in people with secondary progressive MS was complete. There is no indication of the length of this study or when the results will be published.

Being prescribed Aimspro

Aimspro is not licensed in the UK and its availability is based on a 'specials' licence. The Medicines and Healthcare Products Regulatory Agency (MHRA), the body that licenses drugs in the UK, ensures that products are manufactured and supplied lawfully. For unlicensed products such as Aimspro, there are exemptions that allow for the supply subject to certain conditions to people who have clinical needs that cannot be met by licensed medicines.

Prescription is on a named patient basis, which allows a doctor to prescribe an unlicensed drug to an named patient based on that individual's clinical needs. Supply has to be arranged by the doctor and the manufacturer on an individual basis. Funding for named patient prescriptions may or may not be accepted by the local primary care trust or health board.

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