Well, we have just about had enough this week. First Tysabri gets pulled, and now Aimspro (also known as goat serum) has apparently halted their trial currently underway on SPMS patients. A cryptic message on Aimspro's website claims that the trials at St. George's Hospital in London were stopped because of "concerns regarding hospital implementation of agreed product handling protocols." This came as "a result of frequent breaches of the agreed protocol for conducting the trial on the part of the Hospital."
Quite frankly, our guess is as good as yours as to what in the world that might mean. Some honest guesses: The hospital was mishandling the drug delivery (not likely, as if a hospital cannot administer a drug correctly, who can?), or more likely, the hospital was not observing the blinding of the trial (placebo vs. therapy)? All conjecture at this point.
What we do know are the following:
1) This trial is now delayed indefinitely
2) The therapy is still being made available to the patients in the halted trial... presumably a good sign.
Pardon our humanity, but we feel we have all earned enough "karma" this week to have some sort of outrageous scientific breakthrough by the end of this month...
Please click "read more" to see the full (and mysterious) release...
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Full Press Release
Daval halts trial over hospital protocol concerns.
A statement from Daval International: 2.3.05
With the completion of one successful trial at the Radcliffe Hospital Oxford, Daval International brought the trial for secondary progressive multiple sclerosis at St George’s Hospital in London to a halt because of concerns regarding hospital implementation of agreed product handling protocols.
On Tuesday 1st March 2005 Daval International’s lawyers wrote to St George’s Hospital instructing St George’s to bring the trial to an immediate halt. This was as a result of frequent breaches of the agreed protocol for conducting the trial on the part of the Hospital.
Daval International have advised St George’s Hospital that their multiple sclerosis patients affected by this decision should contact Daval International to discuss their continuing access to Aimspro.
The decision by Daval International to halt the trial was taken with regret and only after extensive consultation. The other treatment programmes being undertaken by the company are unaffected.
