The trial is now up and running...

"We at Laxdale follow with great interest all that is posted on the HD Lighthouse Website. We thought you would like to know about the LAX-101 trial.

The trial is now up and running at centres in the UK, USA, Canada and Australia. Recruitment for the trial is expected to complete in the near future. The treatment lasts for 12 months in each patient. Only when the last patient has completed the study will the code for all the patients be broken so that the statisticians can identify which patients are on LAX-101 and which are on placebo. Because the trial is double blind neither we nor any of the investigators will know what is happening until the code is broken and all the results are analysed. We expect that it will be a few months before all the data can be collected from all the centers and fully analysed, so that it will be in 2003 before we finally know what has happened. We will then submit the data to the FDA and to regulators in other countries and also to a medical journal for publication. The full results will not be made public until they have been published in a medical journal.

Please understand that this has to be a careful and thorough process. This trial is being conducted by some of the world's leading investigators in Huntington's Disease and it is intended to be large enough to give a definitive answer one way or the other as to whether LAX-101 works. It is our intention that the evidence collected should be strong enough to persuade regulators, governments and insurance companies that LAX-101 should be provided to all patients who might benefit.

Without doing this sort of study we could end up with a treatment that works but which is not available to most patients because those who must approve it and pay for it are not convinced by the evidence. We hope that everyone will understand what we are trying to do."

All of us at Laxdale, and at our US partner Amarin, continue to work as rapidly and effectively as possible to bring LAX-101 forward. We appreciate the support and goodwill you have shown us thus far and will continue to work to earn it in the future.

All the best,

David Horrobin
==============
Laxdale Ltd, Kings Park House, Laurelhill Business Park, Stirling FK7 9JQ, Scotland.
Tel: + 44 (0)1786 476000
Fax: + 44 (0)1786 473137
e-mail: admin@laxdale.co.uk

Source: Crispin Bennett, PhD Research Information Manager 30-May-2001

	Read the HDAC/HDLighthouse Forum. Post your comments