Allergy Therapeutics PLC
11 July 2007
11 July 2007
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")
Clinical Development Update
Allergy Therapeutics announces that clinical activity on its Pollinex Quattro
clinical studies has been placed on clinical hold by the FDA whilst the agency
fully assesses the report of a rare adverse event classified by the physician
involved as 'possibly related' to the study drug.
The Company is collaborating fully with the FDA and has provided extensive data,
both as part of the trial routine and supplementary data, including independent
expert assessment. Allergy Therapeutics has also reviewed all the data
available to it concerning this adverse event, considers that it is unlikely
that the event was caused by the study drug and is urgently working with the FDA
to provide any additional information necessary to address and resolve FDA's
concerns.
Allergy Therapeutics has two ongoing Pollinex Quattro studies: Phase III Grass
(G301) and Phase III Ragweed (R301), and has two about to commence/recommence:
the Grass safety study (G302) and a Phase II Tree study (T204). Of these only
R301 is directly affected as it is the only trial in the treatment phase.
A full update will be provided as soon as the FDA gives material information on
the results of its review.
Keith Carter, Chief Executive of Allergy Therapeutics, said:
"The FDA has a difficult job to do in minimising risk to patients, both on
clinical trials and from marketed pharmaceuticals. It is normal that they
should exercise caution. We believe the evidence strongly supports the view
that the event was unlikely to have been caused by Pollinex Quattro and we are
seeking urgent clarification of the FDA's position."
There will be a conference call for analysts at 11.00am.
Please dial +44 (0)20 7138 0843 to access the call.
For further information
Allergy Therapeutics +44 (0) 1903 845 820
Keith Carter, Chief Executive
Tom Holdich, R&D Director
Bridgewell +44 (0) 20 7003 3000
Shaun Dobson
Financial Dynamics +44 (0) 207 831 3113
Ben Brewerton
This information is provided by RNS
The company news service from the London Stock Exchange
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.