Allergy Therapeutics PLC
04 July 2006
Allergy Therapeutics plc, "Allergy Therapeutics" or "the Company"
Successful end of Phase II meeting with FDA - Allergy Therapeutics to proceed
with Phase III development of Pollinex Quattro
Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company
focused on allergy vaccination, announced today that the Company has concluded
a successful end of Phase II meeting with the Food and Drug Administration (FDA)
in the United States for its ultra short course grass pollen allergy vaccine
Pollinex(R) Quattro ('Grass MATAMPL').
Following a broad ranging review of Pollinex Quattro's preclinical,
manufacturing and clinical data, and, subject to minor clarifications, the FDA
has accepted the Company's plans to conduct a single pivotal Phase III trial for
registration of Pollinex Quattro Grass.
With a clear understanding of the path to achieve the regulatory submission, the
Company will now finalise preparations for a randomized, placebo-controlled,
double-blind study to confirm the efficacy of Pollinex Quattro in patients with
seasonal allergic rhinitis due to grass pollen exposure. Dosing of patients is
expected to commence in Q4 2006.
Evidence of the safety and efficacy of Pollinex Quattro has been established
through earlier clinical trials in Europe and is further supported in clinical
practice via the named patient use of the vaccine in over 74,000 patients.
Keith Carter, Chief Executive Officer of Allergy Therapeutics, said:
"We have been working with the Agency for nearly two years and share the aim of
making a standardized and rigorously tested allergy vaccine available for health
care professionals in the US."
"The market opportunity is vast, with the American Academy of Allergy Asthma and
Immunology estimating that 33 million allergy shots a year are given in the
United States alone."
Tom Holdich, Director of R&D said:
"This is an important milestone for the Company and follows two years of United
States focused development. The FDA's rigour and expertise are renowned and we
are pleased that their independent review of the technology and the development
programme has been achieved. A successful outcome of this Phase III trial will
open the door for Pollinex Quattro to become the first registered, next
generation allergy vaccine in the US.
"Pollinex Quattro has been designed to address the major unmet needs in allergic
rhinitis and , if confirmed, its therapeutic profile is truly transformational
compared with current treatments."
-ends-
For further information, please contact:
Allergy Therapeutics plc
Keith Carter, Chief Executive Officer +44 (0)1903 845 820
Bell Pottinger
Dan de Belder / Emma Charlton +44 (0)20 7861 3232
About Pollinex Quattro
There are three programmes of subcutaneous immunotherapy in clinical
development. The three programmes are Pollinex Quattro Grass, Pollinex Quattro
Tree & Pollinex Quattro Ragweed, all of which are based on proprietary
technologies. Preparations for initiating all three Phase III developments
later this year are well underway and collectively these form the "Caution:
Allergen" programme. In addition there is an oral vaccine development currently
in phase II development.
Pollinex Quattro vaccines contain three distinct technologies which act
synergistically. Natural allergens are chemically modified to improve safety
and allow for delivery of higher doses. These are combined with a depot
technology to provide prolonged desensitization and further improved
tolerability. Finally, the immune response is specifically enhanced and
directed by an adjuvant, monophosphoryl lipid A (MPL) (R). MPL is a Toll-Like 4
Receptor (TLR4) agonist and has been extensively tested in Pollinex Quattro and
other late stage and registered vaccines including GlaxoSmithKline's Fendrix(R)
and Cervarix(R).
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.