Commencement of Pollinex(R) Quattro Grass Dosing.
- Category: Vaccines
- Published on Monday, 29 January 2007 02:00
- Hits: 4494
LONDON, UK | Jan 23, 2007 | Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company focused on allergy vaccination, announces that it has dosed the first patient in its pivotal Phase III grass allergy trial. This international trial will be undertaken at approximately 96 centres in 4 countries and will involve enrolment of over 1000 patients. The majority of patients will be recruited in the United States.
Pollinex Quattro is an ultra-short course vaccine requiring only four shots over three weeks and incorporates the TLR4 agonist adjuvant MPL(R). In contrast, existing vaccine treatments typically require between 16 and 50 injections taken under specialist supervision prior to the start of the hayfever season. Pollinex Quattro therefore has the potential to transform allergy treatment by providing a safe, effective and highly convenient method of vaccination. The Company has three programmes of Pollinex Quattro allergy vaccines in clinical development: Grass, Tree and Ragweed.
The primary objective of this double blind, randomised trial is to compare the efficacy of Pollinex Quattro Grass versus placebo.
The trial design and endpoints have been approved by regulatory bodies including the Food and Drug Administration in the United States. This single trial, if successful, is suitable for registration in both the United States and Europe, with a Biologics License Application ('BLA') planned for the first half of 2008.
A similar Phase III trial is planned for Allergy Therapeutics' Pollinex Quattro Ragweed allergy vaccine in the 2007 ragweed pollen season.
Evidence of the safety and efficacy of Pollinex Quattro has been established through earlier clinical trials in Europe. Furthermore, substantial exposure data in more than 87,000 patients is available from the named patient programme in Europe.
The market opportunity is considerable with the American Academy of Allergy, Asthma and Immunology estimating that 33 million allergy injections a year are given in the United States. Allergic rhinitis (hay fever) is a large and growing problem. Prevalence estimates vary on a country by country basis but range from 14-29% of the total population*. Worldwide over 150m people are estimated to suffer from allergic rhinitis and the prevalence is increasing*. There is a substantial unmet medical need in a market currently worth an estimated US$12 billion per annum.
* Decision Resources Allergic Rhinitis June 2005
Keith Carter, Chief Executive of Allergy Therapeutics, said:
'Today's announcement represents another step towards Allergy Therapeutics' aim of developing patient friendly, highly-effective treatments for hay fever sufferers worldwide. It is a significant trial, involving a large number of patients and, as the pollen season window is relatively short, we are already actively recruiting patients to participate in the study.
'This is the first registration trial for an allergy vaccine ever undertaken in the United States, which is a significant achievement for a company of our size. Achieving this milestone underlines the quality of our earlier work and the substantial safety data which underpins the entire Pollinex Quattro pipeline.'
Dr Lawrence DuBuske, Consultant in Allergy at Brigham and Women's Hospital of Harvard Medical School, said:
'We are very excited to be a participating site in what we hope to be a landmark trial by Allergy Therapeutics. The trial could potentially demonstrate that Toll Like Receptor activation together with modified allergen administration can provide both rapid and safe symptom relief for patients with seasonal grass allergy. This large trial harnesses recent advances in our understanding of the mechanisms of modulation of immune responses and its success could provide the basis for the first new allergen-specific therapy for allergic rhinitis in the United States.
'The requirement for only four pre-seasonal injections to achieve benefit from this treatment could lead to a substantial increase in the number of allergy sufferers who will consider allergen specific immunotherapy as a desirable treatment option.'
For further information
Allergy Therapeutics +44 (0) 1903 844 722
Keith Carter, Chief Executive
Financial Dynamics +44 (0) 207 831 3113
About Pollinex Quattro
There are three programmes of subcutaneous immunotherapy in clinical development; Pollinex Quattro Grass, Pollinex Quattro Ragweed & Pollinex Quattro Tree, all of which are based on proprietary technologies. Collectively these form the 'Caution: Allergen' programme. Pollinex Quattro Ragweed is currently under review by Health Canada. In addition, an oral vaccine development is completing its first phase II study.
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). 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)
About Allergy Therapeutics plc
Allergy Therapeutics plc is a UK AIM-listed specialty pharmaceutical company focused on allergy vaccination. It has a profitable core business achieving sales of allergy vaccines of over £24m in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure.
SOURCE: Allergy Therapeutics plc