Allergy Thera. Regulatory News (AGY)

9 Jun 2008 07:00



Monday 9 June 2008

Pollinex® Quattro data presented at European Academy of Allergology and Clinical Immunology meeting

Largest ever global study shows ultra-short course allergy vaccine is safe and highly efficacious

Study met its primary efficacy endpoint

Further to the announcement made on 14 May, Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company focused on allergy vaccination, presented further details of its Pollinex Quattro Grass Phase III study, G301 at the European Academy of Allergology and Clinical Immunology meeting on Sunday 8 June 2008. The data was presented by the Lead Investigator of the United Kingdom sites, Professor Anthony Frew, Professor of Allergy and Respiratory Medicine at the Brighton and Sussex Medical School.

Study G301 examined the safety and efficacy of Pollinex Quattro in the treatment of seasonal allergic rhino-conjunctivitis ("SAR") caused by grass pollen. G301 was a double-blind, placebo-controlled study comparing the symptom plus medication score of patients given four injections of Pollinex Quattro to those patients receiving placebo. The trial enrolled 1,028 patients at 84 centres in the United States, Canada and Europe. The study met its primary efficacy endpoint and demonstrated that Pollinex Quattro has statistically significant clinical benefits over placebo. Furthermore, the data show that the product is effective for both moderate and severe SAR sufferers, is effective during both the peak and the entire pollen season, and improves the quality of life of the patients.

Key results presented include:

In the Intent To Treat population (all patients in the study) there was a 13.4% improvement with Pollinex Quattro over placebo in efficacy during the four peak pollen weeks of the season (p = 0.0038).

In the prospectively defined patient population who fully recorded key outcomes, there was a 26.9% improvement with Pollinex Quattro over placebo in the same efficacy endpoint (p = 0.0031).

Patients with severe SAR treated with Pollinex Quattro versus placebo experienced a statistically significant 17.1% improvement in the same efficacy endpoint (p = 0.0023).

In the Intent To Treat population (all patients in the study) there was a statistically significant 12.0% improvement with Pollinex Quattro over placebo in efficacy during the entire pollen season (p = 0.0093).

Patients treated with Pollinex Quattro versus placebo experienced a statistically significant improvement in Quality Of Life during the pollen season (p = 0.01513).

In all cases the percentage improvement with Pollinex Quattro over placebo in the prospectively define patient population who fully recorded key outcomes significantly exceeded that of the Intent To Treat population.

The treatment was well tolerated with almost every patient completing the course of injections (95.3% on Pollinex Quattro versus 97.9% on placebo).

Very few patients discontinued the study due to adverse events (1.4% on Pollinex Quattro versus 0.8% on placebo).

There was no difference in patient withdrawals from the study due to serious adverse events (0.2% on Pollinex Quattro versus 0.2% on placebo). 

During each of the four injections, the majority of patients on Pollinex Quattro suffered no adverse events (in each of the four injections, in order, 64.8%, 65.3%, 62.9% and 70.2% patients experienced no adverse events).

Adverse events were mainly related to local area site reactions and were generally mild and transitory.

Allergy Therapeutics intends to use the results to support a Marketing Approval Application in the European Union with a submission planned for Q1 2009. Allergy Therapeutics believes that Pollinex Quattro has the potential to transform the treatment of allergy, changing the lives of patients and providing an important new tool for the specialists who treat them. The worldwide market for allergy treatments is estimated to be in excess of $10 billion.

Current therapeutic options are mainly limited to symptomatic therapies and/or conventional allergen immunotherapy which can require up to 90 injections in over three to five years. These long dosing regimes represent a significant treatment and economic burden for allergy sufferers.

Dr Lawrence DuBuske, Consultant in Allergy, Brigham and Women's Hospital, Harvard Medical School and Principle investigator for G301, said: 

"G301 is a landmark study clearly demonstrating the high efficacy of a four injection immunotherapy regimen for grass pollen induced allergic rhinitis. There is no other study in the literature which both includes over 1,000 subjects and shows such indisputably strong benefit compared to placebo. This study unequivocally positions Pollinex Quattro at the forefront of advances in the treatment of allergic diseases."

For further information

About the G301 study

Study G301 was a double-blind placebo-controlled study conducted in 94 centres in the United States, Canada and Europe. A total of 1,028 patients were recruited into the study and randomised to receive Pollinex Quattro Grass or placebo. Patients were scheduled to receive 4 injections of either Pollinex Quattro or placebo treatment over three weeks prior to the 2007 grass pollen season. Patients recorded rhino-conjunctivitis symptoms and medication intake over the course of the pollen season from May to September. The primary outcome of the study was the difference in combined symptom plus medication score between active and placebo treatment over the four peak pollen weeks of the season assessed in the whole ('Intent-To-Treat') study population. 

About Pollinex Quattro

Pollinex Quattro is a four injection therapeutic vaccine for the treatment of allergic conditions which offers same season relief in as little as three weeks after treatment. It is a family of specific standardised vaccines representing a potentially extensive franchise for Allergy Therapeutics and is a novel entrant in the multibillion dollar global allergy market. It is currently available in Europe on a named patient basis.

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® and Cervarix®.

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 100,000 patients is available from the sale of 'named patient' products in Europe.

About Seasonal Allergic Rhino-conjunctivitis

Seasonal allergic rhino-conjunctivitis is commonly referred to as hayfever when it is caused by pollen. It is a widespread disease that usually occurs during the pollen season. It is characterized by sneezing, rhinorrhea, nasal congestion and pruritus of the nose, eyes or throat. It is a type I hypersensitivity response in which allergen binds to immunoglobulin E on the surface of mast cells. This response leads to the release of histamine, prostaglandins and leukotrienes, which cause inflammation, itching and redness.

Datamonitor has estimated that prevalence rates for allergic rhino-conjunctivitis of 15% to 25% are to be found in Europe with grass identified as the most significant allergen. IMS estimates that sales in 2006 of allergic rhino-conjunctivitis therapies were in excess of $10 billion in the seven major global markets.

About Allergy Vaccination

Allergy vaccination or immunotherapy is an effective way of modifying or avoiding disease by influencing the immune system. It is essentially a reinforcement of the body's own defence mechanisms and is similar to preventative vaccination against infectious disease; an area of medicine that has met with spectacular success. In allergy vaccination the mechanism is regarded as a correction of the immune system towards a more normal, non-allergic, response.

Allergy vaccination attacks the underlying cause of the problem and provides a patient benefit which is usually long lasting. The World Health Organisation recognises allergy vaccination as the only treatment to target the immunological cause of allergy with the ability to modify disease progression, decreasing symptoms in the short term and offering long term anti-inflammatory benefits which prevent the development of persistent disease. Allergy vaccination, therefore, has the potential of offering patients a cure for their disease.

About Allergy Therapeutics

Allergy Therapeutics plc is a London Stock Exchange (AIM) listed specialist pharmaceutical company focused on allergy vaccination. It has a growing, profitable core business achieving sales of allergy vaccines of £26 million in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure. The Company is expanding its infrastructure and recently commenced operations in the United Kingdom, Poland, the Czech Republic, Slovakia and Austria.

Allergy Therapeutics has certain exclusive intellectual property rights to the use of MPL in both injected and sublingual vaccines. In addition to progressing to Phase III studies with Pollinex Quattro, the Company has completed a Phase I/II oral vaccine study incorporating MPL.