Date: 2013-02-25
Type of information: Results
phase: 2
Announcement: results from the follow-up phase 2 study
Company: Circassia (UK)
Product: ToleroMune® cat allergy Vaccine
Action
mechanism: The ToleroMune® allergy treatment is based on an approach of using synthetic peptides identified from allergens to induce immune tolerance in the body by generating regulatory T-cells which suppress allergic responses.
Disease: cat allergy
Therapeutic area: Allergic diseases - Immunogical diseases
Country: Canada
Trial
details: Circassia conducted the double-blind phase II study in Toronto, Canada, where investigators randomised 202 cat allergy patients to receive either four or eight standardised doses of ToleroMune treatment, or placebo.
To determine the effect of the therapy, the volunteers systematically recorded their nasal and ocular allergy symptoms, both before and after treatment, whilst exposed to aerosolised cat allergens in a validated environmental exposure chamber.
Latest
news: * On February 25, 2013, Circassia, a speciality biopharmaceutical company focused on allergy, has announced results from its follow up phase II clinical trial with its cat allergy vaccine ToleroMune®. Patients saw a sustained improvement of their cat allergy symptoms two years after they started a four-dose, 12 week course of Circassia’s ToleroMune® cat allergy treatment. The phase II study originally measured the level of patients’ symptoms following Toleromune® treatment, compared with placebo. Two years later, and having received no further ToleroMune® treatment, 50 of the original 202 patients were reassessed. The study showed that these patients maintained consistent symptom improvements both 12 and 24 months after the start of the treatment and found that the treatment reduced symptoms by two and a half to three times the level achieved by other allergy therapies in similar studies.
Circassia is currently conducting a phase III multinational study to test the safety and efficacy of the ToleroMune® treatment in approximately 1,200 subjects from the United States, Canada and Europe and results are expected in 2014.
* On September 27, 2012, Circassia has announced the publication of positive phase 2 results with its ToleroMune® cat allergy treatment in the Journal of Allergy and Clinical Immunology (JACI). The results show that cat allergy patients who received four doses of ToleroMune® treatment over 12 weeks maintained a significantly greater improvement in symptoms one year after the start of the study compared with placebo (p=0.0104).
The study, ‘Fel d 1-derived peptide antigen desensitization shows a persistent treatment effect 1 year after the start of dosing. The trial included 202 patients with cat allergy who received placebo or Circassia's ToleroMune® treatment, which consists of seven synthetic peptides derived from the major cat allergen Fel d 1. One year after the start of the study, 89 patients returned to reassess their symptoms while exposed to cat allergens. The study found an immediate and continuing improvement in patients' symptoms following four doses of the ToleroMune® treatment over 12 weeks, and a significant decrease compared with placebo one year after the start of the trial despite no further dosing. The authors note that the symptom reduction represents a substantial improvement over a number of allergy treatment approaches investigated previously. The ToleroMune® treatment was well tolerated and had a safety profile similar to placebo.
(Patel D et al. Fel d 1-derived peptide antigen desensitization shows a persistent treatment effect 1 year after the start of dosing: A randomized, placebo-controlled study. J Allergy Clin Immunol 2012 online 17 September. A summary of the study is published on the American Academy of Allergy Asthma and Immunology website.
* On June 13, 2011, Circassia has announced the results of a phase II clinical trial showing that patients who received four doses of its ToleroMune® cat allergy vaccine over a 12-week period maintained a statistically significant reduction in symptoms one year later.The results of the study were presented in the opening Plenary Symposium of the European Academy of Allergy and Clinical Immunology Congress on Sunday 12 June by Professor Mark Larché, Canada Research Chair in Allergy and Immune Tolerance at McMaster University, Canada.
The study followed an earlier randomised double-blind phase II trial in 202 cat allergy patients, in which those who received four doses of Circassia\'s T-cell vaccine over 12 weeks had a significantly greater improvement in their symptoms than those on placebo. The treatment was extremely well tolerated.
The new results show that one year after the start of the original study, the treated group\'s tolerance to cat allergens was maintained, and had continued to improve substantially following the completion of the treatment, despite the patients receiving no booster doses. As a result, immediately following treatment, the patients had experienced a 94% improvement in their total rhinitis symptoms compared with placebo. By the end of the 12-month study, the ToleroMune T-cell vaccine had reduced the same patients\' symptoms by 133% more than placebo (p=0.01). This treatment effect is 2.6 - 4.3 times that achieved by several currently approved allergy therapies in key clinical trials.
Circassia now plans to advance its cat allergy treatment into phase III testing in 2012.
* On February 1, 2011, Circassia announced that the company''s ToleroMune® cat allergy treatment significantly reduced patients' symptoms in a recently completed, large-scale phase II clinical trial. The study results show that the ToleroMune T-cell vaccine had an immediate and growing treatment effect as allergen exposure increased. The key patient group, which received four doses of the T-cell vaccine over a period of 12 weeks, had significantly reduced levels of allergy symptoms when compared with placebo (p=0.05). These patients experienced a 55% greater improvement in their symptoms despite a larger than anticipated placebo effect. Throughout the study the ToleroMune treatment was extremely well tolerated, with a safety profile similar to placebo.
The study also confirmed the treatment's highly favourable safety profile. The successful trial represents an important development milestone for Circassia's ToleroMune T-cell vaccine technology. The study was the first to use the company's commercial room-temperature-stable formulation, and provides confirmatory proof-of-concept for the final stage of development of its cat allergy T-cell vaccine.
