New immunotherapy treatment with Alternaria Alternata (Alt a 1)

Immunological response

Significant increase of Ig G4 antibodies in serum

Exact dosage

Therapeutic dose of 0.25 μg/mL of Alt a 1

Lypholised

Guaranteed stability

Good tolerability

Clinically tested cluster administration schedule

Picture1

High Diagnostic Efficacy

Diagnosis by prick test with purified Alt a 1 allergen

Wheal Area

The wheal areas obtained with Alt a 1 protein are significantly greater than with extract of total Alternaria alternata and extract without Alt a 1.

Alternaria alternata

Alt a 1 is recommended for diagnosis and treatment of Alternaria alternata-sensitised patients. The major Alternaria alternata allergen is responsible for sensitisation of >90% of the allergic population.

Characteristics of purified Alt a 1

  • Homogeneous product
  • Expressed in units of mass
  • Biologically standardised
  • Allergen-specific immunotherapy
  • Absence of possible sensitisations to other allergens

SDS Page

  • Lane M: Molecular weight pattern
  • Lane A: Complete Alternaria alternata extract
  • Lane B: Alternaria alternata proteins purified by anion-exchange chromatography
  • Lane C: Alternaria alternata proteins purified by cation-exchange chromatography
  • Lane D: Alternaria alternata proteins purified by gel-filtration chromatography (Alt a 1)

Skin Test

Partial and preliminary results of Phase II/III Clinical Trials with Alt a 1

Clinical trial

  • Multicentre, double-blind, randomised, placebo-controlled, parallel-group, clinical trail to evaluate the clinical efficacy and safety of immunotherapy with purified major allergen Alt a 1 in patients with allergic rhinoconjenctivitis with or without mild to moderate asthma, sensitised to fungus Alternaria alternata. 
  • The clinical trial is performed in three arms over 23 participating sites: 2 active at 0.25μg/mL and 0.458μg/mL, and a placebo.

A statistically significant decrease in papule size is obtained after one year of immunotherapy with Alt a 1, both with Alt a 1 and with Alternaria alternata versus the control group.

Skin tests performed with Alt a 1 and Alternaria alternata versus control

Partial results collected after 1 year of treatment in 50 patients patients

Ig E Results

Active vs. control groups

Specific sIgE serum levels vs. Alt a 1 in the three treatment groups (mean ± SEM)

Statistically significant decrease in sIgE at 12 months treatment

IgG 4 Results

Active vs. control groups

Specific sIgG4 serum levels in Alt a 1 in the three treatment groups (median ± SEM)

After one year of immunotherapy, a statistically significant increase in IgG 4 immunoglobulin is seen both in the Active 1 and the Active 2 versus the control group (placebo), where variation in the IgG 4 serum levels was not seen.

Safe and Well-tolerated

Safety

Alt a 1 is a safe treatment with a high level of tolerance; only mild or moderate adverse events were seen. No serious adverse events were reported. Previous clinical trials showed the same safety pattern.

Administration Guidelines

TOP