Tag: Phase II data

Company News: Anergis Presents Sustained Efficacy Data from its AllerT Phase IIb Trial at the AAAAI Annual Meeting

– Contiguous Overlapping Peptide allergy immunotherapeutic AllerT confirms sustained efficacy in the second year following treatment

Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, presented detailed data from the Phase IIb trial of its birch pollen allergy immunotherapeutic AllerT in two separate scientific posters at the AAAAI (American Academy of Allergy, Asthma and Immunology) Annual Meeting in Houston, Texas. The findings were presented on February 22, 2015. Abstracts can be found at www.anergis.ch. AllerT is Anergis´ most advanced long-peptide immunotherapeutic and based on the company´s proprietary Contiguous Overlapping Peptide (COP) platform.

In 2013, the clinical efficacy of AllerT was demonstrated in a field-based, randomized, placebo-controlled, double-blind trial in 239 patients with birch pollen allergy, who received either AllerT (at 50μg or 100μg doses) or a placebo during a 2-month immunotherapy regimen. All main efficacy and safety endpoints were met in this study.

In 2014, the sustained efficacy of AllerT was assessed in the same group of patients during a second follow-up season without additional treatment. In both years, efficacy was evaluated using combined Rhinoconjunctivitis Symptom and Medication Scores (RSMS) as the primary endpoint as well as quality of life (Mini RQLQ) and Night-time Nasal Symptom Score (NNSS) as the main secondary endpoints. The study also measured the levels of allergen-specific immunoglobulins (Bet v 1 specific IgG4) in patients.

The data collected during the second post-treatment season (N=196 patients) proved the sustained efficacy of AllerT, as demonstrated by improvements in the primary endpoint, RSMS, and in the main secondary endpoints, Mini RQLQ and NNSS. The trial also confirmed that AllerT had induced a persistent elevation of anti-Bet v 1 IgG4 antibodies, i.e. measured after one year without treatment.

Company News: CYTAVIS’ Aviscumine Improves Survival of Patients with Metastatic Melanoma in a Phase II Trial

CYTAVIS BioPharma GmbH, a biopharmaceutical company developing derivatives of natural compounds for the treatment of oncological and immunological diseases, today announced Phase II data demonstrating that its lead compound Aviscumine (CY503), an immune potentiator, may improve survival of patients with refractory metastatic melanoma (stage IV).

The open-label Phase II multicenter trial (NCT00658437) was designed to test the influence of subcutaneous injections of Aviscumine (CY503) on progression-free survival (PFS) and overall survival (OS) of patients with unresectable metastatic melanoma (stage IV) after antineoplastic treatment failure. The trial included 31 eligible patients and was conducted at four German sites.

The progression-free survival rate after 3 months was 32.3%, while the 1-year-survival rate was 45.0% and median overall survival time (mOS) 11 months in the full analysis set/intention to treat population (FAS/ITT). In case of the standard therapy with Dacarbazine the 1-year-survival rate is usually about 30% and the mOS between 6 and 8 months, respectively. The majority of treatment-related adverse events were not severe application site reactions and pruritus.

Company News: MediGene Publishes First, Preliminary Results from a Phase II Clinical Trial of EndoTAG-1 for the Treatment of Triple Receptor-negative Breast Cancer

– Study Meets Primary Endpoint –

MediGene today announced first preliminary results from its Phase II clinical trial of EndoTAG(TM)-1 for the treatment of triple receptor-negative breast cancer. The trial in 140 patients was conducted to show efficacy of EndoTAG(TM)-1 against this extremely difficult to treat cancer type, and to further investigate the safety of the drug candidate. The primary endpoint was a progression-free survival rate at 16 weeks of at least 30% of EndoTAG(TM)-1 monotherapy treated patients, and at least 30% of EndoTAG(TM)-1 plus paclitaxel combination treated patients respectively.

Trial results: The group of patients treated with EndoTAG(TM)-1 and paclitaxel combination therapy showed a progression-free survival rate after 16 weeks of treatment of 59.1% (95% confidence interval: 43.2% – 73.7%). The progression-free survival rate of the group with EndoTAG(TM)-1 monotherapy was 34.2% (18,6 % – 51,4 %). In the group that received paclitaxel monotherapy, the progression-free survival rate was 48%. (27,8 % – 68,7%).

Further data, including secondary endpoints, are currently being evaluated and will be published within the next few weeks. Upon conclusion of this analysis, an overall trial evaluation will therefore be possible. The data published today are based on a centralized image evaluation of the trial results regarding progression-free survival. For more information, please see the full press release.