Tag: Phase III trial

Company News: InDex Pharmaceuticals to present results from the COLLECT trial at the 10th Congress of the European Crohn’s and Colitis Organisation

InDex Pharmaceuticals today announced that results from COLLECT, a clinical study of the toll-like receptor 9 (TLR9) agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis, will be subject to an oral presentation at the 10th Congress of the European Crohn’s and Colitis Organisation (ECCO). The congress is to be held in Barcelona, Spain on February 18-21, 2015.

In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis and inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. The study was conducted at 40 sites in seven European countries.

Despite not meeting the primary endpoint of inducing clinical remission measured at week 12, defined by a clinical activity index (CAI) score of ≤4, Kappaproct showed statistically significant improvement on important secondary endpoints at week 4 and 8, including symptomatic remission (blood in stool, number of stools) and registration remission (clinical remission with concurrent endoscopic remission) as well as rate of colectomy at week 22. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident. The data strongly support continued development of Kappaproct as a promising and well-tolerated novel therapeutic option for refractory ulcerative colitis patients. The next phase III study is planned to start this year.

The presentation (Oral presentation #15) titled “Multicentre clinical trial with topical administration of the Toll-Like receptor 9 agonist DIMS0150 shows evidence for efficacy in moderate to severe Ulcerative Colitis” will be held by Professor Raja Atreya from the University of Erlangen-Nürnberg on Friday, February 20th, 2015, at 14.20pm CET.

Company News: Anergis Starts Phase II Dose Ranging Trial with Birch Pollen Allergy Vaccine AllerT

–      Dose assessment for upcoming Phase III trial

Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced the start of a Phase II trial designed to finalize the dose selection for the Phase III study of AllerT. AllerT is Anergis´ lead vaccine against birch pollen allergy that originated from the company´s proprietary Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceutical-grade, long-peptide immunotherapeutics designed for an ultra-fast, safe and long-lasting treatment of allergy patients.

The randomized, double-blind, placebo-controlled, 4-parallel-group trial will assess the dose response efficacy of AllerT across doses of 50 µg, 25 µg, 10 µg compared to a placebo in an environmental exposure chamber (EEC). Approximately 180 birch pollen allergy patients will receive 5 subcutaneous injections over 2 months. All enrolled patients will be challenged with birch pollen prior to receiving AllerT or the placebo, and 4 weeks after the last injection.

The primary endpoint is the change in Total Rhinoconjunctivitis Symptom Scores (TRSS) from the baseline EEC challenge to the post-treatment EEC challenge.

Secondary endpoints are the mean Total Nasal Symptom Scores (TNSS), Total Ocular Symptom Score (TOSS), Individual Nasal Symptom Scores (NSS) and Asthma Symptom Score (ASS), which will also be evaluated from the baseline EEC challenge to the post-treatment EEC challenge. The trial is being conducted in Canada, with results expected in the third quarter of 2015.

Company News: Phase IIb Results of Anergis´ Lead Compound AllerT to be Presented at 2014 AAAAI Annual Meeting in San Diego

– Oral presentation scheduled for March 4, 2014 –

Anergis, a company discovering and developing proprietary allergy vaccines, today announced that the detailed Phase IIb results of its allergy vaccine AllerT will be presented during this year’s annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego, CA. The oral presentation will be given by Prof. Francois Spertini, MD, Principal Investigator of the trial.

Presentation Title: “Ultra-Fast Hypoallergenic Birch Pollen Allergy Vaccine AllerT Is Efficient and Safe: Results Of a Phase IIb Study”

Time and Date: Tuesday, March 4, 2014, at 02:45pm PST.

Session: New Forms of Immunotherapy (session no. 5606)

Location: Convention Center, Mezzanine Level, Room 14AB

AllerT is a pharmaceutical-grade vaccine to treat birch pollen allergies via ultra-fast desensitization. The vaccine is based on the IP-protected Contiguous Overlapping Peptides (COP) technology.

Company News: Anergis Closes Financing Round Totaling CHF 8 M

– Preparation of Phase III trials with lead allergy vaccine AllerT

– Field-based, long-term efficacy milestone in patients from the AllerT Phase IIb trial coming up

Anergis, a company discovering and developing proprietary allergy vaccines, today announced the closing of a financing round totaling CHF 8 million. The financing was fully subscribed by existing investors and directors and was co-lead by Sunstone Capital, BioMedInvest and Renaissance PME/Vinci Capital.

Anergis will use the proceeds to further advance the clinical development of its lead product AllerT, a vaccine to treat birch pollen allergy, and to advance two additional vaccine candidates against house dust mite and ragweed allergies. For AllerT, the funds will specifically allow the preparation of Phase III trials and the conduct of a long-term efficacy follow-up trial of patients who participated in the recently completed field-based Phase II study. The results from this second follow-up season are expected to be available in the third quarter of 2014.