Tag: Vincent Charlon
Company News: Anergis Appoints Kim Simonsen as Chief Development Officer
– Senior Biotech Executive brings over 25 years of drug development expertise
Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced the appointment of Kim Simonsen, MD, as Chief Development Officer. Mr. Simonsen will head Anergis´ global product development from preclinical development to registration, including CMC, clinical development, regulatory affairs and global project management.
Kim Simonsen joins Anergis from Ablynx NV, where he was Chief Operations Officer. Prior to that, he was Senior Director, Global Clinical Development, at ALK Abello A/S, where he led the clinical development of Grazax®, the first marketed grass pollen allergy immunotherapy tablet. From 2000 to 2005, Mr. Simonsen was Chief Executive Officer of the CRO Medicon A/S after having held various clinical development roles at big pharmaceutical companies, e.g. as Medical Director of Novartis Healthcare A/S, Director of Clinical Operations at Novo Nordisk A/S, and as Medical Director and Clinical Expert at Sandoz A/S.
Prior to joining the biopharmaceutical industry in 1986, Mr. Simonsen trained as an MD at Copenhagen University and worked for five years at two different clinics in the Copenhagen area, focusing on internal medicine (gastroenterology, respiratory, cardiology). During his career, Mr. Simonsen has gained extensive experience in clinical drug development, including regulatory affairs, clinical pharmacology, and the design and management of clinical trials and pharmacovigilance. His expertise covers an extensive range of disease indications, incl. allergy immunotherapy, immunology, oncology, rheumatology, and cardiovascular and pulmonary diseases.
Company News: Anergis Announces Completion of Treatment in AllerT Phase II Dose-Ranging Trial
– 213 patients included in trial of novel ultra-fast allergy immunotherapeutic
Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced treatment completion of its Phase II clinical trial of AllerT, a novel long-peptide immunotherapeutic to treat birch pollen allergies. In the trial, 213 patients were randomized to receive target doses of 10, 25 or 50 µg of AllerT or placebo as 5 subcutaneous injections over 2 months. The last patient was treated at the end of March. No serious adverse events and no grade 3 or 4 allergic reactions were reported. The trial is being conducted in Canada and is still blinded. Results are expected in Q3 of 2015.
Company News: Anergis Granted U.S. Patent for Ragweed Allergy Vaccine AllerR
– Anergis receives notice of allowance from U.S. Patent Office for patent on ultra-fast treatment for ragweed allergies
Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced that it received a notice of allowance from the U.S. patent authorities for its patent covering composition and methods of use of its ragweed allergy product AllerR. AllerR is based on Anergis´ unique 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.
Ragweed pollen is believed to be the most allergenic of all pollens. Allergies to ragweed pollen are mostly prevalent in the USA, where they affect an estimated 27 million patients, with a high degree of severity in many of them. Among others, ragweed allergies are a major cause of asthma. Fifty percent (50%) of allergic patients in the United States are sensitized to ragweed.
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.