Archive: Company News
Company News: Long-Term Immunomodulation Induced by Anergis´ COP Allergy Vaccine AllerT Now Extends to the 4th Year After Treatment
Patients with birch pollen allergy who received an ultra-fast allergy vaccine four years ago maintain an elevated level of antibodies against the allergen, reports Swiss biopharmaceutical company Anergis.
The company, which is developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, today announced new data on the immune-regulatory effect of its AllerT vaccine.
In 2008/2009, twenty patients suffering from moderate to severe allergies to birch pollen were enrolled in a double-blind, randomized, placebo-controlled Phase I/IIa trial and received 5 subcutaneous injections over 2 months of either AllerT (N=15) or placebo (N=5). Four years later, all subjects were invited to return to the trial center. In subjects who had received AllerT, blood levels of so-called IgG4 antibodies against specific birch pollen allergens were similar to those reported after 2 years (in 2010) and still 4.5 times higher than the pre-treatment baseline level (p< 0.001). Placebo-treated patients showed no median change from baseline in allergen-specific IgG4 at any time during the trial treatment period, nor after the 2010 and 2012 birch pollen seasons.
Earlier this week, Anergis also announced the start of a large, 300-patient real-life seasonal efficacy phase IIb trial with AllerT in patients allergic to birch pollen. This trial is being conducted in multiple European countries [NCT01720251].
Company News: Anergis Starts European Phase IIb Clinical Trial with AllerT in Patients with Moderate to Severe Allergy to Birch Pollen
– First patient treated with novel allergy vaccine –
Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it has treated the first patient in a large, well-controlled Phase IIb clinical trial in individuals with birch pollen allergy. The trial is designed to evaluate the efficacy and tolerability of a 5-injection / 2- months treatment with Anergis´ lead allergy vaccine, AllerT.
The multicentre, double-blind, placebo-controlled, randomized trial called AN004T was designed in collaboration with an International Steering Committee of experts with comprehensive experience in the design and conduct of allergen-specific immunotherapy trials(1). The trial will enroll about 300 patients with moderate to severe birch pollen allergy from up to 30 trial centers throughout Europe. Trial centers are located in Denmark, France, Latvia, Lithuania, Poland, Sweden and Switzerland. AN004T will evaluate the efficacy and safety of two doses of AllerT in comparison with placebo. The first patient was randomized and treated on November 3rd, 2012, in Vilnius, Lithuania.
As recommended by the European Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases (CHMP/EWP/18504/2006), the efficacy of AllerT will be assessed using a combined symptom and medication score as primary endpoint of the trial (combined Rhinoconjunctivitis Symptom and Medication Score RSMS). RSMS assessment is based on allergy symptom and medication data reported through electronic diaries by the trial subjects during the 2013 birch pollen season. Secondary and exploratory endpoints will include other clinical parameters related to symptoms and/or medications taken for allergy, as well as quality of life and immunological marker assessments.
Company News: Meet akampion at BIO-Europe 2012 in Hamburg
akampion´s management team is going to attend BIO-Europe in Hamburg (November 12-14, 2012). In addition to supporting clients with their IR/PR activities during the conference, we will be available for meetings. If you are interested to learn more about akampion or would like to give us an update on your company´s progress, we will be happy to meet you! You can either request meetings via partneringONE, EBD Group´s leading-edge online partnering system, or send us an email: info(at)akampion.com. We are looking forward to talking to you!
Company News: InDex Pharmaceuticals Granted Japanese Patent for Novel Treatment of Steroid-Resistant Inflammation
InDex Pharmaceuticals today announced that it has been granted a Japanese patent by the Japan Patent Office (JPO). The patent provides protection for the use of Kappaproct® and other DNA-based immunomodulatory sequences (DIMS) for the treatment of steroid-resistant inflammatory diseases, including inflammatory bowel disease, rheumatoid arthritis, psoriasis, asthma, emphysema, and chronic obstructive pulmonary disease.
The patent, entitled “Immunostimulatory Method” covers the use of a broad range of oligonucleotides for the treatment of steroid resistance in patients afflicted with inflammatory conditions. It provides an exclusivity period until at least 2026, with the possibility of up to 5 years of patent term extension after market approval. InDex Pharmaceuticals already holds patent protection for Kappaproct for the treatment of steroid-resistant inflammatory diseases in both Europe and the US.
InDex Pharmaceuticals develops DIMS compounds – synthetic oligonucleotides that function as immunomodulatory agents by targeting the Toll-like receptor 9 (TLR9). The company’s most advanced DIMS product candidate, Kappaproct, is currently in a phase III study in Europe for the treatment of chronic, active, treatment-refractory ulcerative colitis.