Date: 2015-11-09
Type of information: Initiation of preclinical development
phase:
Announcement: clinical trial authorization
Company: Immune Pharmaceuticals (USA - MA, Israel)
Product: bertilimumab
Action
mechanism: monoclonal antibody. Bertilimumab is a fully human, IgG4-type monoclonal antibody that blocks the activity of eotaxin-1. Eotaxin-1 causes eosinophils to migrate towards sites of inflammation where they become activated and release substances that result in tissue damage and enhance inflammation. By blocking the effects of eotaxin-1 on eosinophil function, bertilimumab is a promising clinical stage candidate for a variety of inflammatory conditions, including Ulcerative Colitis, Crohn’s disease, Severe Asthma and Bullous Pemphigoid. Bertilimumab was originally developed by Cambridge Antibody Technology (now part of MedImmune, the biologics division of AstraZeneca). CAT licensed Bertilimumab to iCo Therapeutics, who retains the rights to develop ophthalmic indications (Kerato-conjunctivitis, wet Age-related Macular Degeneration) while Immune Pharmaceuticals took responsibility for product supply and all non-ophthalmic indications in June 2011.
Disease: bullous pemphigoid (BP)
Therapeutic area: Autoimmune diseases - Dermatological diseases - Rare diseases
Country: Israel, USA
Trial
details:
Latest
news: * On November 9, 2015, Immune Pharmaceuticals announced that the FDA accepted the Company's Investigational New Drug (IND) application for bertilimumab, for the treatment of Bullous Pemphigoid (BP). This FDA acceptance enables the Company to expand recruitment for its clinical trials. Immune recently initiated a Phase IIa open label clinical trial in BP in Israel at the Tel Aviv University School of Medicine. This trial is designed to recruit 10-15 patients diagnosed with moderate to severe BP in order to evaluate symptomatic improvement and reduction in the use of steroids. Immune now has the opportunity to treat BP patients in clinical trials conducted in the U.S. in three planned centers, including Mt. Sinai School of Medicine in New York under the direction of Annette Czernik, MD, Clinical Director of Dermatology. * On October 7, 2015, Immune Pharmaceuticals announced that it has submitted an Investigational New Drug Application in the U.S. to expand recruiting for bertilimumab, for the treatment of bullous pemphigoid. Immune\'s U.S. IND application for the treatment of bullous pemphigoid, a rare autoimmune skin disease known to have increased eotaxin-1 levels in serum and blister fluids. The U.S./EU BP patient population is estimated at 60,000 patients and is expected to grow to 90,000 patients by 2025. Immune recently initiated a Phase IIa open label clinical trial in bullous pemphigoid in Israel. This study is designed to recruit 10-15 patients diagnosed with moderate to severe BP in order to evaluate symptomatic improvement and reduction in the use of steroids. Upon approval of the IND, Immune will have the opportunity to treat bullous pemphigoid patients in clinical trials conducted in the U.S. * On June 25, 2015, Immune Pharmaceuticals announced that it is scheduled to initiate its Phase II Bullous Pemphigoid clinical trial on July 1, 2015. Study Initiation is the training of hospital staff to allow for patient screening and immediate patient enrollment into the clinical trial upon selection. The bertilimumab Phase II Bullous Pemphigoid clinical trial is designed as an open label clinical trial in 10 patients, with moderate to severe Bullous Pemphigoid.
