Taipei, Taiwan, November 8th , 2019 — United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from the U.S. FDA to conduct a phase 1 clinical trial with a novel anti-IgE monoclonal antibody UB-221, in patients suffering from chronic spontaneous urticaria (CSU) that is not adequately controlled by standard first-line H1-antihistamine treatments. The lifetime prevalence of chronic urticaria is approximately 1.8%. Chronic spontaneous urticaria occurs in 0.5~1% of the population at any point in time. Two out of three cases of chronic urticaria are spontaneous, with its incidence peaking between 20 and 40 years of age .
The phase 1 trial is a randomized, placebo-controlled, single-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221 as an add-on therapy in 32 patients with moderate to severe CSU.
UB-221 has demonstrated its ability to neutralize free/soluble IgE with 8 folds higher affinity than that of another currently marketed anti-IgE monoclonal antibody therapeutic. In addition, UB-221 has shown to be more effective to down-regulate/reduce IgE synthesis through binding to CD23 receptor on B cell surface. A PK study in monkeys demonstrated two times longer serum half-life of UB-221 than that of the current therapeutic antibody drug. UB-221 is also being developed as the biologic therapeutic for other IgE-mediated allergies, including severe asthma, allergic rhinitis, severe food allergy and atopic dermatitis.
In a shocking reversal, Biogen (BIIB) on Tuesday said that it would resurrect an Alzheimer’s drug that the company previously said had failed and will ask the Food and Drug Administration to approve it. The company said a “new analysis of a larger dataset” showed that the drug, aducanumab, reduced clinical decline in patients with early Alzheimer’s disease on multiple measures of the drug’s effectiveness. That directly contradicts a decision in March to halt studies of the therapy based on the recommendations of an independent monitoring board that was charged with protecting patients in the study. Aducanumab’s failure sent shock waves far beyond Biogen. It was thought to be the last of a series of drugs — the previous ones, from many different drug companies, all failed — that targeted a protein in the brain called beta amyloid. After Biogen’s announcement in March, most researchers and biotechnology executives saw little hope for a drug that would help patients with Alzheimer’s disease even as cases mount. 繼續閱讀 →
One of the many things I’ve learned during four decades of doing research on Alzheimer’s disease is that the work always brings surprises. Biogen’s announcement on Tuesday about its experimental Alzheimer’s drug, aducanumab, was a big one.
That decision was a blow to the hypothesis that a protein called beta-amyloid is a cause of Alzheimer’s. It cast a cloud over years of research, and many of us in the field began feeling like we were swimming upstream against pronouncements that anti-amyloid therapies won’t work. Several biopharmaceutical companies started rethinking their research in this area.
Biogen’s latest announcement is likely to give some in the field whiplash.
We don’t always understand why God works the way He does. But we can be assured that He is always in control. At such times, it’s helpful to remember that God sees the big picture. He’s always working to accomplish His purposes. In this message, Dr. Stanley outlines seven truths from Scripture to remind us that no matter what we see, we can trust God to fulfill all His promises and complete His perfect plan.
Take your Bible-reading to a deeper level as you learn to recognize what your loving and all-powerful Father is communicating to you personally. Dr. Stanley maps out sixteen specific characteristics of a word from the Lord that will help you understand His directions. This practical message will grow your faith, inspire your Bible study, and ready you for service.