Phase III
Almost 15,000 physicians, scientists, health care professionals and industry representatives from around the globe presented research, treatment recommendations and advances toward a diabetes cure at the American Diabetes Association’s 79th Scientific Sessions in San Francisco this week.
The Dutch company Xenikos B.V. announced that the U.S. Food and Drug Administration has approved an investigational new drug application to initiate a U.S.-based clinical Phase 3 registration trial in order to test the efficacy of T-Guard for treating steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
“HealthCaring Conversations is a blueprint for having an efficient but empathic conversation with a patient,” said Suzann Johnson, Janssen’s associate director of clinical insights and experience. “We’re taking good conversations and making them great by putting the patient at the center of every conversation.”
Despite very positive results, the company’s shares were down 1.5% in premarket trading today. Vamil Divan, an analyst with Credite Suisse, wrote in a note to investors, that results “were fairly consistent across various patient subgroups and are clearly positive” for this class of drug, but “we believe investors may have been hoping for greater risk reduction.”
A Phase III trial compared Sanofi’s Soliqua/Suliqua to other GLP-1 receptor agonists (GLP-1 RA), with Soliqua showing a superior decrease of average blood sugar level (HbA1c) after 26 weeks.
Here’s a look at some of last week’s clinical trial announcements, including some from the American Society of Clinical Oncology Annual Meeting you might have missed.
The fixed-dose combination was being evaluated in adults with intermediate and high-risk myelodysplastic syndrome and chronic myelomonocytic leukemia.
Phase III SALAMANDER Trial of Rexgenero’s REX-001 Open and Recruiting
Takeda said that patients treated with Ninlaro in the Phase III TOURMALINE-AL1 study failed to see a significant improvement in overall hematologic response.
During an interim analysis of ELEVATE-TN data, AstraZeneca said Calquence met primary endpoints in patients with previously untreated CLL.
PRESS RELEASES