Biologics

Enlivex Mixed Results of Sepsis Cell Therapy

Enlivex Therapeutics says there were mixed results from its Phase 2 study of Allocetra in patients with sepsis, in which 120 patients enrolled. The company says it is developing Allocetra as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. “Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state,” it says.

Study investigator Bruno François, an intensive care physician and head of the Limoges Clinical Investigation Center (Limoges, France) had this to say: “The study was well designed and executed, although randomization resulted in the Allocetra-treated cohorts having higher frequencies of septic shock and invasive ventilation prior to treatment, as compared with the control group. Because these patient attributes are typically associated with a significantly higher degree of difficulty of treatment and higher mortality rates, the relative effect of Allocetra in some patient subpopulations was challenging to deduce. I am pleased with the unusually low mortality rates across the board in the study, and that Allocetra demonstrated a potential indication of effect in high-risk sepsis patients originating from urinary tract infections.”

Enlives CEO Oren Hershkovitz also acknowledged the “biases” in the study that made it challenging to deduce the relative effect in other patient subgroups. The company intends to “consider, upon reviewing the totality of the data, a potential follow-on, randomized, controlled study of a solely high-risk UTI sepsis population.” He said up to 31% of sepsis cases start as UTIs, and this represents a substantial potential market opportunity for Allocetra.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome