Infectious Disease Division
News Article | February 21, 2017
Markers of Acute Kidney Injury to be Monitored in Forthcoming Clinical Trials BOSTON, MA and MORRISTOWN, NJ--(Marketwired - February 21, 2017) - BioAegis Therapeutics Inc., a privately held biotechnology company exploiting plasma gelsolin's (pGSN) role in immune function announced that it has expanded its clinical advisory board to include John Kellum, M.D. -- noted critical care physician and acute kidney injury expert at the University of Pittsburgh Medical Center. John Kellum, M.D. is a clinician scientist whose research interests span various aspects of Critical Care Medicine, but center in critical care nephrology (including acid-base, and renal replacement therapy), sepsis and multi-organ failure (including blood purification), and clinical epidemiology. His research has received continuous funding from the National Institutes of Health since 2001, and he has active funding from multiple different NIH Institutes. Dr. Kellum has authored more than 300 publications and has also edited several major textbooks including Critical Care Nephrology and Stewart's Textbook of Acid-Base. Steven Opal, M.D. Professor of Medicine, Brown University School of Medicine; Chief, Infectious Disease Division, Memorial Hospital of RI Atul Malhotra, M.D. Division Chief, Pulmonary and Critical Care Medicine, Kenneth M. Moser Professor, Department of Medicine University of California-San Diego. Vice President, American Thoracic Society (2015-16 President) Acute Kidney Injury (AKI) is known to be a common occurrence in Severe Community-Acquired Pneumonia patients (SCAP). Data from a recent study of 1,800 community-acquired pneumonia patients (GenIMS Study) indicated that approximately one-third of SCAP patients were diagnosed with AKI. Patients with AKI exhibited longer stay in the hospital and had approximately ten times the risk of death at discharge (11% versus 1.3%). Plasma Gelsolin Plasma gelsolin (pGSN) becomes depleted in a wide range of inflammatory conditions, and critically low levels associate with significant morbidity and mortality in animals and humans. Data from many independent laboratories documenting that plasma gelsolin administration produces striking recoveries from lethal infections in experimental animals -- in the absence of antibiotic therapy -- strongly supports the rationale for pGSN repletion therapy. Also in support of this approach is the fact that no adverse effects have emerged from extensive preclinical toxicity studies with plasma gelsolin nor from the administration of recombinant gelsolin by different routes to healthy and diseased humans in three separate clinical studies. Based on recent breakthrough findings by Dr. Lester Kobzik at the TH Chan Harvard School of Public Health, plasma gelsolin replacement therapy markedly decreased mortality of murine pneumonia due to its stimulation of macrophages' ability to ingest and kill bacteria. Based on prior studies demonstrating rhu-pGSN's protective effect in models of infection and organ failure, it is expected that this therapeutic will reduce the incidence of acute kidney injury and its longterm consequences. The company is planning to conduct studies to treat severe community-acquired pneumonia, a leading cause of death in the US and around the world despite antibiotics and improved levels of care. Susan Levinson, Ph.D., Chief Executive Officer of BioAegis stated, "We are delighted to add John Kellum to our prestigious clinical advisory board as we advance our development efforts towards our next clinical study." John Kellum commented, "The incidence of AKI in severe pneumonia is well-known, but the long-term adverse effects are often underappreciated. A therapeutic agent such as plasma gelsolin may have the potential to reduce acute kidney injury in these patients." About BioAegis Therapeutics Founded by a group of highly experienced pharmaceutical and business executives, BioAegis' mission is to harness the body's innate immune system to address adverse outcomes in diseases driven by inflammation and infection. This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management's plans, objectives, and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward- looking statements. BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made. 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Pop-Vicas A.,Infectious Disease Division |
Opal S.M.,Infectious Disease Division
Virulence | Year: 2014
Multi-antibiotic drug-resistant (MDR) gram-negative bacilli are becoming a major threat to the standard care of septic patients. Empiric antimicrobial drug regimens to cover likely bacterial pathogens have to be altered in keeping with the spread of MDR pathogens in the health care setting and in the community. Reliable antibiotics for broad spectrum coverage for sepsis such as extended spectrum β-lactam antibiotics, carbapenems, and fluoroquinolones can no longer be counted upon to provide activity against a range of common, virulent pathogens that cause sepsis. In some regions of Asia, South America, and Eastern Europe in particular, MDR pathogens have become a major concern, necessitating the use of potentially toxic and costly antibiotic combinations as initial antibiotic therapy for septic shock. In this brief review, we will focus on the emergence of MDR gram-negative pathogens, resistance mechanisms, and suggest some management and prevention strategies against MDR pathogens.