SOUTH SAN FRANCISCO, Calif. , Jan. 13, 2014 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced the presentation of epidemiological research sponsored by Sanofi Pasteur, KaloBios' exclusive licensee for KB001-A, estimating the incidence of Pseudomonas aeruginosa Ventilator Associated Pneumonia ( Pa-VAP) in at-risk patients requiring intubation and mechanical ventilation. The presentation also describes the risk factors among patients with VAP and Pa-VAP. The new research found similar risk factors and infection rates for VAP across multiple global regions. Moreover, the study results suggest that mechanically ventilated patients who are colonized with Pa are at increased risk of developing Pa-VAP. Sanofi Pasteur is developing KB001-A, KaloBios' anti-PcrV monoclonal antibody (mAb) fragment against Pa for the prevention of Pa‑VAP, in the intensive-care setting. (Logo: http://photos.prnewswire.com/prnh/20130225/MM66380LOGO) The findings were presented Saturday as a poster entitled "Prospective Multinational Observational Study of the Incidence of Ventilator Associated Pneumonia" at the 43 rd Critical Care Congress, Society of Critical Care Medicine, being held January 9-13, 2014 in San Francisco, California. The presentation was made by co-author Marin Kollef, MD, of the Washington University of School of Medicine, St. Louis, Missouri.
The researchers conducted the study in more than 1,800 patients in over 50 intensive care units (ICUs) in the United States, Europe, Latin America and Asia-Pacific. The study found 15.6% of patients in the study across all regions were diagnosed with VAP, with 4.1% diagnosed with Pa-VAP. The researchers also determined the proportion of patients with prior respiratory tract Pa colonization during the study period, among those patients who had surveillance cultures obtained.
"We found that the risk factors and rates of VAP were similar across the regions studied and that patients who were found to be colonized with Pa after requiring more than 48 hours' intubation and mechanical ventilation were at increased risk of developing Pa-VAP," said Dr. Kollef. "The frequency of Pa -VAP was higher in patients who had preceding Pa -positive surveillance cultures: 18% subsequently developed Pa-VAP compared with 4.1% in all patients enrolled in the study."
"These data confirm the importance of Pa as a significant cause of VAP, a condition that can significantly add to the length and cost of hospitalization as well as contribute to increased patient morbidity and mortality," said Nestor A. Molfino, MD, MSc., KaloBios' Chief Medical Officer.About KaloBios KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies designed to treat severe life-threatening or debilitating diseases for which there is an unmet medical need, with a clinical focus on severe respiratory diseases and cancer. Currently, KaloBios has three drug development programs:
- KB003, an anti-GM-CSF mAb with potential to treat inflammatory diseases, being developed for the treatment of severe asthma. Enrollment of 160 patients has been completed in a Phase 2 study in the United States, Europe and Australia.
- KB001-A, an anti-PcrV mAb fragment, partnered exclusively with Sanofi Pasteur and is being developed for the prevention and treatment of Pseudomonas aeruginosa (Pa) infection. KaloBios has retained rights for the cystic fibrosis (CF) indication and is conducting a 180 patient Phase 2 study in CF subjects with chronic Pa lung infection in the United States . KaloBios has received Orphan Drug designation from both the U.S. FDA and the European Medicines Agency for KB001-A for the treatment of Pa lung infection in CF patients. Sanofi is pursuing a ventilator-associated pneumonia prevention indication in the intensive care setting, an indication which has received U.S. FDA Fast Track Designation.
- KB004, an anti-EphA3 mAb, has potential in treating hematologic malignancies and solid tumors. KaloBios is currently testing this drug in a Phase 1 study in subjects with hematologic malignancies.
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