First Patient Enrolled In Combioxin’s First-In-Man Study With CAL02 In Patients With Severe Pneumococcal Pneumonia
GENEVA, SWITZERLAND - Combioxin SA announced today that the first patient has been randomized and dosed with CAL02 in a first-in-man clinical study for the treatment of severely-ill patients with pneumococcal pneumonia.
Severe pneumococcal pneumonia accounts for 20% to 30% of intensive-care units’ patients in shock during the winter season, with a mortality rate that can exceed 30% despite best currently available therapy.
In December 2015, Combioxin SA received approval from the French National Agency for Medicines and Health Products Safety (ANSM) and the Belgian Federal Agency for Medicines and Health Products (FAMHP) to commence the clinical development of CAL02 directly in patients. The first subject was recruited at the University Hospital of Limoges in France.
“The inclusion of a first patient in the CAL02-001 trial constitutes the inception of an important development stage for CAL02” declared Samareh Azeredo da Silveira Lajaunias, director at Combioxin. “We are most grateful to the critical care specialists involved in the trial, who are imparting their knowledge and expertise for the progress of this drug candidate.”
Antonio Perez, Chief Medical Officer, commented "Today, we are pleased to see CAL02 starting its innovative and pioneering approach to combat severe and life-threatening infections.”
ABOUT THE TRIAL
The CAL02-001 clinical trial consists of a randomised, multicentre, double-blind, placebo-controlled trial. The study is led by Dr. Bruno François (University Hospital of Limoges) in France and Prof. Pierre-François Laterre (St. Luc University Hospital) in Belgium, and aims at assessing safety, tolerability, efficacy and pharmacodynamics of two effective doses of CAL02.
For more details on the trial, please consult this link: https://clinicaltrials.gov/ct2/show/NCT02583373
ABOUT CAL02
CAL02 is a novel broad-spectrum non-antibiotic drug designed to capture and neutralize bacterial toxins. Pre-clinical studies have shown that CAL02 as monotherapy or in combination with antibiotics, fully rescues infected mice from deadly bacteraemia and pneumonia infections. CAL02 is active against multi-drug resistant strains. The technology was in-licenced from the University of Bern, Switzerland.
ABOUT COMBIOXIN
Combioxin SA, an affiliate of LASCCO SA founded in 2015, is a Swiss-based biotechnology company dedicated to the development of anti-infective drugs. For more information, visit http://www.lascco.com.
Severe pneumococcal pneumonia accounts for 20% to 30% of intensive-care units’ patients in shock during the winter season, with a mortality rate that can exceed 30% despite best currently available therapy.
In December 2015, Combioxin SA received approval from the French National Agency for Medicines and Health Products Safety (ANSM) and the Belgian Federal Agency for Medicines and Health Products (FAMHP) to commence the clinical development of CAL02 directly in patients. The first subject was recruited at the University Hospital of Limoges in France.
“The inclusion of a first patient in the CAL02-001 trial constitutes the inception of an important development stage for CAL02” declared Samareh Azeredo da Silveira Lajaunias, director at Combioxin. “We are most grateful to the critical care specialists involved in the trial, who are imparting their knowledge and expertise for the progress of this drug candidate.”
Antonio Perez, Chief Medical Officer, commented "Today, we are pleased to see CAL02 starting its innovative and pioneering approach to combat severe and life-threatening infections.”
ABOUT THE TRIAL
The CAL02-001 clinical trial consists of a randomised, multicentre, double-blind, placebo-controlled trial. The study is led by Dr. Bruno François (University Hospital of Limoges) in France and Prof. Pierre-François Laterre (St. Luc University Hospital) in Belgium, and aims at assessing safety, tolerability, efficacy and pharmacodynamics of two effective doses of CAL02.
For more details on the trial, please consult this link: https://clinicaltrials.gov/ct2/show/NCT02583373
ABOUT CAL02
CAL02 is a novel broad-spectrum non-antibiotic drug designed to capture and neutralize bacterial toxins. Pre-clinical studies have shown that CAL02 as monotherapy or in combination with antibiotics, fully rescues infected mice from deadly bacteraemia and pneumonia infections. CAL02 is active against multi-drug resistant strains. The technology was in-licenced from the University of Bern, Switzerland.
ABOUT COMBIOXIN
Combioxin SA, an affiliate of LASCCO SA founded in 2015, is a Swiss-based biotechnology company dedicated to the development of anti-infective drugs. For more information, visit http://www.lascco.com.