GENEVA, SWITZERLAND, 9 August 2016 – Combioxin SA announced today that an
Independent Data Monitoring Committee has unanimously recommended progression of the
ongoing first-in-man trial and dose escalation to the High Dose of CAL02.
An Independent Data Monitoring Committee has reviewed the initial safety data from all six patients in the first cohort of the randomized, multicentre, double-blind, placebo-controlled CAL02-001 trial in patients with severe pneumococcal pneumonia and concluded that results support a positive safety profile for CAL02.
“This is a significant milestone in our program. It is in accordance with our expectations for the profile of CAL02 and we are excited to commence the second part of this “first-in-man trial" declared Samareh Azeredo da Silveira Lajaunias, director at Combioxin.
CAL02 is a novel broad-spectrum, non-antibiotic drug designed to capture and neutralize bacterial toxins. The CAL02-001 clinical study aims at assessing safety, tolerability, efficacy and pharmacodynamics of two doses of CAL02, namely a Low and a High dose, expected to be effective in humans on the bases of preclinical data. 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. Combioxin expects to report additional safety and efficacy results in the first half of 2017.
ABOUT THE TRIAL
Additional information about CAL02-001 can be found at: https://clinicaltrials.gov/ct2/show/NCT02583373
ABOUT CAL02
CAL02 is a novel broad-spectrum, non-antibiotic drug designed to capture and neutralize bacterial toxins released from a range of Gram-positive and Gram-negative pathogens. Preclinical studies have shown that CAL02 fully rescues infected mice from deadly bacteraemia and pneumonia infections. CAL02 is active against multi-drug resistant bacteria. 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, please visit http://www.combioxin.com.
An Independent Data Monitoring Committee has reviewed the initial safety data from all six patients in the first cohort of the randomized, multicentre, double-blind, placebo-controlled CAL02-001 trial in patients with severe pneumococcal pneumonia and concluded that results support a positive safety profile for CAL02.
“This is a significant milestone in our program. It is in accordance with our expectations for the profile of CAL02 and we are excited to commence the second part of this “first-in-man trial" declared Samareh Azeredo da Silveira Lajaunias, director at Combioxin.
CAL02 is a novel broad-spectrum, non-antibiotic drug designed to capture and neutralize bacterial toxins. The CAL02-001 clinical study aims at assessing safety, tolerability, efficacy and pharmacodynamics of two doses of CAL02, namely a Low and a High dose, expected to be effective in humans on the bases of preclinical data. 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. Combioxin expects to report additional safety and efficacy results in the first half of 2017.
ABOUT THE TRIAL
Additional information about CAL02-001 can be found at: https://clinicaltrials.gov/ct2/show/NCT02583373
ABOUT CAL02
CAL02 is a novel broad-spectrum, non-antibiotic drug designed to capture and neutralize bacterial toxins released from a range of Gram-positive and Gram-negative pathogens. Preclinical studies have shown that CAL02 fully rescues infected mice from deadly bacteraemia and pneumonia infections. CAL02 is active against multi-drug resistant bacteria. 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, please visit http://www.combioxin.com.
