Data Monitoring Committee Unanimously Recommends Continuation of Combioxin First-in-Human Clinical Trial with CAL02 in Patients with Severe Pneumococcal Pneumonia
- Category: Small Molecules
- Published on Tuesday, 10 October 2017 19:51
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GENEVA, Switzerland I October 10, 2017 I Combioxin SA, a Swiss-based company specialising in the treatment of severe bacterial infections, announced today that an Independent Data Monitoring Committee has unanimously recommended continuation of the ongoing first-in-human trial in severely infected patients and High Dose continuation CAL02.
The Independent Data Monitoring Committee has reviewed the safety data from a first set of patients treated with a High Dose of CAL02 in 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 at High Dose.
CAL02 is a first-in-class non-antibiotic liposomal drug that neutralizes a large panel of bacterial toxins, protects against infection severity and complications, and improves antibiotic efficacy. This innovative anti-infective agent steers clear from the emergence of drug resistance and is active against pathogens regardless of the resistance profile.
The CAL02-001 clinical study (https://clinicaltrials.gov/ct2/show/NCT02583373) is led by Dr. Bruno François (University Hospital of Limoges) in France and Prof. Pierre-François Laterre (St. Luc University Hospital) in Belgium.
“The unanimous recommendation by the IDMC to continue this study with a High Dose of CAL02 is a significant milestone in our program. We are excited to continue, full speed ahead, with this first-in-human trial which paves the way for the Phase IIb trial with a much broader use of CAL02”, said Jeffrey Jump, Chairman of Combioxin.
Dr. Toni Perez, Combioxin’s Chief Medical Officer, commented: “Bacterial toxins are directly responsible for serious and fatal infection-related complications, extended hospitalisation and tremendous increases in cost of care. Because of their almost ubiquitous presence in bacterial pathogens, they are important targets for broadly applicable antimicrobial prophylaxis and therapeutics. As a unique broad-spectrum anti-toxin agent, CAL02 can defy the most alarming infections which affect critically ill patients and offers a chance for a wiser use of antibiotics in the general infected population.”