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Lazar H, Horn MP, Zuercher AW, et al.
Pharmacokinetics and safety profile of the human anti-Pseudomonas aeruginosa serotype O11 immunoglobulin M monoclonal antibody KBPA-101 in healthy volunteers.
Antimicrob Agents Chemother. 2009 Aug;53(8):3442-6.

This was a dose escalation study, in which four single intravenous doses: 0.1, 0.4, 1.2, and 4.0 mg/kg body weight of Panobacumab (AR-101) were administered to healthy subjects. The maximum concentrations of Panobacumab in plasma correlated with the dose levels, and its mean elimination half-life ranged between 70 and 95 hours. No antibodies against Panobacumab (immunogenicity) were detected. Panobacumab was well tolerated and no serious adverse events were observed.


Lu Q, Rouby JJ, Laterre PF, et al.
Pharmacokinetics and safety of panobacumab: specific adjunctive immunotherapy in critical patients with nosocomial Pseudomonas aeruginosa O11 pneumonia.
J Antimicrob Chemother. 2011 May;66(5):1110-6.

This was the first study in patients with pneumonia. In this pilot clinical trial the main objectives were to evaluate the safety, pharmacokinetics and potential efficacy of three doses of 1.2 mg/kg Panobacumab given every 72 h in patients with hospital-acquired P. aeruginosa (serotype O11) pneumonia. In the 13 patients that received the three doses, the average elimination half-life was of 102.3 hrs (SD: 47.8 hours) and the study drug was also found in some lower respiratory tract samples. Panobacumab was well tolerated. No antibodies against Panobacumab were detected. Despite of the severity of the patients and the expected mortality (32%) as per the APACHE II score, all patients that received three doses survived within the 30 days study period. In each of these 13 cases, pneumonia was cured, on average 9 days after treatment was started, and only two subjects suffered a recurrence of their pneumonia.


Q. Lu, A. Dugard, P. Eggimann, et al.
Pseudomonas aeruginosa Serotypes in Nosocomial Pneumonia (NP): Prevalence, Patient Characteristics and Clinical Outcome.


Very little is known regarding the prevalence of the Pseudomonas aeruginosa serotypes in hospital-acquired pneumonia as well as whether the serotype plays a role or not in the severity and final outcome of such infection. Clinical and laboratory data from 129 patients, with hospital-acquired pneumonia caused by Pseudomonas aeruginosa were analyzed within a period of 30 days from time of diagnosis of pneumonia. The most frequent serotypes were O6, O11, O10, S2 and O1 and most of the patients were male and older than 50 years. Comparison of the predicted and actual mortality showed that for serotype O1 the actual mortality was higher than predicted (40% vs. 35%), whereas for O11 mortality was as predicted (21% vs 22%) and in the S2 group no patient died (predicted 20%). Mean time to death was 10.9 days, with the longest for O10 infections (15 days) and the shortest for infections with O6 strains (9.2 days). Up to 66% of the patients achieved a clinical resolution, and 5% recurred.


Q. Lu, A. Dugard, P. Eggimann, et al.
Panobacumab Adjunctive Immuno-Therapy for Pseudomonas aeruginosa Hospital-Acquired Pneumonia versus a Cohort Group


The natural history and outcome of hospital-acquired pneumonia caused by Pseudomonas aeruginosa serotype O11 in patients treated with standard antimicrobial therapy, was compared with patients who received Panobacumab in addition to antibiotics. Both groups had the same inclusion and exclusion criteria and the same trial period observation of 30 days. The expected mortality calculated with APACHE II score was of 31% in the group treated with Panobacumab plus antibiotics and of 22% in the group treated only with antibiotics. All patients who received three doses of Panobacumab survived, but 21% died when only antibiotics were administered. All 13 patients that received the three doses of Panobacumab achieved clinical resolution of the pneumonia within the 30 days observational period, although two patients recurred. In the group treated with antibiotics alone, pneumonia was clinically cured in 57% of the cases, recurred in 7% and was not cured in 34% . The clinical resolution of the pneumonia occurred markedly earlier in patients treated with Panobacumab plus antibiotics than in patients treated only with standard antibiotic therapy.

Summary of AR-101 clinical data

P. Aeruginosa Virus

AR-101 AerumabTM

PHARMACEUTICALS

Breakthrough Therapies for

Antibiotic Resistant Infections

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