Progress of Phase I Programme With Oral Iclaprim "Rolling" NDA for Intravenous Iclaprim in cSSSI; Electronic Submission of
First Modules due Before Year-end 2007
REINACH, Switzerland, December 12 /PRNewswire-FirstCall/ -- Arpida Ltd (SWX: ARPN) announced today the enrolment and dosing of the first patients in the Phase II clinical study with intravenous iclaprim in the treatment of hospital-acquired pneumonia (HAP) / ventilator-associated pneumonia (VAP) / healthcare-associated pneumonia (HCAP).
In addition, Arpida announced results of a Phase I study with oral iclaprim. The primary aim of the study was to assess the safety and tolerability of single ascending doses of an oral capsule formulation of iclaprim in healthy volunteers.
Moreover, Arpida today announced that the first modules of the New Drug Application (NDA) for intravenous iclaprim in its first indication, cSSSI, are ready and will be filed before year-end 2007. The filing of the NDA package is expected to be completed by the end of February 2008.
First patients enrolled in Phase II trial with intravenous iclaprim in HAP/VAP/HCAP
Patient recruitment has started and several additional clinical centres are expected to start recruiting within the next few weeks. The trial remains on track for completion in 2008.
HAP/VAP/HCAP as a potential second indication could substantially enhance iclaprim's prospects as a potent novel therapy against multi-drug resistant bacteria. In the area of pneumonia, the need for new drugs addressing MRSA-infections is particularly pressing.
The Phase II trial is designed as a multi-centre, randomised,
double-blind, comparative study. The efficacy and safety of two different
dosing regimens of iclaprim will be compared to the current standard of
care vancomycin. More than 130 patients will be enrolled. Patients will be
treated for 7-14 days and a Test-of-Cure (TOC) visit will be performed 7-14
|SOURCE Arpida Ltd|
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