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Mpex Initiates A Phase 2 Clinical Trial Of Aerosol MP-376 In The Treatment Of Chronic Bacterial Infections In Cystic Fibrosis Patients
Mpex Pharmaceuticals, Inc.
announced that it has initiated a Phase 2 clinical study with MP-376 for
the treatment of pulmonary infections due to Pseudomonas aeruginosa and
other bacteria in patients with cystic fibrosis. MP-376 is Mpex's
proprietary aerosol formulation of levofloxacin, an antibiotic that has
potent activity against key bacterial pathogens, including Pseudomonas
aeruginosa. Delivery of levofloxacin directly to the lungs of CF patients
by the aerosol route can potentially provide a number of safety and
efficacy advantages compared to oral or IV administration. MP-376 is
delivered using a customized configuration of PARI's highly efficient
eFlow(R) electronic nebulizer.
"Based on the preclinical and early clinical work to date, we believe
MP-376 has the potential to be an important new treatment option for CF
patients," stated Dr. Jeffery Loutit, Chief Medical Officer of Mpex
Pharmaceuticals, Inc. "This study, if successful, should allow us to select
the appropriate dose and dose schedule for our pivotal Phase 3 studies,
which we hope to initiate in 2009."
Patients with cystic fibrosis (CF) suffer from chronic infections of
the lower respiratory tract that can be caused by multiple bacteria,
including Pseudomonas aeruginosa. Chronic pulmonary infection is associated
with a decrease in lung function over time from inflammation triggered by
bacteria and their toxins. Periodic exacerbations in the lung result from
bacterial overgrowth, and may require administration of systemic
antibiotics. Chronic pulmonary infections and associated exacerbations are
implicated as a major cause of morbidity and mortality in CF patients.
The Phase 2, multi-center, international randomized, double-blind,
placebo-controlled study (Mpex 204) is expected to enroll 140 stable CF
patients to evaluate the safety, tolerability and efficacy of three dosage
regimens of MP-376 given once or twice daily for 28 days. The doses of
MP-376 to be used in this study are based on clinical and microbiological
data from a previously completed Phase 1b study in which CF patients
received 14 days of varying doses of MP-376. Data from that study indicated
that all doses were well tolerated and that patients experienced a
reduction in bacterial counts of Pseudomonas aeruginosa in sputum.
The primary efficacy endpoint to be assessed in the Phase 2 study will
be microbiological (change in bacterial counts of Pseudomonas aeruginosa in
sputum) over 28 days of dosing. Additional endpoints and exploratory
analyses will include the time to need for other inhaled or systemic
antibiotics, changes in forced expiratory volume in one second (FEV1), and
patient-reported outcomes.
About MP-376
MP-376 is a proprietary formulation of levofloxacin that has been
optimized for aerosol delivery using a customized configuration of PARI's
highly efficient eFlow(R) electronic nebulizer. Levofloxacin is a
fluoroquinolone antibiotic that has been widely used in a variety of
indications for over a decade and has established safety and efficacy when
administered orally or intravenously against many bacterial pathogens,
including Pseudomonas aeruginosa. Administration of MP-376 with a high
efficiency nebulizer to the lungs allows for the delivery of high
concentrations of active drug directly to the site of infection, while
minimizing systemic exposure. Mpex believes this approach has the potential
to improve bacterial killing and reduce resistance development versus
traditional oral or IV routes of administration.
Preclinical and early clinical studies show that aerosol doses of
MP-376 appear to be safe and well tolerated, and exert an antimicrobial
effect when administered once or twice daily. High concentrations of
levofloxacin in the lung delivered using MP-376 are expected to be active
against CF pathogens, including those resistant to aminoglycosides (e.g.,
TOBI(R)) and other inhaled antimicrobial agents.
About PARI Pharma and the eFlow(R) Electronic Nebulizer
MP-376 is delivered by a novel inhalation device, the eFlow(R)
Electronic Nebulizer, developed by PARI Pharma GmbH. eFlow(R) is a quiet
portable nebulizer that enables efficient aerosolization of liquid
medications via a vibrating perforated membrane. Based on PARI's 100-year
history working with aerosols, PARI Pharma is dedicated to advancing
inhalation therapies by developing innovative delivery platforms and new
pharmaceutical formulations that work together to improve patient care.
About Mpex Pharmaceuticals
Mpex Pharmaceuticals is a clinical stage biopharmaceutical company
whose mission is to develop important new therapies to combat the growing
issue of antibiotic resistance. The company's internal development pipeline
focuses on combining proprietary formulations, PK/PD strategies and novel
potentiating agents with proven antibiotics to overcome or directly inhibit
the molecular mechanisms in bacteria responsible for antibiotic resistance.
Mpex's most advanced product candidate, MP-376, is a proprietary aerosol
formulation of levofloxacin that is being developed clinically as a
maintenance therapy for the prevention of bacterial exacerbations in
patients with cystic fibrosis and severe chronic bronchitis. The company
has also built a discovery and development platform and intellectual
property estate around inhibitors of multi-drug resistant (MDR) efflux
pumps (EPIs) found in many gram-negative bacterial pathogens. Bacterial
efflux of antibiotics is a leading source of multi-drug resistance,
particularly in gram-negative organisms. Mpex compounds have been shown in
both in vitro and in vivo studies to overcome efflux-based resistance to
multiple classes of antibiotics.
Mpex Pharmaceuticals, Inc.
http://www.mpexpharma.com
View drug information on Tobi.
Mpex iniþiazã o Faza 2 studiu clinic ale generatoarelor de aerosoli MP-376 în tratamentul infecþiilor bacteriene cronicã În fibroza chistica Pacienþii - Mpex Initiates A Phase 2 Clinical Trial Of Aerosol MP-376 In The Treatment Of Chronic Bacterial Infections In Cystic Fibrosis Patients - articole medicale engleza - startsanatate