Message #121 From:
NewsBot Date: December 19, 2006 01:30:00 PM
GILD News Gilead Announces Preliminary Results From Phase III Study of Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Phase III
AIR-CF2 (CP-AI-005) study of aztreonam lysine for inhalation for the
treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas
aeruginosa (P. Aeruginosa) met its primary efficacy endpoint,
the time to need for inhaled or intravenous (IV) antibiotics, which was
assessed by the onset of common symptoms predictive of a pulmonary
exacerbation. Data from the 247-patient study demonstrated a significant
improvement in time to need for inhaled or IV antibiotics after a 28-day
treatment course of aztreonam lysine for inhalation compared to placebo,
both following a 28-day treatment course of tobramycin inhalation
solution (pooled p-value=0.007 by log rank test). The primary efficacy
endpoint analyzed the pooled data from both aztreonam treatment arms, as
pre-specified under a U.S. Food and Drug Administration (FDA) Special
Protocol Assessment (SPA). Full study results will be submitted for
presentation at an upcoming scientific meeting.
The most common treatment-emergent adverse events were cough, productive
cough, nasal congestion, respiratory tract congestion and wheezing. The
incidence of these events did not differ significantly between the
placebo and the aztreonam lysine groups.
“The completion of this study and achievement
of its primary endpoint is an important step toward our goal of
developing aztreonam lysine for inhalation as a new therapeutic option
for people with CF who have pulmonary Pseudomonas aeruginosa,”
said A. Bruce Montgomery, MD, senior vice president, head of Respiratory
Therapeutics, Gilead Sciences. “Gilead
appreciates the continued support and leadership of the Cystic Fibrosis
Foundation, and we thank the patients and investigators who participated
in this study.”
AIR-CF2 Study Design
AIR-CF2 was a randomized, double-blind, placebo-controlled study
designed to assess the safety and efficacy of a 28-day treatment course
with aztreonam lysine, as well as its ability to maintain or improve
clinical status following a 28-day treatment course of tobramycin
inhalation solution therapy in people with CF who have pulmonary P.
Aeruginosa. Patients were randomized to receive 28 days of treatment
with 75 mg of aztreonam lysine or volume-matched placebo administered
twice or three times daily by the eFlow®
Electronic Nebulizer. Following an overall study period of 126 days,
patients were eligible to enter AIR-CF3 (CP-AI-006), an open-label
follow-up study for patients in AIR-CF2 and AIR-CF1 (CP-AI-007).
“We look forward to further defining the role
of both the twice daily and three times daily dosing in our ongoing
open-label study, where we continue to gather longer-term data on more
than 190 patients,” commented Dr. Montgomery.
Data from this analysis have not been reviewed by the FDA. Aztreonam
lysine is an investigational compound and has not yet been determined
safe or efficacious in humans.
About AIR-CF Phase III Clinical Program
AIR-CF2 is one of three Phase III studies in the AIR-CF clinical
program. The program, which also includes AIR-CF1 and AIR-CF-3, is
designed to determine the safety and efficacy of aztreonam lysine for
inhalation for treatment of people living with CF who have pulmonary P.
Aeruginosa.
AIR-CF1 is a double-blind, randomized, placebo-controlled study designed
to assess the safety and efficacy of a 28-day treatment course of
aztreonam lysine for inhalation in people with CF who have pulmonary P.
Aeruginosa. The primary endpoint is the change at Day 28 from
baseline in respiratory symptoms as assessed by the CFQ-R questionnaire
(a patient-reported tool used to measure health-related quality of life
for people with cystic fibrosis). This study will enroll 140 patients,
who will be randomized to receive 28 days of treatment with 75 mg
aztreonam lysine for inhalation or volume-matched placebo administered
three times daily by the eFlow®
Electronic Nebulizer. This study is currently enrolling patients.
AIR-CF3 is an open-label, multi-center study of patients who
participated in the AIR-CF1 or AIR-CF2 studies. The primary objective of
the study is to evaluate the safety of repeated exposure to aztreonam
lysine for inhalation in people with CF. Each patient’s
participation in the study will last up to 18 months. Patients will
receive treatment with 75 mg of aztreonam lysine for inhalation with the
same regimen they received in AIR-CF1 or AIR-CF2 (twice or three times
daily). Patients will receive up to nine 28-day courses of aztreonam
lysine for inhalation, each of which will be followed by a 28-day
off-treatment period.
About Aztreonam Lysine for Inhalation
Aztreonam lysine for inhalation is an antibiotic candidate currently
being studied in Phase III clinical trials as a treatment for people
with CF who have pulmonary P. Aeruginosa. Aztreonam has potent
activity against Gram-negative bacteria such as P. Aeruginosa.
Aztreonam formulated with arginine is a U.S. FDA-approved agent for
intravenous administration. Aztreonam lysine for inhalation is a
proprietary inhaled formulation of aztreonam and has been designated
with orphan drug status by the U.S. FDA. It is delivered through a novel
inhalation device, eFlow®,
developed by PARI GmbH.
About Cystic Fibrosis
Today more than 30,000 people in the United States have CF. CF is a
chronic, debilitating genetic disease. A major characteristic of CF is
production of abnormally thick, sticky mucus in the lungs, trapping
bacteria and predisposing patients to lung infections, which continually
damage their lungs. Pulmonary infection with Gram-negative bacteria,
particularly pulmonary Pseudomonas aeruginosa, represents the
single greatest cause of morbidity and mortality among CF patients.
Currently there is no known cure for CF, and the goal of CF therapy is
to control symptoms and prevent further lung damage.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the
care of patients suffering from life-threatening diseases worldwide.
Headquartered in Foster City, California, Gilead has operations in North
America, Europe and Australia. For more information on Gilead Sciences,
please visit the company's website at www.gilead.com
or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995, that
are subject to risks, uncertainties and other factors, including risks
related to Gilead’s ability to develop and
commercialize this product. For example, the safety and efficacy data
from additional clinical studies may not warrant further development of
this compound and initiating and completing clinical trials may take
longer or cost more than expected. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is cautioned
not to rely on these forward-looking statements. These and other risks
are described in detail in the Gilead Annual Report on Form 10-K for the
year ended December 31, 2005, filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead and Gilead assumes no
obligation to update any such forward-looking statements.
