March 24, 2009
Gilead Initiates Phase II Clinical Trial of Cicletanine for the Treatment of Pulmonary Arterial Hypertension
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 24, 2009--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has begun
enrolling patients in a Phase II clinical trial of cicletanine
hydrochloride (cicletanine), an oral agent in development for the
treatment of pulmonary arterial hypertension (PAH). The study is
designed to compare the efficacy, safety and tolerability of cicletanine
to placebo in patients with PAH and will enroll 160 patients at
approximately 60 investigational sites worldwide.
“Preclinical and early clinical data suggest that cicletanine may offer
an alternative oral treatment for PAH, potentially working through a
mechanism of action that differs from existing therapies for this
disease,” said Seigo Izumo, MD, Gilead’s Senior Vice President,
Cardiovascular Therapeutics. “We are pleased to be moving cicletanine
into the next phase of clinical development, as we continue to build a
pipeline of therapies for PAH and other serious cardiovascular diseases
that represent significant unmet medical need.”
About the Cicletanine Phase II Study
The cicletanine Phase II study is a randomized, double-blind,
placebo-controlled, multicenter, dose-ranging study designed to evaluate
the safety, efficacy and tolerability of cicletanine for treatment of
PAH (WHO Group 1). The primary efficacy endpoint is the change from
baseline in six-minute walk distance (6MWD) after 12 weeks of treatment.
Secondary endpoints include time to clinical worsening of PAH during the
12-week placebo-controlled treatment period and change from baseline
after 12 weeks in Borg dyspnea index (BDI, a measure of breathing
ability), WHO functional class, SF-36®Health Survey physical
functioning scale and various hemodynamic measures. Eligible patients
include those not currently receiving treatment for PAH as well as those
who are currently being treated with an approved endothelin receptor
antagonist (ERA).
A total of 160 patients (40 per treatment arm) will be randomized
(1:1:1:1) to receive either placebo, 150 mg cicletanine administered
once daily, 150 mg cicletanine administered twice daily or 300 mg
administered once daily. Patients who complete the 12-week
placebo-controlled period will be eligible for long-term treatment with
cicletanine.
Additional information about the study can be found at www.clinicaltrials.gov.
About Cicletanine
Cicletanine is an oral agent invented and developed by Ipsen (Euronext:
IPN), an international specialty pharmaceutical group. Cicletanine is
approved in certain European countries as a once-daily monotherapy
treatment for hypertension. Endothelial dysfunction, known to play a
role in hypertension and PAH, is associated with a deficiency in
vascular nitric oxide. Current data suggest that cicletanine may enhance
vascular nitric oxide availability and vasorelaxation. While the
relationship between endogenous vascular nitric oxide concentrations and
PAH pathology remains unclear, the positive effects of providing
supplemental nitric oxide to PAH patients have been demonstrated,
indicating that enhancement of endogenous nitric oxide concentrations
with cicletanine may prove beneficial.
In July 2005, Ipsen licensed to Navitas Assets LLC, patents and know-how
to develop and distribute (i) cicletanine combination therapy worldwide
and (ii) cicletanine monotherapy in the United States. Ipsen retains
monotherapy rights outside the U.S. In May 2008, Gilead acquired all of
the Navitas assets related to cicletanine.
Cicletanine has been granted orphan drug status for treatment of PAH by
the U.S. Food and Drug Administration (FDA). Cicletanine is an
investigational therapy and has not yet been determined safe or
efficacious in humans.
About Pulmonary Arterial Hypertension
PAH is a debilitating disease characterized by constriction of the blood
vessels in the lungs leading to high pulmonary arterial pressures. These
high pressures make it difficult for the heart to pump blood through the
lungs to be oxygenated. Patients with PAH suffer from shortness of
breath as the heart struggles to pump against these high pressures,
causing such patients to ultimately die of heart failure. PAH can occur
with no known underlying cause, or it can occur secondary to diseases
such as connective tissue disease, congenital heart defects, cirrhosis
of the liver and HIV infection. PAH afflicts approximately 200,000
patients worldwide.
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.
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 the
risks related to our ability to enroll patients in the Phase II clinical
trial as planned, the possibility of unfavorable results of the clinical
trial, the need to modify or delay our clinical trial or to perform
additional trials and the risk of failing to obtain FDA and other
regulatory body approvals. As a result, cicletanine for PAH may never be
successfully commercialized. Further, we may make a strategic decision
to discontinue development of cicletanine for PAH if, for example, we
believe commercialization will be difficult relative to other
opportunities in our pipeline. 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 Gilead’s Annual Report on Form 10-K for the
year ended December 31, 2008, as 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.
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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Nathan
Kaiser, 650-522-1853 (Media)
