Conference Call Scheduled for Today at 7:30 a.m. EDT
HOUSTON, Sept. 14 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals
(Nasdaq: ENCY) today announced interim, topline results from its ongoing
study, STRIDE-2X, evaluating Thelin(TM) (sitaxsentan sodium) and bosentan in
patients with pulmonary arterial hypertension (PAH). This analysis was
conducted for submission to global regulatory authorities.
STRIDE-2X is an extension study of patients enrolled in STRIDE-2, the
Company's second pivotal Phase III trial for Thelin. In the 229-patient
extension trial, 145 patients received open-label Thelin at the recommended
100 mg dose and 84 patients received open-label bosentan dosed according to
its package insert.
Interim topline efficacy results were as follows:
* The mean exposure time for patients treated with Thelin exceeded that
of patients treated with bosentan (43 and 35 weeks, respectively,
p<0.01), due to a higher discontinuation rate in bosentan patients
(37%) than in Thelin patients (21%, p<0.01).
* Median changes from baseline in six minute walk (6MW) were similar for
Thelin patients (17-30 meters) and bosentan patients (17-23 meters) at
three, six, nine and 12 months of therapy (p>0.8 for all time points).
Median endpoint changes were heavily affected by dropouts; the
difference in median 6MW between Thelin (18 meters) and bosentan
(0 meters) was not significant.
* Regarding clinical worsening, over the first year of therapy, 30% of
patients treated with bosentan have experienced a worsening event
versus 20% of patients receiving Thelin (p=0.03).
* Kaplan-Meier estimates of time to World Health Organization (WHO)
class improvement and deterioration were similar for the two drugs
(p>0.1).
Interim topline safety results were as follows:
* The one-year risk of developing liver function abnormalities measured
by Kaplan-Meier analysis was 4% for Thelin patients and 14% for
bosentan patients (p=0.01), with a one-year risk of discontinuation
due to liver function abnormalities of 1% for Thelin patients and 9%
for bosentan patients (p<0.01).
* Patient deaths occurring in the trial have been rare in both groups
with 3.4% of Thelin patients and 3.6% of bosentan patients dying
during the first 12 months (p>0.6).
"These results expand and extend the data observed at 18 weeks in the
STRIDE-2 trial," commented Terrance Coyne, M.D., Chief Medical Officer; Vice
President, Clinical Development of Encysive Pharmaceuticals. "It must be kept
in mind that this trial is ongoing and, as such, the final results may differ.
We look forward to presenting and publishing this data in greater detail in
the future."
Conference Call Information
A conference call is scheduled for Wednesday, September 14, at
7:30 a.m. EDT. The access number for the call is:
Number: (612) 332-0228
Passcode: Encysive Pharmaceuticals
A replay of the call will begin today at 9:15 a.m. EDT, and be available
until September 21, 2005 at 11:59 p.m. EDT. The call replay can be accessed
by dialing:
Number: (320) 365-3844
Access Code: 796084
About STRIDE-2X
STRIDE-2X is the extension study for the placebo-controlled pivotal trial
STRIDE-2. Data for all patients up to one year of active treatment are
included in this analysis. In STRIDE-2, patients were randomized between
double-blind placebo, Thelin 50 mg once daily, Thelin 100 mg once daily or
open-label bosentan for 18 weeks. Patients completing STRIDE-2 from the
Thelin 100 mg or bosentan arms were eligible to enter STRIDE-2X where they
remained on the same therapy. Placebo and Thelin 50 mg patients who completed
the 18 weeks of STRIDE-2 or discontinued prematurely were eligible to enter
STRIDE-2X. Placebo patients entering STRIDE-2X were randomized to Thelin 100
mg or bosentan. Thelin 50 mg patients who chose to participate in STRIDE-2X
were placed in the Thelin 100 mg arm. Patients from the placebo or Thelin
50 mg arms that chose not to enter the extension are excluded from this
analysis because they never experienced active therapy. Premature
discontinuations from the bosentan or Thelin 100 mg arms in STRIDE-2 are
included. Per the STRIDE-2 analysis plan, patients requiring the addition of
new PAH therapies were counted as a clinical worsening event and terminated
from the trial, even if they stayed on bosentan or Thelin therapy. Patients
who have completed one year of active therapy are being transitioned to
routine care for continuation of therapy with Thelin (in STRIDE-3) or
bosentan.
About Thelin and PAH
Thelin is a small molecule that blocks the action of endothelin, a potent
mediator of blood vessel constriction and growth of smooth muscle in vascular
walls. Endothelin receptor antagonists may prove to be effective in the
treatment of a variety of diseases where the regulation of vascular
constriction is important. Thelin is 6,500-fold selective in the targeting of
the endothelin A receptor versus the endothelin B receptor.
Pulmonary arterial hypertension (PAH) is a condition that involves high
blood pressure and structural changes in the walls of the pulmonary arteries,
which are the blood vessels that connect the right side of the heart to the
lungs. PAH causes shortness of breath, limits activity, and is eventually
fatal unless treated successfully with heart/lung or lung transplantation.
PAH is estimated to afflict approximately 100,000 to 200,000 people worldwide,
many of whom are children and young women.
The most frequent adverse events that occurred in patients receiving
Thelin, which were more common than in placebo-treated patients, were
headache, edema, nausea, upper respiratory tract infection, dizziness,
insomnia, nasopharyngitis, and nasal congestion. Because Thelin inhibits the
metabolism of warfarin, a decreased dose of warfarin is needed when
co-administered with Thelin.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in
the discovery, development and commercialization of novel, synthetic, small
molecule compounds to address unmet medical needs. Our research and
development programs are predominantly focused on the treatment and prevention
of interrelated diseases of the vascular endothelium and exploit our expertise
in the area of the intravascular inflammatory process, referred to as the
inflammatory cascade, and vascular diseases. We have successfully developed
one FDA-approved drug, Argatroban, for the treatment of heparin-induced
thrombocytopenia that is marketed by GlaxoSmithKline. The NDA for our lead
drug candidate Thelin(TM) (sitaxsentan sodium), an endothelin A receptor
antagonist for the treatment of PAH, is now under active review by the
Cardio-Renal Division of the FDA. The European Agency for the Evaluation of
Medicinal Products is currently reviewing a Marketing Authorization
Application for approval of Thelin within the European Union. In addition, we
have an earlier stage clinical product candidate in development, TBC3711, a
next generation endothelin receptor antagonist. To learn more about Encysive
Pharmaceuticals please visit our web site: http://www.encysive.com .
This press release contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. These forward-looking
statements are subject to certain risks, trends and uncertainties that could
cause actual results to differ materially from those projected. Among those
risks, trends and uncertainties are our estimate of the sufficiency of our
existing capital resources, our ability to raise additional capital to fund
cash requirements for future operations, timelines for initiating new clinical
trials, planned announcements of clinical data, the possibility of obtaining
regulatory approval, our ability to manufacture and sell any products,
potential drug candidates, their potential therapeutic effect, market
acceptance or our ability to earn a profit from sales or licenses of any drug
candidate, our ability to discover new drugs in the future, and our ability to
establish future collaborative arrangements. In particular, careful
consideration should be given to cautionary statements made in the various
reports Encysive, including as Texas Biotechnology Corporation, has filed with
the Securities and Exchange Commission. Encysive undertakes no duty to update
or revise these forward-looking statements.
SOURCE Encysive Pharmaceuticals Inc.
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Related links:
http://www.encysive.com
CONTACT:
investors, Ann Tanabe of Encysive
Pharmaceuticals Inc., +1-713-796-8822; or Marcy Strickler of The
Trout Group, +1-212-477-9007, ext. 27; or media, Dan Budwick of
BMC Communications, +1-212-477-9007, ext. 14, both for Encysive
Pharmaceuticals Inc.
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