Results and Additional Analyses From Study Show That Corthera's Relaxin for Acute...

Results and Additional Analyses From Study Show That Corthera's Relaxin for
Acute Heart Failure is the Strongest Predictor of Improved Longer-Term
Outcomes Following Hospital Discharge When Compared to Other Variables

Data from Phase II/III Study Presented at Heart Failure Congress 2009
Demonstrate Promising Safety and Efficacy Results for Relaxin
SAN MATEO‚ Calif.‚ June 1 /PRNewswire/ -- Corthera Inc. today announced that
the results and additional statistical analyses conducted from Pre-RELAX-AHF,
the Phase II portion of a Phase II/III multicenter, randomized, double-blind,
international study, showed that relaxin, the company's investigational drug
for the treatment of acute heart failure (AHF), was the strongest independent
predictor of improved longer-term outcomes following hospital discharge when
compared to other variables.
The new analyses of predictors of 60-day and 180-day outcomes, which included
univariate and multivariate regression analyses, were presented today by Marco
Metra, M.D., professor of cardiology at the University of Brescia, Italy, and
co-principal investigator of the Pre-RELAX-AHF study, during a late-breaking
clinical trials session at the annual meeting of the Heart Failure Association
of the European Society of Cardiology (HFA-ESC 2009) in Nice, France.
Several variables, including baseline patient characteristics, early
improvement in dyspnea (breathlessness) to day five, physician-determined
occurrence of worsening of heart failure (WHF) during hospitalization,
increased serum creatinine during hospitalization and relaxin administration,
were included in the model to determine the important predictors of the two
outcome measures: 60-day cardiovascular (CV) death or re-admission for heart
failure and 180-day CV death. In the 60-day multivariate analysis, relaxin
treatment was the strongest predictor of less CV death or heart failure
re-admission (p<0.01). Blood urea nitrogen (BUN) on admission (p=0.02) and
WHF during hospitalization (p=0.02) were also significant predictors. Relaxin
treatment was the only significant variable (p<0.01) in both the multivariate
and univariate analyses predicting CV death at 180 days.
"These new analyses, when added to the main results of Pre-RELAX-AHF, provide
further indications that relaxin may be an important new therapy for patients
admitted to hospital with acute heart failure," said Dr. Metra.
Five peer-reviewed posters with data and analyses from Pre-RELAX-AHF were also
presented today. The insights from these analyses provided further evidence on
the types of patients who might benefit from therapy with relaxin, as well as
the mechanisms by which relaxin causes these clinical benefits.
"There is a clear and urgent need for improved therapies for patients with
acute heart failure," said Piotr Ponikowski, M.D., Ph.D, head of the
department of cardiology at the Clinical Military Hospital in Wroclaw, Poland,
a principal investigator of the Pre-RELAX-AHF study and president-elect of the
Heart Failure Association of the European Society of Cardiology. "We are
encouraged by the preliminary results of the Pre-RELAX-AHF study, and we look
forward to confirming them in the larger Phase III study, RELAX-AHF-1."
Stan Abel, CEO of Corthera, added, "Acute heart failure is a global medical
problem. The recognition of this problem by the international cardiology
community underscores the important need for new therapies and the promise
that relaxin holds for patients."
Dr. Metra also presented the main results from Pre-RELAX-AHF for the first
time in Europe on May 31 at the Judges' Choice oral abstracts session at
HFA-ESC 2009. These results were previously presented at the American College
of Cardiology's (ACC) 58th Annual Scientific Session and published in the
Lancet. The data from 234 patients in eight countries showed that when relaxin
was administered with standard-of-care therapy for acute heart failure,
relaxin caused rapid, substantial and sustained relief from dyspnea
(breathlessness). Relaxin also demonstrated consistent trends in improvement
of the hospital course of patients, prevention of heart failure worsening
during hospitalization, shortening of in-hospital stay and improved
longer-term outcomes following discharge when compared to placebo.
Corthera's Pre-RELAX-AHF/RELAX-AHF study is a Phase II/III, multicenter,
randomized, double-blind, placebo-controlled, parallel-group, international
trial designed to evaluate the efficacy and safety of relaxin for the
treatment of AHF. In the Phase II Pre-RELAX-AHF study, the objective was
proof-of-concept and dose and endpoint selection. Patients selected for the
study presented to the hospital with dyspnea due to AHF and with normal or
elevated blood pressure. In the Phase III RELAX-AHF study, the objective is to
confirm safety and efficacy. The Pre-RELAX-AHF/RELAX-AHF study was designed
and conducted in collaboration with Momentum Research, headed by Dr. Gad
Cotter, a noted heart failure expert.

Patients in the Pre-RELAX-AHF study were randomly assigned to receive
intravenous relaxin at doses of 10, 30, 100, or 250 mcg/kg/day or placebo for
two days. The study indicated that the 30-mcg/kg dose of relaxin (relaxin-30)
was the most effective. More patients, approximately 40%, reported moderate or
marked improvements in dyspnea at six, 12 and 24 hours when treated with
relaxin-30, as compared to 23% of patients assigned to placebo (p=0.04).
Relief remained significantly greater at day 14. Researchers also noted trends
with relaxin toward greater weight loss, less need for intravenous diuretics,
and less worsening of heart failure in the hospital. When all of the doses of
relaxin were compared with placebo, hospital stay was one to two days shorter.
Relaxin had a good safety profile in the study.

Following 60 days, 3% of patients in the relaxin-30 group had been
rehospitalized for heart failure and no patients died of cardiovascular
causes, as compared to 17% in the placebo group (p=0.06), a greater than 80%
reduction. After an average follow-up of four-and-a-half months, no patients
in the relaxin-30 group had died of cardiovascular causes, as compared to 14%
of those in the placebo group (p=0.046).

According to U.S. data, there are more than 3 million hospital discharges each
year with heart failure as a diagnosis, with significant short-term
rehospitalization and one-year mortality rates. It is the single largest
expense to Medicare, accounting for more than $13 billion in hospitalization
costs. The great majority of acute heart failure patients have fluid
accumulation in the lungs (congestion) that causes shortness of breath
(dyspnea) and other complications. For these patients, the current standard of
care includes diuretics and vasodilators. Available agents from both of these
classes of agents have been associated with renal impairment, hypotension and
adverse outcomes.

About Relaxin
Relaxin is a naturally occurring peptide hormone that acts as a systemic and
renal vasodilator. Elevated levels of relaxin modulate increases in renal and
cardiac function that meet the increased hemodynamic demands of pregnancy.
Consistent with this natural role of the hormone, pharmaceutically
manufactured relaxin has been shown to have these effects in multiple human
studies of men and non-pregnant women, including patients with heart failure.

About Corthera
Corthera Inc. is a private biopharmaceutical company committed to acquiring,
developing and commercializing therapies for illnesses in the acute care
setting. Corthera's lead product candidate, relaxin, is currently being
evaluated in clinical trials for the treatment of acute heart failure. The
company has worldwide rights to develop and commercialize relaxin. For more
information, visit www.corthera.com.

Contact: David Schull or Andreas Marathovouniotis
Russo Partners
(212) 845-4271
(212) 845-4235
david.schull@russopartnersllc.com
andreas.marathis@russopartnersllc.com

SOURCE Corthera Inc.

David Schull, +1-212-845-4271, david.schull@russopartnersllc.com; or Andreas
Marathovouniotis, +1-212-845-4235, andreas.marathis@russopartnersllc.com, both
of Russo Partners, for Corthera Inc.