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HOUSTON, May 22 /PRNewswire/ -- Texas Biotechnology Corporation
(AMEX: TXB) today announced the results of its Phase III clinical trial,
ARG-911, evaluating NOVASTAN(R) (brand of argatroban) as anticoagulant
therapy for patients with heparin-induced thrombocytopenia (HIT) and
heparin-induced thrombocytopenia and thrombosis syndrome (HITTS). The data,
which will be presented at the annual conference of the International Society of
Thrombosis and Hemostasis on June 12, demonstrated statistical significance in
the primary efficacy endpoint, assessed by an overall composite index. The index
included evaluation of development of new thrombosis, amputation and death.
The index was improved by 19.2% in the HIT population (p= 0.022) and by
20.3% in the HITTS population (p= 0.003). The trial demonstrated that
NOVASTAN was effective in resolving the clinically significant
thrombocytopenia by producing increases in platelet counts of 129% (p= <0.001)
in HIT patients. Platelet counts in HITTS patients improved by 198% (p=
<0.001). ARG-911 was a multi-center study that compared 304 patients treated
with argatroban for up to 14 days (160 with HIT and 144 with HITTS), with 217
historical control patients (108 with HIT and 109 with HITTS). The thrombotic
composite outcome, defined as development of new thrombosis, amputation due
to ischemic complications and death due to thrombosis, was improved in the
treated population by 73.4% (p= <0.001) in HIT patients and 43.8% (p= <0.001)
in HITTS patients.
Development of new thrombosis, a component of the thrombotic index, was reduced by
72.7% (p= <0.001) and 54.4% (p= <0.001) in the HIT and HITTS populations
respectively. A second component of the thrombotic index, death due to thrombosis, was
reduced by 100% (p= 0.013) in the HIT population and by 90.4% (p= 0.002) in the
HITTS population. There was no change in the number of amputations due to ischemic
complications, the third major component of the thrombotic composite. However, the
data indicate that the majority of amputations were deemed necessary prior to a patient
entering the trial. The thrombotic composite endpoint demonstrated greater improvement
versus the overall composite index. This resulted from the NOVASTAN-treated
population being substantially more compromised than the historical control group at
baseline, leading to a greater incidence of death, which is attributable to pre-existing
conditions. There was no increase in major bleeding, the most common side effect of
anticoagulant therapy, in the argatroban-treated population. Minor bleeding, which was
reported as slightly higher in the treated population, was both quickly resolved and not
considered clinically serious. David B. McWilliams, President and Chief Executive Officer
of Texas Biotechnology, said, "We believe these data demonstrate the potential of
NOVASTAN for use as an anticoagulant in patients with both HIT and HITTS. Based
on these results, we will continue to move forward as quickly as possible with the NDA
submission for NOVASTAN."
NOVASTAN is a small molecule direct thrombin inhibitor being developed by Texas
Biotechnology in the U.S. and Canada for use in the injectable anticoagulant market. The
Company has two broad clinical programs for the development of the compound. The
first is for HIT, a serious allergic reaction to heparin, the most widely used injectable
anticoagulant. Currently, there is no viable alternative in the United States to heparin for
patients who develop HIT. Texas Biotechnology is also evaluating NOVASTAN as an
adjunct to thrombolytic agents including t-PA and streptokinase in acute myocardial
infarction. Both programs are being developed in partnership with Synthelabo, a
pharmaceutical unit of L'Oreal, that will market NOVASTAN in Europe. This press
release contains forward-looking information that is 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 attainment of research and clinical goals
of product candidates. In particular, careful consideration should be given to cautionary
statements made in the various reports Texas Biotechnology has filed with the Securities
and Exchange Commission. SOURCE Texas Biotechnology Corporation
(Copyright 1997) |
