Rande
Alert...
TXB
Monday March 13, 12:43 pm Eastern Time
Alert: Texas Biotec Says Novastan Helped Patients in Phase III Drug Trials
(AMEX:TXB, health)
(This is a headline-only alert, although it will likely be followed by an article soon)
Monday March 13, 12:30 pm Eastern Time
Company Press Release
SOURCE: Texas Biotechnology Corporation
Pivotal Phase III Clinical Trial Results for NOVASTAN(R) Presented At
The American College of Cardiology Annual Meeting
Presented Data Supports Use of NOVASTAN(R) (Argatroban) as a Treatment For Patients With Heparin-Induced
Thrombocytopenia, HIT
HOUSTON, March 13 /PRNewswire/ -- Texas Biotechnology Corporation (Amex: TXB - news) today announced, at the American College of Cardiology (ACC)
Annual Meeting held in Anaheim, CA, the presentation of Phase III clinical trial results supporting the use of NOVASTAN (argatroban) Injection as anticoagulant
therapy in patients with heparin-induced thrombocytopenia (HIT). Overall, the results of the study showed that NOVASTAN significantly improved patient
outcomes in the primary efficacy endpoint and provided rapid, adequate anticoagulation with no increase in bleeding as compared to the control group.
NOVASTAN is a synthetic direct inhibitor of thrombin, a key factor in the formation of blood clots.
Bruce Lewis, M.D. Associate Professor of Medicine, Loyola University Medical Center and Chief, Section of Cardiology, Catholic Health Partners presented data
from the pivotal trial, which involved 304 patients treated with NOVASTAN compared to 193 historical control patients. Of the 304 patients who received
NOVASTAN -- 160 patients had HIT (patients with a drop in platelets but no thrombosis at baseline) and 144 had HITTS (patients with thrombosis at baseline).
The control group had 147 HIT patients and 46 HITTS patients.
In this clinical trial, data were analyzed and found to be positive using two statistical methodologies: time-to-event and categorical. The primary endpoint of the study
protocol called for the evaluation of all-cause death, all-cause amputation or new thrombosis over a 37 day study period. In the time-to-event analysis, historical
control patients with HIT had a 68% greater risk of experiencing death, amputation or new thrombosis; while historical control patients with HITTS exhibited a 75%
greater risk of experiencing one of the same endpoints. In this analysis, statistical significance in favor of NOVASTAN was achieved in both the HIT and the HITTS
study arms.
The categorical analysis showed a significant improvement in the composite endpoint outcome in patients with HIT and HITTS treated with NOVASTAN versus
those in the historical control group.
In NOVASTAN treated patients there was a significant reduction in new thrombosis and death due to thrombosis in both study arms. Further NOVASTAN treated
patients rapidly achieved adequate anticoagulation and, relative to controls, experienced significant platelet count improvement. Bleeding events, typically a significant
side effect of an anticoagulant therapy, were not different between the groups.
Heparin-induced thrombocytopenia is an immune-mediated syndrome caused by an adverse drug reaction to heparin and occurs in approximately 300,000 patients
receiving heparin. When a patient is diagnosed with HIT, immediate discontinuation of heparin is advocated for managing the patient, however, continued
anticoagulation is often required.
The initial clinical development program for NOVASTAN has focused on developing the drug as an anticoagulant for the treatment of HIT. On February 22, Texas
Biotechnology announced that it had received an approvable letter from the U.S. Food & Drug Administration for NOVASTAN as an anticoagulant for prophylaxis
(prevention) and treatment of thrombosis in patients with HIT.
Under the 1997 agreement with SmithKline Beecham (SB), SB has the rights to market and co-develop NOVASTAN in the United States and Canada as
anticoagulant therapy for patients with HIT. Texas Biotechnology has the right to co-promote NOVASTAN in North America for indications other than HIT.
SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-
the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at www.sb.com.
Texas Biotechnology is a biopharmaceutical company focused on the development and commercialization of small molecule drugs to treat a variety of diseases
including thrombosis, pulmonary hypertension, heart failure and asthma. In addition to NOVASTAN, the Company has two compounds in Phase II development.
The first, sitaxsentan (TBC11251), is an endothelin receptor antagonist that is being developed as a treatment for pulmonary hypertension and heart failure. The
second, TBC1269, is a selectin antagonist that is currently being developed for the asthma market.
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, attainment of required governmental
approval and availability of financing and revenues sufficient to fund development of product candidates and operations. 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 |
