To: Sleepman who wrote (704 ) 6/9/1998 6:03:00 PM From: Bryan Stone Read Replies (1) | Respond to of 834
Texas Biotechnology Updates Stockholders at 1998 Annual Meeting HOUSTON, June 9 /PRNewswire/ -- Texas Biotechnology Corporation (Amex: TXB) At the 1998 Annual Meeting of Stockholders, held June 9, 1998, David B. McWilliams, President and Chief Executive Officer, reviewed recent developments regarding NOVASTAN(R) (argatroban), Texas Biotechnology's lead product that has been developed initially as a treatment for heparin-induced thrombocytopenia, the two Phase IIA products, TBC11251 and TBC1269, and several of the Company's key research and development programs. Regarding NOVASTAN, Mr. McWilliams stated, "At the time we received the non-approvable letter from the U.S. Food & Drug Administration (FDA), we indicated that Texas Biotechnology would request a meeting with FDA to establish a plan of action on how best to respond to their questions. While we have not yet met with FDA, we have received the Agency's written reviews. Currently, we believe that it will be possible to resubmit the New Drug Application this year and remain committed to satisfying FDA's requirements for market clearance." The Company also reported that TBC11251, the Company's endothelin A receptor antagonist that is being evaluated in an ongoing Phase IIA study for congestive heart failure, has completed patient enrollment. This study, originally designed to recruit up to 45 patients, was terminated early due to the achievement of statistically significant results in 24 patients. Based on these initial results, a second arm of the study, involving another 24 patients, was initiated to test additional dosing regimes. Initial results for this recently completed final arm of the Phase IIA trial are expected in the third quarter. At the meeting, the Company reiterated its intent to secure a corporate partner for TBC11251. TBC1269, the Company's selectin antagonist, is being developed as a treatment for acute asthma. The Phase IIA results for this study involving 20 patients are expected to be available in the third quarter. Also included in the update to shareholders was a discussion of the Company's financial condition, which continues to be characterized by a strong cash position, $40,485,000 as of March 31, 1998. 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 CO: Texas Biotechnology Corporation ST: Texas IN: MTC FIN SU: 06/09/98 17:08 EDT prnewswire.com