To: keokalani'nui who wrote (813 ) 6/26/2001 10:26:03 AM From: keokalani'nui Read Replies (1) | Respond to of 834 Texas Biotechnology and Revotar Biopharmaceuticals AG Initiate Phase I Study With Novel Selectin Antagonist, TBC1269 HOUSTON and BERLIN, June 26 /PRNewswire/ -- Texas Biotechnology Corporation (Nasdaq: TXBI - news) and Revotar Biopharmaceuticals AG announced today the initiation of a Phase I study using the inhaled formulation of bimosiamose, a selectin antagonist formally referred to as TBC1269. The Phase I trial reflects the decision of Texas Biotechnology and Revotar Biopharmaceuticals to develop bimosiamose as an inhaled therapy for asthma. The Phase I clinical trial is a double-blind, placebo-controlled ascending single inhaled dose study designed to determine the safety and tolerability of bimosiamose in 48 healthy volunteers. Richard A. F. Dixon, Ph.D., Senior Vice President and Chief Scientific Officer, at Texas Biotechnology stated, ``Selectins are a family of cell- surface proteins that mediate cell rolling -- the first step in causing white bloods cell to slow down and adhere to the vascular endothelium in response to inflammation or to tissue injury. We believe that blocking these proteins represents a new therapeutic approach for treating many inflammatory diseases.'' Dr. Dixon added, ``The initiation of this trial by Revotar allows us to move forward with the development of this very novel and potentially useful compound. We expect Revotar will also be instrumental in the development and testing of a topical formulation of bimosiamose in patients with psoriasis.'' Rainer Zahlten, M.D., Vice President of Clinical Development at Revotar Biopharmaceuticals stated, ``Based on both the preclinical and clinical results we have seen with this novel compound, we expect that bimosiamose may be of value as a biological response modifier to assist in interrupting the inflammatory process. The fact this compound appears to have a calming effect on inflamed, sensitive airways by reducing airway hyper-activity make it an ideal candidate for the treatment of asthma -- a growing condition that is currently not well-treated by existing therapies.'' Asthma is a chronic inflammatory disorder of the airways that affects over 100 million people worldwide. Prevalence is on the rise, most rapidly among children. Current treatment regimens include bronchodilator medications and corticosteriods. The selectin family of cell adhesion molecules is comprised of three structurally related calcium-dependent carbohydrate binding proteins, E-, P-, and L-selectin. As these three proteins tend to work together to support the inflammatory process, scientists at Texas Biotechnology believe that blocking all three has the potential to provide substantial efficacy and be well- tolerated. In a prior Phase IIa ``proof of concept'' asthma trial using the I.V. formulation, bimosiamose demonstrated statistically significant improvements over placebo as measured by eosinophil recruitment. Eosinophils are white blood cells that are involved in many inflammatory diseases, including asthma. Reductions in lung eosinophils have been shown to improve the course of an asthmatic response. Texas Biotechnology owns 55.2% of Revotar Biopharmaceuticals which it obtained in exchange for licensing bimosiamose to Revotar. Texas Biotechnology has retained North American territorial rights to bimosiamose, but all costs to develop the product for asthma and psoriasis will be borne by Revotar, which has the European rights.