FRAMINGHAM, Mass., Sept. 6 /PRNewswire-FirstCall/ -- GTC Biotherapeutics, Inc. ("GTC," Nasdaq: GTCB) announced that the results from its pharmacokinetic (PK) study of recombinant human antithrombin III (rhATIII) in patients with a hereditary deficiency (HD) of antithrombin were presented today at the British Society for Haemostasis and Thrombosis (BSHT) Annual Scientific Meeting being held at the University of Leicester in Leicester, England.
There were 15 healthy adult HD patients in the PK study, with each patient monitored over a six-day period. Infusion of rhATIII was well tolerated and no serious adverse drug reactions were reported. The study showed that administration of rhATIII produced an increase in plasma antithrombin activity similar to that observed when plasma-derived antithrombin products are used in routine clinical practice. A dosing regimen based on this data has now been developed for an efficacy trial, which is expected to begin before the end of 2002.
"We look forward to beginning the efficacy trial for rhATIII in patients with a hereditary deficiency," stated Geoffrey F. Cox, GTC's Chairman, President and CEO. Dr. Cox continued, "This is expected to be the last clinical study required before GTC files for market authorization for rhATIII in Europe in the first half of 2004."
GTC produces bulk rhATIII from the milk of transgenic goats. Clinical-grade rhATIII is purified from the bulk milk product. The human antithrombin blood protein has anticoagulant and anti-inflammatory properties. Individuals with a deficiency of antithrombin are at risk to develop thrombosis, particularly during situations such as trauma, surgery, pregnancy and childbirth. About 1 in 5,000 people have a hereditary deficiency of antithrombin.
GTC Biotherapeutics develops therapeutic proteins in the milk of transgenic animals. GTC has more than a dozen programs and one product in clinical trials. These programs are focused on developing both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional bioreactor systems. GTC's lead program is rhATIII. Many of GTC's other programs are developing monoclonal antibodies and immunoglobulin fusion proteins for conditions such as rheumatoid arthritis, HIV/AIDS and cancer. Additional information is available on the GTC web site, gtc-bio.com. |
