24th Jun 2005 07:00
BTG PLC24 June 2005 BTG plc: Publication of positive data from TRX4 type 1 diabetes study London, UK, 24 June 2005: BTG plc (LSE: BGC), the medical innovations company,notes that TolerRx, Inc., BTG's licensee for the anti-CD3 technology, hasannounced publication of positive Phase II data on TRX4 (ChAglyCD3), showingthat a six-day course of TRX4 therapy in patients with type 1 diabetes reducedthe amount of insulin needed to control blood glucose levels for at least 18months. Louise Makin, Chief Executive Officer of BTG, commented: "This study suggests TRX4 could be a real step forward in the treatment of type1 diabetes. We look forward to further progress by TolerRx in developing thisnovel therapy." TRX4 is one of six pharmaceuticals commercialised by BTG that are currentlyunder clinical development by BTG's licensees. BTG has three other productsundergoing clinical studies prior to commercialisation. The full text of the announcement by TolerRx follows. POSITIVE DATA FROM TYPE 1 DIABETES STUDY OF TOLERRX'S TRX4 PUBLISHED IN THE NEWENGLAND JOURNAL OF MEDICINE Short-term Administration with Novel Drug Candidate Significantly ReducesInsulin Need in Newly Diagnosed Type 1 Diabetics Cambridge, Mass., June 23, 2005 -- A study published in the June 23 issue of theNew England Journal of Medicine demonstrates that in patients with type 1diabetes, a six day course of therapy with TRX4 (ChAglyCD3) preserves thefunction of insulin-producing beta cells in the pancreas and reduces the amountof administered insulin needed to control blood glucose levels for at least 18months. The study was conducted by a team of clinicians and researchers from France,Belgium, Germany, and England and led by Dr. Lucienne Chatenoud, from theHopital Necker in Paris, as the Principal Investigator and Dr. Bart Keymeulen,from the Academic Hospital at Brussels Free University - VUB, as the clinicalcoordinator. The trial was undertaken by the JDRF Center for Beta Cell Therapyin Europe, directed by Dr. Daniel Pipeleers (Brussels Free University - VUB).The study was supported by the Juvenile Diabetes Research Foundation and wasperformed in collaboration with Dr. Herman Waldmann and his laboratory at theUniversity of Oxford. TolerRx, Inc. is developing TRX4 for the treatment ofpatients with autoimmune diseases, including type 1 diabetes and psoriasis. "Maintaining or improving beta cell function is a major achievement in thetreatment of type 1 diabetics," stated Dr. Chatenoud. "The results suggest thatTRX4 therapy results in greater endogenous insulin production and acorresponding reduction in administered insulin need. TRX4 therapy would beexpected to result in better long-term metabolic control for these patients." "We are very encouraged by the results of this study and the implications it hasfor modifying the disease course in patients with type 1 diabetes," said DouglasJ. Ringler, V.M.D., President and CEO of TolerRx. "We look forward to workingwith our dedicated investigators and regulatory agencies so that TRX4 can bedefinitively established as the accepted inductive therapy for type 1 diabetes." Study Results The multicenter study included 80 subjects recently diagnosed with type 1diabetes. Subjects in the trial were randomly assigned to receive either TRX4(ChAglyCD3) or placebo for only six consecutive days. During the 18 monthsfollowing treatment, subjects were monitored for daily insulin needs andendogenous insulin production as assessed by measuring C-peptide release inducedby an intravenous glucose infusion. At six, 12, and 18 months, beta cellfunction was more effectively maintained in TRX4-treated subjects than inplacebo-treated subjects. Daily insulin dose increased in the placebo group, but not in the TRX4 group.The effect of TRX4 was most pronounced in the patient subgroup with better(greater than the median) beta cell function at study start. In this subgroup,mean insulin dose at 18 months was 0.22 IU/kg/day versus 0.61 IU/kg/day in thecorresponding placebo subgroup (pRelated Shares:
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