Transition receives clearance for E1-I.N.T. trials
Transition Therapeutics Inc (TSX:TTH)
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Last Close 10/13/2004 $1.15
Thursday October 14 2004 - News Release
Dr. Tony Cruz reports
TRANSITION THERAPEUTICS' RECEIVES CLEARANCE TO INITIATE A CLINICAL TRIAL FOR E1-I.N.T.(TM) IN TYPE 1 DIABETICS
Transition Therapeutics Inc. has received clearance from the United States Food and Drug Administration (FDA) to initiate a clinical trial for its lead diabetes product, E1-I.N.T., in type I diabetes patients. This clinical trial will be evaluating efficacy, safety and tolerability of a 28-day course of daily E1-I.N.T. treatments with a six-month follow-up. E1-I.N.T. is a short course combination therapy aimed at stimulating the regeneration of the body's insulin-producing cells. "With our lead diabetes and MS products in patient efficacy studies, Transition continues to execute its business strategy of simultaneously advancing multiple products through clinical development," said Dr. Tony Cruz, chairman and chief executive officer of Transition.
This clinical study will be conducted in clinical centres in the United States. In the near future, Transition plans to expand these trials into type II diabetes patients.
The I.N.T. technology platform, covered by a broad patent portfolio, is based on the discovery that a short course of injections of naturally occurring peptides can regenerate insulin-producing cells in the body. Two lead I.N.T. products are currently under development: 1) E1-I.N.T., a combination of Transition's epidermal growth factor analogue (E1) and gastrin analogue (G1), has completed two phase I clinical trials and has received clearance to initiate a clinical trial to evaluate efficacy, safety and tolerability in diabetes patients; and 2) GLP1-I.N.T., a combination of one of the leading diabetes drug candidates, Glucagon-Like-Peptide-1 (GLP-1), with G1, is currently in preclinical development. In August, 2004, Transition licensed these products to Novo Nordisk A/S for upfront and milestone payments worth up to $48-million (U.S.) plus commercial milestones and royalties.
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