timewarp:
Transition begins enrolment for E1-I.N.T.
2005-09-12 09:48 ET - News Release
Dr. Tony Cruz reports
TRANSITION THERAPEUTICS COMMENCES ENROLMENT OF ITS LEAD REGENERATIVE THERAPY, E1-I.N.T.(TM), IN TYPE II DIABETES PATIENTS
Transition Therapeutics Inc. is beginning patient enrolment for its lead regenerative therapy, E1-I.N.T., in an exploratory phase IIa clinical trial in type II diabetes patients. E1-I.N.T. is a short-course combination therapy aimed at stimulating the regeneration of the body's insulin-producing cells, called islet cells.
"Expansion into type II diabetes significantly broadens the number of patients that can benefit from an islet cell regeneration therapy," said Dr. Tony Cruz, chairman and chief executive officer of Transition. "For these patients, an islet cell regeneration therapy could eliminate the need for daily insulin injections and the many potentially serious complications that are associated with long-term insulin usage."
In this placebo-controlled study, a total of 30 type II diabetes patients will be enrolled. Of these patients, 20 will receive daily treatments of E1-I.N.T. and 10 will receive placebo for 28 days. The patients will be followed for six months after treatment and monitored for islet cell function parameters. The principal investigator of the study is Dr. Sherwyn Schwartz, a noted diabetes researcher and director of the Diabetes and Glandular Disease Clinic in San Antonio, Tex. Interim data from this trial are expected in the fourth quarter of 2005.
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, commenced enrolment for exploratory phase IIa clinical trials to evaluate the efficacy, safety and tolerability of E1-I.N.T. in type I and type II 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, which 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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