"We designed these studies to determine the rhIGF-1 dosing necessary to normalize IGF-1 levels in IGFD children and to understand how rhIGF-1 dosing affects the relationship between the body's IGF-1 and IGFBP-3 levels," said George Bright, M.D., Tercica's Vice President and Medical Director, Endocrinology. "These findings are significant, as they reveal that irrespective of a child's IGFBP-3 status, or the degree of IGF-1 deficiency, IGFBP-3 levels increase in the blood immediately following a dose of rhIGF-1. These increased IGFBP-3 levels may increase the stability of IGF-1 in the bloodstream, which may help guide the optimal dosing of rhIGF-1 to achieve physiologic IGF-1 replacement, and in turn, optimal growth."
The pharmacokinetic studies were designed to study rhIGF-1 dosing in patients with IGF-1 deficiency (IGFD), and its effect on serum IGF-1 and IGFBP-3 levels. The first single-dose, 36-hour study observed 36 patients (12 patients per group) with either severe IGFD, moderate IGFD, or who were IGF-1 sufficient. The patients were randomized to receive a single subcutaneous injection of rhIGF-1. A second chronic-dosing study was performed in 27 patients with moderate IGFD who received multiple subcutaneous injections of rhIGF-1, with once- or twice-daily dosing, for three weeks.
After chronic dosing, although basal IGFBP-3 levels, as expected, fell, there was still a prompt increase in serum IGFBP-3 levels after each IGF-1 injection. The 63 patients -- ranging in age from 9 to 54 years -- showed consistent post-dose increases in mean +/- serum IGF-1 (200 +/- 86%) and IGFBP-3 (32 +/- 21%). The prompt and dose-related rise in IGFBP-3, synchronized to the rise in IGF-1 levels, suggests that IGFBP-3 is not newly synthesized; rather, it is likely recruited into the blood, and/or IGF-1 is stabilized in serum by its binding to IGFBP-3.
About IGF-1 and Primary IGFD
Insulin-like Growth Factor-1 (IGF-1) is the principal hormone necessary
for statural growth. IGF-1 is released in response to stimulation by growth
hormone. Primary IGFD is diagnosed in children who have normal or elevated
secretion of endogenous growth hormone and whose height and serum IGF-1 levels
are more than two standard deviations below the mean. A sub-set of these
children, whose height and serum IGF-1 levels are more than three standard
deviations below the mean, are diagnosed with Severe Primary IGFD.
Primary IGFD afflicts an estimated 30,000 children evaluated for short stature in the United States. Approximately 6,000 children suffer from Severe Primary IGFD and could become eligible for Increlex therapy if approved by the FDA.
About Tercica
Tercica, Inc. is a biopharmaceutical company focused on the development
and commercialization of products to improve endocrine health. The company's
first product candidate, Increlex(TM) (mecasermin [rDNA origin] injection), or
recombinant human insulin-like growth factor-1 (rhIGF-1), is being developed
for the treatment of short stature and associated metabolic disorders. For
further information on Tercica, please visit http://www.tercica.com.
Safe Harbor Statement
Except for the historical statements contained herein, this press release
contains forward-looking statements, including without limitation the
following: (A) increased IGFBP-3 levels may increase the stability of IGF-1
in the bloodstream, which may help guide the optimal dosing of rhIGF-1 to
achieve physiologic IGF-1 replacement, and in turn, optimal growth; (B) that
Primary IGFD afflicts an estimated 30,000 children evaluated for short stature
in the United States; and (C) that approximately 6,000 children suffer from
Severe Primary IGFD and could become eligible for Increlex(TM) therapy if
approved by the FDA.
Because Tercica's forward-looking statements are subject to risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements.
These factors include without limitation: (1) those risks and
uncertainties disclosed from time to time in reports filed by Tercica with the
SEC, most recently Tercica's Form 10-Q filed on May 16, 2005 and Form 8-K
filed on May 19, 2005;
(2) the results from the studies may not extrapolate to
the larger patient population;
(3)Tercica's estimates might not accurately
reflect the number of children afflicted with Primary IGFD and Severe Primary
IGFD; and
(4) that there would be no product launch if the FDA does not grant
Tercica marketing approval, grants Tercica marketing approval covering so few
patients that it is not commercially reasonable for the Company to launch, or
grants Insmed Incorporated's product marketing exclusivity under the Orphan
Drug Act that would block Tercica from being able to market or sell its
product.
These statements are based on information as of the date hereof, and the Company assumes no obligation to update any forward-looking statement.
SOURCE Tercica, Inc.
Web Site: http://www.tercica.com
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