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Tercica Completes Enrollment of Clinical Trial MS308 Evaluating Once-Daily Treatment With Increlex in Children With Primary IGFD

Posted on: Thursday, 31 May 2007, 18:00 CDT

Tercica, Inc. (Nasdaq:TRCA) today announced that the Company has completed enrollment of its MS308 Phase 3b clinical trial, which is a study evaluating the efficacy and safety of the currently approved formulation of Increlex® administered as a once-daily injection in children with Primary IGF-1 Deficiency (Primary IGFD). Increlex is marketed in the United States for the treatment of severe Primary IGFD using twice-daily injections.

In this multi-center, open-label trial, 45 children with Primary IGFD are being treated with Increlex for 34 weeks. The primary endpoint for the trial is height velocity. Children who complete the first 34 weeks are eligible to continue the study for up to an additional year. Data from the initial 34 weeks of Increlex treatment are expected to be available in the second quarter of 2008.

In addition, enrollment is near completion in MS301, with 128 out of 136 patients enrolled in the study as of today. MS301 is a controlled, multi-center, one year Phase 3b registration study evaluating the efficacy and safety of twice-daily Increlex for the treatment of Primary IGFD.

"We are excited to have completed enrollment in MS308, which tests the safety and efficacy of administering Increlex once a day for the treatment of short stature due to Primary IGFD," said Dr. John A. Scarlett, Tercica's President and Chief Executive Officer. "The growing use of Increlex in children with severe Primary IGFD, the recommendation for Increlex approval in the EU by the Committee for Human Medicinal Products and now the completion of enrollment in MS308, make us increasingly excited about the potential and role of Increlex in the treatment of short stature," added Dr. Scarlett.

About Increlex®

The active ingredient of Increlex® is recombinant human insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of growth hormone's (GH) effect on statural growth, and must be present for normal growth of bones and cartilage in children. In Primary IGFD, children's serum IGF-1 levels are low, despite the presence of a normal or elevated GH level. Without adequate IGF-1, children cannot achieve normal height. In children with this disorder, low IGF-1 levels are due to growth hormone resistance associated with mutations in GH receptors, post-GH receptor signaling pathways, or to defects in IGF-1 gene expression. As such, these children cannot be expected to respond adequately to exogenous GH treatment. Some individuals may also have a range of metabolic disorders, including lipid abnormalities, decreased bone density, obesity and insulin resistance.

Primary IGFD afflicts an estimated 30,000 children evaluated for short stature in the United States. Approximately 6,000 children suffer from a more severe form of this disease, called severe Primary IGFD.

Increlex® has been marketed in the United States by Tercica since early 2006. Exclusive rights to develop and commercialize Increlex® were licensed to Ipsen in October 2006 for all regions of the world except the United States, Japan, Canada, Taiwan and certain countries of the Middle East and North Africa.

About Tercica

Tercica is a biopharmaceutical company committed to improving endocrine health by partnering with the endocrine community to develop and commercialize new therapeutics for short stature and other metabolic disorders. For further information on Tercica, please visit www.tercica.com.

Forward Looking Statements

Except for the historical statements contained herein, this press release contains forward-looking statements concerning Tercica's prospects and expectations, including without limitation, that: Tercica expects data from the initial 34 weeks of Increlex treatment to be available in the second quarter of 2008. 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, risks and uncertainties related to the following: (i) due to the uncertainty of any clinical trial, including without limitation, patients who drop out and the difficulties in connection with data retrieval, the data may not be available in the second quarter of 2008 or at all; and (ii) the risks and uncertainties disclosed from time-to-time in reports filed by Tercica, including most recently Tercica's Form 10-Q for the quarter ending March 31, 2007 filed with the SEC on May 4, 2007. Tercica disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

Source: Business Wire

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