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Tercica Announces rhIGF-1 Phase III Efficacy and Safety Data to be Presented at 86th Annual Endocrine Society Meeting 
NEW ORLEANS, LA June 16, 2004 PRNewswire-FirstCall via COMTEX Tercica, Inc. (Nasdaq: TRCA) announced today that detailed results of its Phase III clinical trial of recombinant human Insulin-like Growth Factor-1 (rhIGF-1) for the treatment of severe short stature caused by Insulin-like Growth Factor-1 Deficiency (IGFD) due to Growth Hormone Insensitivity (GHI) will be presented Friday, June 18th, at ENDO 2004, the 86th Annual Meeting of The Endocrine Society. Steven Chernausek, M.D., Professor of Pediatrics, Children's Hospital Medical Center in Cincinnati, a joint principal investigator of the clinical study, will report the positive efficacy and safety results in two separate presentations. The Phase III study was designed to evaluate the safety and the efficacy of treatment with rhIGF-1, measured by improvement in growth rate, in children with severe short stature caused by IGFD due to GHI. Results of the study demonstrated a statistically significant increase (p<0.001) in growth rate over an 8-year period in response to therapy, achieving the study's primary endpoint. In addition, an analysis of safety in the study concluded that long-term treatment with rhIGF-1 appears to be well-tolerated and has an acceptable safety profile. "The development of IGF-1 opens new avenues for the treatment of growth disorders," said Dr. Chernausek. "Short stature is a serious condition and these data demonstrate that replacement therapy with rhIGF-1 can bring about a meaningful and sustained improvement in growth." Phase III Data The multi-center, open label study was co-led by Louis Underwood, M.D., University of North Carolina, Chapel Hill, N.C. and Dr. Chernausek, both representing the Growth Hormone Insensitivity Collaborative Group. The study included 65 children with severe short stature caused by IGFD due to GHI, 54 of whom had been treated with rhIGF-1 for a minimum of one year. Details of the study will be presented Friday, June 18th, in a poster session (P3-450 and P3-451) held in the Exhibit Hall from 11:00 a.m. until 12:00 p.m. and 2:30 p.m. until 3:30 p.m. The first presentation by Dr. Chernausek describes efficacy results from the study. The 54 patients evaluated were severely IGF-1 deficient at the time of enrollment. At the start of therapy, they ranged in age from 2-10 years old, with heights ranging from 28.6 inches to 41.2 inches. The children received twice-daily injections of rhIGF-1 at doses of 80-120 micrograms per kilogram body weight over the course of the study. The trial demonstrated that long-term treatment with rhIGF-1 resulted, on average, in a three-fold increase in the rate of growth in the first year of therapy and a two-fold increase in growth rate over an eight-year period. Compared to pre-treatment growth patterns, children gained, on average, an additional inch per year for each year of therapy during an eight-year period. The second presentation by Dr. Chernausek describes the analysis of safety in the study. The analysis included 65 children with severe short stature caused by IGFD due to GHI whom were treated with rhIGF-1 for up to 10.5 years. No patients dropped out of the study due to adverse experiences. Most adverse events were not related to rhIGF-1 therapy. The most frequent adverse event related to rhIGF-1 was hypoglycemia, which could be managed by eating at the time of each injection. Overall, the safety data represent more than 231 years of patient exposure. "This multi-year study provides the longest and most extensive data to date showing increased height following treatment with rhIGF-1 in children suffering from Primary IGFD," said John Scarlett, M.D., President and Chief Executive Officer of Tercica. "These data will form the basis of our New Drug Application, which we plan to submit to the US Food and Drug Administration by early 2005." "Previously, we could only really ask whether a child with short stature was growth hormone deficient," said Ron Rosenfeld, M.D., Senior Vice President, Medical Affairs, Lucile Packard Foundation for Children's Health, Stanford University and an expert on IGFD. "Now, we have a better understanding of the role of IGF-1 deficiency in statural growth and recognize that many cases of short stature are linked to primary IGF-1 deficiency, which may be appropriately treated with rhIGF-1." Insulin-like Growth Factor-1, a naturally occurring hormone, is a 70 amino acid protein that must be present in tissues for normal growth and metabolism in humans. About IGFD Primary IGFD has been found to be a key underlying cause of short stature in children who are growth hormone insensitive. Primary IGFD is characterized by short stature, IGF-1 deficiency and growth hormone sufficiency. Short stature is medically defined as occurring in approximately 2.5 percent of all children. In addition, Primary IGFD can lead, in children and adults, to a range of other metabolic disorders with serious consequences to long-term health. These metabolic disorders can include lipid abnormalities, decreased bone density, obesity, insulin resistance and cardiovascular disorders. About Tercica Tercica, Inc. is a biopharmaceutical company focused on the development and commercialization of rhIGF-1 for the treatment of short stature, diabetes and other endocrine system disorders. Tercica's initial target indications include Primary Insulin-like Growth Factor-1 Deficiency (Primary IGFD) in both children and adults. In addition, the company is pursuing clinical studies of rhIGF-1 as a treatment for diabetic populations with extreme insulin resistance. For further information on Tercica and Primary IGFD, please visit www.tercica.com. This press release contains forward-looking statements regarding Tercica's development and commercialization of treatments for short stature, diabetes and other endocrine system disorders. This press release also contains forward-looking statements regarding the efficacy and safety results derived from clinical trials of rhIGF-1, certain analyses of the results from these trials, the importance of study results, the expected benefits of rhIGF-1 based on the trial results and the expected submission of a New Drug Application with the US Food and Drug Administration. The forward-looking statements are subject to risks and uncertainties that could cause actual events to differ materially from those projected, including the risk that the efficacy and safety results are not accurate or reliable, the risks that the clinical trials were not properly conducted to ensure reliability in results, the uncertainties regarding the significance of the results, the risk that the actual benefits of rhIGF-1 treatment are not significant or meaningful, the risk that our New Drug Application will not be timely filed, or at all, the risk that we will not obtain regulatory approvals for rhIGF-1, or develop, manufacture or commercialize rhIGF-1, and other risks and uncertainties as disclosed from time to time in reports filed by Tercica with the SEC, including Tercica's Form 10-Q for the quarterly period ended March 31, 2004, and any other reports filed by Tercica with the SEC. We assume no obligation and do not intend to update these forward-looking statements. Any statements by persons outside Tercica speculating on the subject matter of this press release, or any other aspects of the company's business, will not be based on internal company information and should be assessed accordingly by investors. SOURCE Tercica, Inc. investors, Tim Lynch, Chief Financial Officer of Tercica, Inc., +1-650-624-4914, or tlynch@tercica.com; or Karen Bergman of BCC Partners, +1-650-575-1509, or kbergman@bccpartners.com, for Tercica, Inc. |
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