Tercica Presents Updated Increlex Long-Term Treatment Data at the 2006 Pediatric Endocrinology Nursing Society Convention; Data Represents 321 Patient-Years of Treatment with Increlex.BRISBANE, Calif. -- Tercica, Inc. (Nasdaq:TRCA TRCA Toronto and Region Conservation Authority TRCA Trademark Remedy Clarification Act TRCA Terminal Radar Control Area (FAA) TRCA Teddy Roosevelt Conservation Alliance ) presented today updated safety and efficacy data from 321 patient-years of treatment with Increlex(TM) (mecasermin (rDNA origin) injection) from long-term studies in children with severe primary IGF-1 deficiency (Primary IGFD) at the Pediatric Endocrinology Nursing Society (PENS) 2006 Annual Convention. Tercica submitted this updated dataset, which was presented for the first time today at PENS, as part of its Marketing Authorization Application (MAA MAA abbr. macroaggregated albumin ) for approval to market Increlex in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community (EU). "This data represents a wealth of additional long-term use information for Increlex. We believe the depth of data, now with 321 patient-years of Increlex treatment and for up to 12.5 years of therapy, continues to support the favorable safety and efficacy profile of Increlex for the long-term treatment of severe Primary IGFD," said John A. Scarlett, M.D., President and Chief Executive Officer of Tercica. There was a significant dose-response effect for Increlex on the first year growth rate for doses of 0.06 to 0.12 mg/kg (60-120 mcg/kg) given subcutaneously twice daily (p=0.0004). The dose of 0.12 mg/kg twice daily was generally associated with the greatest growth responses and with a favorable safety profile. For all doses combined, the mean first year growth rate (8.0 cm/yr) averaged nearly three times the mean pre-treatment growth rate (2.8 cm/yr). The mean growth rates Growth Rates The compounded annualized rate of growth of a company's revenues, earnings, dividends, or other figures. Notes: Remember, historically high growth rates don't always mean a high rate of growth looking into the future. exceeded the mean pre-treatment growth rate through 8 years of treatment. Regardless of the severity of their short stature, efficacy (measured by growth rate) was similar among treated children. Long-term treatment with Increlex appears to be well tolerated. The most common adverse events were hypoglycemia hypoglycemia: see diabetes. hypoglycemia Below-normal levels of blood glucose, quickly reversed by administration of oral or intravenous glucose. Even brief episodes can produce severe brain dysfunction. , lipohypertrophy and tonsillar tonsillar /ton·sil·lar/ (ton´si-lar) of or pertaining to a tonsil. ton·sil·lar or ton·sil·lar·y adj. Of or relating to a tonsil, especially the palatine tonsil. hypertrophy hypertrophy (hīpûr`trəfē), enlargement of a tissue or organ of the body resulting from an increase in the size of its cells. Such growth accompanies an increase in the functioning of the tissue. . Hypoglycemia can be managed by having a meal or snack around the time of dosing. About Tercica and Increlex Tercica, Inc. is a biopharmaceutical company focused on the development and commercialization of products to improve endocrine health. The company's first product, Increlex(TM) (mecasermin (rDNA origin) injection), or recombinant human insulin-like growth factor-1 (rhIGF-1), is the only product approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the long-term treatment of severe Primary IGFD. For further information on Tercica, please visit www.tercica.com. IGF-1 is the principal hormone necessary for statural growth, and 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 yet are resistant to its effects, and whose height and serum IGF-1 levels are more than two standard deviations below normal. A sub-set of these children, whose height and serum IGF-1 levels are more than three standard deviations below normal, are diagnosed with severe Primary IGFD. |
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