TRCA Tercica (MM)

Tercica, Inc. (NASDAQ: TRCA) today announced the first results from the Increlex� Growth Forum Database (IGFD) Registry in two posters presented at the 90th annual meeting of the Endocrine Society in San Francisco. Increlex� (mecasermin (rDNA origin) injection) is currently approved in the United States for the treatment of severe Primary IGF-1 Deficiency. �Data from the IGFD Registry showed that children treated with Increlex� at the higher end of the recommended-dose range (? 100 ?g/kg twice daily) had better growth rates than children treated with lower doses,� said Sandra L. Blethen, M.D., Ph.D., Vice President, Medical Affairs at Tercica. �In addition, these data showed adverse events were not dose-related, and thus emphasize the importance of treating children with severe Primary IGFD using adequate doses of Increlex�,� Dr. Blethen added. The two posters describing these results being displayed on June 16 during the Poster Session �CLINICAL - Growth Deficiency: Cause & Treatment� are titled: The Growth Response to Insulin-Like Growth Factor-1 Treatment during the First Year of Therapy in Prepubertal Children Is Dependent on Mean Increlex� Dose. [Poster #P2-563] AJ Cohen, R Levy, S Blethen, J Kuntze, J Hertz, J Frane, The Endocrine Clin PC, Memphis, TN; Rush Presbyterian St Luke's Med Ctr, Chicago, IL; Tercica, Brisbane, CA; Santa Monica, CA Safety of Increlex� Treatment in the IGFD Registry. [Poster #P2-564] J Kuntze, S Franklin, J Hertz, J Frane, S Blethen, Tercica, Brisbane, CA; Connecticut Children's Med Ctr, Hartford, CT; Pediatric Endocrinology of San Diego Med Group, San Diego, CA; Santa Monica, CA The IGFD Registry began enrolling patients in the Web-based program in May 2006, and allows physicians to register and enter information on a real-time basis. Increlex� was studied in children with short stature and low IGF-1 levels not associated with growth-hormone deficiency. The efficacy analysis presented is based on the height velocity of 36 pre-pubertal children who were tracked for 12 months. The children were split into two groups with one group receiving doses greater than 100 ?g/kg BID (mean dose 115 ?g/kg) and a second group receiving doses below 100 ?g/kg BID (mean dose 60 ?g/kg). There were no significant differences in the baseline characteristics of the two groups in terms of their initial height, their parents� height, their levels of growth hormone or their levels of IGF-1. The safety data presented are based on 237 patients who were followed for a total of 158 patient years. The safety analysis found no statistically significant relationship between dose and adverse events. No new safety signals or unexpected serious adverse events occurred. First Analysis of Safety Events from a Prospective Trial Evaluating Increlex� Treatment in Children with Primary IGFD Tercica also announced the results of the first safety analysis from an ongoing, 12-month, multi-center, open-label clinical trial (study MS-301) comparing twice-daily Increlex� treatment (40, 80, 120 ?g/kg) with observation-only in children with growth failure due to Primary IGFD. Primary IGFD was defined as height and IGF-1 standard deviation scores of