Tercica Announces Results from Increlex(R) IGFD Patient Registry and Other Increlex(R) Studies at the 90th Meeting of the Endocr

  
    
  
  
    
      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