Tercica Announces Results From Increlex(R) IGFD Patient Registry And Other Increlex(R) Studies At The 90th Meeting Of The Endocrine Society
"Data from the IGFD Registry showed that children treated with Increlex® at the higher end of the recommended-dose range (≥ 100 μg/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 μg/kg BID (mean dose 115 μg/kg) and a second group receiving doses below 100 μg/kg BID (mean dose 60 μg/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 μg/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
Tercica Announces Rezultate din Increlex (R) IGFD pacientului registry ºi Alte Increlex (R) studiile la a 90-a Reuniune a endocrine Societate - Tercica Announces Results From Increlex(R) IGFD Patient Registry And Other Increlex(R) Studies At The 90th Meeting Of The Endocrine Society - articole medicale engleza - startsanatate