Tercica Initiates Phase 3b Study for Treatment of Primary IGF-1 Deficiency

Tercica, Inc., a biopharmaceutical company focused on the development and commercialization of recombinant human insulin-like growth factor-1 (rhIGF-1) for the treatment of short stature, diabetes, and other endocrine system disorders, has initiated a phase 3b clinical study to investigate the use of rhIGF-1 as a therapy for children with short stature caused by primary IGF-1 deficiency. The study will enroll approximately 160 pre-pubertal children with primary IGFD whose height and serum IGF-1 levels are more than 2 standard deviations below normal, and will evaluate the safety and efficacy of rhIGF-1 in promoting statural growth. The primary endpoint of the study is change in height standard deviation (SD) score over 1 year.

Key Takeaways:

Tercica has initiated a phase 3b clinical study to investigate the use of recombinant human insulin-like growth factor-1 (rhIGF-1) as a therapy for children with short stature caused by primary IGF-1 deficiency.
The study will enroll approximately 160 pre-pubertal children with primary IGFD whose height and serum IGF-1 levels are more than 2 standard deviations below normal.
The study is designed to evaluate the safety and efficacy of rhIGF-1 in promoting statural growth, with the primary endpoint being change in height standard deviation (SD) score over 1 year.
The study is expected to take approximately 2 years to complete.
Primary IGFD afflicts an estimated 30,000 children evaluated for short stature in the United States.
An estimated 6,000 of these children have severe primary IGFD.
Tercica's rhIGF-1 has previously shown positive clinical study results in severe primary IGFD, with statistically significant increases in serum IGF-1 levels.

Statistics:

Approximately 160 pre-pubertal children will be enrolled in the phase 3b study.
The study will take approximately 2 years to complete.
An estimated 30,000 children in the United States have primary IGFD.
Approximately 6,000 of these children have severe primary IGFD.
Tercica has previously reported positive phase 3 study results, showing a statistically significant increase in serum IGF-1 levels.

Sources:

Tercica, Inc., (TRCA)
NewsRx.com
NewsRx.net
University of Texas Health Science Center at San Antonio
Obesity & Diabetes Week