Tercica Inc. (TRCA)

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Tercica Initiates Phase II Clinical Trial with Next-Generation Growth Hormone Product for the Treatment of Short Stature
Tuesday January 22, 4:05 pm ET

BRISBANE, Calif.--(BUSINESS WIRE)--Tercica, Inc. (NASDAQ: TRCA - News) today announced that the Company has begun dosing the first patient in a Phase II clinical study evaluating the combination of Genentech, Inc.’s recombinant human growth hormone Nutropin AQ® (somatropin [rDNA origin]) and Tercica’s recombinant insulin-like growth factor-1 Increlex® (mecasermin [rDNA origin] injection). The primary objective of this trial is to assess the efficacy, measured as first-year height velocity, and safety of three different combination regimens of growth hormone and IGF-1 compared to growth hormone alone in the treatment of short stature associated with IGF-1 deficiency.

“With demonstrated synergies in pre-clinical studies, the combination of growth hormone and IGF-1 could have the potential for several important therapeutic benefits compared to either growth hormone or IGF-1 monotherapy alone for the treatment of patients with short stature,” said John A. Scarlett, M.D., Tercica’s President and Chief Executive Officer. “We are pleased to be starting the Phase II clinical trial just six months after signing the agreement with Genentech,” continued Dr. Scarlett.

Development of GH/IGF-1 Combination Product in Short Stature

Potential of GH/IGF-1 Combination Product: The combination product will be studied in children with short stature not associated with growth hormone deficiency, who also have low IGF-1 levels. A potential cause of short stature in this group of patients could be a suboptimal IGF-1 secretion in response to growth hormone stimulation alone. Pre-clinical studies suggest that co-administration of GH and IGF-1 may increase specific growth responses greater than growth hormone alone. Therefore, Tercica believes that treatment with a combination of both GH and IGF-1 may be superior to monotherapy of growth hormone alone in a subpopulation of children with low IGF-1 and short stature not associated with growth hormone deficiency.

Study design: This Phase II study, referred to as MS316, is a randomized clinical trial comparing three different combination regimens to growth hormone alone. The three combination arms each contain a different ratio of IGF-1 to growth hormone. The primary efficacy endpoint is height velocity during the first 12 months of therapy. After evaluation of the primary endpoint, the study will be continued to evaluate long-term effects. Approximately 100 patients will be enrolled in the study. Tercica expects to complete enrollment in mid-2009.