Having completed Phase I studies of SomatoKine (its novel IGF-BP3complex), which not only demonstrated safety at high doses but also stimulation of bone and connective tissue metabolism, US biopharmaceutical company Celtrix is now moving the product into Phase II testing.
SomatoKine is the recombinant equivalent of the natural complex formed by the anabolic hormone insulin-like growth factor-I (IGF-I) and its major binding protein (BP3). The company notes that severe physical trauma, extended illness and aging are frequently associated with abnormally-low blood levels of IGF-BP3.
Initial targets are elderly patients with reduced bone and muscle mass who have undergone hip fracture surgery. This patient population currently totals about 300,000 in the USA and is expected to grow substantially.
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