B2036 PEG IN ACROMEGALY TREATMENT

$0M01FY2000RRNIH

New York University School Of Medicine, New York NY

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Abstract

Acromegaly is a hormonal disorder that occurs when a tumor in the pituitary gland produces excess growth hormone (GH). Excess growth hormone secretion leads to elevated levels of insulin-like growth factor 1 (IGF-1). Thus subjects with acromegaly have high levels of circulating GH and IGF-1. If GH is normalized, the mortality of subjects returns to normal. It is presumed that normalization of IGF-1 has the same effect. B2036-PEG is the first of a class of novel growth hormone receptor antagonists. The projected mechanism of action of B2036-PEG is the reversible binding to the GH receptor which will lead to blocking of signal transduction and reductions in circulating IGF-1. The primary objective of this open-label extension study is to assess the long-term safety, tolerability, and efficacy of B2036-PEG in the treatment of acromegaly. The dose will be titrated in an attempt to normalize IGF-1 levels.

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