Date: 2016-06-28
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Xoma (USA - CA)
Product: XOMA 213
Action
mechanism: monoclonal antibody. XOMA 213 is a neutralizing monoclonal antibody directed against the prolactin receptor (PRLR). Upon administration, this anti-prolactin receptor antibody binds to PRLR and prevents the binding of the peptide hormone prolactin (PRL) to its receptor. In some cases, including prolactinomas, which are benign tumors of the pituitary gland in both men and women, prolactin excess secretion can lead to various clinically significant abnormal signs and symptoms.
Disease: prolactinomas
Therapeutic area: Endocrinological diseases - Hormonal diseases
Country: Spain
Trial details:
Latest
news: * On June 28, 2016, Xoma announced it has initiated its Phase 2 proof-of-concept study for XOMA 213 (formerly referred to as LFA102). XOMA 213 is a monoclonal antibody that neutralizes prolactin induced signaling. Prolactin is a protein that in normal post-partum females enables the production of milk. In some cases, including prolactinomas, which are benign tumors of the pituitary gland in both men and women, excess secretion can lead to various clinically significant abnormal signs and symptoms.
The open-label, mechanism of action, single-dose, multi-center study is designed to evaluate two dose levels of XOMA 213 in up to 35 subjects and confirm its ability to curtail prolactin signaling. The study will take place in Spain and safety will be monitored throughout.
"By initiating this mechanism of action study for XOMA 213, we bring a second endocrine-focused asset into mid-stage development," said Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer at XOMA. "Prolactinomas, which are benign tumors of the pituitary gland, have serious medical consequences, particularly infertility and osteoporosis. Ten to twenty percent of patients do not respond to or are intolerant of current standard of care medications. Based upon the results from this proof-of-concept study, we will be able to determine the value of further developing this antibody for treating patients with symptomatic hyperprolactinemia."
