XOMA Initiates Phase 2 Proof-of-Concept Study of XOMA 213
BERKELEY, Calif., June 28, 2016 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today it has initiated its Phase 2 proof-of-concept study for XOMA 213. XOMA 213 (formerly referred to as LFA102) 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.”
About XOMA Corporation
XOMA Corporation is a leader in the discovery and development of therapeutic antibodies. The Company's innovative product candidates result from its expertise in developing ground-breaking monoclonal antibodies, including allosteric antibodies, which have created new opportunities to potentially treat a wide range of human diseases. XOMA's scientific research has produced a portfolio of five endocrine assets, each of which has the opportunity to address multiple indications. The Company's lead product candidate, XOMA 358, is an allosteric monoclonal antibody that reduces insulin receptor activity, which could have a major impact on hyperinsulinism. The Company recently initiated Phase 2 development activities for XOMA 358 in patients with congenital hyperinsulinism and in patients who experience hypoglycemia following gastric bypass surgery. For more information, visit www.xoma.com.
Certain statements contained in this press release including, but not limited to, statements related to anticipated timing of clinical trials, anticipated timing of the release of clinical data, regulatory approval of unapproved product candidates, the anticipated process of clinical data analysis, the anticipated success of any clinical trial, cash usage, or statements that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.
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Released June 28, 2016