XOMA Announces Positive Results from its Phase 2 Proof-Of-Concept Study of Prolactin Inhibition
April 24 2017 - 7:00AM
XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery and
development of therapeutic antibodies, today announced that it has
achieved positive Phase 2 proof-of-concept results for X213 in
physiological hyperprolactinemia (HPRL). X213 is a monoclonal
antibody that neutralizes prolactin action.
“This proof-of-concept study was an important milestone in
demonstrating the potential efficacy of this novel antibody. We
believe that X213 could be a treatment option for a wide range of
patients with hyperprolactinemia including prolactinoma and
anti-psychotic induced HPRL as the signs and symptoms are similar
irrespective of the etiology,” said Jim Neal, Chief Executive
Officer of XOMA. “Consistent with our business strategy, we intend
to maximize the value of X213 for shareholders by seeking a license
partner for the program.”
The Phase 2 study was a multi-center, open-labelled, randomized,
single-dose, controlled trial of intravenously administered X213 in
women who wished to suppress lactation immediately post-partum. The
results of the study indicate that X213, when given as a single
700mg intravenous infusion during the first day post-partum, was
effective in suppressing milk secretion, as well as breast
engorgement and pain in 100 percent of the treated women. In
addition, none of the treated women experienced rebound breast
symptomatology during the 21-day study period. While the study was
not intended, or powered to show statistical significance, it
demonstrated that X213 was: safe and well tolerated; caused no
significant adverse events (SAEs); showed favorable
pharmacokinetics with a terminal half-life of two weeks and;
demonstrated target (prolactin receptor) engagement and mechanism
of action confirmation by serum prolactin profiling.
“The findings from this proof-of-concept study are encouraging
and confirm that X213 inhibits prolactin signaling and thus, may be
effective in blocking effects of symptomatic hyperprolactinemia,”
said Dr. Shlomo Melmed, endocrinologist, Dean of the Medical
Faculty and Professor of Medicine, Cedars-Sinai Medical Center, Los
Angeles. “New classes of drugs such as X213 may offer benefit to
the up to 20 percent of patients who do not respond to, or are
intolerant of, current standard of care involving dopamine agonist
medications.”
Prolactin is a multifunctional hormone that is primarily
secreted by the pituitary and whose best-known functions are
related to lactation and reproduction. In pregnant women, excess
prolactin secretion (hyperprolactinemia) occurs to enhance breast
development and to induce lactation postpartum. Commonly
encountered etiologies of hyperprolactinemia include prolactinoma,
medication effect, kidney failure, cystic or granulomatous
pituitary lesions, and disorders which interfere with hypothalamic
inhibition of prolactin release. Prolactinomas, benign tumors of
the pituitary gland, hypersecrete prolactin with significant
medical consequences, particularly hypogonadism, infertility and
osteoporosis.
About X213 X213 (formerly LFA 102) is a
first-in-class allosteric inhibitor of prolactin action. It is a
humanized IgG1-Kappa monoclonal antibody that binds to the
extracellular domain of the human prolactin receptor with high
affinity at an allosteric site. The antibody has been shown to
inhibit prolactin-mediated signaling, and it is potent and
similarly active against animal and human prolactin receptors.
The Phase 2 study evaluated the safety, tolerability,
pharmacokinetics and pharmacodynamics of X213 in post-partum women.
The study was conducted at multiple medical centers in Spain.
About XOMA CorporationXOMA has an extensive
portfolio of products, programs, and technologies that are the
subject of licenses the Company has in place with other biotech and
pharmaceutical companies. Many of these licenses are the
result of the Company's pioneering efforts in the discovery and
development of antibody therapeutics. There are more than 20 such
programs that are fully funded by partners and could produce
milestone payments and royalty payments in the future. In order to
maximize its value in a licensing transaction, XOMA continues to
invest in X358, an allosteric monoclonal antibody that reduces
insulin receptor activity, as the antibody could have a major
impact on the treatment of hyperinsulinism. For more information,
visit www.xoma.com.
Forward-Looking StatementsCertain statements
contained in this press release 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, including
statements regarding: X213 as a potential treatment option for
patients with hyperprolactinemia including prolactinoma and
anti-psychotic induced HPRL; XOMA's portfolio of partnered programs
and licensed technologies; XOMA's intent to license X213 and X358;
and statements that otherwise relate to future periods. 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.
Investor contact:
Luke Heagle
Pure Communications
+1 910-726-1372
lheagle@purecommunications.com
Media contact:
Colin Sanford
Pure Communications
+1 415-946-1094
csanford@purecommunications.com
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