XOMA Finalizes Plans for Gevokizumab Phase 3 Clinical Program in Pyoderma Gangrenosum
April 28 2014 - 9:00AM
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced today that based
on its meeting with the U.S Food and Drug Administration (FDA), the
Company is finalizing its plans for a gevokizumab Phase 3 program
in pyoderma gangrenosum (PG), a rare neutrophilic dermatosis of
painful expanding necrotic skin ulcers. During the meeting, the
Company and the FDA reviewed the data generated from XOMA's pilot
trial in six PG patients. The pilot study was designed to
determine if gevokizumab, an IL-1 beta modulating antibody, should
be explored in pivotal studies in patients with active
PG. XOMA is incorporating the FDA's verbal and written
responses regarding the clinical design of the studies into a final
Phase 3 program, which it will submit to the Agency for any final
comments.
The Phase 3 program is expected to include two double-blind,
placebo-controlled clinical studies, each of which is designed to
enroll approximately 60 patients with active PG. The primary
endpoint is complete wound closure of the target ulcer at
approximately four months. XOMA anticipates conducting these
parallel studies in the United States and several other
countries.
"The interest we have received from the medical community and
the patients who suffer from pyoderma gangrenosum ulcerations
reflect their desire to have access to therapeutic options that
have been studied specifically in and are approved for this
under-served patient population. We were very pleased the FDA
agreed PG is a serious rare condition that has been identified as
an unmet medical need with no approved therapies and that the input
we received has allowed us to design a Phase
3 program we believe we can successfully execute in our
targeted PG population," stated Paul Rubin, Senior Vice President,
Research and Development and Chief Medical Officer of
XOMA. "While we await final comments on our protocol, we are
actively engaged in site identification and pre-study start-up
activities to ensure their investigators and clinical staff are
prepared to enroll eligible patients as quickly as possible once we
launch the studies."
Gevokizumab has been granted Orphan Drug Designation by the FDA
for the treatment of PG.
About Gevokizumab
Gevokizumab is a potent monoclonal antibody with unique
allosteric modulating properties and has the potential to treat
patients with a wide variety of inflammatory diseases. Gevokizumab
binds strongly to interleukin-1 beta (IL-1 beta), a
pro-inflammatory cytokine, and modulates the cellular signaling
events that produce inflammation. IL-1 beta has been shown to be
involved in diverse array of disease states, including
non-infectious uveitis (including Behçet's uveitis), cardiovascular
disease, and other auto-inflammatory diseases.
Gevokizumab currently is being studied in a global Phase 3
clinical program, termed EYEGUARD™, which is being conducted by
SERVIER and XOMA. This program is designed to determine
gevokizumab's ability to treat acute non-infectious uveitis (NIU)
involving the intermediate and/or posterior segment of the eye in
EYEGUARD-A, to prevent disease flares in patients with Behçet's
uveitis in EYEGUARD-B, and to prevent disease flares in NIU
patients who are controlled with steroids in EYEGUARD-C.
XOMA has a Proof-of-Concept (POC) program underway in which the
Company is exploring the efficacy and safety of gevokizumab in
multiple indications. Separately, SERVIER initiated a Phase 2 study
to determine gevokizumab's ability to reduce arterial wall
inflammation in patients with marked atherosclerotic plaque
inflammation and who have experienced an acute coronary syndrome
event in the previous twelve months, as well as POC studies in
polymyositis/dermatomyositis, giant cell arteritis, and Schnitzler
syndrome. Information about gevokizumab clinical studies can
be found at www.clinicaltrials.gov and
www.clinicaltrialsregister.eu.
About Pyoderma Gangrenosum
Pyoderma gangrenosum (PG) is a rare neutrophilic dermatosis of
painful expanding necrotic skin ulcers. The U.S. Department of
Health and Human Services' National Institutes of Health's Office
of Rare Disease Research lists PG occurring in about 1 per 100,000
people. Claims data compiled over the past three years indicate the
number of diagnosed PG patients has ranged between 11,000 and
14,000 annually. Approximately 50 to 70 percent of the PG
patient population has an underlying systemic condition, while the
remainder is idiopathic (unknown cause). The most prevalent
underlying condition is inflammatory bowel disease (IBD), most
commonly ulcerative colitis and Crohn's disease. The prognosis for
PG is directly linked to the patient's response to therapy for the
underlying disease. Physicians treat patients with systemic
therapies that are approved for the underlying disease and topical
therapies applied directly to the ulcers; however the ulcers may
take up to two years to heal. Despite the ongoing use of systemic
therapy, up to 46 percent of patients experience a relapse.
About XOMA Corporation
XOMA has built a portfolio of innovative therapeutic antibodies,
both in late-stage clinical development and in preclinical
research. XOMA focuses its antibody research and development
on allosteric modulation, which offers opportunities for new
classes of therapeutic antibodies to treat a wide range of human
diseases. XOMA's lead product candidate, gevokizumab (IL-1
beta modulating antibody), is in a global Phase 3 program in
non-infectious uveitis with its partner SERVIER and multiple
proof-of-concept studies in other IL-1-mediated
diseases. XOMA's scientific research also produced the XMet
program, which consists of three classes of preclinical antibodies,
including Selective Insulin Receptor Modulators (SIRMs) that could
have a major effect on the treatment of diabetes.
More detailed information can be found at www.xoma.com.
About SERVIER
Founded in 1954, SERVIER is an independent French pharmaceutical
research company. Its development is based on the continuous
pursuit of innovation in the therapeutic areas of cardiovascular,
metabolic, neurologic, psychiatric, bone and joint diseases, as
well as cancer. In 2013, the company recorded a turnover of 4.2
billion euros. 91% of SERVIER drugs are consumed internationally.
27% of turnover from SERVIER drugs were reinvested in Research and
Development in 2013. With a strong international presence in 140
countries, SERVIER employs more than 21,000 people worldwide. The
SERVIER Group contributed 35% to the 2013 French trade surplus in
the pharmaceuticals sector.
Forward-Looking Statements
Certain statements contained in this press release including,
but not limited to, statements related to anticipated timing of
initiation and completion of clinical trials and proof-of-concept
trials, sales of approved products, and the positive outcome of our
clinical trials or receipt of marketing approval by the U.S. FDA or
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-Q 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.
CONTACT: XOMA Corporation
Company and Investor Contact:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media Contact:
Canale Communications
Carolyn Hawley
619-849-5375
carolyn@canalecomm.com
SERVIER
SERVIER Communication Department
+33 1 5572 6037
presse@servier.fr
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