XOMA Announces Significant Step Toward Initiating Pediatric Phase 2 Clinical Study for XOMA 358 in Children with Congenital H...
October 19 2016 - 9:00AM
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced today the United
Kingdom’s Medicines and Healthcare Products Regulatory Agency
(MHRA) has accepted in principle the Company’s proposal to initiate
a multi-dose Phase 2 clinical study of XOMA 358 in children two
years and older diagnosed with Congenital Hyperinsulinism (CHI).
“MHRA officials clearly recognize the importance
and complexity of conducting a clinical program in CHI, an orphan
disease that affects children and infants for whom few effective
treatment options are available. The comments resulting from our
national advice meeting with the MHRA officials, regarding its
requirements to support expedited clinical development for XOMA
358, were clear and thorough,” commented Paul Rubin, MD, Senior
Vice President Research and Development and Chief Medical Officer
of XOMA. “Upon their formal review and acceptance of our
protocol, XOMA will be able to launch its first multi-dose extended
treatment clinical study for XOMA 358 in CHI patients over the age
of two.”
“Today’s announcement reflects the priority we
have placed on our regulatory efforts. Opening our clinical
program to younger patients and offering multi-dose studies is a
critical step to accelerate XOMA 358 development and reach the
patients we believe are most likely to benefit from this
first-in-class monoclonal antibody. Additionally, the
regulatory body in Germany recently approved our plan to conduct a
repeat-dose clinical study in CHI patients over the age of 12.
Our first German site has begun enrolling patients and has
already contributed to a substantial acceleration in enrollment in
our XOMA 358 studies,” stated John Varian, Chief Executive Officer
of XOMA. “We look forward to continuing our conversations
with the MHRA, the European Medicines Agency (EMA), and the US Food
& Drug Administration (FDA) to advance the development of XOMA
358, enabling us to get this important treatment to children in
need as expeditiously as possible.”
About XOMA 358Insulin is the
major physiologic hormone for controlling blood glucose levels.
Abnormal increases in insulin secretion can lead to profound
hypoglycemia (low blood sugar), a state that can result in
significant morbidities, including brain damage, seizures and
epilepsy. XOMA, leveraging its scientific expertise in allosteric
monoclonal antibodies, developed the XMet platform, consisting of
separate classes of selective insulin receptor modulators (SIRMs)
that could have a major effect on treating patients with abnormal
metabolic states.
XOMA 358 is a fully human negative allosteric
modulating insulin receptor antibody derived from the XMet
platform. It is being investigated as a novel treatment for
non-drug-induced, endogenous hyperinsulinemic hypoglycemia (low
blood glucose caused by excessive insulin production), as well as
hypoglycemia after bariatric surgery and other related disorders.
XOMA is conducting Phase 2 development activities for XOMA 358 in
patients with congenital hyperinsulinism (CHI) and in patients with
hypoglycemia post-bariatric surgery (PBS). A therapy that
safely and effectively mitigates insulin-induced hypoglycemia has
the potential to address a significant unmet therapeutic need for
certain rare medical conditions associated with hyperinsulinism.
More information on the XOMA 358 clinical trial may be found at
www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
About Congenital Hyperinsulinismi, ii,
iii, ivCongenital Hyperinsulinism (CHI) is a genetic
disorder in which the insulin cells of the pancreas (beta cells)
secrete inappropriate and excessive insulin. Ordinarily, beta cells
secrete just enough insulin to keep blood sugar in the normal
range. In people with CHI, the secretion of insulin is not properly
regulated, causing excess insulin secretion and frequent episodes
of low blood sugar (hypoglycemia). In infants and young children,
these episodes are characterized by a lack of energy (lethargy),
irritability or difficulty feeding. Repeated episodes of low blood
sugar increase the risk for serious complications, such as
breathing difficulties, seizures, intellectual disability, vision
loss, brain damage, coma, and possibly death. About 60 percent of
infants with CHI experience a hypoglycemic episode within the first
month of life. Other affected children develop hypoglycemia by
early childhood. Current treatments for CHI are limited to medical
therapy and surgical removal of part or all of the pancreas
(pancreatectomy).
About XOMA CorporationXOMA
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 the treatment
of hyperinsulinism. The Company is conducting Phase 2 development
activities for XOMA 358 in patients with congenital hyperinsulinism
and in patients with hypoglycemia after bariatric surgery. 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:
the future progress of the XOMA 358 clinical program, the medical
need and market demand for XOMA 358, anticipated future study sites
and enrollments, the possible expansion of clinical testing to
younger patients, the overall promise of XOMA 358, 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.
i ghr.nlm.nih.gov/condition/congenital-hyperinsulinism. ii
www.chop.edu/conditions-diseases/congenital-hyperinsulinism/about#.VXncFU3bKHt.
iii
www.chop.edu/conditions-diseases/congenital-hyperinsulinism/about#.VXneYE3bKHu.
iv www.ojrd.com/content/pdf/1750-1172-6-63.pdf.
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:
Julie Normart
W2O Group
415-946-1087
jnormart@w2ogroup.com
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