NEW YORK, July 23, 2015 /PRNewswire/ --
ACI Association has initiated research coverage on XOMA
Corporation (NASDAQ: XOMA). Select highlights from the internally
released reports are being made available to the general public
(included below), with access to the entirety of the research
available to new members.
Today, membership is open to readers on a complementary basis at
the following URL: http://www.aciassociation.com/?c=XOMA
Highlights from our XOMA Report include:
- Grant of Orphan Drug Designation - On
June 16, 2015, XOMA Corporation
reported that the U.S. Food and Drug Administration (FDA) has
granted Orphan Drug Designation to XOMA 358, a fully human
allosteric monoclonal antibody that reduces both the binding of
insulin to its receptor and downstream insulin signaling, for the
treatment of congenital hyperinsulinism (HI).
- Benefits to the Drug Developer - The Company
informed that the FDA Office of Orphan Products Development (OOPD)
grants Orphan drug designation to novel drugs or biologics that
treat a rare disease or condition affecting fewer than 200,000
patients in the United States. The
designation provides benefits to the drug developer in form of
seven years period of U.S. marketing exclusivity, tax credits for
clinical research costs, clinical research trial design assistance,
the ability to apply for annual grant funding, and waiver of
Prescription Drug User Fee Act (PDUFA) filing fees.
- Views of Management - Commenting on the
development, Paul Rubin, M.D.,
Senior Vice President, Research and Development, and Chief Medical
Officer at XOMA said, "The orphan drug designation for XOMA 358
recognizes its potential to address a significant unmet medical
need for patients with congenital hyperinsulinism. Patients with
hyperinsulinism, a rare and devastating disease, secrete
inappropriate and excessive insulin, which cause dangerously low
blood sugar levels that can lead to brain damage or, in rare cases,
death."
- Study Results - The Company had presented positive phase
1 data on XOMA 358 at the Endocrine Society's Annual meeting (ENDO
2015) in March 2015. Results of the
study, in which 14 healthy volunteers received XOMA 358 and 5
received placebo, showed XOMA 358 reduced insulin receptor
signaling and increased glucose production after exogenous insulin
injection. In the study, XOMA 358 appeared to be well tolerated,
with no serious adverse events observed. Discussing the results of
the study, Rubin said, "We recently completed a positive Phase 1
study, results of which suggest XOMA 358 is active against the
insulin receptor and shows potential in treating patients who
experience an endogenous over-production of insulin. Congenital
hyperinsulinism is one of the indications we are considering for a
Phase 2 study, which we expect to initiate later this year."
To find out how this influences our rating on XOMA Corporation
read the full report in its entirety here:
http://www.aciassociation.com/?c=XOMA
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