Dr. Alan Kivitz to Chair XBiotech’s Natrunix Program in Rheumatoid Arthritis
XBiotech (NASDAQ: XBIT) today announced that Alan Kivitz M.D. is
now Lead Investigator & Study Chairman for its clinical
research program for Natrunix in Rheumatoid Arthritis.
XBiotech believes Natrunix will be a breakthrough therapy for
rheumatological diseases. The company has now enrolled about 33% of
the 210 patients it is recruiting for a Phase II, Double-Blind,
Placebo-Controlled, Randomized study, examining Natrunix in
combination with methotrexate for the treatment of Rheumatoid
Arthritis. There are presently about 25 clinical trial sites across
the United States that are participating in the study. Dr. Kivitz,
who is actively treating subjects at his clinic in Altoona,
Pennsylvanian commented, “Despite all the breakthroughs in our
ability to treat Rheumatoid Arthritis there continues to be an
unmet need for some patients with this disease. I am excited to be
part of a clinical trial program studying a novel approach to
Dr. Kivitz has had a prodigious medical career treating
arthritis and rheumatic diseases. He received his medical degree
from Albany Medical College, New York, trained in internal medicine
at the North Shore University Hospital and Memorial Sloan Kettering
Cancer in New York and then completed rheumatology studies at
Albany Medical College. Dr. Kivitz has authored over 500 research
articles, abstracts, and clinical studies relating to
osteoarthritis, osteoporosis and rheumatoid arthritis and has
lectured on his findings around the world. Dr. Kivitz has served on
advisory boards for major drug developers, including AbbVie, Amgen,
Bristol-Myers Squibb, Celgene, Genentech, GlaxoSmithKline, Janssen,
Pfizer, Regeneron Pharmaceuticals, Sanofi-Genzyme, Takeda, and UCB.
Above all Dr. Kivitz is focused on finding new approaches to treat
arthritis and rheumatic disorders.
John Simard, President and CEO of XBiotech commented, “We are
honored to have Dr. Kivitz chair this study for which we are
eagerly anticipating results.”
Nearly forty-years ago investigators began to describe a key
role for interleukin-1 in cartilage destruction and disease
progression in arthritis and degenerative arthropathies1.2 Indeed
finding biological therapies to target interleukin-1 was an initial
impetus for the nascent biotechnology industry in the late 1980s.
But confusion over the nature of the interleukin-1 meant that
therapies designed to target its activity failed to hit the mark
for all potential disease indications.
The confusion about interleukin-1 is highlighted by the fact
that there is in reality no such substance as interleukin-1!
Rather, interleukin-1 actually refers to two separate and distinct
molecules—IL-α and IL-1β —each playing unique roles in health and
disease. The α and β Interleukin-1 molecules are chemically and
physically distinct and under different genetic and post
transcriptional regulation. The α and β molecules are thus deployed
with disparate temporal and spatial distribution and with
unique biological functions. Nonetheless, despite great
anticipation for blocking “interleukin-1” activity clinically, no
therapeutic besides Natrunix has been developed to specifically
and exclusively block IL-1α activity in rheumatology.
Natrunix exclusively and specifically blocks IL-1α. Targeting
IL-1α is crucial, since it may be the key interleukin-1 potentiator
of pain and inflammation in affected tissues in affected joints.
Natrunix is not only unique in how it targets interleukin-1, it
also extraordinary because it is a monoclonal antibody (unlike any
other marketed therapeutic antibody) derived from a naturally
occurring immunoglobulin—identified from a healthy human donor with
natural immunity to IL-1α. XBiotech calls Natrunix a True Human
XBiotech is pioneering the discovery and development of targeted
antibodies based on its True Human™ technology. The company’s
mission is to discover and commercialize its pipeline of truly
natural human antibodies for treating serious diseases such as
inflammatory conditions like rheumatology, infectious disease,
cardiovascular disease and cancer. XBiotech’s has several candidate
products including those that specifically block the activity of
interleukin-1 alpha (IL-1α). Cloned from individual donors who
possess natural immunity against certain targeted diseases,
XBiotech’s pipeline of True Human antibodies are intended to
deliver unmatched safety and efficacy. At the Company’s 48-acre
campus, located just minutes from downtown Austin, XBiotech has a
fully integrated biopharma headquarters, including biological GMP
manufacturing facilities, research and QC testing
laboratories, quality and clinical operations. For more
information, visit www.xbiotech.com.
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1 Bunning et al. The effect of interleukin-1 on connective
tissue metabolism and its relevance to arthritis Agents Actions
Suppl. 1986:18:131-52.2 Vershure & Van Noorden. The
effects of interleukin-1 on articular cartilage destruction as
observed in arthritic diseases, and its therapeutic control. Clin
Exp Rheumatol. 1990 May-Jun;8(3):303-13.
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