AUSTIN, Texas, Nov. 14, 2023 (GLOBE NEWSWIRE) -- 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 RA."
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 arthropathies(1.2) 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-? and IL-1? -each playing
unique roles in health and disease. The ? and ? Interleukin-1 molecules are
chemically and physically distinct and under different genetic and post
transcriptional regulation. The ? and ? 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-1? activity in rheumatology.
Natrunix exclusively and specifically blocks IL-1?. Targeting IL-1? 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-1?. XBiotech calls Natrunix a True Human Antibody.
About XBiotech
XBiotech is pioneering the discovery and development of targeted antibodies
based on its True Human(TM) 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-1?). 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
(http://www.xbiotech.com).
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Contact
Wenyi Wei
wwei@xbiotech.com (mailto:wwei@xbiotech.com)
Tel. 737-207-4600
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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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