TIDMIMM
Immupharma PLC
08 July 2013
8 July 2013
ImmuPharma PLC
IMMUPHARMA APPOINTS WORLDWIDE KEY OPINION LEADERS TO SCIENTIFIC
ADVISORY BOARD FOR LUPUZOR PHASE III
ImmuPharma plc (LSE:IMM) ("ImmuPharma" or the "Company" or the
"Group"), the specialist drug discovery and development company, is
delighted to announce that it has appointed some of the world's
most eminent physicians to provide scientific advice and support
for Lupuzor's pivotal phase III programme.
The Five Scientific Advisory Board members are:
Dr. Daniel J. Wallace, M.D., F.A.C.P., F.A.C.R (USA)
Associate Director, Rheumatology Fellowship Program,
Cedars-Sinai Medical Center, Los Angeles, Clinical Professor of
Medicine, David Geffen School of Medicine at UCLA and Expert
Reviewer, Medical Board of California.
Prof. David Isenberg, MD, FRCP, FAMS (U.K.)
Professor of Rheumatology, University College Hospital,
London
Prof. Vibeke Strand, MD, FACP, FACR (USA)
Clinical Professor, Adjunct, Division of Immunology and
Rheumatology, Stanford University School of Medicine
Prof. Cees GM Kallenberg, M.D., Ph.D. (Netherlands)
Professor, Department of Rheumatology and Clinical Immunology,
University Medical Center Groningen
Dr. Lee S. Simon, MD, FACP, FACR (USA)
Principal, SDG LLC and former FDA Division Director
Commenting on the announcement, Dr Robert Zimmer, President
& Chief Scientific Officer of ImmuPharma, said: "We are
delighted and honoured to be associated and have the support of
such a group of prominent physicians in the area of lupus. It has
to be noted that Dan Wallace was a co-author of a publication
Zimmer et al. ACR 2012 showing that Lupuzor was able to improve
(according to the standard criteria) more than 60% of the patients
after only 3 injections and that this number increased up to 80% in
a sub-set of the patient population 3 months thereafter even
without treatment. These results are by far the best ever seen in a
Lupus study and are due to the novel mechanism of action of Lupuzor
which tackles specifically the intrinsic biological events
constitutive of the Lupus disease at a very upstream level, which
is not the case for the currently approved Monoclonial Antibody
therapies which act downstream with poorer efficacy results. It is
an important step as we go forward with Lupuzor towards starting
phase III and we look forward to announcing further news of our
progress in due course."
Detailed biographies of the five Scientific Advisors are shown
below.
Dr. Daniel J. Wallace, M.D., F.A.C.P., F.A.C.R (USA)
Associate Director, Rheumatology Fellowship Program,
Cedars-Sinai Medical Center, Los Angeles, Clinical Professor of
Medicine, David Geffen School of Medicine at UCLA and Expert
Reviewer, Medical Board of California.
Dan Wallace was raised in the Carthay Circle/Fairfax area of Los
Angeles. After attending Fairfax High School, he received his
undergraduate and medical education at the University of Southern
California, graduating with an MD. His graduate medical training
included an internship at Brown University in Providence, Rhode
Island, medical residency at Cedars-Sinai Medical Center in Los
Angeles and a fellowship in rheumatology at UCLA. He is Board
Certified in both Internal Medicine and Rheumatology.
While a fellow at UCLA, he conducted pioneering arthritis
research that landed his picture in Time magazine and developed a
close relationship with his mentor, Edmund Dubois. Dr Dubois had
the largest lupus practice in the United States at the time and was
the principal editor of the only lupus textbook. Dr. Wallace
entered private practice in 1979 with his father, a cardiologist,
but assumed Dr. Dubois' practice on his passing in 1985. He is the
author of 6 medical textbooks (including the last 6 editions of
Dubois' Lupus Erythematosus, All About Fibromyalgia, The Lupus
Book, All About Osteoarthritis, The New Sjogren's Syndrome
Handbook, and Fibromyalgia & Other Central Pain Syndromes), 25
book chapters, and over 300 medical publications. The latter have
appeared in the New England Journal of Medicine, Annals of Internal
Medicine, the Lancet, Journal of Clinical Investigation, Journal of
Immunology, and Journal of the American Medical Association.
Wallace's academic efforts include having served as Chief of
Rheumatology at Cedars-Sinai Medical Center, Century City Hospital,
and the City of Hope Medical Center in Duarte, CA. He is currently
a Clinical Professor of Medicine at the David Geffen School of
Medicine at UCLA. His clinical practice is based at Cedars-Sinai,
where he is involved in the care of 2,000 lupus patients, the
largest practice of its kind in the United States and co- directs
the Cedars Sinai Rheumatology fellowship program. The Wallace
Rheumatic Disease Research Center currently runs over 30 clinical
trials for patients with rheumatoid arthritis, lupus, ankylosing
spondylitis, psoriatic arthritis and fibromyalgia. The center has
been the recipient of multiple National Institute of Health grants.
20% of his time is spent in teaching and research, providing free
medical care.
Dr. Wallace's volunteer work has entailed serving as Chairman of
the Lupus Foundation of America, the Research and Education
Foundation of the American College of Rheumatology, and on the
Board of Directors of the United Scleroderma Foundation, the Lupus
Research Institute and the American Society for Apheresis. He has
served on the Medical Advisory Board of the Sjogren's Syndrome
Foundation and the American Fibromyalgia Syndrome Association. His
service has been recognized by being named as among the 200 best
doctors in the nation by Town and Country Magazine, best doctors in
Los Angeles by Los Angeles Magazine, Best Doctors in America
editions since 1994. Dr. Wallace is the recipient of the Lupus
Foundation of America Humanitarian Award, Achievement award of the
Lupus Research Institute, Spirit Award of the Scleroderma
Foundation and the Jane Wyman Humanitarian Award of the Arthritis
Foundation. His efforts have raised over $20 million for various
rheumatic disease organizations.
Prof. David Isenberg, MD, FRCP, FAMS (U.K.)
Professor of Rheumatology, University College Hospital,
London
Professor Isenberg graduated from St Bartholomew's Hospital in
1973. He trained in General Medicine, Rheumatology, Neurology,
Psychiatry and Gastroenterology becoming a Research Fellow at
UCL/the Middlesex Hospital in 1979. Awarded an MD Thesis (in 1984),
based on studies of myositis. During a year of research at Tufts
University, Boston, he became interested in autoantibody
structure/function and origin. Appointed Consultant Rheumatologist
in November 1984 becoming a professor in 1991 and was given the
arc's Diamond Jubilee chair of Rheumatology at UCL London in 1996.
Has been elected to Fellowships of both the Royal College of
Physicians and the Academy of Medical Sciences. His specialist
involvement is in autoimmune rheumatic diseases, notably systemic
lupus erythematosus, Sjögren's syndrome, myositis and the
anti-phospholipid antibody syndrome.
His principal clinical interests have been in the development of
disease activity and damage assessment tools in patients with
lupus. Chair of the British Isles Assessment Group and also the
Chair (1998-2003) of the Systemic Lupus International Collaborating
Clinics group (SLICC). Has undertaken many roles for the arc in the
past 20 years and is the past president of the British Society for
Rheumatology (2004-2006) and is currently chairing the Society's
Biologics Register Committee. He is the 2010 recipient of the
Evelyn Hess Prize from the Lupus Foundation of America for his
contribution to lupus research and treatment.
Prof. Vibeke Strand, MD, FACP, FACR (USA)
Clinical Professor, Adjunct, Division of Immunology and
Rheumatology, Stanford University School of Medicine
Vibeke Strand, MD, is an adjunct clinical professor in the
Division of Immunology and Rheumatology at Stanford University
School of Medicine. She has been a clinical rheumatologist for 32
years, previously in subspecialty practice in San Francisco and as
a clinical research investigator, and senior director of clinical
research at 3 pharmaceutical and biotech companies.
Since 1991, she has led a consulting practice offering clinical
research and regulatory strategy expertise to pharmaceutical and
biotech companies focusing to translate basic research into
rational design of randomized controlled trials, evaluate their
results, and defend approval of novel products to the FDA and EMA
for autoimmune diseases, including rheumatoid arthritis [RA],
osteoarthritis [OA], systemic lupus erythematosus {SLE], gout and
fibromyalgia [FMS]. Over the past 20 years she has participated in
the development of all the approved biologic agents and synthetic
DMARDs in RA and SLE.
Dr. Strand's commitment to promoting forums for the discussion
of rational product development among industry, FDA, and academia
led to her establishing and co-chairing the biyearly "Innovative
Therapies in Autoimmune Disease" meetings [1988 - 2007]. She has
been an invited speaker at FDA Arthritis Advisory Committee
meetings discussing Guidance Documents for RA, OA, SLE, FMS, and
pain. Since 1992 she has served as a member of the Executive
Organizing Committee of the international Outcomes in Rheumatology
Clinical Trials [OMERACT] consensus conferences [1992 - 2014];
co-chairing OMERACT 7 (2004) and 11 (2012); with a strong interest
in patient-reported outcomes. She helped found and co-chaired the
Clinical Immunology Society Spring Fellows School. She is on the
Board of the Northern California chapter of the Arthritis
Foundation and their Medical and Scientific Committee, and the
Scientific Advisory Board of CORRONA. She has authored over 265
original publications, is a Fellow of the American College of
Physicians (1982), the American College of Rheumatology (1986) and
is a member of the Cosmos Club (1994). She graduated from
Swarthmore College with honors in a double major: Zoology and
Sociology/Anthropology and from the University of California
San
Francisco School of Medicine.
Prof. Cees GM Kallenberg, M.D., Ph.D. (Netherlands)
Professor, Department of Rheumatology and Clinical Immunology,
University Medical Center Groningen
Professor Cees GM Kallenberg received his medical training at
the Medical School of the University of Leiden, The Netherlands.
After getting his degree as an MD in 1972, he got additional
training in surgery and served as a military MD in the Dutch Army.
In 1975 he started his training as a resident in Internal Medicine
at the Groningen University Hospital and was registered as
internist in 1980. He worked as an internist and finished his PhD
studies on the subject 'Raynaud's phenomenon and Systemic
Autoimmune Disease' successfully in 1982. He further trained in
immunology and medical immunology and was registered as
immunologist and medical immunologist. He was appointed as
associate professor in Internal Medicine - Clinical Immunology in
1985 and as a full professor in 1993.
He has written more than 500 articles in international
peer-reviewed journals, gives lectures as an invited speaker on his
research topics on all major international meetings, and is an
editorial board member of several journals in clinical immunology,
nephrology and rheumatology.
Dr. Lee S. Simon, MD, FACP, FACR (USA)
Principal, SDG LLC and former FDA Division Director
Dr. Simon is a Rheumatologist and has been the Division Director
of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products
(DAAODP) (2001-2003), within the Center for Drug Evaluation and
Research (CDER), FDA. He has been the recipient of several Quality
Performance Awards and a Faculty Recognition Award from the FDA. He
has served on and has been the Acting Chair of the Arthritis
Advisory Committee of the DAAODP (1993-2001). He has also served on
the advisory committees for the Division of Over the Counter Drugs
(1996), Center for Devices (1995), and for the Division of
Hematologic and Gastroenterologic Drug Products (1996). He has also
served as a consultant for DDMAC (1993), the American Hospital
Formulary (1990) and AMA Drug Products (1990). He is presently a
Principal in SDG LLC, a consulting firm helping companies to create
successful drug development programs through good designs and using
insightful regulatory strategy (2004-).
He has been a clinical Rheumatologist for 25 years. He is a
fellow of the American College of Physicians (1991) and the
American College of Rheumatology (1986). Dr. Simon has had
extensive experience in drug development in the US, and has served
on consulting advisory boards for many different companies. This
experience includes drugs and other therapeutics used for pain,
anti-inflammatory effects, alteration of bone turnover, as well as
modifying inflammatory disease states. He was a National Institutes
of Health (NIH) funded investigator for 12 years working at the
"wet bench" developing methodologies for in vitro measures
approximating collagen turnover including the development of a
commercial assay for measuring the carboxy-terminal portion of type
I procollagen as a marker of new bone synthesis (1981-1993).
He has served for two terms on the Board of Directors of the
American College of Rheumatology (ACR) (1991-1993, 1994-1997),
served as the Chair of Education for the ACR and on the committee
of the National Arthritis Foundation. He has served as the
Scientific Abstract Selection Chair of the Annual Meeting of the
ACR (2002). He has been awarded the 2003 Distinguished Service
Award of the ACR and has been awarded the 2003 Scientific
Leadership Award of the Lupus Research Institute. He served on the
Steering Committee of IMPAACT, a group developing recommendations
for the design and implementation of clinical trials investigating
pain. He is on the Steering Committee and was Co-chair of the 2004
and 2012 OMERACT (Outcome Measures in Rheumatology) Biannual
Meeting. OMERACT is a constituent group of the World Health
Organization (WHO) through the International League of Associations
of Rheumatology (ILAR). He served on the Steering Committee of the
NIH Osteoarthritis Initiative (2001-2003). Dr. Simon has served as
Chair of the biannual "Innovative Therapies in "Autoimmune Disease"
conference sponsored by the ACR, FDA, NIH, and the Arthritis
Foundation (2001-2005).
He has been on the editorial board of multiple journals and has
authored more than 110 original publications, review articles and
chapters, and has served as a co-editor of 4 books. He was Co-chair
of the American Pain Society Guideline on the Treatment of Chronic
Pain in Chronic Arthritis (1999-2001). He has presented on topics
related to drug development, Rheumatology, the assessment and
treatment of pain and bone disease. He served on the Scientific
Advisory Committee of the National Osteoporosis Foundation, has
been the Vice Chair of Medical Affairs of the Arthritis Foundation,
Massachusetts Chapter as well as serving on its Board of Trustees
(1992-2001). He was an Associate Professor of Medicine at Harvard
Medical School (1995-2003) where he had been full time faculty
since 1981, an Associate Chief of Medicine, Beth Israel Deaconess
Medical Center (BIDMC) (1999-2001), Director of the Core Medicine
Clerkship (1986-2000), Director of Clinical Rheumatology Research
(1995-2001), Director of Graduate Medical Education at the BIDMC
and the Deaconess Hospital (1989-2001), and Chair of Rehabilitation
Services at the Deaconess Hospital (1986-1995), Harvard Medical
School before joining the FDA. He served as a voluntary faculty
member at Harvard and the BIDMC from 2004-2009 at which time he
left to pursue a full time consulting practice in drug development
and regulatory strategies.
For further information please see the Group's web site,
www.immupharma.org, or contact:
ImmuPharma PLC
Robert Zimmer, President & +33 389 66 13
Chief Scientific Officer 22
Dimitri Dimitriou, Chief Executive
Officer +44 20 7152 4080
Lisa Baderoon, Head of Investor +44 7721 413
Relations 496
Panmure Gordon & Co +44 20 7459 3600
Fred Walsh, Hannah Woodley
Notes to Editors
ImmuPharma
ImmuPharma is focusing on developing novel medicines with high
sales potential in specialist markets with serious unmet need.
ImmuPharma has five drug candidates in development, two platform
technologies and approximately 70 patents. The Company's most
advanced drug candidate, Lupuzor(TM) a potential blockbuster drug
for Lupus, a chronic autoimmune disease has recently received the
approval from the US FDA to enter phase III with a Special Protocol
Assessment and "Fast Track" designation. The Company's second
potential blockbuster compound in cancer "IPP-204106" is completing
a new Phase I/ II clinical trial with the next generation of
"polyplexed Nucant". ImmuPharma was founded and is led by a
commercially focused Board and management team with extensive
experience. For more information on ImmuPharma please go to:
www.immupharma.org
This information is provided by RNS
The company news service from the London Stock Exchange
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