TIDMIMM
RNS Number : 1916R
Immupharma PLC
15 November 2012
For Immediate Release 15 November 2012
ImmuPharma presents Lupuzor's(TM) Phase IIb data at leading medical congress, the
2012 American College of Rheumatology Meeting, Washington,
D.C.
London Analyst Meeting : Friday 16 November @ 10am
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the
specialist drug discovery and development company, is pleased to
today outline the key abstract information presented on Wednesday
14 November at the 2012 Annual American College of Rheumatology
("ACR") Meeting which was held this week. The ACR Annual Scientific
Meeting is the premier worldwide scientific meeting devoted to
rheumatic diseases and is attended by key opinion leaders and
medical practicioners as well as scientific staff and
pharmaceutical companies. The title of the session was called
"Systemic Lupus Erythematosus - Clinical Aspects and
Treatment".
The presentation was given by the authors of the abstract:
ImmuPharma's President and Chief Science Officer Dr. Robert Zimmer,
together with Daniel J. Wallace, Associate Director, Rheumatology
Fellowship Program, Cedars-Sinai Medical Center, Los Angeles, a
leading practicioner within the field of Lupus and Sylviane Muller,
Research Director at CNRS, Strasbourg, France, who was the key
inventor of Lupuzor. (Full biographies can be found in 'Notes to
Editors').
Lupus is an autoimmune disease which involves the immune system
of the patient targeting multiple organs, with recurrent flares
causing a progressive level of damage and disability - the disease
is clinically heterogeneous (or of varying nature) in its basis
which makes diagnosis difficult. The condition is often
misdiagnosed in the beginning as rheumatoid arthritis. According to
the US Lupus Foundation, it affects up to 1.5m individuals in the
US alone.
The multicenter, randomized, placebo-controlled phase IIb study
of Lupuzor(TM) (P140 with Mannitol as stabilizer) run by ImmuPharma
in patients with Lupus (a dose of 200ug / month in addition to
"standard of care" vs "standard of care" alone), including patients
with clinical SLEDAI-2K scores above 6 and no Bilag A score.
Efficacy was evaluated using the SRI score.
Results: Clinical studies results:
P140 P140 Benlysta*
mannitol trehalose (BLISS-76)
Duration of treatment 3 months 6 months 12 months
Number of patients 273 x
x arms 50 x 3 92 x 2 3
SAE active/placebo 6%/6% 10%/14% 19%/20%
Drop-out rate
active 5% 22% 23%
Drop-out rate placebo 16% 23% 25%
Responder rate
active 62% 34% 43%
Responder rate
placebo 37% 40% 33%
*Shown for comparison from third party clinical data sources
Lupuzor(TM) showed to be safe and met its primary efficacy end
point in lupus patients. Data suggest that Lupuzor(TM) may restore
tolerance by acting as an altered peptide ligand of the T cell
receptor. Lupuzor(TM) also reduces autophagic (cell degradation)
process, which has been shown recently to be abnormally enhanced in
T lymphocytes from lupus mice and patients. The potential reduction
by Lupuzor(TM) of the enhanced autophagy process led to a very
short onset of action, which is supported by the efficacy data.
These data also formed the basis of the review and approval by the
FDA of Lupuzor's phase III programme and grant of a Special
Protocol Assessment and Fast Track designation.
ImmuPharma also presented the data from the additional,
non-pivotal phase II study that ImmuPharma's former licensee,
Cephalon, had performed, using a different stabilizer (trehalose).
ImmuPharma had previously stated that due to the mechanism of
action of trehalose and Lupuzor(TM) , (trehalose is a known inducer
of autophagy), the trial was not expected to produce meaningful
results. As anticipated, trehalose was shown to interfere with the
beneficial effect of Lupuzor(TM) . Its use together with the P140
peptide is therefore inappropriate in the treatment of lupus
patients.
ImmuPharma is in ongoing discussions with potential partners to
conclude a commercialisation deal and commence Phase III
trials.
Commenting on the abstract highlights, Dr Robert Zimmer, Chief
Science Officer said: "We were indeed delighted to have been
selected to present at the ACR meeting this week. I am also
honoured to have two highly prestigious experts in the field of
Lupus, Professor Daniel J. Wallace and Dr. Sylviane Muller, as
co-authors. Based on the data presented, there should now be no
doubt with regards to the superior safety and efficacy profile of
Lupuzor(TM) , as validated by the FDA and EMA's green light for
late-stage Phase III trials to commence."
Analyst meeting on Friday 16 November @ 10am Venue: Buchanan
Communications, 107 Cheapside, EC2.
Following today's announcement ImmuPharma will host an analyst
meeting on Friday 16 November in London to provide full disclosure
of the abstract paper and clinical analysis of the Lupuzor Phase
IIb study. The presentation will be given by Dr Robert Zimmer and
ImmuPharma's CEO, Dimitri Dimitriou. Please contact Lisa Baderoon,
Head of Investor Relations if you would like to attend
(lisa.baderoon@immupharma.com).
Ends
For further information please contact:
ImmuPharma plc + 44 (0) 20 7152 4080
Dimitri Dimitriou, Chief Executive
Officer
Dr Robert Zimmer, President and Chief
Scientific Officer
Richard Warr, Chairman
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
Buchanan + 44 (0) 20 7466 5000
Mark Court
Panmure, Gordon & Co., NOMAD & Broker +44 (0) 207 886 2500
Fred Walsh
Espirito Santo Investment Bank, Joint
Broker +44 (0) 20 7456 9191
Richard Crawley
Cenkos Securities plc, Joint Broker +44 (0) 20 7397 8900
Stephen Keys, Camilla Hume
Andy Roberts
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. ImmuPharma was founded and
is led by a commercially focused Board and management team with
extensive experience.
For more information, please visit www.immupharma.com
Biographies
Dr Robert Zimmer, President and Chief Science Officer,
ImmuPharma
Dr. Robert Zimmer was the founder and chief executive officer of
both ImmuPharma Switzerland and ImmuPharma France. He is an expert
in clinical pharmacology and life cycle management. He was
instrumental in developing a substantial number of products for
clients including Roche, GlaxoSmithKline, Abbott, Searle,
Sanofi-Aventis and Lilly. He began his career in Roche's
headquarters in Basle as coordinator of clinical pharmacology and
international clinical leader. He subsequently joined Jago Pharma,
the drug delivery company, and became a director and head of
research and development at SkyePharma after it acquired JAGO. He
obtained his MD at Strasbourg Medical School and his PHD at the
University of Aix-Marseille.
Dr Sylviane Muller, Research Director at CNRS & Co-founder
of ImmuPharma France
Dr Muller is Distinguished class Research Director at the CNRS
and head of the 'Immunologie et chimie thérapeutiques' unit of the
Centre National de la Recherche Scientifique, the largest
scientific research institution in France. Her field of expertise
covers autoimmunity, immuno-peptides and synthetic vaccines. She
has made 23 patented discoveries and is widely published. She was
also a founder of Neosystem, now Polypeptide-France, a leading
peptide development and manufacturing company. She is the key
inventor of ImmuPharma's Lupus lead drug candidate Lupuzor and has
been working in this field for more than ten years.
Dr Daniel J Wallace, Associate Director, Rheumatology Fellowship
Program, Cedars-Sinai Medical Center, Los Angeles
Dr Wallace received his undergraduate and medical education at
the University of Southern California, graduating with an MD in
1974. 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. He is the author
of 6 medical textbooks (including the last 4 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), 19 book chapters,
and over 250 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. 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 3 National Institute of Health grants. 20% of
his time is spent in teaching and research, providing free medical
care.
About The American College of Rheumatology "ACR"
The American College of Rheumatology's mission is advancing
rheumatology. The organization is for physicians, health
professionals, and scientists that meets the mission through
programs of education, research, advocacy and practice support.
The ACR provides professional education for its members through
several venues. The Annual Scientific Meeting is the premier
scientific meeting devoted to the rheumatic diseases. This meeting
draws thousands of rheumatologists and arthritis health
professionals from around the world. A winter rheumatology
symposium, spring clinical meetings, and other topical conferences
round out the ACR's educational offerings.
The ACR publishes Arthritis & Rheumatism, the premier
scientific journal for research in the rheumatic diseases.
Arthritis Care & Research is published by the Association of
Rheumatology Health Professionals, a division of the ACR. This
journal focuses on the health services and clinical aspects of
rheumatology.
The Association of Rheumatology Health Professionals, a division
of the American College of Rheumatology, is a professional
membership society composed of non-physician health care
professionals specializing in rheumatology, such as advanced
practice nurses, nurses, occupational therapists, physical
therapists, psychologists, social workers, epidemiologists,
physician assistants, educators, clinicians, researchers, research
coordinators and office staff.
The ACR Annual Meeting - The Premier Meeting in Rheumatology
The ACR Annual Meeting is the must-attend event for anyone
involved in research or delivery of rheumatologic care or services.
Innovative sessions, ground breaking scientific abstracts,
education developed based on practice gaps, the return of popular
session formats, as well as hands-on skill training sessions are
just some of the highlights.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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