Immupharma PLC ImmuPharma & Simbec-Orion - Investigators Meeting (0384J)
15 December 2015 - 6:00PM
UK Regulatory
TIDMIMM
RNS Number : 0384J
Immupharma PLC
15 December 2015
FOR IMMEDIATE RELEASE 15 DECEMBER 2015
OVER 70 LUPUS SPECIALISTS GATHER IN PARIS FOR LUPUZOR'S PHASE
III
INVESTIGATORS MEETING
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the
specialist drug discovery and development company, is pleased to
provide a summary of the Investigators Meeting which was held in
Paris on 11(th) /12(th) December. The key objective of the event
was to bring together key specialists in the field of Lupus who
will be actively involved as clinical investigators in ImmuPharma's
Phase III Lupuzor(TM) pivotal trial and to brief them about the
protocol and the complicated but required procedures to assess
efficacy in the Lupus trial.
The event was jointly organised by ImmuPharma and Simbec-Orion,
the Company's contract research organisation conducting the study.
The meeting was attended by over 70 investigators and senior
coordinators from the USA and Europe who will be involved in this
pivotal Phase III trial for Lupuzor(TM).
The meeting was introduced by ImmuPharma's Fanny Valleix, Head
of Clinical Research in charge of the study and Dr Robert Zimmer,
President and Chief Scientific Officer. Dr Daniel Wallace,
Associate Director, Rheumatology Fellowship Program, Cedars-Sinai
Medical Center, Los Angeles, a member of ImmuPharma's Scientific
Advisory Board and a Principal Investigator for Lupuzor(TM)'s Phase
III trial also presented. His presentation was entitled "The
evolution of drug discovery in Lupus: Current status and future
directions". Prof Sylviane Muller, the inventor of Lupuzor(TM) and
Research Director at the CNRS (the French national center for
scientific research) presented Lupuzor's origins, its unique
mechanism of action with supportive data of the compound's strong
safety and efficacy profile.
A summary video of the event including interviews with Prof
Sylviane Muller, key ImmuPharma, Simbec-Orion and Principal
Investigator personel is available on the Company's website :
www.immupharma.org/interviews
Commenting on the event, Tim McCarthy, Chairman, said: "This
auspicious event brought together some of the most important
specialists and investigators in the field of Lupus. The enthusiasm
which everybody displayed within the meeting was truly overwhelming
and demonstrates how important this Lupuzor(TM) trial is to so many
people who are involved in bringing an effective treatment to Lupus
patients around the world. As a further key milestone accomplished
and the first US sites now opened for recruitment of Lupus
patients, as confirmed on the ClinicalTrials.gov website, we look
forward to providing further positive updates on this Lupuzor(TM)
Phase III study as it progresses."
-Ends-
For further information please
contact:
+ 44 (0) 20
ImmuPharma plc (www.immupharma.org) 7152 4080
Tim McCarthy, Chairman
Lisa Baderoon, Head of Investor
Relations + 44 (0) 7721
Twitter: @immupharma 413496
Panmure, Gordon & Co., NOMAD & +44 (0) 20 7886
Broker 2500
Fred Walsh, Duncan Monteith, Corporate
Finance
Charles Leigh-Pemberton, Corporate
Broking
Notes to Editors
ImmuPharma PLC
ImmuPharma is a pharmaceutical development company listed since
2006 on AIM of the London Stock Exchange (LSE:IMM), focusing on
developing novel medicines with high sales potential in specialist
markets with serious unmet need. ImmuPharma is led by a
commercially focused Board and management team with extensive
experience. For more information please go to:
www.immupharma.org
Lupuzor(TM)
Lupuzor(TM) (also referred to as forigerimod, rigerimod,
IPP-201101 or P140 is ImmuPharma's lead compound and a potential
treatment for lupus (or Systemic Lupus Erythematosus), a chronic,
potentially life-threatening auto-immune disease. Lupuzor(TM) has a
novel mechanism of action aimed at modulating the body's immune
system so that it does not attack healthy cells, and avoids causing
adverse side effects. It has the potential to halt the progression
of the disease in a substantial proportion of patients.
Lupuzor(TM) has been granted Fast Track status by the US FDA and
approval to start Phase III under Special Protocol Assessment
(SPA). This SPA was subsequently amended due to its strong safety
and efficacy profile to allow for a reduced number of patients in
the pivotal Phase III trial thereby reducing the projected cost and
time of development considerably.
The pivotal Phase III clinical study is entitled "A 52-Week,
Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study
to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101
Plus Standard of Care in Patients With Systemic Lupus
Erythematosus". It is a pivotal study designed to demonstrate the
safety and efficacy of IPP-201101 and as a last step prior to the
filing of the drug for approval with the US Food & Drug
Administration ("FDA") and the European Medicines Agency ("EMA").
For more information please visit:
www.ClinicalTrials.gov/lupuzor
Commercial Opportunity
Current drugs either have serious side effects or have limited
effectiveness. GSK's Benlysta's approval paves the way for
Lupuzor(TM) (first Lupus drug approved in over 50 years). There are
an estimated 1.5 million patients in US, Europe and Japan. For more
information on Lupuzor(TM) please visit: www.lupuzor.com
The CNRS
The CNRS, the French National Center for Scientific Research, is
Europe's largest public research institution. It produces knowledge
for the benefit of society. With nearly 33,000 employees, a budget
exceeding 3.3 billion euros in 2014 (including a self-generated
income of 701 million euros), and offices throughout France, the
CNRS is present in all scientific fields through its 1100
laboratories. With 20 Nobel laureates and 12 Fields Medal winners,
the organization has a long tradition of excellence. It carries out
research in mathematics, physics, information sciences and
technologies, nuclear and particle physics, Earth sciences and
astronomy, chemistry, biological sciences, the humanities and
social sciences, engineering and the environment. For more
information please visit: www.cnrs.fr/index.php
Simbec-Orion
Simbec-Orion is a full service CRO operating from first in human
Phase I clinical studies through to pivotal Phase III studies and
Phase IV post marketing studies. The Company has expertise in all
drug types, dosage forms and delivery mechanisms and in later stage
development has particular expertise in oncology, rare and orphan
diseases. Simbec-Orion supports its clients with its own in-house
full service central laboratories, pharmacovigilance, data
management and statistics, pharmacy, medical management. For more
information please visit: www.simbec.com and www.orioncro.com
This information is provided by RNS
The company news service from the London Stock Exchange
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