TIDMIMM
RNS Number : 4606E
Immupharma PLC
04 November 2015
FOR IMMEDIATE RELEASE 4th NOVEMBER 2015
LUPUZOR PHASE III PIVOTAL TRIAL UPDATE
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the
specialist drug discovery and development company, is pleased to
provide an update on the progress of its Phase III clinical trial
of Lupuzor(TM), its lead programme for the potential breakthrough
compound for Lupus, the life threatening auto immune disease.
The pivotal Phase III trial is progressing in conjunction with
Simbec-Orion, the Company's contract research organisation
conducting the study. A number of important operational and
regulatory milestones have now been reached in order to allow the
recruitment of the first patients into the study this year,
particularly:
-- Recruitment is anticipated to occur in up to 45 investigator
sites. 10 sites in United States and 35 in Europe to ensure the
screening of 270 potential patients, in order to recruit the
required 200 patients for the trial.
-- In the United States the trial has been approved by a major
Central Institutional Review Board (IRB) which will allow several
sites to participate through a single IRB. It is expected that the
first sites in the US will be fully initiated in late
November/early December and will commence recruiting patients
thereafter.
-- In Europe the study is progressing through the centralised
Voluntary Harmonisation Procedure (VHP). The VHP application was
submitted on 28 October 2015 and this has up to a 60 day review
window. The applications to local Ethics Committees will happen in
parallel as well as the applications to the local EU Member states.
The EU VHP sets out that the study will take place in the United
Kingdom, Germany, France, Italy, Czech Republic, Hungary and
Poland. In Europe it is expected that the first sites will become
fully initiated in January and will then commence patient
recruitment thereafter.
-- As an integral part of the study the 'Investigator Meeting'
which will include around 100 investigators and senior coordinators
from the USA and Europe, will be held in Paris on 11-12th December
2015. The meeting will be introduced by Mr Alain Fuchs, Président
of the Centre National de la Recherche Scientifique (CNRS),
ImmuPharma's scientific collaboration partner.
Further updates on the progression of the Lupuzor(TM) Phase III
trial will be announced, as appropriate, as the trial
progresses.
Tim McCarthy, Non-Executive Chairman of ImmuPharma said:
"Following my recent appointment as Chairman I have now had the
opportunity to review the progress of the Phase III study with both
the Immupharma development team and Simbec-Orion. I am confident
that given the dedication and expertise of the Immupharma team
combined with the experience of Simbec-Orion, the study will
progress as planned with the anticipation of completing the study
by the end of 2017."
Ronald Openshaw, CEO of Simbec-Orion further commented:
"We continue to work closely with the development team at
ImmuPharma on the Lupuzor(TM) Phase III trial. Lupuzor(TM) has the
potential to be a significant treatment for lupus sufferers
globally and we are delighted to be contributing to its progress
through this last stage of development."
Robert Zimmer, President and CSO of ImmuPharma added:
"Dr Fanny Valleix, our VP Clinical development at ImmuPharma
France is leading the project. She brings her strong expertise
gained from her past as project director at an international
contract research organisation as well as an independent
consultant. The Lupuzor(TM) project is in good hands."
For further information please contact:
+ 44 (0) 20
ImmuPharma plc 7152 4080
Tim McCarthy, Chairman
Lisa Baderoon, Head of Investor + 44 (0) 7721
Relations 413496
Simbec-Orion +44 (0) 1443
Ronald Openshaw, CEO 690977
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 rigerimod 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 titled "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").
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. The
target price per patient is estimated to be around $10,000 -$20,000
per year. For more information on Lupuzor(TM) please visit:
(www.lupuzor.com)
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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