Immupharma PLC First European Site Opens - Patient Recruitment (4663R)
March 09 2016 - 1:00AM
UK Regulatory
TIDMIMM
RNS Number : 4663R
Immupharma PLC
09 March 2016
RNS : FOR IMMEDIATE RELEASE 9 MARCH 2016
FIRST EUROPEAN SITE OPENED IN FRANCE AND PATIENT RECRUITMENT
COMMENCES
IN LUPUZOR'S PIVOTAL PHASE III STUDY
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the
specialist drug discovery and development company, is pleased to
provide a further update on the progress of its pivotal Phase III
clinical trial of Lupuzor(TM), its lead programme for the potential
breakthrough compound for Lupus, the life threatening auto immune
disease.
ImmuPharma is pleased to confirm that the first European site in
Bordeaux, France is open and the patient recruitment process in
Europe has now commenced. This follows on from the Company's recent
announcement in February that the first US Lupus patients had
commenced dosing.
Recruitment in this pivotal Phase III study for Lupuzor(TM) will
occur in up to 45 investigator sites. 10 sites in United States and
35 sites in Europe to include France, Hungary, Poland, Germany,
Czech Republic, Italy and the UK.
Further updates on the progression of the Lupuzor(TM) Phase III
trial will be announced, as appropriate, as the trial progresses.
Progress on the trial can also be seen at:
www.ClincialTrials.gov/lupuzor.
Commenting on this event, Tim McCarthy, Chairman, said:
"Following the initial US sites being opened and the first Lupus
patients having commenced dosing we are delighted that we have hit
another key milestone with patient recruitment started in our first
European site in France. We look forward to providing further
positive updates on this Lupuzor(TM) Phase III study as it
progresses throughout this year and 2017."
-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.
ImmuPharma announced on 1 March 2016 the successful completion
of a GBP8.4 million fund raise, comprising a Placing and
Subscription. Monies raised will principally be used to complete
the pivotal Phase III trial of Lupuzor(TM).
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
There are an estimated five million people globally suffering
from Lupus, with approximately 1.5 million patients in the US,
Europe and Japan (Source: Lupus Foundation of America). Current
'standard of care' treatments, including steroids and
immunosuppressants, can potentially have either serious side
effects for patients or limited effectiveness, with over 60% of
patients not adequately treated. GSK's Benlysta is the first Lupus
drug approved in over 50 years and paves the path to market for
Lupuzor(TM). Based on conservative estimates, and taking into
account that Benlysta is priced currently at approximately $35,000
per patient per year, Lupuzor(TM) would be entering a market with
the potential for multi-billion dollar sales. For more information
on Lupuzor(TM) please visit: www.lupuzor.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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