Immupharma PLC European Patients Commence Dosing in Lupuzor (3712A)
07 June 2016 - 4:00PM
UK Regulatory
TIDMIMM
RNS Number : 3712A
Immupharma PLC
07 June 2016
RNS : FOR IMMEDIATE RELEASE 7 JUNE 2016
ImmuPharma PLC
("ImmuPharma" or the "Company")
FIRST EUROPEAN PATIENTS COMMENCE DOSING IN LUPUZOR'S PIVOTAL
PHASE III STUDY
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is pleased to provide a further 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.
ImmuPharma is pleased to confirm that the first European sites
opened have now commenced dosing Lupus patients. 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 in Europe.
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 the event, Tim McCarthy, Chairman, said: "This a
further key milestone for ImmuPharma's Lupuzor(TM) trial with now
both the US and European sites dosing Lupus patients. We look
forward to providing further positive updates on this Lupuzor(TM)
Phase III study as it progresses throughout this year and
2017."
Lupuzor Symposium on 8 & 9 June : Key Presenter : Prof.
Sylviane Muller
As recently confirmed, a Lupuzor(TM) Symposium is being hosted
this week with Prof. Muller, inventor of Lupuzor(TM) presenting on
the unique 'Mechanism of Action' of Lupuzor(TM), also known by its
chemical name 'Forigerimod' or 'P140'. Prof. Muller will also
provide further evidence of the role the P140 molecule can take in
the potential treatment of other autoimmune diseases.
For more information or if you would like to attend one of the
briefings, please email: lisa.baderoon@immupharma.com. A video of
the presentation will be available on the Company's website from
Monday 13 June on:
www.immupharma.org/events&conference.org.
-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 together with confirmation of EIS and VCT qualifying
status. Monies raised will principally be used to complete the
pivotal Phase III trial of Lupuzor(TM). Following the issue of the
New Ordinary Shares ImmuPharma has 121,781,219 ordinary shares of
10 pence each (the "Ordinary Shares") in issue.
Lupuzor(TM)
Lupuzor(TM) (also referred to as Forigerimod, 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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