Immupharma PLC US PATIENTS COMMENCE DOSING IN PHASE III STUDY (0032P)
February 15 2016 - 2:01AM
UK Regulatory
TIDMIMM
RNS Number : 0032P
Immupharma PLC
15 February 2016
RNS : FOR IMMEDIATE RELEASE 15 FEBRUARY 2016
FIRST US PATIENTS COMMENCE DOSING 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 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 US sites opened
in December 2015 have now commenced dosing 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 is
the next key milestone for ImmuPharma's Lupuzor(TM) trial and we
are therefore delighted that following the initial US sites being
opened, we can now confirm that the first Lupus patients have
commenced dosing. With recruitment going to plan, 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 5 February 2016 the successful
completion of a conditional GBP8.3 million fund raise, comprising a
Placing and Subscription. Completion of the Placing, Subscription
and the Sharing Agreement remains subject, inter alia, to the
approval of the Resolutions at a General Meeting to be held at 10
a.m. on 22 February 2016. For more information please go to:
www.immupharma.org/aimrule26/circulars.
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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