Immupharma PLC Update on the progress of Lupuzor (1261I)
December 07 2015 - 2:00AM
UK Regulatory
TIDMIMM
RNS Number : 1261I
Immupharma PLC
07 December 2015
FOR IMMEDIATE RELEASE 7 DECEMBER 2015
LUPUZOR(TM) PIVOTAL PHASE III TRIAL RECRUITING FIRST US LUPUS
PATIENTS
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.
The Company is pleased to confirm that the first US sites are
open for recruitment of patients. This will be acknowledged on the
U.S. National Institutes of Health - ClincialTrials.gov website
shortly.
Recruitment in this pivotal Phase III study for Lupuzor(TM) 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. This trial is due to be completed by the end of
2017.
Further updates on the progression of the Lupuzor(TM) Phase III
trial will be announced, as appropriate, as the trial
progresses.
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
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. 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
END
RESKMMGZVVRGKZM
(END) Dow Jones Newswires
December 07, 2015 02:00 ET (07:00 GMT)
Immupharma (LSE:IMM)
Historical Stock Chart
From Jun 2024 to Jul 2024
Immupharma (LSE:IMM)
Historical Stock Chart
From Jul 2023 to Jul 2024