TIDMIMM
RNS Number : 1275J
Immupharma PLC
07 September 2016
RNS : FOR IMMEDIATE RELEASE 7 SEPTEMBER 2016
ImmuPharma PLC
("ImmuPharma" or the "Company")
UPDATE ON LUPUZOR'S PIVOTAL PHASE III STUDY
ImmuPharma Invited to Open an Additional Site in Mauritius
Up to 30 Lupus patients ready for enrolment
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 has been requested to open a new site in Mauritius to
participate in the current pivotal Phase III Lupuzor(TM) trial. Cap
Research, a leading contract research organisation in Mauritius,
will be leading the trial and patient recruitment. It is
anticipated that around 30 Lupus patients will commence recruitment
within this new site over the next few weeks as part of the ongoing
200 patient Lupuzor(TM) trial.
Mauritius, with a population of around 1.2 million, is prevalent
to a high proportion of Lupus sufferers, with approximately 3000
current Lupus patients. In May 2016, Prof. Sylviane Muller,
inventor of Lupuzor(TM), was invited to visit Mauritius as a guest
of 'Lupus Alert', the country's pre-eminent Lupus foundation which
has been following the progress of Lupuzor(TM) since the
commencement of its pivotal Phase III trial.
Over one week, Prof. Muller had an audience with Ameenah
Gurib-Fakim, Mauritius' President and a prominent scientist. Prof.
Muller also met with high ranking government officials, leading
Rheumatologists and the Ministry of Health, which is responsible
for approving clinical trials in the country, delivering
presentations. TV/radio interviews on Lupuzor(TM) were also
conducted. Discussions focused primarily on the Government's strong
interest for ImmuPharma to include Mauritius in its current pivotal
Phase III trial for Lupuzor(TM).
Further updates on the progression of the Lupuzor(TM) Phase III
trial will be announced, as appropriate, as the trial continues.
Progress on the trial can also be seen at:
www.ClinicalTrials.gov/lupuzor.
Commenting on the announcement, Tim McCarthy, Chairman, said:
"We are delighted to have been requested by the Mauritian
Government and the Country's leading Lupus specialists to
participate in our trial. Mauritius with its high proportion of
Lupus sufferers clearly highlights how necessary an effective Lupus
therapy such as Lupuzor(TM) is needed for such a debilitating
disease. We look forward to providing further positive updates on
our Lupuzor(TM) Phase III study as it progresses further through
this year and into 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
& Broker) 7886 2500
Fred Walsh, Duncan Monteith, Corporate
Finance
Charles Leigh-Pemberton, Corporate
Broking
Northland Capital Partners Limited
(Joint Broker)
Patrick Claridge, David Hignell,
Corporate Finance +44 (0)20 3861
Rob Rees, Corporate Broking 6631
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.
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
About Lupus Alert (www.lupusalert.com)
Lupus Alert is the only registered Non Government Organisation
(NGO) that provides active physical, moral, emotional and financial
support to patients and families with Lupus and other related
autoimmune diseases in Mauritius. Founded in January 2000, Lupus
Alert has been applauded for its pioneering work and vision:
-- Lupus Alert was awarded the Mauritius Council of Social
Service Outstanding NGO Award in 2003 and the most Outstanding
Volunteer Award by the Mauritius Council of Youth Leaders in 2004
and in 2009.
-- Lupus Alert received the International Lifetime Achievement
Award in the control of Systemic Lupus Erythematosus (SLE) on
26(th) June 2010 during the 9(th) International Congress on SLE
held in Vancouver.
-- For her extraordinary work in disease awareness and patient
advocacy Dalilah Kalla, a lupus patient, was awarded the 2011 JCI
Outstanding Young Person of Mauritius and is among the 2011 JCI Ten
Outstanding Young Persons of the World (JCI TOYP) recipient in the
category of humanitarian and voluntary leadership.
-- Over 3000 people may have lupus in Mauritius and 90% of those
affected are teenagers and young adults between the ages of 10 and
35 years.
-- Lupus Alert's vision is to make sure that all people with
lupus in Mauritius have guaranteed access to competent health care,
high quality treatment and are ensured all support required to live
a comfortable life.
About Cap Research (www.cap-research.com)
Cap Research is a CRO (Clinical Research Organisation), based at
Phoenix (Mauritius), conducting medical and clinical trials phases
I, II and III. Incorporated since 2013, its research centre is
synonymous of excellence and has the know-how whilst using the
latest technical development in the field of clinical research. It
is the first private trial research centre in Mauritius performing
studies for phases I, II and III.
This information is provided by RNS
The company news service from the London Stock Exchange
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September 07, 2016 02:00 ET (06:00 GMT)