LONDON, January 25, 2017 /PRNewswire/ --
ImmuPharma PLC (LSE: IMM), the specialist drug discovery
and development company, provides further details of patient
participation following confirmation in December that ImmuPharma
had successfully completed, on target, patient recruitment into its
pivotal Phase III clinical trial of Lupuzor™, its lead programme
for the potential breakthrough compound for Lupus, the life
threatening auto-immune disease.
(Logo:
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Study Summary
• 200 patients successfully recruited and
randomised (dosed)
o 293 patients initially screened
illustrating the demand from physicians for a new safe and
effective treatment for Lupus
• 7 Countries and 28 sites are participating in the
study
o US: 11 sites with 70 patients
randomised
o Europe: 5 Countries and 16 sites with 81
patients randomised
o Mauritius: 1 site with 49
patients randomised
• Study status as at the end of January 2017
o over 80% of patients will have been treated
for at least 3 months
o 2 patients have completed the study
o 24 patients will have been treated for 9
months
o 50 patients will have been treated for 6
months
o 90 patients will have been treated for 3
months
• To date no drug (active or placebo) related 'Serious
Adverse Events' have been reported. This is consistent
with the strong safety profile of Lupuzor™ shown in its Phase IIb
study
• Top line results estimated to be reported in Q1 2018
Tim McCarthy, Chairman of
ImmuPharma said: "We are delighted to now
provide more details involved in the completion of recruitment of
patients within our Lupuzor™ Phase III trial in Lupus.
293 patients were initially screened in this study. This
illustrates the demand from physicians to meet the unmet medical
need, for an effective and safe treatment for this debilitating and
life threatening disease.
With the trial on track, two patients already safely
completing their 12 month dosing regimen, we look forward to
providing further updates on this pivotal Phase III trial as it
progresses through 2017."
Dr. Robert Zimmer, President
& Chief Scientific Officer added: "Thanks to
the diligent work performed by Dr. Fanny
Valleix, Head of Clinical Research at ImmuPharma in
conjunction with Simbec-Orion, our contract research partner, we
achieved our goal to complete patient recruitment before the end of
2016.
Contacts:
ImmuPharma plc
(http://www.immupharma.org)
Tim McCarthy, Chairman
+44-(0)-20-7152-4080
Lisa Baderoon, Head of Investor Relations
Twitter: @immupharma
+ 44-(0)-7721-413496
SOURCE Immupharma PLC