ImmuPharma & Simbec-Orion - Investigators Meeting

RNS Number : 0384J

Immupharma PLC

15 December 2015

 

FOR IMMEDIATE RELEASE

15 DECEMBER 2015

OVER 70 LUPUS SPECIALISTS GATHER IN PARIS FOR LUPUZOR'S PHASE III

INVESTIGATORS MEETING

ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to provide a summary of the Investigators Meeting which was held in Paris on 11^th/12^th  December. The key objective of the event was to bring together key specialists in the field of Lupus who will be actively involved as clinical investigators in ImmuPharma's Phase III Lupuzor™ pivotal trial and to brief them about the protocol and the complicated but required procedures to assess efficacy in the Lupus trial.

The event was jointly organised by ImmuPharma and Simbec-Orion, the Company's contract research organisation conducting the study. The meeting was attended by over 70 investigators and senior coordinators from the USA and Europe who will be involved in this pivotal Phase III trial for Lupuzor™.

The meeting was introduced by ImmuPharma's Fanny Valleix, Head of Clinical Research in charge of the study and Dr Robert Zimmer, President and Chief Scientific Officer.  Dr Daniel Wallace, Associate Director, Rheumatology Fellowship Program, Cedars-Sinai Medical Center, Los Angeles, a member of ImmuPharma's Scientific Advisory Board and a Principal Investigator for Lupuzor™'s Phase III trial also presented.  His presentation was entitled "The evolution of drug discovery in Lupus: Current status and future directions".  Prof Sylviane Muller, the inventor of Lupuzor™ and Research Director at the CNRS (the French national center for scientific research) presented Lupuzor's origins, its unique mechanism of action with supportive data of the compound's strong safety and efficacy profile.

A summary video of the event including interviews with Prof Sylviane Muller, key ImmuPharma, Simbec-Orion and Principal Investigator personel is available on the Company's website : www.immupharma.org/interviews

Commenting on the event, Tim McCarthy, Chairman, said: "This auspicious event brought together some of the most important specialists and investigators in the field of Lupus. The enthusiasm which everybody displayed within the meeting was truly overwhelming and demonstrates how important this Lupuzor™ trial is to so many people who are involved in bringing an effective treatment to Lupus patients around the world. As a further key milestone accomplished and the first US sites now opened for recruitment of Lupus patients, as confirmed on the ClinicalTrials.gov website, we look forward to providing further positive updates on this Lupuzor™ Phase III study as it progresses."

-Ends-

For further information please contact: ImmuPharma plc (www.immupharma.org) + 44 (0) 20 7152 4080 Tim McCarthy, Chairman Lisa Baderoon, Head of Investor Relations Twitter: @immupharma         + 44 (0) 7721 413496 Panmure, Gordon & Co., NOMAD & Broker [phone] 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 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

Current drugs either have serious side effects or have limited effectiveness. GSK's Benlysta's approval paves the way for Lupuzor™ (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™ please visit: www.lupuzor.com

The CNRS

The CNRS, the French National Center for Scientific Research, is Europe's largest public research institution. It produces knowledge for the benefit of society. With nearly 33,000 employees, a budget exceeding 3.3 billion euros in 2014 (including a self-generated income of 701 million euros), and offices throughout France, the CNRS is present in all scientific fields through its 1100 laboratories. With 20 Nobel laureates and 12 Fields Medal winners, the organization has a long tradition of excellence. It carries out research in mathematics, physics, information sciences and technologies, nuclear and particle physics, Earth sciences and astronomy, chemistry, biological sciences, the humanities and social sciences, engineering and the environment. For more information please visit: www.cnrs.fr/index.php

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

 

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