Immupharma Regulatory News (IMM)

ImmuPharma plc

Cancer programme IPP-204106 progresses into further clinical trials

First cancer patients in new trial begin dosing

ImmuPharma plc (LSE:IMM) ("Immupharma" or the "Company" or the "Group"), the specialist drug discovery and development company, is pleased to announce that its cancer programme IPP-204106 has begun further clinical trials with the next generation of "polyplexed Nucant".

The first patients have started dosing in this new Phase I/II clinical trial.This "polyplexed Nucant" formulation has shown an impressive efficacy of about 10 times over the previous Nucant version in pre-clinical cancer models and represents a new discovery in that it combines the previous IPP-204106 Nucant version with a specific excipient that forms micro/nano structures.  IPP-204106 has a novel mechanism of action aimed at preventing proliferation, inducing apoptosis and also controlling angiogenesis.

ImmuPharma has made promising progress with its anti-cancer nucleolin antagonist ("Nucant") peptide programme. Having received approval from the French regulatory authorities, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) it initiated an initial Phase I dose ranging tolerability and safety study in three hospitals in France which is now completed. Patients were suffering from different types of cancer including breast, lung and bladder cancers which had all metastasised. No serious drug related adverse events were reported. 6 out of the 14 patients had a proven stabilization and for 2 out of the 6 the stabilization lasted for more than 6 months.

For this next Phase I/II study based on the next generation "polyplexed Nucant", it is planned to re-evaluate the safety in a preliminary Phase I dose ranging tolerability study with the new formulation (first dose level about to be completed shortly) followed by a Phase II efficacy study designed to treat various cancers in approximately 30 patients to identify appropriate biomarkers. This trial will be conducted in three hospitals in Europe including the prestigious Institute Jules Bordet, an Integrated Multidisciplinary Centre which is the only autonomous hospital in Belgium totally dedicated to cancer.  Our further intention is to conduct follow-up studies on patients showing the appropriate biomarkers with glioblastoma (brain tumour), metastatic melanoma, and pancreatic cancer where nucleolin plays a key role.

Recent scientific publications have demonstrated that by interfering with the pathway of nucleolin and other related membrane proteins, a strong growth inhibition of cancer cells as well as a strong induction of apoptosis was observed confirming initial results. In May 2011, IPP-204106 (also referred to as N6L) was chosen to feature on the front cover of 'Cancer Research', a prestigious medical journal of the American Association for Cancer Research. The article was entitled 'A Simple Approach to Cancer Therapy Afforded by Multivalent Pseudopeptides That Target Cell-Surface Nucleoproteins', and was authored by a number of researchers working at or with the CNRS, the research institution with which ImmuPharma is collaborating.

Dr Robert Zimmer, MD, PhD, ImmuPharma's President and Chief Scientific Officer, commented: "The clinical development of our cancer programme continues to be a key priority for ImmuPharma. It is therefore extremely encouraging to see the first patients dosed in this new trial. The improved formulation of the "polyplexed Nucant" is a great achievement for both ImmuPharma and our partner, the CNRS, and further strengthens our position in this field."

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Notes to Editors

ImmuPharma

ImmuPharma is focusing on developing novel medicines with high sales potential in specialist markets with serious unmet need. ImmuPharma has five drug candidates in development, two platform technologies and approximately 70 patents. The Company's most advanced drug candidate, LupuzorTM a potential blockbuster drug for Lupus, a chronic autoimmune disease has recently received the approval from the US FDA to enter phase III with a Special Protocol Assessment and "Fast Track" designation. ImmuPharma was founded and is led by a commercially focused Board and management team with extensive experience. www.immupharma.com

Institut Jules Bordet

The Institute Jules Bordet, an Integrated Multidisciplinary Center, is the only autonomous hospital in Belgium totally dedicated to cancer. It covers both cancer screening and clinical care, is involved in research activities and is at the same time a teaching hospital at a high level.

The smooth cooperation between these three activities presents an original aspect and an important plus for the approach to the disease.

The original aspect of oncological practice at the Institut Jules Bordet is based upon the truly multidisciplinary therapeutical approach, reinforced by a single patient file that is used by all physicians regardless of their specialty. This file is present at all consultations and hospitalizations and collects all medical information on the patient. After establishment of the diagnosis, decisions about treatment are taken by common agreement, by a collective reflexion of surgeons, radiologists and internists, based upon the most modern therapeutical techniques.

The development of today's cancerology would not have been possible but for an intense laboratory and clinical research.

The "Laboratory for Research and Clinical Investigation"is pursuing fundamental research, especially in the field of hematology, mammary cancerology, on melanome and pulmonary cancer etc, activities that have led to hundreds of scientific contributions recognized on an international level.A fundamental aspect of the Institute Jules Bordet is the close integration of research and practical oncology; as a consequence clinical research is permanently present in the treatment the physicians apply. A number of these clinical research programs are carried out in cooperation with national and international centers, especially in the framework of the EORTC (European Organization for Research and Treatment of Cancer) that was founded at the Institute Jules Bordet in 1964.

Academically and in the framework of the missions entrusted to the Institute Jules Bordet by the Université Libre de Bruxelles, the Institute has gained a reputation for the quality of its teaching of graduate and post-graduate courses. Every year the Institute forms and trains several oncologists who later practise their specialities in hospitals of Belgium as well as young researchers who will return to their respective hospitals to make use of their newly acquired expertise.

The Institute Jules Bordet distinguishes itself by its vocation as an integrated multidisciplinary center, developing the most recent approach and therapies based on active research, thus radiating both on the national and the international level.