Last checked at 30 Jan 2009 07:00
For Immediate Release 30 January 2009
LupuzorTM Phase IIb study
shows a positive result and achieves statistical significance
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to announce that a planned interim analysis of its Phase IIb clinical trial comparing LupuzorTM to placebo in patients with systemic lupus erythematosus (also known as lupus) has demonstrated statistically significant superiority of LupuzorTM over placebo.
During the course of its Phase IIb study an interim analysis was performed and reviewed by an independent Data Monitoring Committee according to ICH guidelines. This analysis was conducted after 125 randomized patients had completed the 12 week treatment period, half of them having also completed the additional 12 week follow-up (week 24).
The primary efficacy measure was a 'SLEDAI response' defined as a decrease of at least 4 points in the SLEDAI score, a scale generally accepted by physicians as an assessment of the clinical activity of Lupus patients, a lower score representing lower disease activity. The analysis of the data has demonstrated that the 200mcg dose of LupuzorTM administered every four weeks was statistically significantly superior to placebo (p = 0.015). Lupuzor was generally well-tolerated with no significant drug related adverse events recorded. All these data follows on from the successful results which we saw with the preliminary Phase IIa trial.
Based on this interim analysis, ImmuPharma has discontinued the recruitment of more patients for the Phase IIb study. The 147 patients already randomized will continue the study to completion according to the protocol. A full analysis of the data will be provided in due course.
Dr. Robert Zimmer, President & Chief Scientific Officer said:
"We are absolutely delighted by these results. It is, according to our knowledge, the first drug showing significant superiority over placebo in the treatment of Lupus patients with such an excellent safety profile.
These results are also the primary success milestone of a story which started in 2001 with a collaboration initiated with the CNRS unit headed by Dr Sylviane Muller in Strasbourg and further supported by a wonderful collaboration with a network of highly competent Contract Research Organizations (NeoMPS France for API manufacturing, CERB France for toxicology, Quality Assistance Belgium for analytics and more importantly Genexion Switzerland which took a key role in the design and conduct of the clinical trials). Our success is also their success. We are now actively progressing the preparatory phase of the Phase III program."
For further information please contact:
ImmuPharma PLC:
Dimitri Dimitriou, Chief Executive Officer + 44 20 7152 4080
Richard Warr, Chairman + 44 20 7152 4080
Dr Robert Zimmer, President & Chief Scientific Officer + 33 389 32 76 50
Buchanan Communications:
Lisa Baderoon + 44 20 7466 5000
Rebecca Skye Dietrich + 44 20 7466 5000
Panmure Gordon & Co +44 151 243 0963
Andrew Burnett
Rakesh Sharma
Andrew Clanfield
More information on the company can be found at www.immupharma.com
Notes to Editors:
About ImmuPharma
ImmuPharma PLC is a drug discovery and development company headquartered in London, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It has research operations in France (ImmuPharma (France) SA) and Switzerland (ImmuPharma AG). ImmuPharma is dedicated to the development of novel drugs, largely based on peptide therapeutics, to treat serious medical conditions such as autoimmune diseases characterised by:
blockbuster potential in niche markets
low promotional costs in few specialised physicians and centres and
lower risk of drug development and lower development costs
ImmuPharma is a currently developing drug candidates for five different medical conditions, each of which would represent a significant breakthrough in its field. The furthest advanced drug candidate targets Lupus, a disease for which there is currently no cure or specific treatment. The other four address 1) cancer, 2) moderate to severe pain (such as that experienced by cancer sufferers and post-operative patients), 3) MRSA and similar severe hospital-acquired resistant infections and 4) inflammation.
All five have significant sales potential as well as low marketing costs and a relatively low risk of development failure. One or more have the potential to be fast-tracked by the US Food and Drug Administration according to "Guidance for Industry: Fast Track Drug Development Programs - Designation, Development and Application Review" issued July 2004 and could therefore obtain their market authorization by 2010.
Key to the potential success of ImmuPharma is its unique collaborative agreement with Centre National de la Recherche Scientifique, France's scientific research institution. This agreement grants ImmuPharma worldwide exclusive rights to exploit certain key discoveries.
In addition to its five leading drug candidates, ImmuPharma has a drug development pipeline using its rights to a virtual chemical library of hundreds of thousands of molecules as well as an innovative technology for converting peptides to drug candidates.
ImmuPharma has the option to commercialise its assets itself or to license them to other pharmaceutical companies at an earlier stage.
The products
Treatment of Lupus (IPP-201101)
This is a long-term treatment for Lupus, a chronic, life-threatening autoimmune disease where the immune system attacks healthy cells. There is currently no cure and existing medications only treat the symptoms whereas ImmuPharma's drug candidate has the potential to produce remission of the disease in a substantial proportion of patients.
Based on independent forecasts, the value of ImmuPharma's Lupus drug is estimated to be "substantial" with peak annual sales forecast to generate in excess of $4 billion.
Cancer (IPP-204106)
IPP-204106 has a dual mechanism of action, acting both in preventing angiogenesis as well as proliferation. IPP-204106 is a nucleolin antagonist, the lead molecule in a family of pseudopeptides designed to block the activity of a protein called nucleolin. Located essentially in the nucleus of normal cells where it is protected, nucleolin is much more abundant at the surface of the cells which are proliferating as well as the surface of active endothelial cells where it can be a target for antagonist peptides.
Cell surface expressed nucleolin is involved in the proliferation processes as well as in cell transformation. It is also a receptor for many growth factors and plays a key role in angiogenesis. Nucleolin antagonists have therefore both anti-angiogenic and anti-proliferative properties.
Preclinical data have shown that nucleolin antagonists inhibit the growth of tumours and metastasis in many cancer types. They prevent the implantation of tumours and block angiogenesis. They also inhibit the proliferation of certain types of leukaemia cells. Based on the mechanism of action nucleolin antagonists are active as long as surface nucleolin is present, irrespective of the type of cancer. Preliminary data have also shown the absence of toxicity.
Severe pain relief (IPP-102199)
ImmuPharma is developing a non-addictive compound for relieving moderate to severe pain, such as experienced by cancer sufferers and post-surgical patients. Most existing treatments are opioid-based (explain) and tend to have serious side effects. ImmuPharma's new treatment is based on met-enkephalin, the body's internal analgesic. IPP-102199 is being developed to have major advantages over morphine such as longer pain relief duration and reduced side effects. The market for chronic opioids in the US currently exceeds $3.5 billion and is growing by more than 10 to 20 per cent a year.
Antibiotic for MRSA and similar highly resistant infections (IPP-203101)
This is a novel antibiotic to counter the effects of MRSA and other severe hospital-acquired, resistant infections which affect some two million people in the US, according to the US Centers for Disease Control and Prevention. ImmuPharma's drug candidate uniquely uses an electrical charge rather than biochemical methods against MRSA and other bacterial strains. It is hoped this novel approach will reduce their potential to become resistant.