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Biotech / Medical : Indications -- Lupus/Nephritis

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From: nigel bates5/10/2006 8:24:10 AM
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ImmuPharma
announces successful results from its phase I clinical trial with
IPP-201101 for Lupus

- Phase II to start soon -

10th May. ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,
announced today that it has successfully completed the placebo-controlled phase
I study involving 24 healthy volunteers of its lead compound IPP-201101 for
Lupus, a chronic, life-threatening autoimmune disease.

This study, which took place in France, was the first administration in humans
for IPP-201101 and was designed to assess its safety and tolerability. The
preliminary safety report confirmed that the drug was safe and well-tolerated.

These encouraging results have allowed ImmuPharma to proceed with a phase II
proof-of-concept and efficacy study in Lupus patients in Europe. The phase II
study protocol was recently approved by the ethics committees and has been filed
with the appropriate regulatory authorities. The dosing of Lupus patients in
this study is expected to start soon and the trial will measure recognised
surrogate markers of clinical efficacy, in preparation of the pivotal phase III
studies.

To that effect, ImmuPharma has also scheduled a meeting with the FDA to design
the appropriate development programme to get market authorisation of the drug in
the US.

Dr Robert Zimmer, President and Chief Scientific Officer of ImmuPharma, said:
'IPP-201101, which has blockbuster potential, is a novel concept for the
treatment of Lupus. IPP-201101 modulates the signalling of CD4+ cells and may
also interact with the T-reg pathway. The key element is that IPP-201101 has
been designed to interact only with the CD4+ cells linked to Lupus and leaves
intact the remaining immune system, allowing Lupus patients to be protected by a
fully operational immune system unlike the currently used therapies such as high
dose corticoids and immunosuppressants. When administered appropriately it has
the potential to stop the progression of the disease and should therefore be
prescribed as early as possible during the course of the Lupus disease. The
already available preclinical package demonstrating efficacy and selectivity for
Lupus together with the good results of the phase I safety and tolerability
study in man are critical in this respect and may offer clear benefit for the
patients when compared to the current therapies.'
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