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Innate Immunotherapeutics’s Phase 2B Clinical Trial On SPMS To Start Recruiting Patients Following Perth Site Obtaining Ethics Approval



8/19/2014 8:59:06 AM

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Innate Immunotherapeutics Ltd (“Innate”, “the Company”) (ASX:IIL) has today announced that the Western Australian Neuroscience Research Institute (WANRI) has received approval to commence patient recruitment for the Company’s Phase 2B trial of MIS416 in patients with Secondary Progressive Multiple Sclerosis (SPMS).

The ethics approval was granted by Bellberry Human Research Ethics Committees (HREC) – an independent ethics review board compliant with strict National Health and Medical Research Council (NHMRC) guidelines for clinical trials.

The approval enables WANRI to commence patient recruitment immediately with the first patients expected to be dosed within the next 2-3 weeks following extensive baseline measurements of their present MS related symptoms.

WANRI has been selected by Innate as the study's lead site due to its strong focus on investigating the causes and improving the therapy and management of patients suffering from multiple sclerosis. The Institute has a strong focus on providing the best clinical management for multiple sclerosis available.

“We are really pleased to be leading this trial. SPMS affects 30% of the MS population at any moment in time, and there are no approved long term effective treatment options for these patients. We all hope that MIS416 might be the drug to address this urgent need,” said Dr Allan Kermode, clinical Professor of Neuroimmunology at WANRI.

The Phase 2B trial will recruit up to 90 SPMS patients across multiple sites in Australia. The trial is a double blinded randomised study where 60 patients will receive MIS416 and 30 will receive a placebo. Patient will be treated once weekly for 12 months. The primary goal of the trial is to determine the efficacy and safety of MIS416 compared to patients treated with the placebo.

Previous non-placebo controlled MIS416 studies found that 80% of patients with SPMS had shown a 30% or greater improvement in at least one measure of their MS-related symptoms.

Notably, patient stakeholder groups such as Multiple Sclerosis Research Australia (MSRA) and the United States National Multiple Sclerosis Society (US MS Society) have both expressed strong support of Innate’s pursuit of an effective treatment for SPMS.

Dr Matthew Miles, CEO of MSRA said: “Australia has a strong cohort of world-leading MS neurologists who are highly experienced clinical trial investigators and strongly committed to supporting the development of new treatments for their patients.”

The Company expects key trial sites in the Eastern States to obtain ethics approval over the next month with other centres to follow.

For further information, please contact the persons below or visit the Innate Immunotherapeutics website at www.innateimmuno.com

About Multiple Sclerosis (MS)

Multiple Sclerosis (MS) is a chronic disease of the central nervous system, where the body’s immune system attacks the myelin sheath surrounding the nerve fibres. The damaged myelin disrupts the communication mechanism of parts of the central nervous system. This results in a wide range of symptoms, which may include loss of balance and muscle coordination, difficulty walking, slurred speech, tremors, stiffness, cognitive impairment, depression, fatigue and bladder problems.

There are two main forms of MS, an early ‘relapsing-remitting’ stage of disease and a later, more disabling ‘secondary-progressive’ stage of disease. Worldwide, 30% of all MS sufferers have SPMS and there are currently no approved disease modifying drugs for the safe and effective ongoing treatment of this highly disabling form of the disease. 23,000 Australians and 2.5 million people around the world live with MS. There are currently no effective treatments in halting the accumulation of disability in patients with the progressive forms of MS.

About MIS416

The microparticle, MIS416, is a biologically derived novel immune modulator and can target both the regulatory functions and the defensive (pathogenic) functions of the innate immune system. MIS416 targets myeloid cells, a sub-set of innate immune cells not currently targeted by existing or other ‘in-trial’ MS drugs.

Myeloid cells have only recently been recognised as a significant potential therapeutic target in SPMS. Myeloid cells have the capacity to remodel the deregulated immune activity which is an important part of the disease process in SPMS. These same cells, remodelled in the correct fashion, can also promote neuro repair pathways critical to slowing or reversing disability in SPMS.

For Further Information:
Mr Simon Wilkinson, CEO
+64 21 661 850

Media:
Gabriella Hold, Buchan Consulting
03 8866 1203/0411 364 382
ghold@buchanwe.com.au

Investors
Rebecca Wilson
0417 382 391
rwilson@buchanwe.com.au

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