Innate Immunotherapeutics Multiple Sclerosis Study of MIS416

Press Release – Innate Immunotherapeutics

Innate Immunotherapeutics today announced that the dose confirmation part of the company’s Phase 2A trial of drug candidate MIS416 in patients with the progressive form of MS will commence in early January 2012.Innate Immunotherapeutics Advances Progressive Multiple Sclerosis Study of MIS416

Auckland, 11 November, 2011 – Innate Immunotherapeutics today announced that the dose confirmation part of the company’s Phase 2A trial of drug candidate MIS416 in patients with the progressive form of MS will commence in early January 2012.

The announcement follows the successful conclusion of a dose escalation study in 16 patients with either primary progressive or secondary progressive MS conducted at Primorus Clinical Trials (Christchurch, NZ). The upcoming dose confirmation study will test a potentially therapeutic dose level of MIS416 in 15 patients with secondary progressive MS over a three month period.

Both parts of the 2A study are designed to establish the safety and tolerability of Innate Immunotherapeutics’ immune modulating microparticle and to also establish a dose level to be trialed in a larger scale Phase 2B clinical trial in late 2012.

The current trial is being partly sponsored by the U.S. National MS Society Fast Forward programme in collaboration with Merck Serono and has also attracted significant support from the New Zealand Government’s Ministry of Science and Innovation.

Innate Immunotherapeutics’ CEO, Simon Wilkinson, said the Company was delighted to have successfully completely the first part of the study and paid tribute to the patients and trial centre staff. “This study commenced just two weeks after the major earthquake that struck Christchurch on September 4th last year. Since that time there have been over 8,000 aftershocks including major quakes on Feb 22nd and June 13th. Despite the significant disruption caused to the Christchurch infrastructure and people’s lives, both patients and staff have soldiered on and been unwavering in their support of the study. We are indebted to them.”

About Multiple Sclerosis
Multiple sclerosis (or MS) is a chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord, and optic nerves. MS is the most common, non-traumatic, disabling neurological disease in your adults. Approximately 80% of sufferers are initially diagnosed with the relapsing-remitting form of disease for which there are now approximately nine approved disease-modifying therapies. Over 50% of sufferers go to develop the secondary-progressive form of MS. At this time, there are no therapies specifically approved to treat the secondary-progressive form of MS.

About MIS416
MIS416 is the lead product from Innate Immunotherapeutics’ proprietary microparticle immune stimulant (MIS) technology. In addition to its potential use in the treatment of MS, the company is conducting preclinical studies of MIS416 as both a standalone therapy for certain cancers and as an adjuvant in multiple cancer treatment vaccine developments. MIS technology is based on the use of a bacterially derived therapeutic microparticle incorporating multiple naturally occurring ligands, which, when administered, can activate synergistic innate signalling pathways. By activating and/or regulating important innate immune system mechanisms, Innate Immunotherapeutics’ microparticle immunomodulator technology presents a new way to fight infections and certain cancers, and to treat selected autoimmune diseases.

About Innate Immunotherapeutics
Innate Immunotherapeutics Limited (formerly Innate Therapeutics) is a public unlisted biopharmaceutical company based in Auckland. The company is focussed on the development of a new generation of immune response modifiers for potential use in the treatment of progressive MS and other autoimmune diseases, certain cancers, and as a novel cellular and humoral adjuvant.

For further information visit:

www.innateimmunotherapeutics.com
www.primorus.co.nz
www.nationalmssociety.org/fast-forward//index.aspx

ENDS

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