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.
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