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    You are here : Home » MS Research News » Drugs » MIS416

    MIS416

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    MS trial drug MIS416 gets global spotlight

    Innate Therapeutics LogoResearch details of a drug that may help people with secondary progressive multiple sclerosis (MS), developed by New Zealand biopharmaceutical company Innate Immunotherapeutics, is being highlighted at the world’s biggest annual gathering of MS specialists and pharmaceutical companies, ECTRIMS, in Lyon, France today.

    Innate’s study co-principal investigator, Dr Alison Luckey, talk about the result of 1B/2A trials of its drug MIS416 in the late breaking news section of ECTRIMS. More than 6,000 people attend the conference.

    Simon Wilkinson, chief executive of Innate Immunotherapeutics, says results of the Phase 1/2 clinical trial have shown MIS416 to be well tolerated and identified a clinical dose for further evaluation.

    "For most international clinicians and researchers into MS this will be the first time they will heard about our drug, that it has been in early stage trials and most importantly that early results are encouraging," he says. "We are grateful for the support of the United States National MS Society at ECTRIMS, especially for the credibility and validation of our programme the society’s support provides."

    Neurologist Professor Tim Anderson, co-principal investigator for the study, announced in June this year that preliminary data indicate MIS416 is safe and well tolerated. The MS-related clinical status assessment tools used during the study also indicate that the trial agent may have had some positive effect for many of the treated patients.

    During the dose confirmation portion of the study, eight of 10 patients with secondary progressive MS treated with MIS416 for 12 weeks showed some improvement in their MS-related signs and symptoms.

    Innate Immunotherapeutics plans to enroll MS patients in 2013 for a 12 month Phase 2B study to investigate the sustainability of the improvements in seen in the first study.

    "We plan to conduct most of the next study in Australia, to take advantage of that country’s greater patient availability," Mr Wilkinson says. "If we can get appropriate local support it would be good to also have trial sites in New Zealand too. Right now we are working hard during the next few months to raise around US$10 million that we need to run that longer phase 2B study. We are certainly hopeful our exposure at ECTRIMS will help us with that."

    In addition to the support of the United States-based National Multiple Sclerosis Society, Innate has had financial support from the New Zealand Ministry of Science and Innovation. It is also collaborating with New Zealand and US universities that specialise in oncology research, to conduct preclinical studies of MIS416 in other applications, including treatment vaccines for a number of different cancers.

    Source: Voxy.co.nz © Copyright 2012 Digital Advance Limited (12/10/12)

    Interim results from phase 2 study of MIS416 in secondary progressive MS

    Innate LogoInnate Immunotherapeutics today announced positive interim data from the company's Phase 1/2 clinical trial of MIS416 in patients with chronic progressive multiple sclerosis (MS).

    Results of the open-label, dose-escalation/confirmation trial showed MIS416 to be well tolerated and identified a clinical dose for further evaluation. Moreover, during the dose confirmation portion of the study, 8 of 10 patients with secondary progressive MS who were treated with MIS416 for 12 weeks showed some improvement in their MS-related signs and symptoms.

    "The preliminary data indicate that MIS416 was safe and well tolerated, and the MS-related clinical status assessment tools used during the study also indicate that the trial agent may have had some positive effect for many of the treated patients," said neurologist Professor Tim Anderson, M.D., co-principal investigator for the study. "For example, 50% of the study subjects showed some improvement in EDSS scores over the relatively short 12 week duration of the trial. These interim results are encouraging and merit the consideration of a randomized controlled trial in patients with secondary progressive multiple sclerosis."

    Study Design

    The aim of the study, conducted in New Zealand, was to evaluate the safety, tolerability and pharmacodynamics of intravenously administered MIS416 in patients with chronic progressive MS. During the dose finding phase, Investigators enrolled a total of 19 patients with primary or secondary progressive MS, 16 of whom completed the study. The subsequent dose confirmation phase treated 11 patients with secondary progressive MS over a 12 week period.

    Primary endpoints for the study included safety and tolerability, including maximum tolerated dose and recommended Phase 2 dose, of weekly intravenously administered MIS416, as well as the pharmacodynamics of the agent. Secondary endpoints aimed to document any changes in MS clinical status occurring during the 12-week dose confirmation phase of the study. These were determined through a variety of standard MS assessments including the MS Functional Composite (MSFC), Fatigue Severity Scale (FSS), Short Form Health Survey (SF-36) and Expanded Disability Status Scale (EDSS). Innate Immunotherapeutics expects to complete the Phase 1/2 study and announce final results in late 2012.

    "We are very encouraged in the potential of MIS416 as a treatment for secondary progressive MS based on the results from this trial to date, as well as observations in a small number of patients who have received MIS416 under New Zealand compassionate use protocols," said Simon Wilkinson, Innate Immunotherapeutics chief executive officer. "We intend to investigate the sustainability of the improvements in clinical status seen in this study through a 12 month Phase 2B study, which should begin enrollment in early 2013. We plan to conduct this study in Australia, to take advantage of that country's greater patient availability, the availability of excellent principal investigators and the financial support offered by the Australian government."

    "This increasingly coherent research around symptomatic relief, especially for those with secondary progressive forms of Multiple Sclerosis, is an exciting and extremely positive move in the right direction for those with MS and their families," said Rosie Gallagher, National Director, Multiple Sclerosis Society of New Zealand. "Disease modifying therapies for those with MS tend to be of the immune-suppressant variety and are specifically for those with the relapsing-remitting form of the disease; however, these treatments have little to no effect on secondary progressive MS patients. This is a worry for the future, as around 75% of those with the relapsing-remitting form of the disease will eventually move into being classified as secondary progressive. We therefore welcome and encourage more research into MIS416, which, as well as potentially offering relief to those with this debilitating chronic illness, also gives hope to those with secondary progressive MS in that they may finally have a tangible symptomatic treatment option."

    "Fast Forward is pleased to help advance Innate's important research which is designed to speed the development of an effective treatment for secondary progressive MS," said Dr. Timothy Coetzee, Chief Research Officer at the National Multiple Sclerosis Society.

    About MIS416

    MIS416 is the lead product from Innate Immunotherapeutics' proprietary immune modulating microparticle technology. The technology is based on the use of a bacterially derived, therapeutic microparticle incorporating multiple naturally occurring ligands, which when administered can activate synergistic innate immune signaling pathways to down regulate chronic inflammation, reduce autoimmune factors and help repair damaged tissue. In addition to its potential use in MS, the company is conducting preclinical studies of MIS416 in other applications, including oncology co-therapy and the treatment of infectious diseases.

    Source: MarketWatch Copyright © 2012 MarketWatch, Inc (18/06/12)

    Progressive Multiple Sclerosis study of MIS416 advances

    Innate LogoInnate 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 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.

    Source: Scoop Health © Scoop Media 2011 (15/11/11)

    Progressive Multiple Sclerosis therapeutic trial funded

    Innate LogoInnate Therapeutics today announced funding support from Fast Forward, LLC, a not-for-profit organization established by the U.S. National Multiple Sclerosis Society and EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany.

    The award of funds will help support the conduct of a Phase 2A clinical trial in patients with progressive forms of MS using MIS416, a naturally occurring agent derived from bacteria. “We are delighted to gain this substantial funding as well as to be able to work with Fast Forward and their collaborative partner, EMD Serono,” said Simon Wilkinson, the Chief Executive Officer of Innate Therapeutics.

    The award from Fast Forward and EMD Serono, which provides US $550,000 over 15 months is one of the first given in the Accelerating Commercial Development category from a funding program designed to accelerate the development of research discoveries into new or improved therapies for people with multiple sclerosis.

    “We are pleased to announce the 2009 funding recipients who will work to advance promising early- and late-stage projects in MS that could ultimately help patients,” said Bernhard Kirschbaum, PhD, Executive Vice President, Global Research and Development at Merck Serono, an affiliate of Merck KGaA, Darmstadt, Germany. “EMD Serono is committed to advancing scientific and medical knowledge and to furthering key research that has the potential to help people living with MS.”

    “The promise of current research like that undertaken by Innate Therapeutics to change the MS landscape is exciting, and it fuels the collaboration between Fast Forward and EMD Serono in advancing science in key areas of focus to speed the development of new therapies and innovations to benefit people living with MS. We are proud to be able to provide resources for those working to end MS and look forward to seeing the results stemming from these projects,” said Dr. Timothy Coetzee, President of Fast Forward.

    About MIS416

    MIS416 is the lead product from Innate Therapeutics’ proprietary microparticle immune stimulant (MIS) technology. In addition to its potential use in MS, the company is conducting preclinical studies of MIS416 in other applications, including oncology co-therapy and the treatment of infectious diseases. 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 immune signaling pathways. By activating and/or regulating important innate system mechanisms, Innate Therapeutic’s microparticle immunomodulator technology presents a new way to fight infections and certain cancers, and to treat select autoimmune diseases.

    About Fast Forward, LLC

    Fast Forward, LLC, established by the National Multiple Sclerosis Society as part of a comprehensive approach to MS research and treatment, focuses on speeding promising research discoveries towards commercial drug development. Fast Forward accelerates the development of treatments for MS by connecting university-based MS research with private-sector drug development and by funding small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS.

    About Innate Therapeutics Limited

    Innate Therapeutics Limited is a public unlisted biopharmaceutical company based in Auckland, NZ. The company is focused on the development of a new generation of immune response modifier for potential use in the treatment of multiple sclerosis and other autoimmune disease, a range of infectious diseases, certain cancers, and as a novel cellular and humoral adjuvant.

    Source: Innate Therapeutics Limited (07/05/10)

    New Zealand biotech to test Multiple Sclerosis treatment

    MIS416A clinical trial to test a promising new multiple sclerosis therapeutic gets underway in Christchurch later this month.

    The therapeutic, developed by Auckland biopharmaceutical company Innate Therapeutics, also has the potential to fight certain cancers and infectious diseases.

    The trial will test MIS416, a naturally occurring agent derived from bacteria, in people with progressive multiple sclerosis (MS). The trial has begun recruiting patients and will be conducted at the Primorus Clinical Trials purpose-built unit in Christchurch.

    Innate Therapeutics has sourced New Zealand and American funding for the trial. The Foundation for Research, Science and Technology (FRST) is investing NZ$600,000 through TechNZ, its business assistance programme. This is being matched with US$550,000 from the US not-for-profit, Fast Forward. Established by the United States National Multiple Sclerosis Society, Fast Forward is committed to providing support to accelerate the development of research discoveries into new or improved therapies for people with MS.

    US and New Zealand MS specialists say MIS416 has the potential to change the landscape for people living with MS. It is understood to work by a combination of mechanisms involving down-regulation of chronic inflammation, reduction of autoimmune factors, and damaged tissue repair. There are currently no drugs specifically approved to treat the progressive forms of MS in New Zealand.

    Innate Therapeutics’ CEO, Simon Wilkinson, said the company had chosen MS as its initial disease target because of very encouraging signs in a small number of patients who had early access (under the Medicines Act) to the drug on compassionate grounds and because of the funding from Fast Forward.

    “We are delighted to gain the substantial funding invested by TechNZ and Fast Forward, which has allowed us to begin this important trial. The ongoing difficulty for small biotechs anywhere is funding and the mechanism that the US MS Society has established with Fast Forward encourages researchers and developers, such as ourselves, to come forward with candidates,” he said.

    “However, as we have already found, the involvement with Fast Forward is more than about the dollars. We now have access to their networks and clinical expertise. MS is an exciting field to be in. For a therapeutic to be able to stop the progression of this debilitating condition is exciting. The wow factor would be seeing the partial reversal of symptoms.”

    The Foundation for Research, Science and Technology’s General Manager Manufacturing and High Growth Firms, Richard Bentley, says the TechNZ investment was awarded with two key benefits in mind – for people living with MS and for New Zealand’s clinical trials sector.

    “We think this investment has the potential to make a huge difference to developing a new therapy. Local clinical trial teams will also gain invaluable experience through working with international experts and other companies. This type of experience is hugely beneficial when it comes to building national capability. And the potential of economic gains to come with a successful trial, through licensing deals, is very exciting,” Mr Bentley said.

    Fast Forward’s President Timothy Coetzee says: “The promise of current research like that undertaken by Innate Therapeutics to change the MS landscape is exciting and we are delighted to provide this support to speed the development of this new therapy that has the potential to help people living with MS”.

    The Multiple Sclerosis Society of New Zealand’s National Director, Rosie Gallagher, says the society is extremely excited about the prospect of a new medication for those with progressive MS.

    “There has been very little progress in terms of disease therapies for those with this type of MS and the fact that it is being developed by a Kiwi company and trialled within New Zealand is a great highlight for us. We offer our full support to this venture and hope for an outcome which will benefit those who are struggling with the effects of this devastating condition.”

    Co-principal investigators for the Phase 2A trial are Primorus’ Medical Director and clinical trials specialist Dr Alison Luckey and Professor Tim Anderson. Professor Anderson is a consultant neurologist with the Canterbury District Health Board; Professor in the Department of Medicine, University of Otago, Christchurch; and Acting Director at the Van der Veer Institute for Parkinsons and Brain Research.

    The initial stage of the trial aims to establish the recommended therapeutic dosage level of MIS416 administered weekly over a four week period in 12 to 18 patients. A dose confirmation stage will follow when 12-18 patients will be treated with the recommended dosage level weekly for a six month period.

    With trials proceeding according to schedule, Innate Therapeutics estimates the drug could be on the market by 2016.

    The company confirms it is also conducting preclinical studies using MIS416 in other applications, including oncology co-therapy and the treatment of infectious diseases.

    About Innate Therapeutics

    Innate Therapeutics Limited 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 MS and other autoimmune diseases, a range of infectious diseases, certain cancers, and as a novel cellular and humoral adjuvant.

    Source: Scoop Independent News - Health (16/09/10)

    © Multiple Sclerosis Resource Centre (MSRC)

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