Author Topic: Phase 2b trial for MIS416 for SPMS  (Read 114 times)

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Offline agate

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Phase 2b trial for MIS416 for SPMS
« on: August 05, 2014, 02:52:52 pm »
BioNews offers science research updates, mainly from Texas academic facilities, and seems to be largely supported by the pharmaceutical industry. Nevertheless, this is from the MS News Update from BioNews, August 4, 2014:

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After Delay, Innate Immunotherapeutics’ MIS416 Trial For Secondary Progressive MS Therapy To Begin Enrolling in August

In spite of an eight week delay, New Zealand-based Innate Immunotherapeutics is still planning to enroll patients for its phase 2b clinical trial that will study the experimental drug MIS416 for secondary progressive MS. The clinical research organization (CRO) involved in the management of the trial informed the company about the delay, which came as a result of agreements between clinical investigators and trial sites that have taken longer to finalize than initially anticipated.

The patient enrollment was planned for the end of June. However, the CRO now expects enrollment for the trial to begin in August. Innate Immunotherapeutics will now also engage in the process of finding additional trial sites in order to accelerate the rate of appointment, as well as maximizing the rate of enrollment once each trial site has commenced treating patients. ...

In order to continue evaluating MIS416, the trial will enroll up to 90 patients with the secondary progressive form of multiple sclerosis (SPMS) throughout Australia across eight investigational trial sites. Patients will be administ[ered]  the drug once weekly for 12 months. The trial will be double-blinded and randomized, ensuring that 60 of the participants will receive MIS416 and the other 30 will receive a placebo. The experimental medication has been studied at the ongoing compassionate program and revealed promising results in studies led by researchers at  Victoria University of Wellington.

[In] the study, published in the PLOS ONE journal, researchers demonstrated that the drug developed originally to treat the relapsing-remitting form of MS is efficient in the treatment of secondary progressive multiple sclerosis as well. However, the research team has not fully understood what makes the therapy effective.
“We know this drug works, but we are not sure why,” explained Dr. Anne La Flamme, Associate Professor in Victoria’s School of Biological Sciences and head of the MS Research Programme at the Malaghan Institute of Medical Research. ”This study has helped us understand the pathways that are driving the disease and how the medication alters the immune system, giving us a better idea of why MIS416 works as well as insight into how to treat patients and predict who will do better on this sort of medication.”

... The company advised that patients will have to visit the clinic every week as part of the trial.
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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Re: Phase 2b trial for MIS416 for SPMS
« Reply #1 on: August 25, 2014, 07:34:41 pm »
More on this from MS Weekly News/BioNews Services, August 25, 2014:

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90 Secondary Progressive MS Patients To Be Recruited To Test Novel Experimental Therapy

 Leonor Mateus Ferreira



New Zealand and  Australian-based biotechnology company Innate Immunotherapeutics recently announced that it has begun to recruit patients with Secondary Progressive Multiple Sclerosis (SPMS) for its phase 2B trial of its experimental therapy MIS416. The study, which will be administered by the Western Australian Neuroscience Research Institute (WANRI), was recently approved by the Bellberry Human Research Ethics Committees (HREC), allowing the clinical trials to commence.

The approval granted by the independent ethics review board indicates that Innate’s study complies with strict National Health and Medical Research Council (NHMRC) guidelines for clinical trials, which will allow WANRI to initiate the recruitment process immediately. As a result, the company is expecting to start dosing the first patients during the next 2-3 weeks, after performing extensive baseline measurements of their present MS related symptoms.

“We are really pleased to be leading this trial,” said Dr. Allan Kermode, a clinical Professor of Neuroimmunology at WANRI. ”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.”

For the double blinded randomized trial, the company will recruit up to 90 SPMS patients in Australia, 60 of which will be given MIS416 and the other 30 with placebo. Both of the groups will be treated once weekly for 12 months.  The research team aims to determine the efficacy and safety of MIS416 compared to patients treated with the placebo.




The biologically derived novel immune modulator MIS416 targets not only the regulatory functions, but also the defensive functions of the innate immune system, and it is the first MS drug to attack the myeloid cells, which is a sub-set of innate immune cells that have only recently been recognized as important in the treatment of SPMS. Previous trials have already demonstrated that the drug improved the symptoms of 80% of patients with SPMS by 30% or more in at least one measure of their MS-related symptoms.

Multiple Sclerosis Research Australia (MSRA) and the United States National Multiple Sclerosis Society (US MS Society) have already expressed strong support of Innate’s pursuit of an effective treatment for SPMS. “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,” explained the CEO of MSRA, Dr. Matthew Miles.

The next step is to extend the key trial sites to the Eastern States, which the company expects to start by next month.


MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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MIS416 failed Phase II clinical trial
« Reply #2 on: August 09, 2018, 08:55:03 pm »
This is old news but may have some relevance to the US national news just now--from the National MS Society Website:


https://www.nationalmssociety.org/About-the-Society/News/Results-Announced-from-Phase-2-Trial-of-MIS416-in


From the Washington Post (August 8, 2016) there is the news that Representative Chris Collins (Rep., NY) is under indictment for insider training. It seems he was a stockholder in Innate Immunotherapeutics, which was developing a new drug for secondary progressive MS. He had knowledge about the failure of the clinical trial and passed that information along to relatives, advising them to dump their stock, before this was public knowledge.  Although the drug hasn't been named, my guess is that it was MIS 416.


https://www.washingtonpost.com/business/2018/08/08/rep-christopher-collins-r-ny-charged-with-insider-trading-federal-prosecutors-announce/?utm_term=.ded4bf4c9ef1
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.