Italians are using Iplex for ALS

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urikc

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Insmed Incorporated has been requested by the Italian Ministry of Health, to make its drug, IPLEX(TM) (rhIGFI/rhIGFBP-3), available to physicians in Italy to treat patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease.

The request comes as a result of several Italian Court rulings ordering the Italian National Health System to provide the drug to specific ALS patients who have petitioned the Court. Through an agreement with Cephalon, which holds European patent rights to IGF-1 pertaining to the treatment of ALS, Insmed will be able to provide IPLEX to physicians in Italy. IPLEX will be distributed through an expanded access program, with Insmed receiving payment for drug from the Italian Health Authorities.
 
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Al

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Interesting. Has anyone heard of any trials using this drug in Canada or the U.S.?
 

urikc

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not in us

and most likley not in canada either. But sounds like itialian Docs wnated so bad they went thru their couirt system for about 2yrs to get government approval.

My close friend has ALS, and he is researching if there is anyway he could get them from italy.

Iplex is made by US company Insmed and it is FDA approved but not for ALS indicator yet. It may take couple of years if not more to get FDA approval here.
 

CindyM

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Does anyone know anything about this drug? I have not heard of it. CIndy
 

patricia1

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Al said:
Interesting. Has anyone heard of any trials using this drug in Canada or the U.S.?
that drug has been around for a while it is a growth hormone use for children who are short They are trying to get it approved for use in als I cant see why you cant get your neuro to give it to us Pat
 

raj7065

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Off Label

Maybe doctor can prescribe it off label since it a FDA approved product for another indication.
 

patricia1

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I am sure they can Ill ask my Boss He is a MD See what he thinks Pat
 

Omar

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But is it slowing the progression? and are they sure about it? or just like Rilutek! with some it works and with others no
 

raj7065

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Found out that apparently that Iplex can only be sold in Itlay due to the patent lawsuit that was settled with Genetech and Terricica. Iplex can be sold off label since it is FDA approved, but not for ALS or short stature in the United States. Can be sold off label for other indications which are not ALS or short stature related. Also they are still gathering data from the trials in Italy. Hopefully, they will release the data in a few months, but if it does show to work, they still have problem in that the cannot sell it in the US due to patent settlement with Genetech.
 

raj7065

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MDA-ALS Division

Here is link for ongoing trials from various companies for ALS. Hopefully one of them will have good results. Also good research site for anybody wanting to enlist in any of the trials.


http://www.mda.org/research/ctrials.aspx
 

patricia1

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Spoke to my neuro about Growth hormones He said that was studied years ago with not good results.Pat
 
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why use gene therapy

when stem cells can deliver IGF directly to neurons? Do you have any idea what gene therapy would mean for ALS? The genes are turned on permanently. See it is so easy to fall into the dogma of science and believe that just because something is from the Salk institute it is going to cure. Do you realize how much money gets thrown away on studies that have nothing to do with actually improving the condition?

Well I dont want to talk too much about stem cells since some on this group is going to start attacking me like they did to helpingmum

Seriously, when you support research make sure that they are actually doing research that makes sense instead of paying a prof's salary and ego !

Ask our friend Fred Gage how much he made of Stemcellsinc and how many patients that helped...just ask...
 
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