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andyvaughn

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Here I go again, beating the seemingly dead horse of IPLEX. While there is no research available to fully substantiate the claim that IPLEX either slows progression, or reverses symptoms of ALS, I have been able to contact patients that were able to take the drug, and from what I have read, think that the drug shows too much promise to be ignored. I understand it isn't a miracle drug, nor a cure, but slowing progression is about the best it seems to hope for with ALS today. I have sent the following letter to every media outlet that I can think of, with some adjustments depending on the receiving. I am submitting it here in the hopes that maybe some of you are also interested, and could forward the letter as you see fit? I refuse to stand idly by and watch my husband disintegrate without a fight!
Andrea wife of Pals Jim.

To whom it may concern: (Or whatever saluation is approprite to the receiver)

I am going to summarize as best as possible the current issue which all of us living with ALS face, specifically as it relates to the drug IPLEX. While I have tried to provide as basic text as possible, to fully understand the entire issue, several points have to be made. Please bear with the length, the dryness and detail necessitated in this summary.

In the briefest possible summation, IPLEX is a drug manufactured by Insmed. IPLEX essentially is an improved version of a drug called Increlex, which is manufactured by Genentech/Tercica. (Tercica is the licensing arm of Genentech). Genentech/Tercica took Insmed to court, for patent infringement, and March 7th, 2007, the case was settled.

Specifically, Insmed is allowed to market IPLEX for most non short stature indications, including ALS. However, the caveat is that they may only market IPLEX for use in ALS patients in Italy.

Now, at the time of this settlement, Insmed purportedly assured the ALS community in America that they would continue to provide IPLEX to their ALS patients, in an “opt in” agreement. However, they have yet failed to do so. Insmed’s current policy, when queried about IPLEX use anywhere but Italy, is to state that Increlex is a suitable alternative. However, Increlex and other drugs using different names but with similar chemical properties, have repeatedly failed to halt disease progression in clinical trials. Increlex is NOT the same as IPlex IPlex is IGF-1 with a binding protein IGF-3 that helps deliver the needed IGF-1 to muscles most damaged, achieves results more rapidly, allows for higher dosages without adverse side effects, and requires only one injection daily. Increlex is the same drug as Myotrophin (developed by Genentech and licensed to Tercica), that contains only IGF-1 and has been tested repeatedly over the last 10 plus years with no positive results. In fact, Myotrophin just failed yet another trial as a therapy against ALS in clinical testing. Press releases on this should be forthcoming at any moment.

Insmed could do several things, which they have yet to do. They could provide the drug to ALS patients here and provide royalty to Genentech. They could apply for orphan drug status, which is a process as complex as ALS itself, and they do currently lack the scientific rationale for use of IPLEX. And finally, the most rapid and beneficial approach would be for Insmed to begin immediately an open-label clinical test trial of IPlex for those with ALS and HIV-AIDS on a “compassionate use” basis. Supply IPlex free of charge for those who participate.

As you are aware, ALS is a fatal neurodegenerative disease. The disease has an unrelenting progression from onset towards total paralysis. ALS was first noted in medical journals in the mid 1800’s and to date, we have only one FDA approved drug on the market for use in ALS. That drug is called Rilutek and its most generous studies suggest that it extends life by a mere 90 days.

IPLEX has been suggested to significantly slow the progression of ALS. Some patients have even reported regaining function. There is a gentleman by the name of Carlo Bruno, who has spoken extensively in the Italian community about his use of IPLEX. To date, Mr. Bruno claims to continue to be ambulatory with only the use of a single point cane, and was diagnosed many years ago. If he was not on IPLEX statistically he should be dead, or on a vent. Those, unfortunately, are the only options for patients with ALS.

In closing, I realize this is a complex issue. However, ALS is a complex disease, and the pharmaceutical industry seemingly even more complex. I appeal to you simply in hope. In the past few months I have watched my once vivacious, strong husband disintegrate. He is rapidly losing the ability to speak and eat, has lost most use of his left arm, his left leg, and his right arm is beginning to lose function. To my family, my husband isn’t a statistic; he isn’t worth losing to the financial greed displayed by an industry that somehow masks itself as our friend. So, if my plea appears somewhat desperate, the truth is that it is. The complexities of the pharmaceutical industry and the FDA have held the ALS community hostage long enough.

To summarize how I think public awareness could help. I can simply say that, in the years I worked as an RN in HIV/AIDS research I witnessed it first hand. Who can forget Elizabeth Glaser, and her determination to save both herself and her children from the devastation of AIDS? Or more recently, the Abigail Alliance, who has generously offered to review this issue as well. I have seen that advocacy can indeed move mountains, that public sympathy and a demanding that treatment be made readily available and not denied to those with a terminal illness can sway the sentiment of even the federal government. I hope that my summary has illuminated how public sentiment and information could be helpful to our family, to every patient who suffers from ALS today, and the yet undiagnosed, destined to this terrible fate.

If I can further illuminate any of this, please feel free to contact me at any time. I will be happy to avail myself to anyone who has questions or comments.

With sincere gratitude

Andrea Reimers
(I deleted my personal contact info for this post, but added my address and phone number to letters submitted to the media)
 
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feelinghopeful

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feelinghopeful

HI There I couldn't help but read your story-any luck with this IPLEX?
My brother-in-law was diagnosed in December 2007 and he has drastically changed since his diagnosis.
How is your husband doing now? What has he been taking?

I look forward to hearing from you.
Feelinghopeful
 

wright

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This is the first time I've seen this thread. Did anything ever come of it? Very well written by the way.
 

andyvaughn

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Wright,
Alas, our persistent (our being Team Iplex, an international group of Pals/Cals) efforts have resulted in a public policy statement made by Insmed offering their sincere apology that they cannot give any ALS patient BUT Italians Iplex....
A group of PALS/CALS and interested parties will be protesting on the West Front Lawn of the Capitol Building, 11/11/2008 - (this date was chosen as Veterans with ALS want to join our group and offered support, a statement of necessity) we are marching/rolling/scooting from 10am to 4pm, meeting at the protest site at 8am for distribution of flyers, buttons/literature etc. I have lists of DC area hotels for any who are interested and the area is wheelchair accessible. Jim and I hope to see you there!
Andrea - wife of Pals Jim
 

wright

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I won't be able to make it but I hope there is a big showing. Tell us how it goes. Take care.
 

brendapals

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I wonder if anyone knows, can this drug not be ordered FROM Italy? Are the only people allowed to take it Italian citizens? Can we go to Italy, get the script and the med, and come back home?
These are a few of the questions my hubby asked me, and of course, I have no clue how to answer.
Thanks to all,
brenda
 

Jennifer51

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I have an italian neuro who works in london, so the next time I see him at the als clinic, I will make sure and ask him..(unfortunately my next appointment is in December.....I deliberately chose to see him because he has connections with the doctors who dealt with the lithium study in Italy. My hubby is italian by birth and we have a holiday home there, so if there is anyway this drug is viable I will do my darndest to get it. I will also ask the mnd assoc in the UK if their researchers have any dealings with this drug...we all want answers and help. jennifer51
 

gbrown

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Brenda:

It is my understanding from reading Andrea's posts on the ALSTDI forum that you have to be an Italian citizen and have to get an attorney and sue the Italian government to get the drug IPLEX. In addition you have to sue the government each year to be able to continue the drug. Andrea can probably shed more light on this subject.
Gordon
 

andyvaughn

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Gordon, your response is 100% accurate. The terms of the settlement between Insmed, Genentech and Tercica allow for Iplex ONLY to be distributed to Italian ALS patients, specifically, Italian citizens. Each Italian ALS patient has to sue their local courts, win the right to the drug, which is then distributed to the Ministry of Health/treating physician to give to the patient.
Andrea.
 

peter2008

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Iplex

Iplex Pipelines is a leading manufacturer and supplier of PVC and polyethylene pipeline systems in Australasia. Along with access to international pipeline products, technology, and service initiatives, Iplex Pipelines has built a reputation for solving individual. iPlex is a high-density, multi-functional, high-performance video processing platform designed for the unique requirements of IPTV, broadband and mobile
=====================================================
Peter
Our mission is to provide high quality end to end solutions to the BPO segment in a manner that will improve the operational efficiency while reducing the cost of the services to the client.
 
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Jennifer51

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IPLEX or now MYOGANE

Cor all that suing lark for iplex...I will still ask my italian neuro in london about it...but now I have come up with another drug, from another als website...MYOGANE anyone ideas or info or experience with this one.? I am seeing my normal neuro today for liver function tests...but he is such a pig, dont know if I dare mention the drugs to him....HE is quite clearly the DOCTOR and I am only the damn patient...thats why he studied all those years ...ne ne ne....and does not approve of my looking at things on the internet.. Thankfully the italian neuro at the als clinic is a total sweetie jennifer51
 

Jennifer51

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Myogane

Here is a link to an article about Myogane....
http://www.phytopharm.co.uk/news/newsreleases/?id=6895...........
sounds promising...although my main neuro, who I saw today, new nothing about it or IPLEX...he did not even know about the proposed lithium trial in the uk. ! No wonder I go to a specialist mnd clinic where they are a bit more up to date with stuff....I also asked him about my plan to collect the cord blood from my new grandchild due in april 09...he was very excited about the possibilities. There is going to be some lecture or something with a lot of neuros in the UK next week, so he is going to ask lots of questions for me regarding all these new drugs and possible treatments. Just hope they have some answers. jennifer51
 

gbrown

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IPLEX Release

"Yahoo"
The decision to release IPLEX to all PALS around the world is the best news that I've heard in a long time. Andrea Vaughan and "Team IPLEX" are to be congratulated on a job well done. This win just goes to show what people working together with grit and determination can accomplish. The demonstration is still going to be held tomorrow in Washington, but we have already won a victory.

I know that the details will have to be worked out, but this is a win win situation for everyone.
Gordon
 

freddiesnetty

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Yeah...........I am so excited to hear this, have been responding to alot of emails hoping that something would pay off...........AMEN
netty
 

kelly

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Andrea,
My husband and I just want to jump up and down and give you a big hug and kiss. Your determination is admirable. Know that we are there in spirit for the protest tomorrow.
Fondly,
Kelly Ragan
 
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