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#23939 - 10/27/06 09:07 AM Re: Sirna Update
Mack10 Offline
Contributor

Registered: 11/18/05
Posts: 32
I agree with everything you just said, hopefully we will see it before we get into double digits. However I have heard because this is done through topical delivery and not throught injection or swallowing, this drug will have a much easier time getting FDA approval. Hopefully it will be much easier to conduct clinical trials also. So that could be very helpful because if a normal drug take 5-7 maybe this one will take 3-5 or 4-6. nonetheless, lets just get them started soon and make sure it works.

Maybe questpharmatech, photoderma or applisonix will bring something that will help keep us under control until then

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#23940 - 10/27/06 09:42 AM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 86
I wrote Applisonix the other day and they said it will be quite some time before any product is available...at least in the US.

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#23941 - 10/27/06 06:14 PM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
Hmm first time I'm hearing about this Applisonix technology, seems interesting but the website isn't very informative. Looks like they are based in Israel so will probably get approval in Europe/Middle East before the USA.

Also they never mention "permanent" hair removal at all, only "long term" hair removal. From their graph they seem to equate it with waxing, the primary benefit being that their technology is pain free and can be used on all skin types (unlike laser/IPL).

Still any breakthrough is a good one...still my bet is on Sirna for the "magic cream".

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#23942 - 10/27/06 06:26 PM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
Quote:

However I have heard because this is done through topical delivery and not throught injection or swallowing, this drug will have a much easier time getting FDA approval. Hopefully it will be much easier to conduct clinical trials also.




Yep one would think that a topical drug would go through the approval process much faster than anything ingested or injected. However as I believe this will be the first topical form of genetic manipulation (not sure about this?) the FDA may be very cautious with it and wish to take more time investigating its long term safety implications. Even if it was approved say in 2010, I might (depending on how much worse my condition gets) be willing to wait an additional few years just to get an idea of the overall public reaction to the drug. I certainly don't want to trade in my hair for cancer or any other sacrifices in my physical health.

Just hoping that there are no serious snags in the clinical trials and everyone who participates in them are not harmed in any way.

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#23943 - 10/27/06 09:49 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 86
Eddy,

This isn't genetic manipulation. Therefore, there is much less risk. RNAi works by destroying the messenger RNA which tells our DNA to produce certain proteins. It is highly specific. No mRNA getting to the DNA, no protein production. When the protein that signals the hair follicle is no longer produced, no hair is produced.

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#23944 - 10/28/06 02:45 AM Re: Sirna Update
newbie133 Offline
Contributor

Registered: 08/11/06
Posts: 15
awesome stuff.. sounds prommising ahy.
too bad it sounds likely that the clinical trials will start next year ahy? i mean if they were schedueld to start this year it should have already begun since the 4th quater started in october and there hasnt been any word of it starting thus far. ahh well minor setback for what seems to b the end to all this ugliness.. tryna keep the glass half full here help me out ppl.

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#23945 - 10/29/06 03:54 PM Re: Sirna Update
Mack10 Offline
Contributor

Registered: 11/18/05
Posts: 32
jme1,

Just wondering why they said it will be so long before the US sees this product. Is it because the product is gonna take that long to develope or because of the approval process. One would think that if the product is approved in europe, it wouldnt take that long to get the product approved in the USA. At least more than a year or two.

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#23946 - 10/29/06 06:35 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 86
Mack,

When I wrote the US rep and asked him when he believed this would be hitting the US market, he just said it would be some time and gave no reason. I think it has to do with the fact that the product is still in the development stages and will be needing funding for production/further development or something along that line.

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#23947 - 10/30/06 02:48 AM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
Quote:

Eddy,

This isn't genetic manipulation. Therefore, there is much less risk. RNAi works by destroying the messenger RNA which tells our DNA to produce certain proteins. It is highly specific. No mRNA getting to the DNA, no protein production. When the protein that signals the hair follicle is no longer produced, no hair is produced.




Your totally right I'm not sure why I wrote "genetic manipulation" earlier...I think the point was that it is still a very new technology and because of that the FDA may want to take a longer look at the safety implications. Granted they state it is highly specific, therefore shouldn't have any adverse affect on surrounding cells and tissue, but this is something that will have to be first understood and verified by the FDA, and I'm just not sure how long that whole process will take.

However I feel we may be getting a bit ahead of ourselves as that doesn't really become a factor until Phase III of the Clinical Trials...let's just hope Phases I and II are successful first.

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#23948 - 10/30/06 03:27 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 86
Sirna was just bought by Merck today for 1.1 billion. I don't know what that will mean for the current drug developments.

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