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#23929 - 03/23/06 08:50 PM Re: Sirna Update
sol1 Offline


Registered: 04/01/05
Posts: 13
Loc: US
Hi there,

I am so glad that there are people out there that have faith in science and are not willing to settle for less or bicker about things. I have had very unsuccesful laser therapy. I still think a home laser could be useful if it is safe and cheap and I think the technology is out there. I believe strongly in the consumer voice.
How do you suggest encouraging these companies to develop products that will be cheap, efffect and in the market soon? Are you e-mailing the companies directly? I feel like if we encouraged more people to speak up and write to these companies, they would spend more energy towards this issue. Unfortunately there is so much stigma associated with it that it is hard for many to talk about.
Also, I was wondering if any of you have a science background. I have a BS in genetics and I am a med student. I really think we can solve this problem for many people in the near future.

Thanks to those of you who have faith in technology and the voice of people. Do any of you have suggestions on how we as consumers can encourage more progress in this arena?

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#23930 - 03/23/06 10:53 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 91
Sol,

I haven't had any direct contact with Sirna but I check their website often and I keep an eye out on their ticker symbol since they are a publicly traded company...Any "new" news that comes out about developments in the company hit Wall Street pretty fast.

I don't think they really need any encouragement from the general public. They know this is a multi-billion dollar industry and so they want to take advantage of this fact. The cosmetic enhancement and surgery industries are huge so this is another reason companies like Sirna are getting in to this area. Another reason I believe that Sirna is working on this particular treatment (permanent hair removal), is that it's a proof of concept treatment for their other treatments they are currently working on.

I do have a science background...not genetics but aquatic biology and chemistry.

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#23931 - 07/30/06 10:19 AM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/08/06
Posts: 55
Hi everyone,
Just flicking through the site. It seems that SiRNA and Quest are the only current hopes for a "permanent solution". With Quest already conducting clinical trials and stating that they should know by the end of the year if they will be able to go any further with their product. However looking at their stock price and size of their company in comparison to SiRNA (and the quality of researchers at SiRNA) it leads me to believe that the real breakthrough will be with SiRNA in the next few years.

Browseing through SiRNA's website I was curious if anyone could tell me what it means by "(Q4 06/Q1 07)" on their product pipeline page:

http://www.sirna.com/wt/page/product_pipeline

If you look above this you can see their SiRNA 027 (AMD) product has "(H2 2006)" written next to it.
I assume these are some kind of codes in the clinical trials/testing process but does anyone know what they all mean???
I tried contacting SiRNA to ask about the general progress on their hairless product but haven't received a reply in over a week.

Well hopefully someone knows what's going on over there?
Any insiders on the forum? ;-) lol

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#23932 - 07/30/06 03:12 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 91
Eddy,

"Q4 06/Q1 07" simple means that they are planning on starting clinical trials either the fourth quarter of 2006 (which starts October 1 and goes through December 31) or the first quarter of 2007 (January 1 through March 31).

Sirna 027 (AMD) is the product they are currently completeing the second round of human trials on. This product is being studied as a possible treatment for macular degeneration.

Hope that helps.

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#23933 - 07/31/06 07:48 AM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/08/06
Posts: 55
Thanks for that...so I guess once they begin human trials we'll see that changed to H1, H2, etc...cool that's all I wanted to know (I figured it was something to do with the financial quarters, but the H2 threw me off I think).

Well hopefully this progresses along as quickly as possible.
See ya in three years I guess! Sad, but still some light at the end of the tunnel.

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#23934 - 10/18/06 02:26 AM Re: Sirna Update
dfahey Offline

Top 10 Contributor

Registered: 10/27/03
Posts: 9505
Loc: Columbus, Ohio

More info from the sirna website about the hairless gene:


http://www.sirna.com/wt/page/dermatology
_________________________
Dee Fahey, R.N., C.T.
Licensed by the State Medical Board of Ohio for Nursing license and Cosmetic Therapy/Electrolysis license
_____________________
ELECTROLYSIS FAQ'S:

British Institute & Association of Electrolysis

http://www.electrolysis.co.uk/?page_id=16

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#23935 - 10/23/06 01:31 AM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/08/06
Posts: 55
Hi Jme1,

In your first post on this topic you stated Sirna did not expect a release to the general public until 2011? Just wondering where you got that information? As I can't find it anywhere on their website.
I'm not sure how long clinical trials last but as they are hoping to start trials at the end of this year or early next and assuming there are no major problems after a year or so of testing, does it really take another 3-4 years to prepare the product for the market and recieve Govt approval?
Really wish we could speak to someone who works in this area of science to get an idea of the processes involved.

Hopefully the trials go well and we see a product earlier than 5 years from now.

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#23936 - 10/24/06 12:40 AM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 91
Eddy,

I can't seem to find the article that said Sirna's product would be available by 2011. However, a 5 year timeline sounds about right for a "safe" product to go through the 3 testing phases and then get approval.

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#23937 - 10/24/06 02:40 AM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 91
I believe this is where I found the 5 year time line.

http://biz.yahoo.com/e/050331/rnai10-k.html

Look under "The Drug Discovery and Development Process" heading.

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#23938 - 10/26/06 10:45 PM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/08/06
Posts: 55
Thanks for that. I guess the relevent points in regards to time are:

"The new drug discovery and development process is generally considered a long (5 to 7 years or greater) and expensive (greater than $100 million) undertaking, which is subject to many uncertainties and regulatory oversight...
The most significant costs associated with clinical development are the Phase 3 trials, as they tend to be the longest and largest studies conducted during the drug development process...
If Phase 3 trials are successful, the final step in a drug approval timeline is submission of a New Drug Application (NDA) with the FDA. The NDA process may last several years."


So it appears the 5-7 year estimate includes the Drug discovery and preclinical development aspects of the process (which Sirna has nearly completed as Phase 1 of the clinical trials should start soon). Hopefully that means an estimate of 3-4 years might be more accurate since they have already accomplished quite a bit.

Obviously it is still early on and things could go wrong with the drug or with FDA approval so who really knows. Have to be patient I guess but certainly late 2009/early 2010 would be a best case scenario.

Suppose we should see what Quest and Photoderma can do in the meantime then.

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