Sirna Update

Controversial & Unproven Methods Restricted: Genetic Therapy, X-Ray, Photodynamic
#21

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?

#22

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.

#23

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? :wink: lol

#24

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.

#25

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.

#26

More info from the sirna website about the hairless gene:

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

#27

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.

#28

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.

#29

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.

#30

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.

#31

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

#32

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.

#33

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”.

#34

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.

#35

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.

#36

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.

#37

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.

#38

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.

#39

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.

#40

Sirna was just bought by Merck today for 1.1 billion. I don’t know what that will mean for the current drug developments.