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#23909 - 06/18/05 06:31 PM Sirna Update
jme Offline


Registered: 06/18/05
Posts: 5
Hi everyone. I am a new poster and came across the topic of Sirna. I've done a little research on this topic and thought I would share a bit if anyone is interested.

Sirna is a publicly traded company on the stock exchange so if you were to go to say "yahoo" (I hope I can name another website) and go to their finance section and put in their ticker symbol (RNAI), you can read about the company and any news that is coming out about their work etc.

I've read a few posts regarding gene therapy and the dangers involved. siRNA (short interfering RNA) is not gene therapy per se. With gene therapy you are removing a defective gene and replacing with a non defective one or you are trying to fix the defective gene in some way shape or form. This is dangerous because of possible damage to other genes etc.

With siRNA technology (this is not something new. There are a number of biotech companies that are investigating different therapies from macular degeneration to huntingtons disease), you are not messing with the gene, you are only blocking the messenger RNA from making a certain protein.

I look at it this way. Take two people, and place them on opposite sides of a room. Person A has a flashlight which would represent the gene and the beam of light representing the messenger RNA. If person flashes a beam of light at person B it causes person B to react (which would represent the cell making a protein). If a piece of paper (representing siRNA) blocks the beam of light, the message does not get to where it needs to go. The flashlight (gene) has not been modified, its message just doesn't get to where it needs to go...ie, the protein is not made by the cell.

This product will be administered by a doctor. I believe the reason for this is simply liability. Some people have no problems reading the directions on the side of a prescription bottle...others do. Could you imagine if this was sold over the counter or even given out by prescription? I have heard stories of people going to a party, passing out and having friends nair their eyebrows. Well, I think you can see where I am going with this.

The product (Trichozyme)is suspended in an alcohol base which is then placed on the skin. I am guessing the alcohol helps with absorbtion in to the hair follicle a lot easier than a thick cream. Sirna has so far done in vitro and in vivo studies to prove the product makes it in to the hair follicle cells. This is very important. A major headache for siRNA researchers for other ailments has been the delivery mode. Cells do not readily take up RNA. When they have RNA knocking on their door they automatically "think" virus. This must not be a problem for this product.

From what I have read, they expect to start human trials in 2006 and will have a product for general public use by 2011.

I hope some of this was helpful. Again, this is just research I have done, so things could change.

jme

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#23910 - 06/19/05 09:45 PM Re: Sirna Update
md1239 Offline
Major Contributor

Registered: 01/14/05
Posts: 188
Loc: DC
"From what I have read, they expect to start human trials in 2006 and will have a product for general public use by 2011."

Feel free to wait till 2011, then...


Edited by md1239 (06/19/05 09:45 PM)

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#23911 - 06/20/05 03:07 PM Re: Sirna Update
jme Offline


Registered: 06/18/05
Posts: 5
md,

5 to 6 years is not that long off. I was just updating the list on Sirna. This is hopefully going to be a viable option for those who have had little success with laser treatments or those that don't have the many hours needed to invest in something like electrolysis.

jme

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#23912 - 06/20/05 05:38 PM Re: Sirna Update
md1239 Offline
Major Contributor

Registered: 01/14/05
Posts: 188
Loc: DC
In 5-6 years you could have any amount of hair removed permanently that you would like, without the help of any magical rub on cream.

Besides, even when/if something like this is developed, side effects of medications often don't show up for years. The side effects of today's permanent and long-term hair removal methods is well known because there are virtually zilch.

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#23913 - 06/20/05 06:26 PM Re: Sirna Update
dfahey Offline
Top 10 Contributor

Registered: 10/27/03
Posts: 3320
Loc: Columbus, Ohio
New drugs cost a huge fortune to develop. The average research and development costs for a new drug is about 800 million dollars. That's one of the reasons a new drug introduced to market costs so much more than the ones that have been around for years. Most drugs take ten years to get through the hoops of the FDA. An exception is cancer drugs. They don't cost as much on the research + development side because you can't really test them on non-cancerous patients - they go straightway to the ones that need to try something quickly. My point is, not only will this drug take time to get to the general public, but it will be very, very costly.

My other speculation is, if a doctor is needed to prescibe and administer it, will the turf wars start? If a doctor has a laser, for instance, will she/he advise the patient (who hasn't tried laser) to just have laser because they have had better results with laser for 8 years and the side effects of this new medicine are unknown? Laser therapy would bring more money than a mere office visit to administer the stuff. The pursuit of money always makes humans behave pathetically. If other non-laser doctors go ahead and prescibe and administer this medicine, then you would see the food fight start. It would threaten the laser physicians and the laser industry as a whole. I wouldn't be a bit surprised for the fierce lobbying to begin as to what medical specialty would have the privelege of dispensing this drug.

If I was as hairy as some explain they are, I'd try to find out if I could participate in the clinical trials, because this does sound like it is far from the reach of the general public.

Dee
_________________________
Dee Fahey, R.N., C.T.
Licensed by the State Medical Board of Ohio for Nursing license and Cosmetic Therapy/Electrolysis license

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#23914 - 06/20/05 07:11 PM Re: Sirna Update
jme Offline


Registered: 06/18/05
Posts: 5
I'm not sure I agree with you on the fighting between those physicians that use lasers and those that might use this new product. It's difficult to say how much Trichozyme will cost when it becomes available, but if it is more expensive than lasers, then there will always be a niche for lasers. We live in a free market society too. There have been numerous medications and treatments developed over the years that have fallen to the wayside because of better medications and treatments, that is just the way it goes.

Again, when I wrote the post, they stated a release of 2011. A lot of things can change between now and then, but the whole reason for my post was just to update previous posts on the subject.

Md,

You state that in 5 or 6 years you could have all the hair you wanted removed permanently. What about those that have tried laser over and over with little or no results? What about those that have no access to someone who performs electrolysis?

jme

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#23915 - 06/20/05 08:30 PM Re: Sirna Update
dfahey Offline
Top 10 Contributor

Registered: 10/27/03
Posts: 3320
Loc: Columbus, Ohio
jme, I forgot to tell you how wonderful your first post was about Trichozyme. I really liked the flashlight analogy. Thank you for telling us about this with such clarity. It is truly an exciting new developement and please post as often as you know anything new about the research.

Thanks,

Dee
_________________________
Dee Fahey, R.N., C.T.
Licensed by the State Medical Board of Ohio for Nursing license and Cosmetic Therapy/Electrolysis license

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#23916 - 06/22/05 05:29 AM Re: Sirna Update
md1239 Offline
Major Contributor

Registered: 01/14/05
Posts: 188
Loc: DC
Quote:


Md,

You state that in 5 or 6 years you could have all the hair you wanted removed permanently. What about those that have tried laser over and over with little or no results? What about those that have no access to someone who performs electrolysis?

jme




Well I would suggest to those people that they either try another laser practitioner - perhaps someone more reputable - or to visit www.wrope.com or www.electrology.com to search for an electrologist closest to them. Some of those who are in desperate need of an electrologist without one near them can travel if they wish, instead of holding their breath for the possibility that maybe in 5-6 years there might just be a miracle medication to work. I could just be myopic though.

My point is, if this condition really strikes someone as an urgent "problem," there is no logic in waiting 5-6 years for something that could be a faint hope.

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#23917 - 07/09/05 03:07 PM Re: Sirna Update
jme Offline


Registered: 06/18/05
Posts: 5
Although this is not exactly related to the permanent hair removal product Sirna is developing, in a round about way it is.

Just recently, Sirna completed a private stock sale worth $28 million. This money will allow them to go ahead with their scheduled clinical trials that are about to start soon. Stage I trials for their hair removal product is scheduled for 2006. This is a very important step because clinical trials are very costly and it's even more difficult if you are a small biotech company. This will give them enough money to continue with all their planned trials for over 2 years.

jme

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#23918 - 07/25/05 02:41 PM Re: Sirna Update
jme Offline


Registered: 06/18/05
Posts: 5
Just an update on Sirna. Not exactly hair related but definitely good news that will trickle down to hair removal.

A study published in Nature Biotechnology shows the first demonstration that Sirna's technology works in patients.

In this study involving hepatitis B, there was a 95% reduction in the hepatitis B virus in patients.

jme

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#23919 - 09/04/05 05:04 AM Re: Sirna Update
00beagle Offline
Member

Registered: 08/24/03
Posts: 16
Loc: Australia
Great work JME!

Cheers from downunder....

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#23920 - 10/26/05 07:43 PM Re: Sirna Update
malie Offline
Major Contributor

Registered: 09/05/05
Posts: 81
Thought I'd email them and see what is happening. Here is their response.

"We are still in basic Research and Development phase of this program. Clinical Trials would be due to start in 2007. Progress we are making will be publicly announced as we are a public company, so feel free to stay tuned!"

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#23921 - 11/13/05 04:45 PM Re: Sirna Update
00beagle Offline
Member

Registered: 08/24/03
Posts: 16
Loc: Australia
Thanks maile!

could be a while by the sounds, but still some positive prospects me thinks:)

b.

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#23922 - 12/20/05 05:48 PM Re: Sirna Update
ChuckGo Offline


Registered: 12/20/05
Posts: 2
FYI I am just Filling in Sirna Info
---
Sirna Dermatology is developing new treatment solutions based on RNAi
technology. Sirna Dermatology's first product is a novel siRNA-based
product, Trichozyme, designed for permanent hair removal.

The company anticipates initiating human trials in 2006

Gene newly identified by Columbia researchers may improve hair
removal
www.eurekalert.org/pub_releases/2003-05/cuco-gni050603.php

Sirna Therapeutics Launches Dermatology Division Targeting Permanent
Hair Removal With siRNAs

www.datawarehousingsurvival.com/content/view/2574/2/

www.sirnaderm.com/index.html

short interfering RNA (siRNA)

Sirna Dermatology has targeted a critical gene essential for hair
growth and has demonstrated that reduction of this gene's expression
by a topically administered chemically modified siRNA permanently
disrupts hair follicle integrity in an animal model.

The company anticipates initiating human trials in 2006

Sirna's proprietary siRNA formulations are designed to be applied
topically to patienst in a series of physician administered
treatments. Sirna and Skinetics Biosciences have worked together to
conduct preclinical in vitro and in vivo studies showing that these
siRNA reach the cells at the base of the hair follicle, where they
inhibit the production of proteins necessary for hair growth. We
strongly believe siRNAs have the potential to profoundly impact
aesthetic procedures in the medical setting, such as permanent hair
removal, and we are excited to be a part of this ground-breaking RNAi
research in the dermatology area.

SirnaDerm's approach is to target the problem at the molecular level
by inhibiting the proteins that lead to excessive hair growth. Click
here to view a video of the process (1.8 Mb).
www.sirnaderm.com/media/mpegs/sirna2_WMV.wmv

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#23923 - 12/25/05 02:44 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
I haven't checked this post out in a while. I was registered with a different e-mail address and forgot the p.w. and all so I re-registered.

I've been keeping an eye on Sirna for some time now. Not much new to report though. Plans are still for first phase trials to begin in 2006. With all the success they have had with their macular degeneration and hepatitis C work, which involves complicated delivery systems, the outlook for their hair removal treatment looks very good.

jme

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#23924 - 02/15/06 09:23 PM Re: Sirna Update
gw2 Offline


Registered: 02/15/06
Posts: 2
Sirna is in the forefront of what may become the next quantum leap in drugs: RNAI technology. Hair removal is only one market; more "important" ones are Huntington's Disease, Age-related Macular Degeneration, Hepatitis C, diabetes, hearing loss, and cancer.

It will take a while to clear the FDA hoops, but clinical studies to date show remarkable effectiveness and lack of side effects. Sorry if I sound like a commercial for them, but I'm excited. This has real potential to change people's lives for the better! And yes, "magic creme" it will be.

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#23925 - 02/16/06 02:13 PM Re: Sirna Update
Mack10 Offline
Contributor

Registered: 11/18/05
Posts: 32
They have had good success so far with there trials so far in other drugs. I recieved and e-mail from them saying that they plan recieve and IND filing (investigative new drug)this year. I was afriad that because it is not the most important drug in their pipeline it may take longer. However they seem to be intent on creating a hair removal product, probably because they realize the potential for profit the drug could have. I hope they realize that there is probably not one American over the age of 18 that commits some method a hair removal (that they wish they wouldnt have to) on a regular basis. A product that actually works and doesnt have the side effects or cost of laser, would probably be the most profitable cosmetic product ever.

Furthermore, for the doubters who say this is a magic cream that wont work. Come on, this is a product that was developed by the top researcher in hair removal and hair genetics (Christiano), which was then bought by a reputable company that has raised alot of millions (I dont know what the exact number is) of dollars in a few short years. Also their other drugs, based on the same technique of delivery have shown extreme promise (95% effeciency on hepatitis C, way better than laser can promise and this is just stage 1 clinical trials)in clinical stages.

Therefore all the people who work for a laser company who cannot admit that these drug has a legitimate chance and is different from hair inihibitor creams such as KALO is being completely biased and not looking at the facts

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#23926 - 02/16/06 02:39 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
Mack,

Although they plan trials later this year, this drug will make it to the public before all the other drugs they are working on. The main reason for this is that, Trichozyme (if it still has this name), is applied to the skin and does not get taken up in to the body like the others. Drugs that are ingested or injected generally have to go through a more rigorous test phase before they are approved.

If this treatment does pan out the way they believe it will, then the hair removal market is going to be wide open to them. Some don't seem to realize that advances are made in medicine every day...new procedures replace old. If a person had to choose between having this treatment, being zapped repeatedly by a laser, or poked by needles, I think most would choose this method.

jme

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#23927 - 02/16/06 04:58 PM Re: Sirna Update
gw2 Offline


Registered: 02/15/06
Posts: 2
Another reason for Sirna to make hair removal an early target is that it's a relatively easy target. As a topical, it skirts the delivery problem that other RNAi therapeutics must address. Also I believe the targeted sequence is relatively straightforward, without the need to address mutant variants. And there may be less resistance to large scale adoption since nothing is injected or swallowed.

Sirna is in a race to prove the effectiveness and safety of RNAi technology, and to do it before competitors! So this will get early support. Then, they'll bring on the more difficult ones.

Just a speculation, but if they can identify and silence a gene sequence which produces hair, perhaps they can also find and silence a sequence which produces baldness. The markets are huge!

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#23928 - 03/21/06 08:53 PM Re: Sirna Update
tehbeast Offline
Banned

Registered: 02/22/06
Posts: 30
Loc: California
how do i become a test patient ?

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#23929 - 03/23/06 12:50 PM Re: Sirna Update
sol1 Offline


Registered: 03/31/05
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 02:53 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
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 03:19 AM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
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 08:12 AM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
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 12:48 AM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
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 - 10/17/06 07:26 PM Re: Sirna Update
dfahey Offline
Top 10 Contributor

Registered: 10/27/03
Posts: 3320
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

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#23935 - 10/22/06 06:31 PM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
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 - 10/23/06 05:40 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
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 - 10/23/06 07:40 PM Re: Sirna Update
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
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 03:45 PM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
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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#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: 88
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: 88
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: 88
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: 88
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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#23949 - 10/30/06 04:20 PM Re: Sirna Update
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
"Combining the expertise of both companies will significantly accelerate the development of RNAi-based therapeutics."

That from the CEO of Sirna. WOW! So that was the BIG news that people were expecting. Damn, really wish I had bought the stock now!
Oh well hopefully this is good news. The 100 billion at Merck's disposal should help speed things up, not to mention grease the wheels with the FDA (not that that is necessarily a good thing - I just mean that they probably have a better idea of how the approval process works, etc).

I can't see them halting development on the hairless product when they are so close to Phase I, especially since the success of this product alone will justify the $1 billion price they just paid for Sirna.

I think Sirna realized that they needed a bigger partner if they are to tackle the major diseases currently in their pipeline.
Hopefully this is good news for all people awaiting developments in Sirna's pipeline and for the development of this technology as a whole.

Certainly this area seems to be heating up fast in the medical world!

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#23950 - 10/30/06 05:24 PM Re: Sirna Update
jme1 Offline
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Registered: 12/25/05
Posts: 88
Well it wasn't a hostile take over which is good. It was something the stock holders owning a majority of the stock agreed upon. I believe it will not be finalized until the end of first quarter or second quarter of 2007.

I do hope everything remains the same and no developments are cancelled.

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#23951 - 10/31/06 01:48 PM patent database
jeffk Offline
Contributor

Registered: 10/31/06
Posts: 39
hi everybody,

I think i have a very interesting link for you.
Its a database for worlwide patents of the european patent office.

You can type in e.g. "hair removal" and get a list of all patents in this area.

I even found the patent of Angela Christiano on the third site. A very good description of the "magic cream". As far as i can remember it will NOT have a permanenent effect. So continuous application is necessary. However, this patent is older than 2 years and progress was made.

You also find a patent of the applisonix from israel.

But i think that if you combine the sirna, photoderma, pharmaquest and applisonix applications a nearly permanent
removal can really be possible.

http://gb.espacenet.com/search97cgi/s97_cgi.exe?Action=FormGen&Template=gb/en/quick.hts


Edited by jeffk (10/31/06 02:22 PM)

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#23952 - 10/31/06 02:36 PM Re: patent database
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
Wow, thanks for that! The document seems that it could answer certain questions about their goals in regards to permanence, if the hair needs to be epilated first (yes?), and so on. When I have more time I'll give that a good read, but just flicking through Cristiano's patent (huge document) I found this interesting paragraph:

"[0087] Applicant's have found that RNAi can be used to inhibit translation from dsg4 and/or nude protein mRNA, resulting in hair removal or inhibition of hair growth. This hair removal generally is reversible by ceasing application of the RNAi inducing oligonucleotide, thus providing cosmetic and therapeutic methods, as well as methods useful for laboratory experimental mammals, and for dehairing in the leather industry. For long term or even permanent hair removal, such inhibition of dsg4 and/or nude mRNA can be combined with inhibition of hairless expression, e.g., using RNAi inhibition of hairless mRNA."


So it appears that they may eventually be able to offer different topical applications of varying strength depending on how long a client wishes to stay hair free?
However my guess is that the "permanent" application will never be made because:

1. It would mean that the customer would only need to purchase the product once and therefore hurts sales in the long run as more and more people achieve their permanent "fix". ie. the anti-thesis of any corporate product.

2. A mistake by the applying physician would mean permanent hair removal in an area that the client may not have wanted such a result, thus opening up the physician and perhaps Sirna to costly lawsuits.


I really can't think of any product out there that offers a permanent solution to anything. It seems to me that the medical/pharmacutical world aren't really interested in "cures" but only interested in "treatments" which people have to continually take over and over, as this is truely where the profits lie.
I hope Sirna will be different but I doubt it. Merck certainly know how this game is played.

On second thought the only thing I can think of is the laser eye surgery, I think that is a "permanent" correction of your vision...but no doubt involves constant visits to the optomitrist to ensure things are "okay" and probably some eyedrops to take everyday for the rest of your life or something, so they get your money that way! Plus the prodcedure itself is very expensive as well.

Sorry I think I'm just overly cynical of corporate greed...but even if Sirna's "magic cream" isn't 100% permanent I still think a cream that could painlessly remove (and keep hair away) for a month or so would still be a dramatic improvement over painfull and embarassing laser/waxing sessions. As if the cream really doesn't have a permanent effect I am sure it could be sold safely for home use eventually. Also a cream based product really seems to be the ideal way to treat the problem as many areas on the body are difficult to reach and treat properly with laser/waxing/etc.

I actually said a long time ago that I bet the real task for Sirna, Quest, PhotoDerma, etc is making sure that the product ISN'T too permanent and much of their time would be spent on finding a balance in strength so that people would be satisfied of its long term effects but still have to purchase it over and over if they wanted to continue to enjoy those effects.

I hope I'm wrong in all this, and that a "permanent" solution is what researchers are gunning for...I guess we will see.

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#23953 - 10/31/06 05:24 PM Re: patent database
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
Eddy,

You make some valid points, but I think there are other things to consider. I have not read the document yet so I can't comment on that.

Sirna's hairless gel/cream Trichozyme I believe is a breakthrough. I don't think Sirna would have taken on this project if they didn't see promise. They also would not still be touting it as permanent if the results of both invitro and invivo studies showed otherwise. If the results of both of these two studies proved less than promising, I think it would have been dropped.

I believe the whole reason why this product would be administered through a physician is because of its permanence. I don't think you would want to have this cream available by prescription or on drug store shelves. I could just imagine some of the problems that would arise from this. I've heard of people having their heads and eye brows shaved at parties after they have passed out. A permanent hair remover in the wrong hands would not be good.

As far as possible liabilities to Sirna or a physician administering this product to someone and they then turning around years later to bring up a frivolous lawsuit...again, I don't think that will happen. It hasn't happened with laser which shows permanence in some individuals and I don't think it's happened with electrolysis. IF it's administered by a physician, it would be a voluntary medical treatment and a waiver of some sort would possibly need to be signed prior to treatment along with information on the implications of the treatment.

In the worst case scenario, Trichozyme proves to be a product that needs to be used more than once (as in it's not a permanent solution). IF that is the case, Sirna would have to know the benefits of this product outweigh all other treatments available...meaning, it's painless and lasts long enough so people do not seek other treatments available. It would make no sense for Sirna (or Merck for that matter) to put so much time, effort and money in to a product that only lasts as long as any other depilatory on the market. The costs would also have to be competitive with other treatments IF it proves to not be a permanent solution.


Edited by jme1 (10/31/06 05:28 PM)

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#23954 - 10/31/06 06:55 PM Merck
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
I read in an article tonight that there is a possibility Merck may not continue on with Sirna's current pipeline. Of course this is just one so called "expert." He mentioned that Merck's main objective is to get the RNA technology for oncology.

If that was the case, I wonder if Dr. Christiano would take the technology elsewhere...that is, if she was able to.

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#23955 - 11/03/06 01:55 PM Re: Merck
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
Hmm that doesn't sound good. I suppose they will determine how far along each of Sirna's current programs are, how much more it will cost to see them through, and compare that with each program's potential to generate profits if successful.

I understand that Merck's goal may be in Oncology but it seems like Sirna specifically recruited these specialists (eg. Christiano and others) to deal with the application of SiRNA's in combating dermatological conditions, in particular permanent hair removal.
i.e. I don't think they could just switch from working in dermatology to Oncology overnight.

So unless Merck has plans to shut down the dermatology section of Sirna, give all these scientists their walking papers and run the risk of them taking their research to other competitors, they might think again and allow them to continue their developments in this area.

A topical application for permanent hair removal has the potential to be a "blockbuster" drug (this is what all pharmacutical companies dream of and is defined as any drug/treatment that can generate over $1 billion in annual sales).
Given that it is a topical treatment and nearly in its clinical stages, it should be relatively less expensive to develop in comparison with other ingested/injected drugs and promises huge rewards if they are successful.

The risk/reward factor here seems to be low for such a huge corporation as Merck and I am sure that Cristiano and the other scientists who have been working hard on this product will fight to keep development alive.

Sirna's third quarter results should be out sometime this month so hopefully they will give some indication about progress and future plans.

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#23956 - 11/04/06 09:45 AM Re: Merck
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
Eddy,

You may be right. I don't think that anyone knows for sure what will happen. So called "experts" have a way of always being wrong.

I think it would be to Merck's advantage to get this product out. They would profit very well if it proves to be a success.

I'm pretty certain we won't know one way or the other until Quarter 1 '07 since that is when the sale becomes final, and it also was the possible start for Stage I trials for this product.

It would be nice to contact either Sirna or Merck in regards to this, but I'm thinking that you wouldn't have much luck with that.

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#23957 - 11/05/06 02:24 AM Re: Merck
newbie133 Offline
Contributor

Registered: 08/11/06
Posts: 15
yeah ive sent them a nice long email.. im sure u guys have tried this too tho.. ahh well if they do respond u guys will b the first to hear about it.. i asked them if they were still going to continue with thier current pipeline and asked them about the hair removal in particular and i also asked them if they were gonna keep the scheduel if they do keep the present pipeline.. as in will they go ahead and start clinical trials this year or next year etc.
ill keep u updated

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#23958 - 11/06/06 02:46 PM www.epilar.net
jeffk Offline
Contributor

Registered: 10/31/06
Posts: 39
hi everybody,

also on the database-site are the guys from
www.epilar.net (or www.cosmedical.dk)

Currently they are establishing a net of b2c providers.
Maybe another possibilty.

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#23959 - 11/07/06 02:16 PM Re: www.epilar.net
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
That epilar stuff seems just like all those other topicals (ie. Kalo, Epilstop, etc) which you are to apply immediately after waxing and it is supposed to inhibit hair growth, and after enough sessions stop hair growth completly...I tried Kalo myself for about 6 months and saw no improvements, just another scam which led me to this site in the search for real permanent answers...so far the only companies that seem to be working on this are Sirna, Photoderma, Quest, and Applisonix...all the rest seem to be scams. Am I wrong?

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#23960 - 11/07/06 05:39 PM Re: www.epilar.net
jme1 Offline
Major Contributor

Registered: 12/25/05
Posts: 88
Eddy,

I believe that Applisonix will be categorized more as a temporary solution. Quest and Photoderma are still up in the air. They say permanent then not, then....


Edited by jme1 (11/07/06 05:41 PM)

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#23961 - 11/17/06 06:00 PM Re: www.epilar.net
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
Just got this response from Sirna via e-mail:

"Sirna agreed to be acquired by Merck & Co. on Oct. 30, 2006. If the transaction is approved, Sirna will become a wholly owned subsidiary of Merck late in December or in Q1 ’07. There will be no new information on the hairless program until the acquisition has been completed."

Seems to suggest that Merck is in the process of deciding whether to continue or discontinue the hairless project. As I said before I think it is in their interest to carry on development.
Most say that Phase III is the most complicated part of the clinical trials but for me I think the longest and most difficult part of developing any product is in the discovery and pre-clinical development, simply because here they have to make sure that the product is somewhat effective and safe for use on humans. After all they don't want to kill or severely injure anyone in the trials, so most of the safety work will have to be carried out before this.
To me it would at this point be about 60% ready for the market and the rest of the development in the clinical phases is testing the exact results on humans, rather than animals, and making minor adjustments to increase safety and effectiveness.
I think if any product makes it to Phase III the biggest hurdle is getting FDA approval, which perhaps makes it the longest phase out of the three.

That said I believe most of the really hard work has probably been done by the scientists at Sirna and now they just have to refine the product in the clinical trials....I'm hoping they get the chance to do this, would be such a shame if they have to start all over again somewhere else.

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#23962 - 11/17/06 08:29 PM Re: www.epilar.net
Eddy Offline
Major Contributor

Registered: 07/07/06
Posts: 53
http://v3.espacenet.com/origdoc?DB=EPODOC&IDX=WO2006068687&F=0&QPN=WO2006068687

Been looking at the patent applications again put forth by Christiano and Sirna. The above link briefly describes their "claims" of what the product will acheive.

As seen in point 2. - their goal is currently inhibition of hair for one month, possibly longer. Doesn't really sound like permanence to me. :-(

As in points 3 and 4. - the hair cycle still effects the application of the product (ie. hair growth must be "synchronized" by waxing, etc before the product can be applied and the hair must be in the correct growth phase for the product to be effective). :-(


This of course means multiple treatments for a product that may not deliver permanent results. Far from the magic cream I think we are all hoping for! (ie. one or two treatments, with permanent results) :-(

I suppose the only real advantages over laser will hopefully be reduced cost, treatment of light hairs on varying skin types, and reduced pain in application (however you will still have to wax, ect beforehand so perhaps even lazer will be more painless if taking this into account?)

Oh and I forgot the best part, we only have to wait another 3-5 years for this "breakthrough".

What I don't understand is why would someone pay to get waxed, which typically lasts about 3-4 weeks, only to pay more to have a product applied that claims to delay hair regrowth for the same amount of time! Additionally if the hair cycle still applies one se