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another group going after CDiff, which just pushed a P3 through. Theyve popped a bit recently on the news.

http://www.prohostbiotech.com/news_details.php?news_id=431

Positive top-line results from a pivotal Phase 3 clinical study of the Optimer’s lead anti-infective drug candidate, OPT-80, in patients with Clostridium difficile Infection (CDI). The results demonstrate that 92.1% of patients treated with OPT-80 achieved clinical cure vs. 89.8% for Vancocin. In addition, only 13.3% of patients treated with OPT-80 experienced a recurrence vs. 24.0% for Vancocin (p = 0.004). Patients treated with OPT-80 had a global cure (cure with no recurrence within four weeks) of 77.7%, greater than Vancocin at 67.1% (p = 0.006). OPT-80 was well-tolerated.
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Fuma102 or anyone, can we talk about CDiff cures/treatments here?

My understanding is that there are only a couple treatments for it (which suggests huge moat), and strikingly OPTR is at a 52week high in this market. If they've found the best drug, should we expect them to go much higher? How big is this market? If no one knows/posts I'll start looking into this and post what I find here.

From Fuma's post:
another group going after CDiff, which just pushed a P3 through. Theyve popped a bit recently on the news.

http://www.prohostbiotech.com/news_details.php?news_id=431

Positive top-line results from a pivotal Phase 3 clinical study of the Optimer’s lead anti-infective drug candidate, OPT-80, in patients with Clostridium difficile Infection (CDI). The results demonstrate that 92.1% of patients treated with OPT-80 achieved clinical cure vs. 89.8% for Vancocin. In addition, only 13.3% of patients treated with OPT-80 experienced a recurrence vs. 24.0% for Vancocin (p = 0.004). Patients treated with OPT-80 had a global cure (cure with no recurrence within four weeks) of 77.7%, greater than Vancocin at 67.1% (p = 0.006). OPT-80 was well-tolerated.


I just had a second family member in a year battle Cdiff on the way out, pretty horrible to have your whole body go septic after cdiff has run wild. Yes, each of these two were very old and in poor health. But I'd never even heard of it before, just makes me wonder if it's more prevalent now.

Sarah
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very generally speaking, in my quite limited experience... (perhaps JPG or missash can elaborate, as I know these two have several decades of experience on me...)


I just rotated through the ICU, and they were pretty clueless has to how to handle flagyl (metronidazole), and vanco resistant CDiff. I actually bookmarked one of JPGs posts aout vanco in the ICU setting for CDiff (11/25/07), more on this later. As for the ICU I was just in, we would throw the kitchen sink worth of antibiotics at vanco resistant CDiff, we didnt have a choice (Zyvox, Suprax, tetracycline, cubicin, to name a few)

so, here's the big problem....
1) Cdiff normally resides in your intestines.
2) use of antibiotics dramatically increases risk of cdiff infection as you kill off everything else but cdiff in your gut. (thus, as people live longer and are exposed to more and more antibiotics, and more and more bacteria the more they visit a healthcare facility, the more prone they are to these worse infections (VRE, MRSA, vanco-resistant Cdiff, etc)
3) an increasing lifespan along with the maturation of ICUs increases the risk for resistant Cdiff for reasons outlined above.
4) .... there are only 2 drugs that are thrown at CDiff- flagyl and vanco. last year, there were few vanco resisistant strains, now, as many as 25% of strains are vanco resistant.

..... 5) bad diarrhea when a patient has been on antibiotics is often assumed to be because of CDiff, and almost always vanco or flagyl is started empirically & immediately.

and finally.... even ICU folks are not acutely aware of something other than vanco to throw at CDiff. I'd wait to be sure that one of these end up in an "algorithm" to treat CDiff, or in a medical ICU journal that heavily recommends usage of an antibody.



"Dr Watson said: "Clostridium difficile costs Europe £1billion a year in healthcare costs. You could view that as saved money or saved beds.""
.... http://www.dailymail.co.uk/health/article-510758/Jab-beat-C-...

I think that is a hugely inflated number, and I dont believe there is a vaccine on the horizon that will be heavily used in the US within the next 5-8 years.... however, I do believe that the actual amount spent on antibiotic treatment warrants a market value higher than OPTR is fetching.

what OPTR, or any other CDiff mab maker does NOT need is this: some ICU journal making recommendations against their use the way that the American Diabetes Association recommended against using new agents like Byetta. If an ICU journal puts out a strong rec for it, and an ICU has good results after using it, the medical/surgical floors will soon follow. Its going to be awhile, but just a year ago consider what JPG wrote:

"We haven't had an ICU death in over 6 months since we started giving high dose vanco early and enterally. " (http://boards.fool.com/Message.asp?mid=26129179)... now, there are numerous reported cases of vanco resistant cdiff.

unfortunately, I dont follow ICU magazines closely. I can check my prescriber's letter monthly but thats about it. (its a "cheat sheet" for those that write prescriptions on the latest literature with the latest recommendations from various governing bodies)...


Lastly, one thing to keep in the back of your mind. Just in case you miss the boat on Cdiff mabs, there is a strong association with VRE and vanco-resistant Cdiff. So, a VRE (vanco-resistant enterococcus) mab may be useful (http://www.ingentaconnect.com/content/bsc/ajg/2000/00000095/... , a bit dated, sorry). Just a thought.



Cheers to all. Good Luck investing in 2009!
-Fuma
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don't go long antibiotic stocks. just look at fda's recent actions. targanta, replidyne, etc etc etc.

if anything, short into fda decisions, especially on run-up after phase ii or iii.

D
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Thanks for all the feedback Fuma!

2) use of antibiotics dramatically increases risk of cdiff infection as you kill off everything else but cdiff in your gut. (thus, as people live longer and are exposed to more and more antibiotics, and more and more bacteria the more they visit a healthcare facility, the more prone they are to these worse infections (VRE, MRSA, vanco-resistant Cdiff, etc)

3) an increasing lifespan along with the maturation of ICUs increases the risk for resistant Cdiff for reasons outlined above.

4) .... there are only 2 drugs that are thrown at CDiff- flagyl and vanco. last year, there were few vanco resisistant strains, now, as many as 25% of strains are vanco resistant.


Both my two relatives who died this past year struggled with CDiff at the end, one was riddled with it. And the docs tried various types of high-levels of probiotics near the end.

This may be a stupid question, but there aren't any prescription probiotics are there?

Sarah
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Jumping in here.

With probiotics available in yogurt etc., what would be the benefit for any Rx probiotics?
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With probiotics available in yogurt etc., what would be the benefit for any Rx probiotics?

a) megadoses - i.e. those whose systems have been ravaged by massive amounts of antibiotics need more than just you or I

b) guaranteed amounts, testing, and proven combinations - the supplement world runs pretty fast and loose and you have less assurance you're getting exactly what they say is in the bottle

c) benefit to the drug companies? more income

In my family's case - relative A got a doctor who was familiar with probiotics and put together a list and amounts, and then he "prescribed" them so that the nurses would regularly dose the patient. But my sister had to chase down a source, since the probiotics weren't readily available. Relative B got a different doctor who prescribed Acidophilus only - associated caregivers claimed to not know there were other probiotics. Relative B suffered more and died faster, but who knows there are so many different variables. Relative B was only in for an ankle surgery and then caught multiple hospital-based infections.

Maybe this is only a quality of life issue.

I just know that if drug companies *could* benefit, there would be more testing, more availability, and much wider education.

Sarah
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Sarah,

As with other vitamins & supplements, often we can as biological beings absorb only so much.

Thusly why our pee is way yellow after breakfast & that mega multi vitamin.

We may absorb probiotics as we can as well. Not sure to tell the truth, but I am way comfy with my half tub of oranic 7 stars plain yogurt / day Rx.

If you are on antibiotics of ant sort, do make sure you eat some yogurt or cottage cheese to reintroduce those good bugs back into the gut.

You know.
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Replying for Fuma - making this thread easier to find.

Someone wiser than me said the following:
"Dr Watson said: "Clostridium difficile costs Europe £1billion a year in healthcare costs. You could view that as saved money or saved beds.""
....http://www.dailymail.co.uk/health/article-510758/Jab-beat-C-...

I think that is a hugely inflated number, and I dont believe there is a vaccine on the horizon that will be heavily used in the US within the next 5-8 years.... however, I do believe that the actual amount spent on antibiotic treatment warrants a market value higher than OPTR is fetching.

what OPTR, or any other CDiff mab maker does NOT need is this: some ICU journal making recommendations against their use the way that the American Diabetes Association recommended against using new agents like Byetta. If an ICU journal puts out a strong rec for it, and an ICU has good results after using it, the medical/surgical floors will soon follow. Its going to be awhile, but just a year ago consider what JPG wrote:

"We haven't had an ICU death in over 6 months since we started giving high dose vanco early and enterally. " (http://boards.fool.com/Message.asp?mid=26129179)... now, there are numerous reported cases of vanco resistant cdiff.

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