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Curis (CRIS) hedgehog inhibitor
What are the chances this thing shows efficacy in the ligand driven cancers (as opposed to the mutation drive, ie Basil Cell Cancer - where it has already shown tremendous activity).
TIA
Stock showing some decent activity over the past couple of days in a weak market.
Listened to the conference call.
Not much new. Doesn't sound like they have the final dosage down for '534 pivotal which I would assume they would need for an SPA agreement.
Fall seems a likely time for start of trial IMO
Very good question.
I don't know.
I can see why EXEL mgmt can be trusted when they say BMY dumped it because (at least 3) their drugs are overlapping XL184. However, I don't trust George Scagnos anymore. He's getting $1.2 million a year and hasn't delivered anything.
XL184 seems like it has clear evidence of efficacy, but, then again, who knows with Scagnos running the company. Do you trust the evidence? Can you trust the evidence with him at the top?
Personally.....I think the Board of Directors should just sell this company in its entirely (but I don't know if thats even possible the way they have spread all their partnerships out so thin).
You can add Exelixis XL184 to that list...
(it was just recently dumped by BMY)
The stock dived because, essentially, Rida ('573 at the time) was their own drug in humans, and, with that news, there wouldn't be any real "news" for another 2 years (which essentially it was how it played out).
Having three drugs in the pipe is a good thing and it's unfortunately Ariad didn't have more money in the bank ($200-250 million) because we probably would have trials in solid tumors for '534 and '113 would be a lot further along.
Much money was wasted on the frivolous lawsuit of patents. That money would have been well spent on things in the clinic instead of trying to shake down big pharma. It's a shame.
Ariad is looking a lot better. If Rida succeeds in P3, this company is going to be a leader. IMO.
MK-2206
Another AKt-inhibitor with great potential when combined with mTOR.
Rida needs Merck. Merck needs Rida. Combo studies will generate the business.
...and that's whats "unfortunate" about the situation.
Deforolimus/Ridaforolimus, at the time, did not have a valid targeted agent to use in combination.
Recent data in broad medical publications clearly have said that combining mTORs with other agents targeting pathways in the PI3 Kinase are more likely to show higher levels of efficacy due to their interaction with feedback loops which make the drug (in this case RIDA) less effective and prone to causing the cancer to grow (e.g., the cancer evolves and finds a way around the inhibitor - but you already know this).
mTORs will be MUCH more likely to succeed in combination, and I think DALO (IGF1R) is a great combination and has been spoken about quite frequently in medical journals (regarding the interaction between the two class of drugs).
Single agent mTOR is much more risky and my reasons for believing SUCCEED might not "succeed".
I think the only way to use Ridaforolimus going forward is to use it on a combination study with DALO or another one of Merck's compounds to get synergy on interactive pathways.
It's clear that mTOR and IGF1R have a synergistic effect in feedback mechanisms.
It's unfortunate that Ariad didn't use DEFO in combination with another drug in their SUCCEED trial as it would have added the chances of success significantly.
Same goes for the Endometrial trials and NSCLC study. I just don't see them showing stellar results unless you knock out another path in the PI3-kinase.
No, Don. I'm not confused.
Until it starts dosing in humans, it's vaporware.
Good promise, however.
How did '464 work out for shareholders, Don?
All your arguments sounds very familiar to other arguments made when '464 was on the petri dish and it was hailed as the next Gleevec.
8 years later (?) the analog to '464, '534, still hasn't been approved. Yes, there sure is overwhelming evidence that '534 will be a major success, but only since it was proven to be so after dosing dozens of patients - - - not smearing a sample on a dish or putting a pellet in a mouse, like they are doing with '113, or '464.
How is it a "scam"?
Of course Ariad's '113 works 10 x better than Pfizer's crizotinib. Of course it does because it's in a petri dish on xenographs. Ariad has "bragging rights" on their petri dish product until they actually get it into a single human being (around mid-2011). So, don't expect to see any FDA approval from '113 until 2014 (earliest).
Essentially vapor-ware until they get it into a human being.
From a blog post
It seems someone who is very connected to the Ariad trials is saying that July 2010 is the start date of the '534 pivotal trial (assuming all the paperwork goes correctly).
(I will not divulge the blog post - but you can do your own homework and find it if you like)
reliable sources saying July 2010 for the start of the P2 trial
I asked DonShimoda a simple question about Ariad.
He has wild speculations (very wild) that AP534 could get $300 million upfront plus large percentage royalties behind.
I have asked him several times to show me one single compound that has ever gotten this (and he still refuses). Why?
I can only guess because it doesn't fit his agenda.
Don, care to answer the question?
All bios are getting dumped.
It's consolidation
what is so "interesting" about this "tidbit"?
We all knew '534 is going to be partnered?
Why should be be so interested in Dodion focusing on '534 partnering? Or did you just post this as a "puff piece" for Ariad?
Thanks
" we then could easily see 300+ plus upfront money and 30-50 percent royality split if we go that route"
What other compound have you seen get $300 million (+) upfront with a 30-50% royalty split? Is this real analysis of other pharma compounds or just wild speculation?
I can tell you one thing: Ariad will never get $300 million upfront from ANY ONE COMPOUND. That's pretty much guaranteed.
I agree with that price range (probably the lower end due to the dilutions).
I think $8-$10 is more likely IMO. (if rida is successful).
If Rida shows good results in Endo as well, your range is what I would be looking for.
Much higher if there are some really positive developments on '534.
If Rida is a success, I would be really surprised if we didn't see an offer from someone. I don't know why Merck WOULD'NT want '113 and '534 as well as '573.
I also owned GNVC (took a hit), and also owned HGSI and DNDN (in the single digits; made tons).
You're right. Biotech is risky, and gambling. You never know what you're going to get until the P3 comes out. 90% of the analysts said Benlysta and Provenge would fail. To be honest, it's almost better to go against what the analyst say (which is why I worry about Ridaforolimus in sarcoma).
The difference between Ariad and HGSI and DNDN is that both HGSI and DNDN had novel compounds in giant areas in which both compounds were groundbreaking technology. I don't think the market for Ridaforolimus is groundbreaking (its only maintainence). '534 is more interesting. '113 is another example of a highly targeted compound and very interesting(like '534 and other CML TKIs. I feel like mTORs are more like a primative technology, where it's not really targeting the way Gleevec or '113, or '534 have a specific, unique target which has proven be highly effective.
I do look for a pop in price if Rida is successful. If they ever release the endometrial results before they do the succeed trial, its going to have a big impact on the price of the stock bc it will either give a positive or negative readout on SUCCEED.
I just don't think that you're going to see a massive increase in share price the way you sqw with DNDN or HGSI due to their mTOR.
No, I am not short the stock.
I am long the stock.
I am not short the stock
Yup, they gave them the go-ahead.
And that's all you and I know for CERTAIN (that the trial is still on).
And, since the FDA has given MANY 'go-aheads' at an interim (1st, or 2nd) and the trial has either (a) succeeded, or (b) failed, means, you and I do not know for certain which direction it's going to take.
I don't think that's "spin".
"It's just laughable to imply that rida somehow failed because it didn't reach it's end point EARLY."
Where did I say Rida failed?
I said, based on Harvey and Merck saying the 2nd interim is set up to lead to an NDA filing, and based on the fact that that did not happened, clearly, has a less than positive tone to it.
I agree with Carol Boone.
I still have not to see ONE random post on a blog from a SUCCEED trialee, saying how they are progression free for years, etc. I am sure you could find a single great showing on any number of failed studies such as Novelos, Poniard, Genvec, Genetope, etc., etc. We all know '534 is the real deal because we have seen the real evidence with our own eyes through the posts of many CML surivors. I have yet to see one single person bragging about how great Ridaforolimus is (other than Ariad using Carolyn Boone as their own personal Rida PR campaign).
I would have much more confidence if you could point me to posts in the sarcoma blogs where patients are having overwhelming success speaking of the time of Rida.
BTW, Novelos, Poniard, and Genvec all passed their interim's (whether it be first look, or some a second look), only to see their trial fail hard in the final analysis. Just because a trial passes the 1st, 2nd interim says nothing about the final analysis. For all you know, the doctors/statisticians of the IDMC are giving Ariad and Merck the benefit of the doubt that their drug will catch up to the placebo considering how far along they are, and how money money and effort has been spent into the trial.. It is clear that the drug isn't having overwhelming success like some have stated on other boards (having PFS results of over 50-100% vs. placebo) - if it did, we wouldn't be discussing this right now.
So Don, what if, by chance, the placebo arm shows, by chance, a very large proportion of those patients as having been "cured" due to the intense chemo therapies they had going into the SUCCEED trial?
We've all seen the positive remarks from people in the '534 studies who post their experience on the web. Can you direct me to ONE or even TWO people speaking of their experience on Ridaforolimus in ANY study? Can you show me if their tumor actually shrank, instead of just receiving blisters in their mouth?
Sure, I would like that discussion too.
Unfortunately, on this board, if you even remotely question "why" or have a negative "option" on an answer (instead of pumping your position), you either (a) get your post removed, or (b) get told to stop posting and you're a basher, etc etc.
Pretty sad.
Simple fact of the matter is this: Rida is a 50/50 gamble. Rida could very well end up like many other "failed to acheive its primary endpoints". Many people here think that because it achieved CBR in 71% of patients in a controlled, unblinded, unrandomized setting, that THAT will lead to a positive outcome in Phase 3 here.
Many (including Harvey and Merck) both were saying (Harvey at Q conference calls + Merck at their analyst meeting) that the 2nd interim would likely lead to an NDA filing because it would meet the prespecified SPA criteria. CLEARLY....IT DID NOT.
Now....."why"?
Don, what happened?
Harvey said there was a reasonable chance based on the design..
What happened?
It wouldn't have anything to do with the studies being randomized which messed up his assessment, would it?
straight from Harvey:
Based on the current status of enrollment and disease progression events in the Phase 3 SUCCEED trial of ridaforolimus, as well as the statistical power and design of the trial, the Company believes that there is a reasonable possibility that the available clinical data at the time of the second interim analysis of efficacy by the independent Data Safety Monitoring Board would be sufficient to demonstrate a statistically significant difference in the primary endpoint of the trial, progression-free survival, when comparing the ridaforolimus and placebo treated patients. The Company believes that such an outcome would enable it to submit an NDA to the FDA in mid-2010 and allow for the possibility of FDA approval of ridaforolimus by the end of 2010 or early 2011.
the point to all of this is that we don't know if Rida has better results because their Phase 2 trials were UN-RANDOMIZED.
You can hand select any patient you want in those trials. UN-BLINDED. You can do whatever you want with patient selection.
There is a reason why the 2nd interim didn't produce an NDA nod (despite Harvey saying there was a "reasonable chance" (several times in conference calls) that the 2nd interim would be statistically significant)....that reason is: it wasn't statistically significant, meaning, the drug is working LESS than anticipated.
"Of course
, the one thing we do know is that MRK just plunked down another 50 million so I guess they're satisfied with the second interim results."
Didn't they put down the $50 mill BEFORE the results?
No, I never said it was randomized.
So, did Ariad run a trial in RCC?
Nor was I being sarcastic as well.
All I am saying is, it was apparent that both Harv and Merck thought the 2nd interim would generate the statistics that would give an FDA nod for NDA. That didn't happen.
Why?
"Again, please feel free to point me to any results that support your claim that there are other therapies farther along than rida that will work better in Sarcoma. "
BMY: Brivanib
well considering the Ariad trial wasn't blinded nor randomized I guess comparing apples to apples doesn't really make sense.
We all know that Phase 2 unrandomized studies always have greater efficacy.
..personally, I would like to hear some good statistics too.
We all saw Torisel and Afinitor get FDA nods after their interims (not final analysis).
Sell-side analysts are pawns for investment bankers
It never ceases to amaze me how these crooks do it.
Anyone here follow EXEL
Good company? Bad company? Bad management, good management?
Chart looks good
Should own more of this than EXEL. Will likely be moving more money from EXEL to ALXA
Learn about options expiration day
and triple/quad witching.
Large volume due to options expiration
Not due to "news coming"
Stop the pumping