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LDK-378 had ~80% response rate in patients who had progressed on crizotinib.
Re: Rodman
Did you read this? We all know this crap goes on, but I am glad someone finally got caught - and I hope this is one of the reasons why Rodman has decided to cease operations. Hopefully, Joe Pantginis is next on the FINRA watchlist:
How is this being viewed as a big positive?
SNSS. Perhaps vosaroxin hasn't been selected to go into the Phase 3 portion of the UK "Pick a Winner" trial. This is the trial where they are going head to head with other agents including sapacitabine (CYCC). CYCC is such a POS but, IMO, I think sapacitabine is more effective than vosaroxin.
http://ir.sunesis.com/phoenix.zhtml?c=194116&p=irol-newsArticle&ID=1638489&highlight=
SRPT is moving to Cambridge.
So, does that mean Genzyme or Biogen must be in talks to buy them?
:o)
stock didnt have much reaction so there is still certainly a lot of skepticism. probably has more to do with the fact that its STEM rather than the actual technology.
Great. Maybe in 5 years it will be in a Phase 3. (yawn)
Possible Therapy For Tamoxifen-Resistant Breast Cancer Identified
The hormone estrogen stimulates the growth of breast cancers that are estrogen-receptor positive, the most common form of breast cancer.
The drug tamoxifen blocks this estrogen effect and prolongs the lives of, and helps to cure, patients with estrogen-sensitive breast cancer.
About 30 percent of these patients have tumors that are resistant to tamoxifen.
This study shows how these resistant tumors survive and grow, and it identifies an experimental agent that targets these breast cancers.
COLUMBUS, Ohio – A study by researchers at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) has discovered how tamoxifen-resistant breast-cancer cells grow and proliferate. It also suggests that an experimental agent might offer a novel targeted therapy for tamoxifen-resistant breast cancer.
Like a second door that opens after the first door closes, a signaling pathway called hedgehog (Hhg) can promote the growth of breast-cancer cells after tamoxifen shuts down the pathway activated by the hormone estrogen. A second signaling pathway, called PI3K/AKT, is also involved.
Activation of the Hhg pathway renders tamoxifen treatment ineffective and enables the tumor to resume its growth and progression. As part of the study, the researchers analyzed over 300 human tumors and found that the tumors with an activated Hhg pathway had a worse prognosis.
Finally, the researchers showed that an experimental drug called vismodegib, which blocks the Hhg pathway, inhibits the growth of tamoxifen-resistant human breast tumors in an animal model. The drug is in clinical trials testing for other types of cancer.
Currently, chemotherapy is used to treat hormone-resistant breast cancers, but this is associated with significant side effects. This study has identified targeted therapies that could be an alternative to chemotherapy for these resistant tumors.
The study is published in the journal Cancer Research.
"Our findings suggest that we can target this pathway in patients with estrogen-receptor breast cancers who have failed tamoxifen therapy," says first author Dr. Bhuvaneswari Ramaswamy, a medical oncologist specializing in breast cancer at the OSUCCC – James.
"We describe a link between the hedgehog signaling pathway, which promotes tamoxifen resistance, and the PI3K/AKT pathway," says principal investigator Sarmila Majumder, research assistant professor in molecular and cellular biochemistry at the OSUCCC – James. "Targeting the hedgehog pathway alone or in combination with the PI3K/AKT pathway could be a novel therapeutic option for treating tamoxifen-resistant breast cancer."
Ramaswamy, an assistant professor of internal medicine at Ohio State, emphasizes that novel options are needed for these patients.
"A combined targeted therapy using both hedgehog and PI3K inhibitors could lead to a novel treatment for endocrine-resistant tumors in the future without use of chemotherapy," she says. "And these agents we have identified are all in clinical development for other kinds of cancer."
Approximately 230,000 new cases of breast cancer are expected in the United States in 2012, and almost 40,000 Americans will die from the disease. More than two-thirds of breast cancer cases show high levels of the estrogen receptor (ER). Doctors use the drug tamoxifen to treat these ER-positive tumors, and Ramaswamy notes that the drug has improved the disease-free survival of people with ER-positive breast cancer by 50 percent.
"But 30 to 40 percent of patients taking tamoxifen become resistant to it after about five years," she says. Currently, there are very limited options for these patients and most end up receiving chemotherapy.
Key findings for this study include:
Tamoxifen-resistant breast cancer depends on the Hhg pathway for cell growth;
The PI3K/AKT pathway protects key Hhg signaling proteins from degradation, which promotes activation of the Hhg pathway.
Analysis of 315 invasive breast cancers showed that high levels of the protein GLI1, an important Hhg marker, was correlated with poorer disease-free survival and overall survival.
"Our next step is to organize a clinical trial to evaluate vismodegib in patients with tamoxifen-resistant breast cancer," Ramaswamy says.
Funding from the NIH/National Cancer Institute (grants CA137567 and CA133250) and a Pelotonia Idea grant supported this research.
Other Ohio State researchers involved in this study were Yuanzhi Lu, Kun-yu Teng, Gerard Nuovo, Xiaobai Li and Charles L. Shapiro.
The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute strives to create a cancer-free world by integrating scientific research with excellence in education and patient-centered care, a strategy that leads to better methods of prevention, detection and treatment. Ohio State is one of only 41 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers and one of only seven centers funded by the NCI to conduct both phase I and phase II clinical trials. The NCI recently rated Ohio State's cancer program as "exceptional," the highest rating given by NCI survey teams. As the cancer program's 210-bed adult patient-care component, The James is a "Top Hospital" as named by the Leapfrog Group and one of the top cancer hospitals in the nation as ranked by
U.S.News & World Report.
###
Read more: Possible Therapy For Tamoxifen-Resistant Breast Cancer Identified - FierceBiotech Research http://www.fiercebiotechresearch.com/press-releases/possible-therapy-tamoxifen-resistant-breast-cancer-identified#ixzz255skizZ8
Subscribe: http://www.fiercebiotechresearch.com/signup?sourceform=Viral-Tynt-FierceBiotech Research-FierceBiotech Research
Do you feel they are going to need much deeper testing before this is approved?
My personal belief is that regardless of what we here think, the ONLY thing that matters in regard to the movement of the equity of EXEL is (a) substantive news and (b) when the funds who received both common stock AND convertible shares in the recent financing decide to stop screwing with the stock. For the foreseeable future, this stock is in the hands of whoever got the majority of the 30 million common and also received a load of convertibles. I think that anytime this stock moves "X%" above $4.25 (the offering price of the common) those funds are going to either short the common, or close out their common position, and use the proceeds to pay for their convertible shares (conversion rate of $5.31). Effectively, they could do this over and over again until their common position is "flat" - and just collect on the convertible. These guys had to "pay off" Deerfield a certain amount of money, too, in this financing (unreal). IMO (and I am stupidly long here, because I believe in Cabozantinib), any time you have Deerfield in the equation, and that equation includes convertibles, it is "lights out" for the equity for some time to come - Deerfield is just bad news.
...or, the game ends with REAL news.
EXEL
Would their PFS data they already submitted be enough, with their SPA based on PFS?
What would have been the reason to call the ODAC in the first place? SAEs? Its not as if there was only a 2 week difference between the drug and placebo (eg ridaforolimus)....the Cabo arm showed quite a large improvement in PFS over the control.
Exel
This originally appeared in the June 2012 NEJM.
I will be extremely disappointed if we get a 5:00 pm Friday-type of PR from Exelixis explaining the "second-half" of the story, this Labor Day Weekend.
I don't think that is the case - they would look incredibly foolish (and deceiptful). Having said that, like everyone, I wish there was a little more clarity on the subject.
They are at 3 separate conferences in the next 2 weeks so it's going to be hard for them to beat around the bush if they, in fact, do know if this is a positive or negative consequence.
EXEL
Peter re: EXEL
Do you have any thoughts on what could possibly be wrong (or have gone wrong) with the application?
8x8 moving into UK and Canada shortly. I would expect a large global partner to be announced shortly
http://www.ucstrategies.com/unified-communications-strategies-views/8x8-growing-the-uc-cloud.aspx#.UD5-QtchRWA.twitter
EXEL
FDA cancels ODAC Meeting
http://www.sec.gov/Archives/edgar/data/939767/000119312512374267/d404352d8k.htm
It there any positive or negative read out of this? Positive bias IMO w/o an ODAC I would think.
Was the Japanese Phase 3 study fully enrolled?
My only concern would really be if the FDA started meddling in the MARQUEE trial and halted the study in a similar manner. The MARQUEE trial fully enrolled in the early Spring (if I am not mistaken) and, I thought it enrolled more than anticipated - is the study, this far in, too late for the FDA to halt due to something like ILD?
ARQL
IMO, this is an over-reaction.
"Interesting"
No, not really.
According to BCBS: This program disallows coverage for drugs prescribed for uses other than those approved by the FDA and requires a prior authorization review of other high cost specialty drugs.
Basically, its a high cost drug, and if you want BCBS to pay for it, they need to approve it first ie., authorize it.
I think based on history, the chances of ARQLs NSCLC pivotal trial being halted and unblinded early are essentially slim to none (much closer to none, than slim)
I have no position here, but would truly LMAO if PPHM actually came through with positive results after all the overwhelming negativity on the drug here and Twitter.
Then again, it doesn't seem like the ones who are certain on the drugs success are all that much more than gamblers, so, I dont forsee anything other than another TNFerade type of scenario.
Yup, absolutely. ARIA was looking like a huge dog and was a very frustrating stock to have, for years ( unlike my first foray into ARIA which was pure luck and time when it went from 2 to 40 - just nonsense). The second time around in ARIA took years, frustrating years for it to turn out.
I think for many of the companies i have invested in over the years, I see the "bigger picture" but am often VERY early to the game and often times get frustrated and either sell to early, or just remain a frustrated long, waiting for it to pan out.
Right. What it really comes down to is a little luck, and a lot of conviction, and of course homework.
I certainly hit all three of the above with ARIA. Over the years, three times now, it has been a huge winner for me (2 to 40, ~2 to 13.50, and ~8 to 16.50). Of course, also lucky to hit DNDN and HGSI in the single digits and sell in double digits --- again, need some luck, too.
My only regret, is selling most of ARIA a few points ago, and putting that capital into lesser valued cos ( which are lesser valued for a reason ) - I still think ARIA the stock can go much higher; while my subsequent positions languish.
You can have a stable of 2-3 epic mutli-baggers that can pull forward YEARS worth of returns, and make up for the dogs. Just gotta make sure you have some luck there as well.
Damn. That sucks.
BTW, i passed at 12.00.
What a damn shame. Wanted to buy it, but got distracted somewhere else :(
I wonder if INHX shareholders think they still got screwed?
Both of those have great technology, i just don't own them.
I am invested in every one of those companies.
Why? Do you have any other investments other than Curis? (I hope so, for your own returns sake).
You do understand there is a difference between filing an IND and actually dosing the first patient, correct?
If I were to bet, I would say they file 907 IND in late Q4, and dose first patient in 2013 ( not to mention, Calistoga, Infinity are WAY ahead of Curis now wifh PI3K, and Ibrutinib PCYC will be eons ahead of Curis), so Curis will be just another "me too" compound, more than likely.
So, you think that by spending millions on an IV formula, and then, years later, and MILLIONS later,they come to the realization that, "gee whiz. An oral formula would give more exposure and would be easier for the patients so they dont have to drive to the hospital for 8 hours a week" was GOOD PLANNING?
NO. This was lazy, and stupid planning from a JV CEO. This is just BASIC THINKING. And, how far are they behind? A year. Just like they are a YEAR behind with 907. Ask yourself this: Dan and Mike, what exactly are they doing all day, considering the research is done in China? If they have screwed up this badly, and the stock is LESS than where it was 6 months ago, and LESS than where it was 8 years ago....how on Earth can you possibly continue to support these clowns? It is people like yourself which is the reason why CEOs use shareholder monies as their personal ATM machines - BECAUSE MOST SHAREHOLDERS ARE LEMMINGS and think that just because someone is a CEO, it MUST mean he knows what he is doing. Right?
I love it how you think that delays and screw ups are run of the mill for biotech. Clearly, your eyes have been glazed over by your forever dwindling money in this stock. Dan and Mike deserve to be fired, plain and simple - NOT rewarded with more free options.
Feel free to keep supporting these clowns. I certainly won't be. In fact, I would advocate for Dan to be fired and take his joker CFO with him.
And, BTW....clearly, I am not the only one who agrees with my assessment of Dan and Mike - the stock is down 30% (and falling 5% daily) - and, it's NOT because they're doing a "good job" - quite the contrary. Very sorry if you think down 30% means theyre running the business properly.
"ON SALE"
Wasn't it "on sale" at $5.00, then 4.50, then 4.00?
Will it be "on sale" at 2.99, and will Dan Paseri and the rest of the fools who use CRIS stock as their ATM still be saying "transformational and undervalued".. Yes, according to Dan Paseri, CRIS is undervalued WITH YOUR HARD EARNED MONEY -- NOT HIS.
I wonder if this monkey Dan will actually get 907 going in 2012? I honestly doubt it - I am thinking first quarter 2013. But, dont worry. Dan will still get his bonus and surely cash out ASAP while telling us how Curis is going to have a "transformative 2013". (and his Gimp Michael Gray will be there the whole time as well selling his stock asking YOU to buy it from him).
When you have an executive team (this company is run by two Junior Varsity idiots, Gray and Paseri) who have missed goals by a YEAR (IND for 907 was due in January 2012), and they screwed up the dosing in the IV for 101 so you cant even maximize exposure, and on top of that, we now have shareholders starting a "grassroots" campaign to 'get the word out' on Erivedge (even though Roche, with billions is supposed to be doing that), it really isnt any wonder why this company is doing so poorly.
I once had very high hopes for this company, not anymore. First signs of strength and I will be a strong seller - no sense in waiting around to see what Mike and Dan can screw up next. Not only do they have no clue on how to maximize the company (the stock is less than where it was in 2005, by a mile), these two morons have been selling any chance they get ---- THIS AFTER THEY TELL YOU TO BUY AT CONFERENCES! Truly UNETHICAL IMO.
Dan and Mike - two JV wanna-be executives. And a Board of Directors full of complicent idiots who reward these two idiots time and time again.
When was the last time a single exec actually bought stock in CRIS???
This is NOT the shareholders job to do CURIS marketing for them.
If the moron running this company would have not delayed 907 by a year and then got the dosing all screwed up with 101, the company might actually be worth more than $3.85
Dan Paseri has missed every single goal since becoming CEO - he's a year off his targets in 101 and 907. You actually think this moron will have the decency to email you back in a good matter of time?
I wonder if Dan has even been in the office for the past month. If you call his office, he has never picked up once, nor is there ever even a receptionist to pick the phone up. The CFO is rarely around as well. Someone please tell me what they get paid to do at this company?
I kid you not - I truly wonder if he even works 10 hours a week. What exactly does he do all day?
I have Ariad at 81% institutional ownership of REPORTING funds (those that do, or are required to report holdings to the SEC).
I suspect there's another ~5-8% that are not included in that for NON-REPORTING funds.
Retail base in only about 10% now.
Both good and bad. Good if all those funds hold and don't sell - only going to make it more difficult for anyone who is late to the game. Bad because most are already "all in".
Why does anyone even read Scott Matusow?
For starters, he told everyone here to sell ARIA at 14 because Rida and Ponatinib were the same compound......thats just for starters.
Ironically, Third Point was a big holder prior to the entire Merck deal, and sold around $3.00.
Now, buys back several years later above $15.