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It seems like they discontinued this asset a while back, so I am not surprised by the market's reaction...
Yes - I saw this, but thanks for posting.
The problem I have with the intentionally misleading announcements is that they are fraudulent. On December 1st, 2016, the company announced that the results to date (cohorts 1 + 2) demonstrate
"Excellent Efficacy, Overall Survival Benefit, and Progression Free Survival Similar to or Better than Recently Approved Therapies"
The CEO further stated that
"The efficacy observed with CLR 131 at the 12.5 and 18.75 mCi/m2 single dose compares favorably to drugs recently approved for relapsed or refractory multiple myeloma."
Now, if you look at recently approved drugs, such as daratumumab, their ORR (which is the FDA's measure of efficacy) is much larger than CLRB's ORR of 0% to date, so that statement is a flat-out lie.
On slide 17 of their BIO CEO 2/13 presentation, the company tried to create the impression that they had PRs, but this slide was - interestingly - removed again from the deck...
They removed FLC partial responses from their deck.
Now it's only M-protein (as it should be if M-protein is measurable) and no PRs...
Compare the current deck to that of 2/13...
Did anyone else notice that?
Agree with you - high risk here, so people will want to get out...
Just opening the Ph2 is not necessarily a value driver for me. They had a Ph2 before and that didn't help them much.
I am wondering how they will be enrolling and dosing patients this month (acc'd to their milestones) for the Ph2 while they are still evaluating dose levels in the Ph1. Opening cohort 4 was spun as great news, but in reality it may be pushing out there Ph2 now as they have uncertainty about the starting dose level.
Toldcha this stock is being played by a small number of MMs...
The MMs will have a good morning...
Your arguments are very strong - as always.
You are falling for the co's misleading PRs. All they did was license a patent application. They call it a 'Strategic Relationship' to make it sound better and to benefit from WARFs rep.
Going for naive investors here...
The article I sent you was presented publicly. No fake news here.
No - you just missed the wink.
I pointed you to a reference showing that, in a previous trial, DLTs occurred at the current cohort 4 dose level.
Prove me wrong if you can.
I am balancing out SonOfPCG, who is pumping without reason /arguments...
Also the stock goes up 2cents when I post, so you are welcome ;)
"Company said the tech works" - what else would they tell you?
As I mentioned before, I look at data instead. In solid tumors, CLR131 showed dose limiting toxicities at 31.25 mCi/m2 and as a consequence, development in solid tumors was stopped.
See http://meetinglibrary.asco.org/content/130053-144. Not show how much you know about this, but you don't want DLTs.....
The co is moving into this dose level in MM now (acc'd to their PR), so it will be interesting to see what happens.
Of course it is not a 'comprehensive' measure. No parameter alone, be it ORR of PFS is a comprehensive measure.
But ORR plus duration of response is what the FDA and potential pharma partners are looking at and other MM drugs set a high bar with their >50% ORR in this setting.
"Generally, the FDA has defined ORR as the sum of partial responses plus complete responses. When defined in this manner, ORR is a direct
measure of drug antitumor activity, which can be evaluated in a single-arm study. Stable disease should not be a component of ORR."
This trial is currently at an ORR of 0%. Based on recent approvals, the FDA has accepted RR >28% for approval.
I'm not bashing here, just don't agree with SoW's blind optimism. Prefer to look at data...
Sure - the company's valuation is certainly low, but you also have to look at historical performance data. CLRB has been around since 2004. They had multiple trials with CLR131 and did not continue after solid tumor Phase 1 studies because they were unsuccessful. Their Phase 2 study of CLR124 got chopped halfway.
As much as they praise the platform, history tells a different story and some investors may have lost trust /may not share the same optimism. Hence the low-ball price tag...
I am not shorting this stock any more, but you have to look at the pattern /obvious timing of events here:
Every time the CEO is giving a talk, they try to stir up some hype a day or two prior to it in a desperate attempt to create a bit of momentum. That is of course making it very easy for shorts...
Curious to hear what's new today and if there is some ORR data. I hope we will see some complete responders.
The CEO will likely tout about Ph2 initiation etc., but we NEED ORR DATA.
What numbers /performance is your $100M valuation based on?
Do you think we will finally get some ORR numbers from the CEO today? They have been touting about efficacy, but also have been avoiding ORR.
Today will be exciting.
Kite will be a tough competitor for CLRB in the heme space.
They even have an ORR > 0% in their trials!
http://finance.yahoo.com/news/kite-announces-positive-topline-primary-120000326.html
SoW - CLRB needs more pumpy pump. Seems like you slowed down...;)
"Very good about putting out accurate info"
You mean when they did not report to the SEC that their CMO, a director of the company, left?
http://www.xconomy.com/wisconsin/2017/02/21/after-navigating-ups-and-downs-cellectar-ceo-caruso-looks-to-future/#
Accurate rubbish indeed.
Yes they have received that - http://investor.cellectar.com/releasedetail.cfm?releaseid=886255
Will allow you to go with less patients per trial (vs. non-orphan indications) and potentially into a pivotal Ph2. They don't seem to have the data /outcomes for the latter though.
Usually, they cannot start the Phase 2 until they have narrowed down the dose level in the ongoing Phase 1 study. Tox and safety first, then you move on if warranted.
Hence, if they are about the start cohort 4 of Ph1, I highly doubt there will be a Phase 2 update in June /July.
That was just hot air in an attempt to ride the wave...
Still no word of the ORR, which will be key...
Amen :)
I did contact the co and did not get a response.
SoW - I mentioned facts that can be found in their press releases and yesterdays deck. You can listen to the webcast and download a pdf of the slides and see for yourself.
If you read carefully, you will find irregularities, such as the CMO issue others pointed out before I did.
Hoping things will work out, but wonder how much mgmt is spinning things here.
So I looked at these two pubs and noticed two things:
1) they do not cover radiotherapeutics, but rather optical agents. Cellectar's optical agent has been in the pre-clinical stage in their pipeline for years now.
2) there is no 'validation'. The Nature Reviews article is, as the name indicates, a review about the current state of optical cancer detection during surgery. Has nothing to do with myeloma.
Just another paid-for article, and - as I predicted last week - no ORR numbers from the CEO today.
Don't you guys think it is weird that they have N=4 pts per cohort, but show you only N=2 in their graphs of today's deck?
That would of course make me happy. I work in the field and my patients come first. Right now, there are plenty of excellent options though.
For MM, you have to look at (as you may know) the IMWG response criteria: https://www.sgh.com.sg/Patient-Services/conditionsandtreatment/myeloma/PublishingImages/ass1.png (from http://www.uptodate.com/contents/evaluating-response-to-treatment-of-multiple-myeloma)
Cellectar already anounced that ALL of their cohort 1 and cohort 2 patients achieved stable disease, which is not considered a response. Hence my statement that for cohorts 1 and 2, the ORR was 0%.
This trial is a combo study with dexamethasone (see https://clinicaltrials.gov/ct2/show/NCT02278315), so I would at least expect some activity /response.
As for your volume question: yes, churning. Otherwise you would see much higher gains at these crazy volume/float-ratios.
My home is the far-away planet of due diligence. Why?
If we get good (>50%) ORR numbers for cohorts 1-3 on Monday I'll go back home.
I am not spinning Darzalex, but it is all the rage now since it was the first approved monoclonal Ab for MM. Patients ask for it.
JnJ is dominating first line treatment with Velcade (IP running out this year) and they will move Dara /Darzalex up the line aggressively to maintain that position.
Keep in mind that trials only include heavily pretreated patients, which is exactly why the ORR numbers were so impressive.
The other question is: Would you rather get an infusion or would you prefer to go home to your family being radioactive for a while (as with Cellectar's compound using radioactive Iodine)? Administration of radiation comes with complicated logistics, which is exactly what broke Bexxar's neck. Look up "The Bexxar story" on Xconomy.
If they data are in the "somewhat OK to OK" range, they can partner for a combo trial (almost all MM Tx are combos), so another follow-on Phase 1 trial...
Exited for Monday.
It will depend on the overall response rate. Myeloma is a crazy competitive market. Look at the ORRs of the combination regimens physicians are currently all over: https://jhoonline.biomedcentral.com/articles/10.1186/s13045-016-0283-0#Tab1
So they better have a 50%+ ORR in the first 2 cohorts already. If not announced on Monday, you know that they don't.
And Mazel tov on the new keyboard ;)
I agree. Something big coming, otherwise this puppy wouldn't be back to 1.8% of the share price of 2013.
Looking forward to the performance updates on Monday.
Cohort 3 of Phase 1 trial should be in by now, so maybe the CEO will speak to the overall efficacy and what appears to be a 0% response rate in cohorts 1 and 2.
I see you have very strong arguments. Was I wrong about the BoD, or were you?
Please do me a favor & sink more money into this POS. Time will tell.
I said coming soon, given the claims the company is making in an effort to stay above $1. Pathetic.
You made 5,086 of the 5,592 posts on here. You are just a PCG-paid pumper.
And you accuse me of posting false information here?
Read their SEC filings and go to their website (up-to-date since - as you mentioned - a NASDAQ-listed company).
3 people mgmt team, 4 directors on the BoD.
Suggesting to do some due diligence doesn't make me a scammer.
Err - no.
According to the co's profile on LinkedIn, there are two remaining PhDs,
- Founder, Director, and CSO left (8-K filed July 14th, 2016)
- VP of Clin. Dev. left
- Lead of R&D and Clin. Dev. left
- VP of BD left
- Corp Dev Manager left
- CMO appears to have left, too. Not announced, no replacement announced.
So R&D, BD, and Clin. Dev. seem gone. Thoughts?
You mean the companies PRs?
Here's some news for you Sunofwolf: CLASS ACTION LAWSUIT coming up!
It's obvious to me that this co has PCG churn their stock. Just look at the volume spikes on e.g. 5/20/16, 5/23/16, 1/24/17, the days on which 4-10x of CLRB's float (4.26M) were traded.
If you have ever heard /read about choleric lil' Jimmy and Jeff Ramson, you know what is going on here...
I am still waiting for the scientific evidence showing that their fatty acid vehicle can deliver "more than 30-fold" (as stated in their 6/15/16 PR) Taxol to tumors than the drug in its free form. The announced comparison against Abraxane was never shown, so draw your own conclusions from that.
As for their CLR131 asset: The 12/1/16 PR was missing an ORR statement, which tells me that their ORR up until then was 0%. That's pretty bad.
Same in the 12/6/16 PR for the ASH conference... Only one patient with PFS, 0% ORR in total. If the ORR were >0%, this company would have released 5 PRs about it.
According to LinkedIn, all PhDs and key employees jumped ship last year. Mgmt team is uneducated and pathetic for a biotech.
So yeah. Do your own DD before posting here. If you want to make any money with CLRB, you will a) have to join the class action law suit or b) short the crap out of this pos. It ain't going anywhere...