CLSN released a PR today:
http://www.celsion.com/releasedetail.cfm?ReleaseID=627024
Of which the important parts are shown below:
"Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that the independent Data Monitoring Committee (DMC) for Celsion's Phase III HEAT Study, a multinational, double-blind, placebo-controlled, pivotal study of ThermoDox® in combination with radio frequency ablation (RFA) for hepatocellular carcinoma (HCC) or primary liver cancer, has completed a planned interim analysis for safety, efficacy and futility and unanimously recommended that the study continue to its final analysis as planned. The DMC evaluated data from 613 patients in its review, which was conducted following the realization of 219 progression-free survival (PFS) events within the study population. A total of 380 events of progression are required to reach the planned final analysis of the study.
Celsion also announced today that the DMC, in its review, followed a statistical boundary determined by the Company using the Lan DeMets implementation of the O'Brien-Fleming spending function. This approach allows for the Company to conduct additional interim efficacy analyses prior to final data read-out at 380 PFS events with no increased risk of statistical penalty. The additional analyses may allow for earlier stopping of the study. Additionally, based on its internally modeled estimates of PFS events, Celsion reconfirmed that 380 PFS events are projected to occur in late 2012.
"The DMC's unanimous recommendation is a significant achievement for Celsion based on the most comprehensive review of the HEAT Study to date, including the first-ever review of efficacy results," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Critically, we have the potential to realize a successful outcome to the study prior to its planned completion. We are encouraged by what may be sufficient rationale for conducting an additional preplanned efficacy review prior to the 380 events called for in our protocol, and will seek to amend our Special Protocol Assessment Agreement with the FDA accordingly. We thank the DMC for their work and thorough review, and are grateful for the continued support and enthusiasm from the healthcare community, regulators, our investors and our employees."
The HEAT Study is being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, has received FDA Fast Track Designation and has been designated as a Priority Trial for liver cancer by the National Institutes of Health. Target enrollment of 600 patients was reached in August 2011, after which the DMC conducted this interim efficacy analysis based on the realization of 219 progression-free survival events. Consistent with the Company's global regulatory strategy, Celsion is continuing to enroll patients in the HEAT Study in order to randomize at least 200 patients in China, a requirement for sFDA (State Food and Drug Administration) registrational filing in that country and to ensure timely readout of final data. In addition to meeting the U.S. FDA enrollment objective, the HEAT Study has also enrolled a sufficient number of patients to support, in Asia, registrational filings in S. Korea and Taiwan, two very important markets for ThermoDox®."
So - my thoughts are as follows:
Disappointed? Yes - I did think we had a great shot at interim. Funny thing is, we just don't know: was P-value there but OS not enough of a trend? ("totality of the data")
So what do we know?
Safety is not an issue.
Enrollment at 613 (mid/late Sept?) This worries me a little bit. If 600 was ~ 8/5 and enrollment was 613 on 9/19ish, enrollment in China is slow. However, I believe that only those treated and at least one follow up might qualify under the 613. In that case, true enrollment might be closer to 625ish... I will have to follow up with the company here.
219 evaluated as "events". Q was asked at cc about the # past 190 and MT said "not substantial." 29 over = ~15% surplus... in my book that is substantial, but whatever.
The biggie in my estimation is that DMC advised them to seek an amendment to the SPA, instead of "simply" reccing a continue to 380. There is NO reason for this unless they were awfully close to being close enough to stop the trial. There is no other reason - period.
We have enough cash for about 8-11 months, depending on how much burn changes from the mrq. HEAT costs are "over the hump" supposedly but then we're still enrolling to 700, plus ABLATE expenses start. I assume ~1.7-2M a month, yielding my 8-11 months. We've demonstrated that we're willing to scrape the barrel... In my opinion it depends 1) on the FDA chat re the SPA and how soon we decide to take another peek and 2) on how licensing talks with big pharma (BP) go. Now that we're "de-risked" past the interim, BP may be more willing to loosen the purse strings. I repeat: with the DMC rec to amend SPA, the cat is out of the bag.
Was it Rodman & Renshaw that said $6 if a continue? I'm disappointed today, but especially if the overall market rallies, we'll nudge out of the mid $2s soon enough.
-Trond
Monday, November 28, 2011
Thursday, November 10, 2011
Celsion quarterly call
Following are my notes, in very rough form.
I'm very excited still, but very conscious that an investment here assumes that company guidance for 12 month placebo median PFS is correct. More precisely, it appears that anything up to about 17 months placebo PFS would give great odds at interim, which is 40% worse than guidance! So I am comfortable with such risk, but others need to decide for themselves.
26.6M shares OS, $21.4M cash, Q burn was 6.9M (will slow down somewhat - Q3 was high for HEAT milestone payments)
Acknowledged that burn will decrease slightly simce "hump" of HEAT costs are over in Q3.
380 events "possibly as early as q412".
HEAT enrollment extended to 700.
[me - was 640-650 to allow China to be registrational.]
later in QA acknowledged that 700 will get them to 380 events quicker
No OS (overall survival) bar is set at interim - it is "totality of the data".
Cash should last through 2012 [me- although this would reduce us to scraping the barrel again - doubt they'd go past 2q12]
S Korea and Taiwan are registrational in size, China [believe he said Taiwan in the call, but misspoke] is "quickly approaching" 200.
Japan PMDA still reviewing but no action. Yakult in charge of details of new trial and approach.
ABLATE - data should "closely follow" the approval of TDox. [assuming company guidelines]
Gross margins should be 90%+
SPA says if interim hit FDA would need to be consulted. No specific process.
If only a continue, co guidance is that DMC will only relay that fact. NO EXTRA DATA.
Well placed in terms of competition on horizon.
Co. gets "standard set of data" after continue - but pooled, not broken out per arm - it is still blinded!
No saying when DMC meets or when 190 happened [except we know 190 in 3q11 from the 8k filing. my best guess still second week of Aug '11]
Will not disclose p-value needed at interim. Can figure lots of stat data from that - not fair to all shareholders.
Went to 8-10 weeks for processing data... [believe this incorporates taking "extra care" with data into account w/ the increase over prior 6-8 weeks given]
Not substantially more than 190 events, but included a "safety margin".
Licensing talks continue.
I'm very excited still, but very conscious that an investment here assumes that company guidance for 12 month placebo median PFS is correct. More precisely, it appears that anything up to about 17 months placebo PFS would give great odds at interim, which is 40% worse than guidance! So I am comfortable with such risk, but others need to decide for themselves.
26.6M shares OS, $21.4M cash, Q burn was 6.9M (will slow down somewhat - Q3 was high for HEAT milestone payments)
Acknowledged that burn will decrease slightly simce "hump" of HEAT costs are over in Q3.
380 events "possibly as early as q412".
HEAT enrollment extended to 700.
[me - was 640-650 to allow China to be registrational.]
later in QA acknowledged that 700 will get them to 380 events quicker
No OS (overall survival) bar is set at interim - it is "totality of the data".
Cash should last through 2012 [me- although this would reduce us to scraping the barrel again - doubt they'd go past 2q12]
S Korea and Taiwan are registrational in size, China [believe he said Taiwan in the call, but misspoke] is "quickly approaching" 200.
Japan PMDA still reviewing but no action. Yakult in charge of details of new trial and approach.
ABLATE - data should "closely follow" the approval of TDox. [assuming company guidelines]
Gross margins should be 90%+
SPA says if interim hit FDA would need to be consulted. No specific process.
If only a continue, co guidance is that DMC will only relay that fact. NO EXTRA DATA.
Well placed in terms of competition on horizon.
Co. gets "standard set of data" after continue - but pooled, not broken out per arm - it is still blinded!
No saying when DMC meets or when 190 happened [except we know 190 in 3q11 from the 8k filing. my best guess still second week of Aug '11]
Will not disclose p-value needed at interim. Can figure lots of stat data from that - not fair to all shareholders.
Went to 8-10 weeks for processing data... [believe this incorporates taking "extra care" with data into account w/ the increase over prior 6-8 weeks given]
Not substantially more than 190 events, but included a "safety margin".
Licensing talks continue.
Tuesday, November 8, 2011
MarketWatch contest - round 2 article
MarketWatch is running a contest to find its "Next Great Investing Columnist." I've entered, and my first column made it through the initial round, thanks to social media voting placing me in the top 25.
Now it gets interesting - as they are technically running two contests. There is an "Editors' Pick" winner (who actually wins the gig writing a column) and a "Readers' Pick" (based still on social media voting). The editors picked one additional writer to put through, so there are 26 remaining contestants. This round, 6 total writers will make it through - three Readers' Picks and three Editors' Picks.
I'm pretty much in need of being an Editors' Pick this time, as the top three vote getters in the first round all got more than 300 votes ("likes" on Facebook) and mine, while respectable in the field, drew only 148 votes.
I really don't mean to bag on the actual contest, but allowing the social media voting is a bit of a farce. The lead contestant got over 800 votes, more than twice as many as the second place vote... and the article is in broken English and extremely hard to follow. I guess I need more friends on Facebook. *grin*
I am asking the gentle readers here to visit the column, nevertheless. Any "likes" are certainly welcome, but I would actually appreciate comments in this round. I think the editors are more likely to place some credence on comments this time around!
My second article can be read here:
http://blogs.marketwatch.com/great-columnist/2011/11/07/dont-settle-for-average/
My thanks to all!
Regards,
Trond
Now it gets interesting - as they are technically running two contests. There is an "Editors' Pick" winner (who actually wins the gig writing a column) and a "Readers' Pick" (based still on social media voting). The editors picked one additional writer to put through, so there are 26 remaining contestants. This round, 6 total writers will make it through - three Readers' Picks and three Editors' Picks.
I'm pretty much in need of being an Editors' Pick this time, as the top three vote getters in the first round all got more than 300 votes ("likes" on Facebook) and mine, while respectable in the field, drew only 148 votes.
I really don't mean to bag on the actual contest, but allowing the social media voting is a bit of a farce. The lead contestant got over 800 votes, more than twice as many as the second place vote... and the article is in broken English and extremely hard to follow. I guess I need more friends on Facebook. *grin*
I am asking the gentle readers here to visit the column, nevertheless. Any "likes" are certainly welcome, but I would actually appreciate comments in this round. I think the editors are more likely to place some credence on comments this time around!
My second article can be read here:
http://blogs.marketwatch.com/great-columnist/2011/11/07/dont-settle-for-average/
My thanks to all!
Regards,
Trond
Wednesday, November 2, 2011
Celsion - buy, sell, or hold?
We should be hearing from the DMC (data monitoring committee) regarding the interim results at nearly any moment.
While I am a raging bull as far as Thermodox goes, this is a clinical trial and "anything" can happen. I feel it a very slim-to-none kind of possibility that the trial be stopped for failure, but one has to keep it in mind. If the loss of your dollars here would cause you to lose sleep at night; then it may be time to sell, today.
As long as you can live with that chance, the remaining choices are a recommendation for continuing to the final look or a recommendation for filing for early approval, based on overwhelming statistically significant advantage.
Message boards have been frothy with the odds of success as high as 60% or more. And I have to say, there appears to be some good data backing up such assertations. Nevertheless, the most likely possibility, in my opinion, is simply a continue. So what does that spell, in terms of CLSN's price?
I believe this depends solely (short term) on what data is released with such a recommendation. It is important to note that the DMC does not have to release anything extra. That said, if there is a definite trend, regardless of meeting the higher bar at interim, it is conventionally believed that the committee will say something about the data.
A drop, short term, could easily happen, especially if there is not extra data released. Many stat experts have been saying, contrary to company assertations, that the final look at 380 PFS events will not occur until mid 2013 (company has been guiding for about Q3 2012). With such an extra amount of time in between interim and final, I think the price would drop again to the $2s.
However, with the release of some data, speaking to the improvement seen to date or at least the placebo arm's performance, would go a long way to being able to peg the actual performance of Thermodox. If we can see that at the final, it looks to be a success, we could even see some price appreciation.
A buy here would simply be a lottery ticket for interim success; with normal volatility I'd say a hold here is prudent, again as long as you can stand the possibility of a near 100% loss on an admittedly low chance of trial failure.
Regards,
Trond
While I am a raging bull as far as Thermodox goes, this is a clinical trial and "anything" can happen. I feel it a very slim-to-none kind of possibility that the trial be stopped for failure, but one has to keep it in mind. If the loss of your dollars here would cause you to lose sleep at night; then it may be time to sell, today.
As long as you can live with that chance, the remaining choices are a recommendation for continuing to the final look or a recommendation for filing for early approval, based on overwhelming statistically significant advantage.
Message boards have been frothy with the odds of success as high as 60% or more. And I have to say, there appears to be some good data backing up such assertations. Nevertheless, the most likely possibility, in my opinion, is simply a continue. So what does that spell, in terms of CLSN's price?
I believe this depends solely (short term) on what data is released with such a recommendation. It is important to note that the DMC does not have to release anything extra. That said, if there is a definite trend, regardless of meeting the higher bar at interim, it is conventionally believed that the committee will say something about the data.
A drop, short term, could easily happen, especially if there is not extra data released. Many stat experts have been saying, contrary to company assertations, that the final look at 380 PFS events will not occur until mid 2013 (company has been guiding for about Q3 2012). With such an extra amount of time in between interim and final, I think the price would drop again to the $2s.
However, with the release of some data, speaking to the improvement seen to date or at least the placebo arm's performance, would go a long way to being able to peg the actual performance of Thermodox. If we can see that at the final, it looks to be a success, we could even see some price appreciation.
A buy here would simply be a lottery ticket for interim success; with normal volatility I'd say a hold here is prudent, again as long as you can stand the possibility of a near 100% loss on an admittedly low chance of trial failure.
Regards,
Trond
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