From Seeking Alpha re: CLSN
“The bearish case here is that the platform on which the entire company's technology is based, the liposomal delivery of drugs, cannot be made effective.”
Perhaps CLSN’s failure is depressing all bios involving liposomal delivery.
there is already an ablation needle right in the middle of no more than 4 tumor sites. Think about it.
Ablation radiotherapy is already a "focal/regional" cancer treatment. The ablation needle is image directed right into the center of the tumor and then the "tentacles" of the ablation needle are extended and encircle the tumor. Why not infuse the Thermodox directly and slowly into the tumor site through a second bore in the ablation needle. That is correct "focal/regional" chemotherapy. To quote the best multiple modality physician at DFCI, "Infusing a chemotherapy agent into a peripheral vein to reach a remote site of therapy is firing a cannon off inside the person's body to swat a fly."
The protocol at Clinical Trials said they got two chances at no more than four tumors in 14 days using this technique. The really should have looked at better alternatives.
Actually if you read fuds comments at the end of this thread, they are correct.
Also this analogy has nothing to do with what INSM is investigating in clinical trials.
Manipulating and emotional stock players are poor judges of any scientific or medical technology. Proven by 8 years of being wrong about this stock.
57 studies (Phase II or Phase III under advanced search) are listed using the keywords above. Most are infusing chemo agent through the hepatic artery so as to minimize the whole body toxicity of the chemo agent. CLSN could have at least chosen that adjunctive method to administre Thermodox. But a twin bore ablation needle would have been better.
Thermodox still does not apply to any studies with Arikace. Attempting to make parallels based on liposome technology being used for different drug categories is off point. Arikace is being locally delivered to an organ that is infected in multiple focal areas. That is the point.
From what I've read the Seeking Alpha conclusion is misleading.
The CLSN price drop follows the news that their Phase III study failed to meet its primary endpoint - a 33% improvement in progression-free survival in the patients whose tumours were treated with radiofrequency ablation in combination with heat-sensitive liposomal doxorubicin compared with the progression-free survival in the patients whose tumours were treated with radiofrequency ablation alone.
Liposomal doxorubicin is an established chemotherapy. The liposomal encapsulation keeps the doxorubicin in the bloodstream longer than is achieved with standard doxorubicin injections. I've been arguing for a while now that this is what Insmed will eventually do with iPlex.
CLSN developed a version of liposomal doxorubicin where the liposome is rapidly degraded by the heat from the radiofrequency ablation procedure. The idea, presumably, is that significant numbers of liposome capsules would gravitate to the proximity of the tumour - and be melted during the ablation procedure, releasing lots of concentrated doxorubicin to minimise the escape into the bloodstream of live cells from the tumour released during the procedure.
As yet I've no idea why they set the bar so high in this study.
Yeah, market reaction to CLSN could be the case. Either way, it is still incredibly perplexing why Management conitinues to market Insmed as a One Trick Pony (Arikace) ,ignoring all of the other assets and IP of our Company!
Re your -
"Either way, it is still incredibly perplexing why Management conitinues to market Insmed as a One Trick Pony (Arikace) ,ignoring all of the other assets and IP of our Company!"
- you should bear in mind that others may have a different opinion. How are you with tying shoelaces?
This could very well be the case & I can understand the reaction. I've been following Celsion since May 2011 when insiders were buying at $2.77. Ran all the way past $8 and now failure of HEAT study.
I have much confidence in Arakace using drug [AMAKACIN - already FDA approved] and having the great phase II data. All we need is non-inferior to TOBI data. The liposome does attach and get absorbed into the LUNG releasing the Amakacin drug to the needed delivery location. Any number of reasons could have derailed Celsion's drug.
Sentiment: Strong Buy