I'm in the same position - I've only been accumulating post collapse. I don't really view the failure of phase III as the death blow to clsn, although costly. I view it analogous to Edison trying to get the light bulb working with less room for error. Their post-hoc looks promising and holds the potential for enormous upside, compared to the downside risk. I'm willing to lose my investment - not life changing on the downside, but potentially so on the upside.
In terms of financing, I thought they still had access to another $10 million of non-dilutive debt from Hercules - or have I missed something? They've given Hercules options, but if converted, they only appear to be dilutive by 1%.
I'm with you, good or bad, as many facts as possible would be welcome. Thanks.
I have conceded my 15k shares to a total loss.
I haven't been involved in the stock that far back but since investing in Aug 2013 have lost half my position in CLSN, reverse and declining stock price. Their hasn't been any dilution of the shares to current stockholders except Egen now owns 10%.
How did Sabby Healthcare purchase a large quantity of shares without it showing in the volume? Can you explain why they would increase their position if dilution or stock price could drop significantly?
I just want facts and try to read all the press releases available. I will have to participate on the call as stock short suggests to be able to ask the appropriate questions. Anyone is welcome to post facts so we can have open discussion to dissect...good or bad.
The wording was confusing in the 8k referencing multiple entities and than Company.
In previous reports or calls has there been indication of costs to manufacture the Thermodox? Could any of their current partnerships in Europe provide some cash flow to assist with this?
Can they reverse this stock any further? The limited outstanding shares makes it more difficult to short or purchase options. What could happen next in your opinion?
Did you ever consider that no one cares what you have to say...Just sayin
"The COMPANY will be RESPONSIBLE for the manufacture and supply of quantities of ThermoDox to Impatients for use in such Early Access Programs and Impatients will distribute and sell ThermoDox pursuant to such authorization, exemptions or waivers."
the company is CLSN
manufacturing and supplying quantities costs CLSN $$$$
can you clarify this stock short
In consideration for Impatients' services to implement the Early Access Program and in the event the Company receives regulatory authorization to sell, distribute or market ThermoDox� in the Territory, the Company is obligated to pay Impatients, subject to a maximum cap, a low single-digit royalty of net sales of ThermoDox� in the countries where such regulatory authorization has been obtained. The term of the Agreement is for a period of five years, with automatic renewals for consecutive two-year periods, unless earlier terminated by either party with notice or in the event of material breach, bankruptcy, or insolvency without notice. Seems like Impatients taking on the risk?
you've got a long ways to go to get back to where you were on 01.30.2013
overseas product development will cost clsn $$$$
continue to watch and learn,
Targeted treatment with Thermodox puts more dox on the tumor and results in less side effects.
Investors are ignoring CLSN because of the failed HEAT trial where multiple liver tumors were involved. Apparently, at this time nothing works for multiple HCC in the liver. However, single tumors can be controlled and are being controlled at a rate of 50% better than SOC with RFA. That's a big deal. Patients live two years longer. The DMC will take a look at the data from the OPTIMA trial this fall. If the 50% result is repeated, NDA time.
Here's what's happening with the RCW trial where Thermodox will go on sale in the very near future.
Modern advancements in hyperthermia biology have led to refinements for individualised thermochemotherapy approaches to treatments as well as interesting potential for exploiting hyperthermia in conjunction with cancer vaccines. MR imaging is playing an increasing role for measuring patient response to hyperthermia.
Interest in hyperthermia as a treatment for breast cancer has led to significant advances and research activity, which in turn has had a significant impact on treatment protocol. The National Comprehensive Cancer Network (NCCN) now includes hyperthermia in their Breast Cancer Guidelines as a treatment for recurrent cancer.
Erasmus Medical Centre in the Netherlands is one of Europe's largest hyperthermia centres.
ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. ThermoDox, which is administered intravenously and in combination with local hyperthermia, has the potential to provide local tumor control and improve quality of life. Localized mild hyperthermia (39.5-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
I think Chine is next to approve early access program. CLSN = $$$$$$$$$$$$$$$$$$$$$$$$$$$
Sentiment: Strong Buy
ThermoDox in the Phase II DIGNITY study.
Thermodox is controlling, shrinking, and eradicating tumors where there had been no hope before.
A ThermoDox plus hyperthermia in recurrent chest wall breast cancer. As you know, we continue to report very impressive results in this, difficult to treat, refractory population, so patients post-hysterectomy, who have failed at least two lines of chemotherapy and have failed radiation before enrolling in our trial.
In July, we reported updated interim findings demonstrating that a local response rate of greater than 50% has been observed in the first patients with refractory disease, notably with three complete responses. I’d also point out that these findings are consistent and have been consistent with the objective responses that we’ve seen in two previous Phase I studies accounting for some 27 patients.
You should expect ongoing data from the DIGNITY study, which if it continues to show overwhelmingly positive tumor response results, we will approach FDA to discuss next steps. And if you recall from prior written agreements, we know that FDA will accept local tumor control as the registrational endpoint in this unfortunate highly refractory end-stage population.
Sorry - I meant July 28th, 2014. Perhaps your question refers to the following line in that press release
"The Company notes that, while the data and supporting analysis from the HEAT Study warrant additional clinical development, the information should be viewed with caution since it is based upon a retrospective analysis and this subgroup of the HEAT Study has not reached its median point for OS analysis."
My interpretation of this sentence is that 1) there is justification for the OPTIMA study and 2) the analysis had been based on a group that had never met their median OS point, so caution must be used. Unfortunately, no indication is ever given as to when to expect the group to reach the median OS (which I believe is 30 months). Based on the context of the press release that uses terms like "statistically significant" and "final", its a little difficult to interpret what the ongoing expectation will be for reporting out additional results from the HEAT study. From https://clinicaltrials.gov/ we see that the final completion date is estimated to be Dec 31, 2015. Perhaps we might hear some additional news this year based on this, and I'm with you, if someone knows if this is true and when it will be, that would be good information to have.
Not sure - what we do know is that they indicated that they made their "final" sweep of the HEAT data in a press release dated July 18, 2014. I can only speculate that after the failure of HEAT to meet the PFS target, the study was stopped and the residual data from the post hoc has a limited shelf life ( in this case 5 quarters). I would like to replace speculation with as much information as possible and would greatly appreciate references, links you are willing to share. Many thanks in advance.
HCC / Liver Tumors
The primary endpoint is overall survival. The study is pilot to show a 33% improvement in OS, and I want you to keep 33% in mind. The most recent clinical evidence supports this thesis. It comes from our June 30, 2014 quarterly Overall Survival sweep of the HEAT study patients. In this subgroup of 285 patients, who received standardized RFA treatment, 285 represents 41% of the total study, we noted an 57% improvement in OS in the ThermoDox plus sRFA arm versus standardized RFA alone, 57% improvement.
So 57% improvement versus sRFA alone, that’s over two years improvement in survival. That’s pretty astounding. Two years. A bullet for wedding and graduation. If you recall, Nexavar or sorafenib was approved on just 11 weeks OS benefit. And while there should be caution since this is a retrospective analysis, these findings are nonetheless striking in that they have one remain constant over each of the six quarterly dead sweeps.
Post-hoc findings and hypothesis supporting OPTIMA do not represent our view alone. The data were shared along with our RFA learnings, in particular, with HCC research community during major international medical conferences.
In the final analysis, we have received full support, and I would say, share a great deal of optimism for the OPTIMA study with virtually all of the most important names in HCC research worldwide. I think with some modestly, I’d like to say that, we now know more about the use of RFA to treat the intermediate stage lesions in HCC than just about any company on the planet.
Thank you for sharing that. So, in Feb we can see news on GEN-1. I'll look forward to that. But, I'm really interested in their ability to revive Thermodox for HCC through the OPTIMA trial. My hope, as I'm sure with many others, is that the failed HEAT trial was just a learning experience that gave them the insight to increase OS by 57%. At these levels, the investment seems so worth the downside risk, but I guess we will all have to patiently wait. Best regards.