CLSN (updated to buy) updated to strong buy in Q3-4 2012 (12-14-12 changed to Neutral) 05-09-13 changed to buy 11/28/14 changed to neutral
The company has a unique innovative drug delivery technology ThermoDox®.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. In the HEAT study, ThermoDox is administered intravenously in combination with radio frequency ablation (RFA). 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. A thermal zone created by the RFA releases the entrapped doxorubicin from the liposome.About ThermoDox® and the Phase III HEAT StudyFor primary liver cancer, ThermoDox® is being evaluated in a 600 patient global Phase III study at 75 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, interim efficacy analysis will be performed by an independent Data Monitoring Committee when enrollment in the trial is complete and 50 percent of the PFS events are realized in the study population. Additional information on the Company's ThermoDox® clinical studies may be found athttp://www.clinicaltrials.gov/ct2/show/NCT00617981?term=Celsion+Corporation&rank=1As previously announced, the FDA has granted Fast Track Development for the Company's 600 patient pivotal Phase III clinical trial (the HEAT study) of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), The Fast Track Development Program provides for expedited regulatory review including frequent interactions between the FDA. Celsion is eligible to submit its NDA on a rolling basis and review sections of the NDA with the FDA in advance of submitting the complete submission. The HEAT study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. http://finance.yahoo.com/news/Celsion-Receives-Positive-FDA-prnews-2030575178.html?x=0&.v=1In Sept. 30th Celsion announced that after reviewing data from 401 patients enrolled in its pivotal Phase III ThermoDox ® clinical study (the HEAT study) for primary liver cancer, the Data Monitoring Committee (DMC) has unanimously recommended that the trial continue to enroll patients with the goal of reaching the 600 patients required to complete the study.Strongly recommended for investment in late 2011. Low risk, high rewardNovember 10, 2010 by BiotechInvestCelsion to Hold Third Quarter 2010 Financial Results Conference Call on Thursday, November 11, 2010Celsion Corporation (Nasdaq:CLSN - News), a late stage biotechnology drug development company that is leveraging its heat sensitive liposomal platform to encapsulate and deliver high concentrations of proven chemotherapeutics, today announced that it would hold a conference call to discuss third quarter 2010 results at 2 p.m. ET on Thursday, November 11, 2010. May be CLSN will release some good news i.e. clinical trials updates... Today CLSN pps is close to 52-weeks low (52wk Range: 2.71 - 5.63) so any good news may heat this stock.Low risk, moderate reward.By the way, CLSN technology is linked with BSDM technology. CLSN need BSD-2000 or even BSD-2000/3D for precision thermal activation of ThermoDox®.November 24, 2010 By BiotechInvestCLSN is still cold and it's too early to invest in it now. Will keep it Cold Watch List. April 28, 2011 by BiotechInvestIn last update CLSN said: "Celsion is nearing enrollment completion for the HEAT study and, within a similar timeframe, the pre-planned interim efficacy analysis of this pivotal study by its independent Data Monitoring Committee. We expect thatthese key events will serve to reinforce our confidence in ThermoDox® as a potential first line treatment for HCC as we work toward top-line results from the study in 2012 and the expansion of our ThermoDox® program into multiple indications, including secondary liver cancers, bone cancer and recurrent chest wall breast cancer, in 2011"A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT Study is complete and 190 progression-free survival (PFS) events are realized in the study population.Phase 3 Study of ThermoDox With Radiofrequency Ablation (RFA) in Treatment of Hepatocellular Carcinoma (HCC)Estimated Enrollment: 600Study Start Date: February 2008Estimated Study Completion Date: February 2013Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)Some source said that "Celsion Corporation (NASDAQ: CLSN) is likely to complete its phase III trial for ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, in treating hepatocellular carcinoma or primary liver cancer in 2Q 2011." May be it's a mistake, and CLSN will release only the interim efficacy analysis data in Q2 2011. Any way CLSN become warmer and current company pps ($2.90) is still attractive for biotech investors. October 04, 2011 by BiotechInvest
Finally we are almost here: Interim analysis of phase III study of Thermodox in primary liver cancer should be released very soon. Some sourse said it will be at Sept. 27-28 "Biotech events expected before the end of September: Chelsea Therapeutics(CHTP): Complete FDA approval filing for Northera as treatment for neurogenic orthostatic hypotension. Amarin(AMRN): Complete FDA approval filing for AMR101 for treatment of patients with high triglyceride levels. Celsion(CLSN): Interim analysis of phase III study of Thermodox in primary liver cancer."Well, it's already October...And CLSN pps is still attractive $2.47 If interim data is very positive trial CLSN pps may jump 100-200% in one moment. And crashed to <$1 if data is negative. What is the probability of very good results for Thermodox? My pick is >80% so I will buy CLSN tomorrow (no more than 10k shares). Why I'm so positive? I think that synergetic effect of doxorubicin and hyperthermia is possible here i.e. cancer cells will be severely damaged after this treatment. The hyperthermia will damage cell cytoskeleton and all dividing cells (mostly cancer ones) will go to apoptosis. At the same time doxorubicin that is a DNA-damaging drug will irreversibly crash cancer cell
genome. Thus Doxorubicin will cause both cytotoxic and cytostatic effects. Moreover, Doxorubicin may inhibit TGFbeta-signaling pathway and in such way it will also inhibit metastasis formation. Disclosure: I don't have CLSN positions now, will open it soon.
11.22.11 by BiotechInvestCLSN keeps silence... FDA approved BSDMBSD-2000 Hyperthermia System after 5 years of delay... Sure that Thermodox in combination with BSD-2000 will fight liver cancer with high efficacy (may be even stronger than DCTH). But CLSN pps is $2.89 today and decay continues. Question is why? % of Float Held by Institutional & Mutual Fund Owners: 6%Answer: the funds don't like CLSN. Because fund analysts can't predict CLSN interim results. It's too complicate science for them. Same situation was with DNDN, HGSI and etcetera. But answer is simple here: hyperthermia combined with locally delivered cytotoxic and cytostatic drugs is a innovative 21st century approach to fight cancer.Cancer cells can't survive this double punch: diathermy and high local concentration of cytotoxic and cytostatic drugs. Disclosure: I have CLSN positions. 12.05.11 by BiotechInvest
Everybody is selling CLSN but I'm not. I'm still sure that CLSN approach to treat HCC is innovative and it will show very good results. Why I'm sure? Because I'm scientist and I have an income because I'm thinking. If I stop thinking I will be fired (most of biotech analysts are still not even after such explanations of CLSN technology:"The core of Celsion's tumor-killing technology is Thermodox - tiny, heat-sensitive spheres of fat that contain a payload of the chemotherapy drug doxorubicin. When injected into the body, Thermodox accumulates at the site of the tumor. When the tumor site is heated to about 107 degrees using radio waves (radiofrequency thermal ablation, or RFA), the Thermodox spheres melt, bathing the tumor and adjacent tissue in high levels of doxorubicin. RFA is a procedure often used by doctors to ablate, or remove, relatively small tumors from the liver that can't otherwise be excised surgically. While RFA can be curative, liver cancer can and does recur because some cancer cells remain in the surrounding tissue and start growing again. Celsion believes that the addition of Thermodox to RFA will kill enough of the cancer cells in the liver adjacent to the tumor to prevent or delay the return of the cancer." CLSN Thermodox is a liposomal solution. These liposomes has a unique lipid composition with main compound lipid lysolipid. When RF heat these liposomes above 42ºC the bilayer structure of liposome walls undergoes transition to nonlamellar phase (most likely it's L-to-HI transition) and doxorubicin entrapped inside of liposome just leaks at heated zone. Not destroyed liposomes continue to circulate in bloodstream before again enter the liver. And by the way 42ºC is not ablation temperature (people survive it), it's hyperthermia treatment temperature. BTW the lysolipid micelles (HI phase) and free lysolipid molecules will also help to kills cancer cells and it will increase membrane permeability to deliver doxorubicin inside cells. DCTH delivers drug directly in portal vein of liver and then blood from the liver is drained through an isolation-aspiration catheter, and then directed outside the body to proprietary filters, which reduce the concentration of chemotherapeutic agent before this blood is returned to the body.DCTH method is very complicate and expensive, CLSN is cheaper and not invasive (only IV injection of liposomes and hyperthermia treatment of liver). And DCTH approach can be used only for isolated organes like liver or kidney. Disclosure: I have CLSN positions and will keep them before phase III trial results release.12.14.12 by BiotechInvestI have changed my opinion for CLSN to Neutral. In January company will release data from clinical trial and CLSN pps will jump or crashed badly ($1-2 is the best scenario). Why I change my minds?Just asked myself several questions: 1) Will CLSN technology prolong cancer patients survival 5 times from control group? Answer is NO2) If treated group live 20-30% more will FDA approve this treatment? Answer is NO
3) If it's +50% Overall Survival (OS) and FDA approve treatment will doctors sent patients for ThermoDox (50% OS or DCTH treatment (5 times increase Overall survival time)? Answer is NO
The placebo group was treated just by RFA (Combination With Radiofrequency Ablation Compared to RFA-Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma) and we know now from BSDM data that this treatment alone is very effective against all cancers. DCTH treatment was against cutaneous melanoma that has metastasized to the liver not for HCC but it prolonged OS 5 times. And DCTH has phase II:Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancerphase II trial is studying how well giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.Estimated Enrollment: 105Study Start Date: September 2004Estimated Study Completion Date: August 2014Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)Determine progression-free and overall survival of patients treated with this regimen.If OS in phase II is 300-400% and CLSN <100% it means that CLSN technology is dead. If one treatment 2-3 times more effective no one doctor will send patients for less effective treatment. Disclosure: I don't have CLSN shares now and will not buy it. 01.30.2013 by BiotechInvestCLSN is still keeping silence about phase III results. They were promised then in January. It's very bad sign. It seems like that statisticians can not get any big difference between placebo treatment group (RFA only) and ThermoDox+RFA group. If it's less than 20-25% CLSN is doomed. DNDN won when got 22% but it was SPA with FDA that results should be at >20%. I even think about to short CLSN right now because if this silence continues to February investors will panic and sell CLSN. 01.31.2013 by BiotechInvest
Terrible news for CLSN technology believers... At the beginning I also was a believer but the deductive analysis of numerous facts showed me that I'm wrong. I hope that my friends that follow me on this website and on Twitter don't have >80% losses now.Any way it was a great attempt to fight cancer and CLSN management also were the biggest believers in this technology. And their losses are also terrible. Disclosure: never believe in analysis that performed by fool people, they are mostly wrong. 02.25.2013 by BiotechInvestLast comment about CLSN before I send it in Archive New technologies in biotech are rare but even if sometimes they look very attractive biotech investors should analyze their science basis. CLSN science basis was very attractive but objective analysis showed me that it's just "biotech science fiction". Sure that CLSN management believed in technology because they never sell a share. And even China company (Zhejiang HISUN Pharmaceutical Company for China) wast $5M for licensing this dead technology.I hope that next time they will ask me about consulting before to buy something. It will be much cheaper. My prediction about CLSN trial results were 100% correct - complete fail because of control group treatment (RFA). What is the future of CLSN? Infinite dilutions and pps decline to $0.something... Technology failed and BP is not interesting anymore. But any way it was great attempt to cure cancer! Bravo, CLSN scientists and management! 05/09/13 by BiotechInvestWell, it was to early to send CLSN to archive:"The Company recently reported, based on the post hoc analysis, that ThermoDox® in combination with radiofrequency ablation (RFA) markedly improved progression free survival (PFS) and overall survival (OS) in patients who had optimal RFA."Finally CLSN scientists and management said the truth: they were stupid when they planned clinical trial and set non-optimal RFA treatment. It needs to be longer because may be liposomes circulate through liver several times after injection. So, now CLSN technology may have a future. I already bought it at $0.89 and will keep it for a long (acquisition or new trial). 05/22/13 by BiotechInvestDCTH is practically crashed by panel voting so CLSN become a last hope for liver cancer patients. CLSN should seriously think about partnership for future optimization of ThermoDox treatment. They have patents in USA, Europe and Asia so the partner might be from any region. China likes RFA cancer treatment, bought recently BSDM equipment and they were interesting in CLSN treatment. Look like that China pharma may save CLSN and get an innovation liver cancer treatment approval in Asia. Europe will be also interesting. As usually USA liver cancer patients will get nothing during next 5-6 years. 11/28/14 by BiotechInvest
I put CLSN on radar and will wait for good enter pps. 52wk Range is $2.38 - 4.74 and current pps is $2.63 so we are very close to acceptable entry pps.
"Enrolled First Patient in the Phase III OPTIMA Study. In early September, Celsion announced that the first patient had been enrolled in its pivotal Phase III OPTIMA Study of ThermoDox®in combination with optimized radiofrequency ablation (RFA) in patients with primary liver cancer. The trial is expected to enroll 550 patients at up to 100 sites in North America, Europe, China and Asia Pacific. The primary endpoint for the trial is Overall Survival. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).The Company ended the current quarter with $43.8 million in cash, investments and accrued interest on short-term investments. Revenue from licensing collaborations totaled $125,000 in each of the first three quarters of 2014 and 2013. Net cash used in operations was $14.8 million for the nine months ended September 30, 2014 compared to $6.1 million in the same prior year period. This $8.7 million increase in 2014 was due to higher operating costs in 2014 related to the initiation of the Phase III OPTIMA Study, the inclusion of post-acquisition operations for CLSN Laboratories (EGEN, Inc.) and the one-time acquisition costs associated with the EGEN acquisition. In addition, cash used in operations during 2013 was favorably impacted by a $5 million cash payment from Celsion's Chinese collaborator, Zhejiang Hisun Pharmaceutical Company, received in January 2013 for a non-refundable technology transfer fee." Phase III OPTIMA looks promising now but the results (even interim) will be known only in 2019:
Estimated Enrollment: 550
Study Start Date: June 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
So, without partnership CLSN cash positions look week and future dilutions are possible. I set NEUTRAL rating for next 2 years.