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Post by JHam on Jul 13, 2014 15:34:44 GMT
Celsion Corporation is an oncology drug development company focused on the development of treatments for those suffering with difficult to treat forms of cancer. As of December 31, 2011, the Company's product ThermoDox is being evaluated in a Phase III clinical trial for primary liver cancer (the HEAT study), a Phase II clinical trial for colorectal liver metastasis (CRLM) and a Phase II clinical trial for recurrent chest wall breast cancer. ThermoDox is a liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a range of cancers. Localized heat at mild hyperthermia temperatures releases the encapsulated doxorubicin from the liposome enabling high concentrations of doxorubicin to be deposited preferentially in and around the targeted tumor. In June 2014, it acquired all of the assets of EGEN Inc.
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Post by HeyNow on Jul 14, 2014 0:18:48 GMT
Came across this company that is at an interesting point.
Back at the start of 2013 it announced that it failed to meet its primary endpoint in a Phase 3 trial in liver cancer for its sole therapeutic, which is a heat-activated liposomal formulation of the common chemotherapy doxorubicin. The stock crashed from almost $40/share to where it is today at $3/share. Since that announcement though, a few interesting things seem to have happened.
The post-hoc and follow-on analysis of that trial indicate that while progression-free survival (primary endpoint) wasn't met, overall survival (a secondary endpoint) still might be (the median OS for the treatment groups has't yet happened so that analysis is still to come). More importantly though, it seems that a subset of their patients (about 50%) that received the optimal time (45 minutes) of RFA (the way they heat activate the liposomal release of the drug) did way better in the treated vs. control arm. The post-hoc analysis showed a 55% improvement with a p<0.05. Based on that analysis they redesigned, got FDA clearance, and are currently enrolling and treating a new Phase III trial with those newly defined endpoints called the OPTIMA trial.
In addition to liver cancer they are trying the same therapy in breast and prostate cancer and soon brain cancer I believe. Part of the reason the stock crashed so precipitously is because they only had this one drug candidate. Not only does it look like they still have a promising path to approval with this new designed trial, but they've done a few other things that give this company comfortable footing for the next few years. They did some fundraising and currently have about $50 million in cash and current assets. Considering they have a market cap of about $50 million, things are intriguing. Also they've recently invested in broadening their clinical and preclinical pipeline by acquiring another drug delivery company Egen Inc. Their burn rate is not unreasonable and they already have cash on hand to last them into 2016. They have two interim analyses planned for their new Phase III trial so if things go well, thise could be a bargain for a Phase III company at $50 million market cap.
Also, insiders have been buying company shares over the past few months.
Also, the company is listed on the Nasdaq.
I'm still doing some research myself but I think I'm going to keep a close eye on this stock. The Price to book of basically 1 combined with a reasonably low cash burn ratelimits the downside enough for me to maybe open a position soon.
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Post by JHam on Jul 14, 2014 2:53:57 GMT
Thanks for bringing this one up HeyNow. They remind me of FOLD a bit in terms of missing their primary end points in Phase 3, mainly due to trial design (and then the subsequent pps crash). Nice chunk of cash on hand and delicious market cap  I'll definitely take a closer look. I like that insiders are buying. |
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Post by selluwud on Jul 15, 2014 12:17:46 GMT
finance.yahoo.com/news/celsion-corporation-announces-commercialization-reagent-120000972.htmlPotential in Life Science Research Validates Newly Acquired Technology Platforms for the Delivery of Plasmid DNA and a Variety of RNA in Mammalian Cells PR Newswire Celsion Corporation 15 minutes ago LAWRENCEVILLE, N.J., July 15, 2014 /PRNewswire/ -- Celsion Corporation (CLSN), a leading oncology drug development company, today announced initiation of sales of its proprietary reagent products for life science research. Celsion's reagent products are based on its newly acquired proprietary delivery platform technologies, TheraPlas™ and TheraSilence™. TheraPlas™ and TheraSilence™ are designed for optimal transfection (intra-cellular delivery) of plasmid DNA and RNA into human (and other mammalian) cells. "Our newly commercialized reagent platform provides Celsion with yet another avenue for validation of its newly acquired technology, offering the potential to generate modest revenues in support of our high-potential oncology pipeline," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "The potential of this technology is demonstrated in EGEN-001, an IL-12 DNA plasmid vector, developed using the TheraPlas™ platform, which enables cell transfection followed by persistent, local secretion of the immuno-oncology cytokine IL-12. Adding to promising results seen to date, we look forward to the outcome of an ongoing, Phase Ib trial of EGEN-001 in platinum-resistant ovarian cancer, and to initiating a Phase I study in glioblastoma multiforme, or brain cancer, in the first half of 2015." Nucleic acid transfection reagents are widely used in industry and research institutions. Celsion's broad reagent portfolio consists of products that are suitable for delivery of plasmid DNA and a variety of RNAs including siRNA, microRNA, mRNA and anti-sense RNA. These reagents are simple to use and provide a high efficiency transfection with low cytotoxicity into a variety of cell types spanning a broad range of cell lines. The underlying technology supporting the reagent business is the same nucleic acid delivery platform technology that Celsion is advancing through clinical and preclinical testing for the treatment of ovarian and glioblastoma cancers and other difficult to treat diseases, including lung cancers.
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Post by JHam on Jul 15, 2014 12:19:28 GMT
Right on cue. Interested to see how the market reacts.
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Post by HeyNow on Jul 15, 2014 12:49:28 GMT
Hey JHam... IL-12 plasmid sounds familiar? FYI, by and large there are two main ways to get a DNA plasmid inside of a mammalian cell - transfection (which requries the aid of a delivery vehicle such as a liposome), or electroporation. These guys use liposomes and ONCS uses electroporation. That's by coincidence I didn't even know they had this IL-12 platform, hadn't got that deep into this newly acquired EGEN company. I'm not sure there will be a huge reaction to this but it's an interesting move because it will bring in some revenue for them (albeit a small amount from the research community). Maybe I'll call them for a free sample to try out in my experiments?? Regardless, Small progresses like this have to begin bring this company up from the $50 million market cap... My fund should clear today, if CRIS keeps going up before I can buy I'll be inclined to buy CLSN instead |
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Post by HeyNow on Jul 15, 2014 13:34:40 GMT
One thing I noticed following this for the last few days is the volume is virtually 0...
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Post by HeyNow on Jul 15, 2014 15:16:18 GMT
I have a small token position here as well now at 3.17. Although I have small positions now, they aren't much and I'm mostly going to be watching this and CRIS closely as possible places to relocate some ACTC money if ACTC spikes like I expect in the next few months
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Post by selluwud on Jul 21, 2014 12:46:36 GMT
For you CLSN investors. finance.yahoo.com/news/celsion-corporation-announces-1-million-120000190.htmlCelsion Corporation Announces $1 Million NIH, NIBIB - Career Development Award Grant for Glioblastoma Research with ThermoDox® and HIFU Advances Ongoing Collaboration with Brigham and Women's Hospital, Harvard Medical School PR Newswire Celsion Corporation 21 minutes ago LAWRENCEVILLE, N.J., July 21, 2014 /PRNewswire/ -- Celsion Corporation (CLSN), a leading oncology drug development company, announced today that its ongoing collaboration with Dr. Costas Arvanitis of Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School, has been expanded through the recent award of a $1 million Career Development Award from the National Institutes of Health's Center for Biomedical Imaging and Bioengineering (NIBIB). The grant will support preclinical studies evaluating ThermoDox®, the Company's heat-activated liposomal encapsulation of doxorubicin, in combination with High Intensity Focused Ultrasound (HIFU), for the treatment of brain tumors. The grant, titled "Controlled Delivery and Release of Chemotherapy in Brain Tumors with FUS" provides on average of $200,000 in annual funding for five years, and will be used to advance preclinical development of ThermoDox® for the treatment of brain cancers, including GBM, under the Company's January 2014 collaboration with Brigham and Women's Hospital, Harvard Medical School. "This peer-reviewed grant award builds upon our ongoing collaborative work to explore treatments for brain tumors," said Costas D. Arvanitis, Ph.D., Brigham and Women's Hospital, Harvard Medical School. "Delivering chemotherapeutic agents across the blood-brain barrier is particularly challenging, but in recent years we have discovered that this could be achieved using focused ultrasound, including enhanced delivery of liposomal doxorubicin. We are hopeful that this grant will allow us to determine the potential utility of a promising therapeutic application for one of the most insidious cancers - glioblastoma." "Glioblastoma is a highly aggressive and deadly form of brain cancer for which there are few treatment options," said Michael H. Tardugno, Celsion's President and CEO. "Working with a prominent cancer research group like Dr. Arvanitis and his team, combined with the financial support of the NIH, will help accelerate the research required to elucidate the potential of ThermoDox® combined with HIFU in this difficult to treat cancer, and provide a path forward for larger, more comprehensive Phase II studies." If promising results are obtained from these Phase I studies, a Phase II grant application will be submitted to include more comprehensive studies of ThermoDox® and HIFU for the treatment of GBM brain tumors. About Glioblastoma Multiforme (GBM) Brain Tumors Glioblastoma multiforme (GBM), WHO classification name "glioblastoma", is the most common and most aggressive malignant primary brain tumor in humans, involving glial cells and accounting for over 50% of all functional tissue brain tumor cases and nearly 20% of all intracranial tumors. In 2013, projected US incidence of brain tumors approaches 23,000 cases, with projected mortality at 14,000 cases. Treatment can involve chemotherapy, radiation and surgery. Median survival with standard-of-care radiation and chemotherapy is normally 15 months, and median survival without treatment is approximately 4½ months. About 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. ThermoDox® is being evaluated in a Phase III clinical trial for primary liver cancer and a Phase II clinical trial for recurrent chest wall breast cancer. Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by radiofrequency ablation (RFA) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor. |
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Post by HeyNow on Jul 21, 2014 13:26:25 GMT
I might be the only one, lol. Anyone else own shares?
Regarding the news i tend to see these gov't grants as more of a validtion of the science then a big business development... these federal funding agency grants arent easy to get
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Post by selluwud on Jul 21, 2014 13:37:25 GMT
I might be the only one, lol. Anyone else own shares? Regarding the news i tend to see these gov't grants as more of a validtion of the science then a big business development... these federal funding agency grants arent easy to get After you brought them to the board's attention I have put them on my watch list. Good luck. |
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Post by HeyNow on Jul 22, 2014 18:18:18 GMT
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Post by selluwud on Jul 24, 2014 12:10:09 GMT
Good Call Hey Now!! I would expect a nice reaction to this news. Too bad I didn't buy in. What do you know about AGEN?? they're up this AM finance.yahoo.com/news/celsion-announces-positive-interim-data-120000948.htmlCelsion Announces Positive Interim Data Update from its Phase 2 DIGNITY Study in Breast Cancer ThermoDox® Continues to Demonstrate Impressive Local Response Rate in Refractory Patients PR Newswire Celsion Corporation 5 minutes ago LAWRENCEVILLE, N.J., July 24, 2014 /PRNewswire/ -- Celsion Corporation (CLSN) announced today positive interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox® in Recurrent Chest Wall Breast Cancer (RCWBC). The trial is designed to enroll 20 patients at several U.S. clinical sites and is evaluating ThermoDox in combination with mild hyperthermia. Of the 13 patients enrolled and treated, 10 were eligible for evaluation of efficacy. Based on data available to date, 60% of patients experienced a stabilization of their highly refractory disease with a local response rate of 50% observed in the 10 evaluable patients, notably 3 complete responses (CR), 2 partial responses (PR) and 1 patient with stable disease (SD). These data are consistent with the previously reported positive Phase 1 data in RCWBC. Celsion previously reported combined clinical data from two Phase I trials, the Company's Phase 1 DIGNITY Study and the Duke University sponsored Phase I trial of ThermoDox® plus hyperthermia in RCWBC in December 2013. The two similarly designed Phase I studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapy including chemotherapy, radiation therapy and hormone therapy. There were 29 patients treated in the two trials (11 patients in the Company's DIGNITY study and 18 patients in the Duke study). Of the 29 patients treated, 23 were eligible for evaluation of efficacy. A local response rate of over 60% was reported in 14 of the 23 evaluable patients with 5 complete responses and 9 partial responses. "These clinical results are very encouraging, given the fact that these patients have failed numerous previous treatments and have limited or no treatment options for this aggressive form of breast cancer. A chest wall recurrence of breast cancer has a poor prognosis with a significant impact on the patients' quality of life," said Imran Zoberi, M.D. at Washington University in St. Louis, Mo, a principal investigator for the DIGNITY trial. "I am pleased to be part of this important study and look forward to continuing my involvement in the DIGNITY Study and the future application of ThermoDox in this underserved patient population." "In this population, tumor response is a clinically meaningful endpoint," noted Dr. Nicholas Borys, Celsion's Senior Vice President and Chief Medical Officer. "Unchecked, progression of recurrent chest wall lesions results in severe and debilitating complications. ThermoDox's potential to stabilize, and in many cases affect remission, may provide an opportunity to improve quality of life; an option important for patients and physicians in their battle with this difficult form of malignancy." About Celsion Corporation Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. The pipeline also includes EGEN-001, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has three platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™, TheraSilence™ and RAST ™. For more information on Celsion, visit our website: www.celsion.com. Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses or the possible failure to make such acquisitions or licenses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. |
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Post by HeyNow on Jul 24, 2014 12:53:52 GMT
Excellent... i've no idea what to expect for a reaction... but once the market realizes they are still going strong in the clinic with multiple trials i would hope it corrects to a more reasonable market cap... they are at their book value at 50 million
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Post by JHam on Jul 24, 2014 13:30:24 GMT
Congrats! It is up nicely in pre-market.
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Post by selluwud on Jul 28, 2014 12:47:36 GMT
This looks good to me. I'm not in, but kudos to HeyNow finance.yahoo.com/news/celsion-announces-updated-overall-survival-120000859.htmlCelsion Announces Updated Overall Survival Data from HEAT Study of ThermoDox® in Primary Liver Cancer Latest Data Sweep from a 285 Patient Subgroup Shows An Impressive 57% Improvement in Overall Survival Data Continues to Validate Phase III OPTIMA Study Design PR Newswire Celsion Corporation 43 minutes ago LAWRENCEVILLE, N.J., July 28, 2014 /PRNewswire/ -- Celsion Corporation (CLSN) today announced updated results from its retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC). As of June 30, 2014, the latest quarterly Overall Survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox® and optimized RFA provided a 57% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.639 (95% CI 0.419 – 0.974) with a p-value of 0.037. "As the data from the HEAT Study matures, it increasingly underscores the significant potential of ThermoDox® plus optimized RFA to markedly improve Overall Survival in primary liver cancer patients," stated Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Diagnostic Imaging and Intervention at the Pisa University School of Medicine in Italy. "There is a pressing need for new treatment options to address HCC, which is a highly prevalent and deadly cancer. The consistency and strength of the HEAT Study data over each of the last five quarterly data analyses provide a strong rationale and clear roadmap for further development of ThermoDox® in this indication." As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox® may significantly improve OS compared to a RFA control in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients. For this group, clinical results indicate a 57% improvement in OS, a Hazard Ratio of 0.639 (95% CI 0.419 – 0.974), and a p-value of 0.037. "The post-hoc HEAT Study data is striking in that it has consistently shown a marked OS benefit for ThermoDox® plus optimized RFA versus RFA alone in each of the quarterly data sweeps, with this 5th, and final data set demonstrating that this survival benefit is statistically significant," stated Michael Tardugno, Celsion's President and Chief Executive Officer. "This impressive clinical data set, together with prospective supportive preclinical study results and multivariate Cox Regression Analyses, reinforces our confidence in the protocol for our Phase III OPTIMA Study in primary liver cancer, which is evaluating ThermoDox® in combination with a standardized RFA protocol in primary liver cancer." The HEAT Study and prior post-hoc analyses were presented at multiple medical conferences over the past year, including: the 2014 American Society of Clinical Oncology 50th Annual Meeting in June 2014; the 5th European Conference on Interventional Oncology in April 2014; the International Liver Cancer Association Annual Conference in September 2013; the European Conference on Interventional Oncology in June 2013; and the World Conference on Interventional Oncology in May 2013. Presentations were made by some of the most highly recognized liver cancer researchers and key HEAT Study investigators. Quarterly overall survival data analyses have been conducted with the full support of these researchers and clinical investigators. 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. |
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Post by HeyNow on Aug 7, 2014 13:23:44 GMT
secfilings.nasdaq.com/filingFrameset.asp?FileName=0001437749-14-014484%2Etxt&FilePath=%5C2014%5C08%5C07%5C&CoName=CELSION+CORP&FormType=8-K&RcvdDate=8%2F7%2F2014&pdf=Plenty to be optimistic about here, no unexpected hiccups - I think this company is on the way back up. Recent Corporate Highlights Completed Acquisition of EGEN, Inc. In June, Celsion completed its acquisition of EGEN, Inc., a privately-held biopharmaceutical company focused on the development of nucleic acid-based therapeutics for the treatment of cancer and other difficult to treat diseases. The acquisition included EGEN's Phase Ib DNA-based immunotherapy product candidate EGEN-001 and its therapeutic platform technologies, TheraPlas™ for delivery of DNA and mRNA and TheraSilence™ for delivery of RNA. Advanced Global Regulatory Efforts in Support of the OPTIMA Study. During the second quarter, Celsion received regulatory clearance to initiate its Phase III OPTIMA Study evaluating ThermoDox® in combination with optimized radiofrequency ablation (RFA) in patients with primary liver cancer at clinical trial sites in Taiwan, Hong Kong, South Korea, Malaysia and Canada. Celsion also announced that it has filed Clinical Trial Applications in the Philippines and Thailand, as well as a request for a Voluntary Harmonization Procedure (VHP) in Europe, which provides for the assessment of multinational clinical trial applications across several European countries, including Germany, France and Spain. The OPTIMA trial is designed to enroll 550 patients at up to 100 sites in the North America, Europe, China and Asia Pacific and support registration in key liver cancer markets worldwide. Reported Positive Updated Survival Data from the HEAT Study. In July, Celsion announced updated results from its retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox® in combination with RFA in primary liver cancer. As of June 30, 2014, the latest quarterly Overall Survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox® and optimized RFA provided a 57% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.639 (95% CI 0.419 - 0.974) with a p-value of 0.037. This data provides a strong rationale for the Company’s ongoing Phase III OPTIMA Study. Announced Positive Interim Data from Phase 2 DIGNITY Study. In July, Celsion reported remarkable interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox® in combination with mild hyperthermia in refractory patients with recurrent chest wall breast cancer. Based on data available to date, 60% of 10 evaluable patients experienced a stabilization of their highly aggressive disease, with 3 complete responses (CR), 2 partial responses (PR) and 1 patient with stable disease (SD). Initiation of Clinical Trial Evaluating ThermoDox ® Plus HIFU in Metastatic Liver Cancer. In August, a proof of concept clinical study of ThermoDox® in combination with ultrasound-guided High Intensity Focused Ultrasound (HIFU), in patients with metastatic liver cancer was initiated. The trial, which is supported by the National Institute for Health Research Oxford Biomedical Research Centre, will be carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering, and the Oxford University Hospitals NHS Trust. Announced $1 Million NIH Grant for Glioblastoma Research with ThermoDox ® and HIFU . In July, Celsion and Brigham and Women's Hospital, Harvard Medical School expanded their collaboration through the recent award of a $1 million Career Development Grant from the National Institutes of Health's Center for Biomedical Imaging and Bioengineering (NIBIB). The grant will support preclinical studies evaluating ThermoDox® in combination with HIFU for the treatment of brain tumors. Launched Commercialization of Reagent Products. In July, Celsion launched sales of its proprietary reagent products for life science research based on its newly acquired proprietary delivery platform technologies, TheraPlas™ and TheraSilence™, which are designed for optimal transfection (intra-cellular delivery) of plasmid DNA and RNA into human (and other mammalian) cells. Also - still $50 million in current assets and $45 million stockholder's equity
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Post by HeyNow on Sept 2, 2014 13:34:06 GMT
www.digitaljournal.com/pr/2157197Here's an excerpt from the PR "The Phase III OPTIMA Study is a global, pivotal, double-blind, placebo-controlled clinical trial that is expected to enroll 550 patients at up to 100 sites in the North America, Europe, China and Asia Pacific. The study is evaluating ThermoDox® in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. 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). As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox® may significantly improve Overall Survival compared to a RFA control in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients. For this group, clinical results indicate a 57% improvement in Overall Survival, a Hazard Ratio of 0.639 (95% CI 0.419 – 0.974), and a p-value of 0.037.
" Enrollment of the first patient in our pivotal Phase III OPTIMA Study marks a significant milestone in our effort to deliver ThermoDox® as a novel, first-line treatment for patients with primary liver cancer," stated Michael H. Tardugno, Celsion's President and Chief Executive Officer. "The trial was developed in consultation with leading primary liver cancer, statistical and regulatory experts and is based on extensive analysis of prior clinical and preclinical studies of ThermoDox® plus optimized RFA. We are now focused on successfully executing the trial, which is designed to establish a clear path to approval in major liver cancer markets worldwide. "
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Post by JHam on Sept 2, 2014 17:40:11 GMT
www.digitaljournal.com/pr/2157197Here's an excerpt from the PR "The Phase III OPTIMA Study is a global, pivotal, double-blind, placebo-controlled clinical trial that is expected to enroll 550 patients at up to 100 sites in the North America, Europe, China and Asia Pacific. The study is evaluating ThermoDox® in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. 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). As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox® may significantly improve Overall Survival compared to a RFA control in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients. For this group, clinical results indicate a 57% improvement in Overall Survival, a Hazard Ratio of 0.639 (95% CI 0.419 – 0.974), and a p-value of 0.037.
" Enrollment of the first patient in our pivotal Phase III OPTIMA Study marks a significant milestone in our effort to deliver ThermoDox® as a novel, first-line treatment for patients with primary liver cancer," stated Michael H. Tardugno, Celsion's President and Chief Executive Officer. "The trial was developed in consultation with leading primary liver cancer, statistical and regulatory experts and is based on extensive analysis of prior clinical and preclinical studies of ThermoDox® plus optimized RFA. We are now focused on successfully executing the trial, which is designed to establish a clear path to approval in major liver cancer markets worldwide. " Nice news! What do you make of the non-reaction by the market? Already priced in perhaps? |
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Post by HeyNow on Sept 2, 2014 17:51:36 GMT
I dunno man... This stock has, like, 0.00000 volume every day. Case in point - 17k volume today. That's crazy to me. I think it is just beaten down so bad by the original Phase III near miss that it needs some tangible clinical trial results to build trust again.
I still have my little token position and have been planning all along to actually invest a sizable amount (for me) with proceeds from selling ACTC into the publication/uplist. I think as long as this trial progresses the market cap will recover to something more reflecting a phase III company with ample cash. And I think the new Phase III has a very good chance to succeed. If so, it is a big market worldwide.
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I'll definitely take a closer look. I like that insiders are buying.