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Post by HeyNow on Sept 4, 2014 13:49:26 GMT
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Post by Yelk on Feb 1, 2015 3:42:23 GMT
Hello everyone - Took note of this tonight. The chart looks very, very appealing with what I've listed below unless I am totally missing something I can't see. Information dated Nov 11, 2014 so keep in mind much of the time to next announcements has already past and the news is still blank so far... Read the full article (quite lengthy) seekingalpha.com/article/2672025-celsions-clsn-ceo-michael-tardugno-on-q3-2014-results-earnings-call-transcript?part=single. While this isn't a BCLI type stock I think we could see some consistent steady growth here from the current position of 52 week low. This company is trading at cash level with finances good until mid 2016 with multiple catalysts and potential partnerships. I'm no analyst and am not familiar of the company as all the below was done in 2 hours but isn't that put a TP of ... $4 for 2015? Summary: - Phase III OPTIMA study is progressing very, very well - CFDA clearance of the OPTIMA study in early 2015, pre-negotiating contracts and readying documents for IRB submission. Activity recruiting patient at some 15 sites now. Recently received the MAA approval via the Virtual Harmonization Process or VHP to begin the trial in Europe and plan to bring sites onboard in German, France, Italy and Spain in the near term. Support for OPTIMA is significant and comes from; one, an exhaustive retrospective analysis of the previous Phase III HEAT study; it’s based on convincing post-hoc OS data; and is further reinforced with prospective confirmatory pre-clinical data in animal and computational models. In September, the first patient in our Phase III OPTIMA trial in primary liver cancer, also known as HCC or hepatocellular carcinoma
- Advance first immunotherapy candidate GEN-1 formerly referred to as EGEN-001 into a study to more fully establish the relationship between the activation of cellular immunity and combined with the standard of care and efficacy in first line ovarian cancer patients. Phase I trial is expected to fully define and OPTIMA dose to enhance population and powering for high potential lower risk registrational program. Looking waords an agreement with the FDA in the first quarter of 2015 to initiate the study. GEN-1 into a second indication. While they could very well become the priority for the company and that’s in glioblastoma multi form of GBM or more commonly known as brain cancer. Our plan is to file an IND for Phase I study in this indication in the second quarter of 2015. Support from the medical community for both of these trials is compelling as is our data.
- Phase II DIGNITY study Enrollment should be complete 2H 2015 and hopefully interim data late 2015
- Celsion Corporation and myTomorrows Partner to Introduce ThermoDox® Early Access Program in Europe for Patients with Recurrent Chest Wall Breast Cancer
- On January 6, 2015 Celsion announced the submission of its Phase I clinical trial protocol to the FDA for GEN-1, the Company's DNA-based immunotherapy for the localized treatment of cancer. The protocol is designed to establish a safe dose and biological activity of GEN-1 in newly diagnosed ovarian cancer patients who will be undergoing neoadjuvant chemotherapy. GEN-1 has demonstrated encouraging safety and efficacy data in a previous Phase I monotherapy trial in patients with peritoneally metastasized ovarian cancer, and is currently being evaluated in a Phase Ib trial in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer. position to launch clinical studies in this syndication in the first half of 2015
- GEN-2, our RNA therapeutic based in TheraSilence platform, GEN-2’s potential has been demonstrated in numerous preclinical studies show a unique capability for payload delivery with lung specificity. Although early, excited about the potential of the TheraSilence platform and look forward to providing updates on efforts as progress through critical preclinical studies.
Jeffrey Church - SVP, CFO and Corporate Secretary:"Cash is projected to take us well into the second half of 2016Our cash usage over the first three quarters of 2014 has been $1.6 million per month, and is estimated to reach approximately $2 million per month with the full implementation of the OPTIMA study, and the integration and clinical development of the newly acquired assets from EGEN. This is well passed the announcement of many key development and partnering activities. I just summarize by saying we are clearly well positioned for the strong balance sheet and a number of value creating opportunities across multiple programs, perhaps most importantly our programs are addressing some of the most critical needs on oncology today. Primarily liver cancer, ovarian cancer, recurrent chest wall breast cancer and of course glioblastoma multiform. We are addressing first line settings and evaluating solutions for indications or treatment options are limited. We’re advancing our Phase III OPTIMA trial for ThermoDox, targeting registration in significant markets around the world, and building momentum with our pipeline. We look forward to advancing our ThermoDox DIGNITY program and GEN-1 through keep data readouts and into additional studies over the next six to 12 months. We have a strong balance sheet with resources and capabilities to advance our key development programs. We believe that we have the right mix of programs and technology in our pipeline to assure value for our shareholders. And most importantly, to make a significant difference in a lives of cancer patients and their families." Michael Tardugno - President and CEO "Well positioned, Celsion has now has multiple opportunities to create value for our shareholders and represents a development company, I’m sure that you will agree of unique proportion, well positioned to bring each of our programs forward into clinical trials over the next six to 12 months." Attachments:
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Post by Yelk on Feb 19, 2015 0:57:43 GMT
Too bad I didn't buy with this post when I had faith Has risen nicely this last while.
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Post by JHam on Feb 19, 2015 2:53:45 GMT
Too bad I didn't buy with this post when I had faith Has risen nicely this last while. Yeah. There are so many great opportunities right now in biotech, it's difficult to stay patient with one particular stock.
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