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Celsion Corp. Message Board

  • clsn_bounce_starts_now clsn_bounce_starts_now Apr 26, 2013 8:45 AM Flag

    Griffin Securities updates Celsion to a HOLD, provides note

    It's available today, sounds positive

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    • "Emerging data from the HEAT Study post analysis demonstrates that ThermoDox® markedly improves progression free survival (PFS) and overall survival (OS) in patients who had optimal RFA. "

      "we are encouraged that the HEAT Study analysis has
      identified a sizable patient subgroup that benefits from ThermoDox."

      "We believe the recent
      trial’s data may serve as a basis for approval"

      The entire report can be found on Investor Village website. Written by Keith Markey PHD, MBA from Griffen Securities

    • "Emerging data from the HEAT Study post analysis demonstrates that ThermoDox® markedly improves progression free survival (PFS) and overall survival (OS) in patients who had optimal RFA. "

    • Thats april 23 news you updated it today....................lol

    • We believe Celsion is in a position to consider an acquisition that would diversify the R&D pipeline and
      thereby reduce the risk associated with any one drug under development. Given the Company’s current
      market capitalization and the cash on hand, management should have an attractive group of acquisition
      candidates from which to select

    • Celsion intends to discuss the HEAT Study results with regulators in the coming months to determine a
      clear path to approval. We believe it may be possible for the Company to conduct a trial considerably
      smaller than the HEAT Study to gain entry into many of the markets in which primary liver cancer is
      significant burden to society. But until the discussions have been completed, the size, timeline, and cost
      of such a trial will remain unknown. Accordingly, we have not prepared financial estimates, but we do
      point out that Celsion has scaled back its employee base to conserve cash.

    • The $46 million of cash on
      hand as of March 31st should provide management with sufficient flexibility to consider various strategic
      alternatives including development of ThermoDox and the acquisition of other drugs/technologies.

    • Link????????????????????????????/

    • HEAT RESULTS PROVIDE AN AVENUE FORWARD
       ThermoDox appears efficacious when heating is optimal. A subgroup analysis of data from the multinational
      trial that ended last fall has offered a potential path toward approval. The heat-sensitive liposomes, which
      release doxorubicin in the vicinity of a heated tumor, yielded a clinical benefit to patients when heating was
      optimized. In other words, ThermoDox performed as designed as long as the radiofrequency ablation (RFA)
      procedure was performed diligently. In hindsight, that makes perfect sense – the drug was intended to expand
      the ablation zone created with RFA but it can only do so when the heat was applied for sufficient time.
       Celsion will meet with regulators to set a new course. The Company will provide regulators with an in-depth
      analysis of the HEAT Study to discuss how best to proceed toward commercialization. We believe the recent
      trial’s data may serve as a basis for approval with a confirmatory study in major hepatocellular carcinoma
      markets. Since marketing partners were already engaged in some regions, there appears to be a path forward.
       The Company has ample flexibility to set a new strategic direction. Celsion closed 2012 with $23 million of
      cash on hand, and subsequently received $5 million from Hisun and raised $19 million from common and
      convertible preferred stock issuances. As a result, we figure the balance sheet had about $46 million of cash at
      the end of the March quarter, and steps have been taken to cut the cash burn rate. Meanwhile, a ThermoDox
      development plan is forming and strategic options, including an acquisition(s) are under review. As a result, we
      have not prepared new financial estimates for Celsion. But we are encouraged that the HEAT Study analysis has
      identified a sizable patient subgroup that benefits from ThermoDox.

      • 1 Reply to clsn_bounce_starts_now
      • HEAT DATA REVIEW
        Celsion has been conducting subgroup analyses of the results obtained from its international clinical trial
        of ThermoDox, a heat-sensitive liposomal formulation of the chemotherapeutic agent doxorubicin. The
        trial, which involved about 700 patients with primary liver cancer, did not meet the endpoint required for
        regulatory approval, but an in-depth inspection of the data has yielded a crucial insight into how the drug
        should be used. First, there were no major differences noted between the major medical centers that
        participated in the trial. Second, race/ethnicity had no bearing on the outcome. But most important, the
        results revealed that when the radiofrequency ablation (RFA) procedure lasted for 45 minutes or more
        ThermoDox provided a marked improvement in progression free survival (PFS) and better overall
        survival.
        Importantly, the clinical benefit was not limited to intermediate-size lesions (3 cm – 5 cm in diameter), but
        included patients with large tumors (5 cm – 7 cm in diameter) who often suffer a recurrence. Thus, it
        appears ThermoDox performed in accordance with its design – the drug was intended to expand the
        heated ablation zone to protect against cells on the periphery of the tumor that survived the higher
        temperature. The caveat is the application of heat must be optimized for ThermoDox to have a benefit.
        Celsion will present information from the HEAT Study at upcoming medical meetings and disclose the
        results in greater detail in peer-reviewed scientific publications.

 
CLSN
2.95+0.01(+0.34%)Apr 17 3:59 PMEDT