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Epizyme, Inc. Message Board

ozzie_ozborne 25 posts  |  Last Activity: Aug 20, 2014 2:23 PM Member since: Mar 22, 2010
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  • Reply to

    FDA Rules governing Clinical holds

    by end2war Aug 20, 2014 11:50 AM
    ozzie_ozborne ozzie_ozborne Aug 20, 2014 2:23 PM Flag

    The FDA saw a liver related death in a small 18 patient ET trial where 90% of the participants experienced liver issues related to the test drug – imetelstat. Their only concern is how this will translate to a larger 200+ patient Phase II trial and what might they expect if the drug is eventually used in the general patient population.

  • Reply to

    Gencaro - Potential Blockbuster Drug Report

    by ozzie_ozborne Aug 19, 2014 8:23 AM
    ozzie_ozborne ozzie_ozborne Aug 19, 2014 8:29 AM Flag


    The company's product Gencaro is an investigational and pharmacological unique beta-blocker and mild vasodilator. At present, there are no beta-blockers that have been approved by the U.S. Food and Drug Administration.

    ARCA Biopharma President and Chief Executive Officer, Michael Bristow, said that if the development program of Gencaro would be successful, it would bring a new phase of pharmacogenetically developed cardiovascular treatment. As such, this would present a good opportunity for the company to improve the options available in the market today.

    It is estimated that the company has IP monopoly with an estimated net present value of $15 billion. Even if a portion of these intellectual properties will be realized, this would be a blockbuster gain for the company relative to its current market capitalization of only $31 million.

    The company does not generate revenues yet. It has net cash of around $21 million in the bank; equivalent to 68 percent of the market cap. Its annual cash burn of $8 million a year is something that investors should seriously consider. At that rate, the company has at least two and half years before they run out of cash.
    While there are clear signs pointing to the enormous success of Gencaro, uncertainties over the outcome of the drug have weighed down on ARCA's share price. However, enterprising investors could ignore uncertainties and put more emphasis on the company's optionality. This is where the ten-baggers lie.

  • ARCA Biopharma (NASDAQ: ABIO), a company focused on producing genetically-targeted remedies for cardiovascular diseases, disclosed that the first patient has already been screened in its GENETIC-AF design clinical trial. The trial will evaluate its flagship product, Gencaro (generic: bucindolol hydrochloride) as a potential cure for the prevention of atrial fibrillation (NYSE:AF) in patients with heart failure and/or left ventricular dysfunction.

    ARCA and Medtronic, Inc. (NYSE: MDT) sealed a collaboration in May 2013 to support GENETIC-AF clinical trial. According to the company, the clinical trial is a Phase 2B/3, multi-centered, randomized, double-blind clinical trial comparing Gencaro to Toprol-XL for the prevention of symptomatic AF in patients with heart failure.

    According to the American Heart Association research, heart failure costs are estimated to double over the next 20 years in an aging population. Further studies from the same organization also show that AF incidence will also increase during the same period.

    AF is a global epidemic cardiovascular disease, which increases the risk of stroke and contributes to heart failure. In a separate report, the global AF market is expected to reach an estimated value of $14.8 billion in 2019, or a compounded annual growth rate of 13.4 percent from 2013 to 2019.
    Pharmacological treatment procedures are currently the preferred method of treatment. It is a low cost alternative to non-pharmacological procedures. Some of the top-tiered pharmaceutical companies have already floated pharmacological treatments in the market. This includes Bristol-Meyers Squibb (NYSE: BMY) and Merck & Co (NYSE: MRK).

  • ozzie_ozborne by ozzie_ozborne Aug 14, 2014 8:16 AM Flag

    We initiated screening of patients for GENETIC-AF in April 2014. We plan to activate approximately 50-60 clinical trial sites in the US and Canada for the Phase 2B portion of the trial. Currently there are 20 active clinical trial sites. We anticipate having the majority of the remaining clinical sites active by the end of 2014. During the second quarter of 2014 we made modifications to certain entry criteria and policies for the trial that we believe will facilitate patient enrollment.

  • Reply to

    Simple Reason for IND/IST Transfer

    by irishtrader52 Aug 7, 2014 9:37 AM
    ozzie_ozborne ozzie_ozborne Aug 7, 2014 1:16 PM Flag

    GOOGLE "Jeremy Smith MPN" and click the first link that comes up. This is the guy who posts as jsandresen1 on Seeking Alpha. Read the article at the link and you'll see why this guy has a hard -- on for Dr. Tefferi.

  • ozzie_ozborne ozzie_ozborne Aug 5, 2014 5:43 PM Flag

    The guy has been with seven companies over the last twenty years. Apparently he doesn’t last long at any of his jobs. Human Genome Sciences hired him as VP Strategy and Corporate Development in August 2011. He didn’t last long there and he didn’t last long at Geron.

  • Reply to

    In Order For geron To Start Multi-Center Ph 2 Trial

    by mruyog Aug 5, 2014 4:19 PM
    ozzie_ozborne ozzie_ozborne Aug 5, 2014 4:40 PM Flag

    No they don't. Where do you come up with this #$%$ ?

  • Reply to

    Does This Mean That

    by mruyog Aug 5, 2014 10:15 AM
    ozzie_ozborne ozzie_ozborne Aug 5, 2014 10:27 AM Flag

    This means that whoever is holding those 25 million short shares is s c r e w e d

  • ozzie_ozborne by ozzie_ozborne Aug 5, 2014 9:38 AM Flag

    MM's probably got caught short yesterday after the 6% increase. Probably going to fight to keep it down today until they can cover.

  • Reply to

    Is Mayo walking away

    by gabe8525 Aug 5, 2014 8:22 AM
    ozzie_ozborne ozzie_ozborne Aug 5, 2014 8:31 AM Flag

    This is great news. Looks like GERN is planning to run the new MF trial under the existing Mayo IND and not their own IND. The company's IND is on hold but Mayo's isn't. The goal is probably to get the FDA to agree that since the Mayo MF IND is not on hold, GERN should be allowed to go forward with the Phase II MF trial under that IND. Sounds like it might work.

  • Reply to

    "Estimated" Participants

    by sacbunt306 Jul 23, 2014 10:26 AM
    ozzie_ozborne ozzie_ozborne Jul 23, 2014 10:32 AM Flag

    Adam is technically correct. If the trial was statistically powered for 148 patients, the missing 8 patients is probably enough to make the results not statistically significant for the intent-to-treat population (148). Per protocol population means those who actually took the treatment (143). Good enough to move it to Phase III no doubt. But the FDA always looks at the intent-to-treat population. We need more data.

  • Anyone know where it went?

  • ozzie_ozborne ozzie_ozborne Jul 8, 2014 1:07 PM Flag

    What you should really be embarrassed about is not knowing how to spell Kool-Aid.

  • Reply to

    Patient Death

    by ozzie_ozborne Jun 4, 2014 10:14 AM
    ozzie_ozborne ozzie_ozborne Jun 4, 2014 12:12 PM Flag


    That’s an excellent point. Scarlett has never indicated what set off the FDA hold in the first place. I simply assumed that as part of the GERN sponsored MF Phase II trial IND application, the company included the ET trail data and the FDA flagged it.

    It’s possible that’s not how it came about. The company would have been required to report the patient’s death to the FDA because the ET trial was still ongoing. This may have been the cause of the FDA hold. This would be an excellent question to ask Scarlett or the company to clarify.

  • Reply to

    Solid presentation

    by dashaftfromgsk Jun 4, 2014 10:31 AM
    ozzie_ozborne ozzie_ozborne Jun 4, 2014 11:32 AM Flag

    Don't know any shrinks in Little Rock, but do know a witch doctor outside Hot Springs. Specializes in voodoo cleansing rituals. Might be able to help with the cheese impaction.

  • Reply to

    Solid presentation

    by dashaftfromgsk Jun 4, 2014 10:31 AM
    ozzie_ozborne ozzie_ozborne Jun 4, 2014 11:14 AM Flag

    My cousin is a psychiatrist up in Bangor. She may be able to help you.

  • Reply to

    Solid presentation

    by dashaftfromgsk Jun 4, 2014 10:31 AM
    ozzie_ozborne ozzie_ozborne Jun 4, 2014 10:42 AM Flag

    He was under time constraints. They actually have a time clock in front of them during these things.

  • Reply to

    Patient Death

    by ozzie_ozborne Jun 4, 2014 10:14 AM
    ozzie_ozborne ozzie_ozborne Jun 4, 2014 10:37 AM Flag

    That's conjecture on his part.

  • Reply to

    Patient Death

    by ozzie_ozborne Jun 4, 2014 10:14 AM
    ozzie_ozborne ozzie_ozborne Jun 4, 2014 10:36 AM Flag

    Unfortunately no.

  • Reply to

    Patient Death

    by ozzie_ozborne Jun 4, 2014 10:14 AM
    ozzie_ozborne ozzie_ozborne Jun 4, 2014 10:22 AM Flag

    Gentleman was sick and elderly with very complicated medical history. Had taken many prior treatments that could have affected his liver. Hepatitis = cirrhosis.

    They had to say imetelstat was "possibly" related because it could not be 100% ruled out.

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