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Trius Therapeutics, Inc. (TSRX) Message Board

bionerd51 28 posts  |  Last Activity: Feb 23, 2015 7:59 PM Member since: Jan 2, 2007
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  • Reply to

    Infectious Disease

    by speedbll Dec 5, 2014 8:33 PM
    bionerd51 bionerd51 Dec 7, 2014 10:00 PM Flag

    Cook rushed the PPMO into the clinic because of the grab results with their porcine experimentation. Arginine concentrated exposure to arterial walls [coronary] can trigger cellular proliferation and that is exactly what happened. The occlusion rate in the Cook trial was significant. Cook should have checked the literature.

    Sentiment: Strong Buy

  • Reply to

    FromTwitter:

    by free_will_000 Dec 5, 2014 3:56 PM
    bionerd51 bionerd51 Dec 7, 2014 10:02 PM Flag

    Ru, Im sure you meant "primary way that etep enters muscle cells".

  • Reply to

    What Drisapersen was designed to do

    by greyzone513 Dec 4, 2014 11:22 AM
    bionerd51 bionerd51 Dec 8, 2014 10:11 AM Flag

    RNA won biotech of year because they failed a pivotal Phase III trial. I guess standards have come down a bit since last years winner.

  • Reply to

    Hammered

    by thigrlsrk Dec 10, 2014 6:40 PM
    bionerd51 bionerd51 Dec 10, 2014 7:53 PM Flag

    thing, It makes you wonder why Biomarin would choose sides with the loser in Duchennes. They are up to something.

    Sentiment: Strong Buy

  • Reply to

    3- Sarepta dmd Trials and counting

    by usagary1 Dec 12, 2014 9:22 AM
    bionerd51 bionerd51 Dec 12, 2014 9:40 AM Flag

    jrrt1, Does anyone not believe if CG needed money he would be releasing relevant data via PR's to raise the stock price? He has gone from biotech CEO of the year 2013 to witness protection.

  • Reply to

    3- Sarepta dmd Trials and counting

    by usagary1 Dec 12, 2014 9:22 AM
    bionerd51 bionerd51 Dec 12, 2014 11:23 AM Flag

    jrrt, They definitely have the data because it is being incorporated into the Phase II data set within the NDA. The entire Phase II data set is unblinded after they began to treat the control cohorts. I am not insinuating that CG is withholding the 168 week data. It's "all hands on deck" in data and statistical crunching of this data for the NDA but if CG needed funding at this point he would release the 168 week data to raise the price share.

  • Reply to

    BMRN and SRPT IP

    by longshortbear Dec 12, 2014 2:58 PM
    bionerd51 bionerd51 Dec 16, 2014 3:10 PM Flag

    JRRT1, Here's independent knowledge of Iversen et al patent for PMO/PPMO/PMO-X and splice correction dated 2004. This patent was possible because of the Kole patent [1995] on splice correction. JRRT1, Here is "independent knowledge" of splicing patent approval dated 2004. This patent was made possible by the Kole patent [1995] Yahoo will not allow patent link Iverson 2004 patent issuance

    Sentiment: Strong Buy

  • bionerd51 bionerd51 Dec 16, 2014 7:14 PM Flag

    JRRT1, That's the first check researchers do when targeting a virus or human genomic target. Are there "off-target" effects with PMO's? Yes, but at a much less significant rate. Depends on length of oligo

  • bionerd51 bionerd51 Dec 17, 2014 8:14 AM Flag

    JRRT1, The only off-target effects that I have heard has occurred in the lab. These "effects" are rare compared to the S-DNA's because the PMO design is longer and starts at the start codon

  • Reply to

    Request for Basis of Assumptions re FDA

    by berrybill725 Dec 23, 2014 4:18 PM
    bionerd51 bionerd51 Dec 25, 2014 3:58 PM Flag

    JRRT1, Biomarin moving ahead with an approval on PhaseII data despite failing all endpoints in their Phase-III trial is unprecedented. I guess it is their version of "Back to the future". The problem with their strategy is that ALL data is on the FDA table, not cherry picked data from an earlier and much smaller trial. I really do not see a window that is open for them at the FDA. The only Hail Mary that I see is for them to ask the FDA to disregard P-3 data set based on different and more refined endpoints, submit P-2 on subgroup analysis and hopes the FDA gives conditional approval pending completion of another larger P-3 trial. No dystrophin endpoints and then hoping the 6MWT trends positively Vs. historical

    Sentiment: Strong Buy

  • bionerd51 by bionerd51 Dec 30, 2014 8:38 AM Flag

    Lands job at Checkmate pharma in Cambridge Mass. He's back into oligo immunotherapy and cg oligostimulators. Yikes! Downward spiral. Many believe he was responsible for the recent "short" attacks on SRPT

    Sentiment: Strong Buy

  • Reply to

    Art Kreig ...

    by bionerd51 Dec 30, 2014 8:38 AM
    bionerd51 bionerd51 Dec 30, 2014 9:02 AM Flag

    starfe, I don't speak to CG. Come up with another source

  • Reply to

    Checkmate using similar technology as SRPT

    by easydoesit0123 Dec 30, 2014 9:39 AM
    bionerd51 bionerd51 Dec 30, 2014 10:11 AM Flag

    Harry, "Catch Phrases" like immune-cancer therapy using S-DNA's implies cg-motifs. These oligos do not knockdown cancer targets via a classic knockdown but triggers TLR's pathway. This approach has been used before [Coley pharma] and has failed miserably.

  • Reply to

    my blind guess

    by simp08801 Jan 8, 2015 8:39 AM
    bionerd51 bionerd51 Jan 9, 2015 4:18 PM Flag

    Tred, The phaseIII was always going to have the following endpoints, dystrophin production, 6MWT and other biomarkers associated with Duchennes. A negative control was also in the cards juxtaposed against the natural history cohort. This has never really changed. Why would CG wait 2+ years before initiating. He didn't make this decision because he was unsure of himself. Do you really believe Glaxo or Biomarin would have waited 2+ years to run a confirmatory trial. Sometimes a drug co. has to make a decision.

    Sentiment: Strong Buy

  • Let me posit a hypothesis that explains the reduction in 6MWT scores at 168 weeks of therapy and why this decline should level-off. The pathophysiology of Duchennes is a progressive one until it reaches it's final state, fibrotic scarring of muscle tissue and death. This tissue is not recoverable. The segments of muscle that are only in the early stages of this disease can be saved by PMO therapy. These are the areas of muscle that should be focused on and not the final state. During 2 years of PMO therapy the stage1 muscle begins to stabilize, creatine kinase levels begin to decrease and physical testing measures stabilizes. The area of muscle that does not stabilize is the unrecoverable muscle. This muscle inevitably marches toward death. Microadhesions, calcium buildup, restrictive muscle contraction and fibrotic scarring. At this stage the pathology begins to tip the scales to a limiting physical contractive state. This should stabilize as the recovered muscle [segments/fibers] improves both the anatomy [structure] and physiology [calcium homeostasis] and then prevents the decline to a final state of the PMO induced recovered muscle. There are 2 ways to test this hypothesis. First, keep treating and following these PMO treated boys and secondly petition the FDA to include a 4-5 yo cohort in the current P-3 trial to prevent less of the muscle from reaching the inevitable untreated state of cell death.

    Sentiment: Strong Buy

  • bionerd51 bionerd51 Jan 26, 2015 7:54 PM Flag

    Variant, The explanation to Drisa's elevated dystrophin data early in their clinical testing was prosensa's choice. Choice to attract a big pharma partner to finance a costly PhaseIII trial. This is called "cherry picking" They enrolled boys who were "high" dystrophin exon 51 pts. As many as 10% of dystrophin patients have abnormally high dystrophin numbers compared to their peers early in the DMD progression. I cannot prove this because pretreatment dystrophin #'s are not available. Since the dystrophin #'s were early on it is unreasonable to conclude that Drisa therapy corrected the Duchenne DMD phenotype. The Phase III data supports my opinion on this matter. To also conclude that the 2'OME oligo produces dystrophin more quickly then the PMO is erroneous. Nothing in the preclinical or clinical data supports that conclusion. The only datapoint in the PhaseII Drisa dataset that is open for discussion is the 24 wk 6MWT values. The stat. sig. values at 24 weeks were due to classic placebo effect. The PhaseIII data set proves the placebo hypothesis. If the FDA evaluates the Drisa NDA for evidence of a therapeutic benefit the FDA will not approve because there was none.

    Sentiment: Strong Buy

  • bionerd51 bionerd51 Jan 30, 2015 1:23 PM Flag

    Dystrophin production was not an endpoint in the P-3 trial. If dystrophin levels were done they weren't released. In the P2, Prosensa did measure dystrophin and compared to eteplirsen, eteplirsen produced 10X'sthe amount Drisa did.

    Sentiment: Strong Buy

  • bionerd51 bionerd51 Jan 31, 2015 5:09 PM Flag

    The source was a Prosensa presentation which has been mentioned on this board at least a dozen times.

    Sentiment: Strong Buy

  • Reply to

    Anyone know if 4th biopsies have been done yet?

    by paris1785 Feb 3, 2015 12:03 PM
    bionerd51 bionerd51 Feb 4, 2015 9:46 AM Flag

    Mush, Retail biopsies can take 3 months but SRPT has a contract with the labs processing these specimens and they will be conducted in a very timely manner. From date of biopsy to SRPT receiving data/slides it should take a ~ month.

    Sentiment: Strong Buy

  • Reply to

    ISIS, TMKR, RNA, etc

    by tredleon Feb 4, 2015 11:25 AM
    bionerd51 bionerd51 Feb 4, 2015 11:44 AM Flag

    Tred, " ISIS is a $7B company with one approved drug that has a black box warning for liver issues" and has no sales or should I say Isis has not provided sales numbers since being approved as a second-line therapy for FHC.

    Sentiment: Strong Buy

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