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  • ifandonlyif2012 ifandonlyif2012 Jul 27, 2012 2:22 PM Flag

    Pancreatic Trial Update

    The enrollment by company for any trial seem slow for a blockbuster cancer therapy. At this rate it will take at least 2 more full years for treatment to reach the market. This assuming H&N pending data is good. The earliest I see Pancreatic in the market using the company treatment is beyond 2015.

    This make me wonder that employees (including BT) of the company try to prolong the existence of the company as long as they can. It is a job for them as the expense of investors.

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    • I am not that pessimistic about the timing of Panc. (i.e.2015) They have probably been planning this and talking to the FDA for at least six months. When they announce it and start the trial they will be much wiser about the number of centers to get on study. There won't be a 6-9 month lag like H&N to get the centers on study. The Gem reo enrolled at 4.5 pt/center per year. The CPR panc is enrolling faster based on the PI's comments. If they are able get 40 centers on study (there are about 120 centers using reo now) and they only needed 120 pts for the trial, this could be enrolled in 7 months. If they started preparing sites after the endpoint of the CPR trial in Feb. they could have 40 sites ready to go before the end of the year. The trial could make its endpoint next year.

      • 2 Replies to nomenome91
      • >>>The Gem reo enrolled at 4.5 pt/center per year. The CPR panc is enrolling faster based on the PI's comments>>>

        In one of his talks, BT did mention that while the enrolment rate in the lung trials was slower than expected, the rate in the panc trials was faster than expected. on the NCI site, they actually recommend panc patients to seek clinical trials as one of the first avenues for treatment since there is really nothing out there for them.

      • As we all know, there have been other trials that have been approved on phase 2 data depending on the need and the indication...It is possible that this could happen with the panc trial...they would still be required to do the phase 3 trial but could have approval based on phase 2 data....
        Also, and not saying it's going to happen, but what about the possibility of orphan drug status because of the low number of new patients each year...if allowed, this would also speed up the process quite considerably...

    • "The earliest I see Pancreatic in the market using the company treatment is beyond 2015"

      If Reo gets approved for H&N and if the PH II Gem and/or Carb/Pax panc results are spectacular or even just good - you will most likely see off label use of Reo in panc before 2015 and before a panc PH III completes IMO.

 
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