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Insmed Incorporated Message Board

  • accugrowth accugrowth Jan 11, 2013 3:06 PM Flag

    ROP Pushed Out Until End of December

    Premacure updated the ClinicalTrials website today. The third site is not yet recruiting and the estimated trial end date is pushed to the end of 2013. This is also in line with the 18 months to 2 year timeline to initiate production of PremIplex per the agreement signed in May 2012.

    You have your update. You do not need to wait for Lewis to present the Q4 CC and say nothing about iPlex, again (unless asked and only a vague comment is made and promises not kept about providing updates). Listen to all 4 of the last conference calls to verify for yourself.

    To 2014....and beyond...(Toy Story reference, just because I still have a sense of humor)

    ClinicalTrials Identifier: NCT01096784
    Insulin-Like Growth Factor I (IGF-I) in the Prevention of Complications of Preterm Birth
    Estimated Enrollment: 80
    Study Start Date: June 2010
    Estimated Study Completion Date: December 2013
    Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

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    • The Gothenburg website was updated in mid December, and Hellstroms recent comments have probably already been posted here, but if not:
      Can be prevented
      Ann Hellstr├Âm, an ophthalmologist and a professor at Sahlgrenska Academy at the University of Gothenburg, is coordinating an international research project of several years' duration which is now able to show that this sight-threatening condition can likely be prevented.

      "There are a number of vital substances that babies normally have access to in the womb but which are drastically reduced in the event of premature birth. One such factor is the growth protein IGF-I, and through experimental and clinical studies we have been able to establish a link between this and development of ROP.

      "Our preliminary results show that by returning IGF-I levels to those normally observed during pregnancy we can prevent the condition, and probably also other complications that can affect premature infants."

    • by accugrowth.Jan 11, 2013 3:06 PM.Premacure updated the ClinicalTrials website today. The third site is not yet recruiting and the estimated trial end date is pushed to the end of 2013. This is also in line with the 18 months to 2 year timeline to initiate production of PremIplex per the agreement signed in May 2012.

      You have your update. You do not need to wait for Lewis to present the Q4 CC and say nothing about iPlex, again (unless asked and only a vague comment is made and promises not kept about providing updates). Listen to all 4 of the last conference calls to verify for yourself.

      To 2014....and beyond...(Toy Story reference, just because I still have a sense of humor)

      ClinicalTrials Identifier: NCT01096784
      Insulin-Like Growth Factor I (IGF-I) in the Prevention of Complications of Preterm Birth
      Estimated Enrollment: 80
      Study Start Date: June 2010
      Estimated Study Completion Date: December 2013
      Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

    • The oft quoted 12 to 18 months is the time it would take to start a facilty and have it approved not any sort of agreement.Ipsen would have to approve this and they have not.The poster is confusing issues.The work being done with the old iplex would have to be done again with the new manufacturing process should Ipsen agree.I say the timeline was pushed out to 2018 years ago

      • 3 Replies to reg_dossier
      • The oft quoted 12 to 18 months is the time it would take to start a facilty and have it approved not any sort of agreement.Ipsen would have to approve this and they have not.The poster is confusing issues.The work being done with the old iplex would have to be done again with the new manufacturing process should Ipsen agree.I say the timeline was pushed out to 2018 years ago

      • The Premacure website is quiet specific in their statement of "exclusive world wide rights to develop and market" rhIGF-1 with or without the binding protein. That would be the basis of extinction for a privately held company like Premacure to make that "claim" without a substantive basis of support. The big part is the grant with five major European players to perform their part in developing the drug. That includes a company in Germany that develops recombinant proteins for diagnostic purposes. But developing a recombinant protein for therapeutics is just a matter of upgrading reagents, performing molecular and sterilization filtrations and transferring the developed techniques to a biopharma grade company, which they have. The saving grace is that the amount of rhIGF-1/rhBP-3 that is needed for one premie is so small in relationship to a short stature kid (one vial had 36 mg in 0.6 ml) that a Premiplex vial might be only one mg of stuff to last one week. The point is that pilot batches for short stature would produce enough Premiplex to treat hundreds of premies.

        The bad news for those interested in investing in Premiplex is that Premacure is going to keep everything privately held for the forseeable future. No public investment opportunities.

        So this will be medically valuable and interesting, but not a big deal for past INSM investors, or INSM. That is why Lewis does not mention Iplex, or the other outlicensed pipeline preparations. They are simply in preclinical development stages except for Premiplex.

        EOS

        Sentiment: Buy

      • I think I have been called you too!. !

        That is correct.IPlex will have to start manufacturing with an Ipsen Ok before a approval enabling trial may begin.
        It took Amylin almost 3 years to get their new mfg plant approved by the FDA when they were successful in a Phase3 trial with Alkermes produced drug.
        Lets hope for some good news from this clinical Phase2 trial so many years in development.It may open the door for a real iplex deal.

    • Thanks Accugrowth, I'm happy to finally see more than one site recruiting..

    • Thanks Accu. At least we know they have some additional funding:

      "Infants born prematurely risk developing the condition ROP, which can result in blindness. Researchers at Sahlgrenska Academy are now able to show that the condition can likely be prevented by administering a growth protein. This research project is now set to receive SEK 54 million from the European Union to fund further research."

      Sentiment: Strong Buy

 
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