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jaylucks • 15 minutes ago The current status and path forward...

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    jaylucks • 15 minutes ago
    The current status and path forward for PRAN for discussions
    • The successful HD REACH2HD phase II trial released in Feb, 2014
    • Opinion leader and professor, Dr. IRA Shoulson, joined PRAN Board in May 2014 to facilitate and guide R&D and licensing processes for both HD and AD in the priority effort.
    • In July 2014, subgroup data analysis of the IMAGINE trial cohort demonstrated efficacy of PBT2 in treating AH patients based on the following observations:
    o In the subgroup of PBT2 treated participants with a baseline of SUVR above 2.5, there was a significant (P value = 0.035) decrease in amyloid burden. 

    o There is a very promising trend towards the preservation of brain volume (as measured by MRI) in PBT2 treated patients compared to placebo patients.
    • Received HD Orphan Drug status from FDA in Sep, 2014 – a significant milestone.
    • The following events will take place as a logical path for PRAN’s product development and commercialization:
    o Orphan drug designation granted by EMEA
    o Orphan drug designation granted by the rest of the world
    o PRAN’s CMC effort in product manufacturing, release testing and quality assurance as well as tech transfer strategy.
    o Partnership for product manufacturing and commercialization
    o Financial infusion from a partner.
    o NDA submission for a conditional or non-conditional marketing authorization.
    o Dependent upon the data of REACH2HD, a PHASE III clinical trial may or may not required for the marketing authorization.
    o A new, well designed trial of PBT2 for AD based on subgroup analysis.
    o A buyout sooner or later.

    There is no need to worry about the funding for PRAN. When the safety and efficacy of PBT2 are established, the big pharmaceutical and investment firms like Pfizer or Deerfield will rush to invest and support the promising drug candidate development and commercialization to benefit the patients, the society and the investors.
 
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