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Celldex Therapeutics, Inc. Message Board

  • mymandon mymandon Feb 28, 2013 3:20 PM Flag

    CDX-1135 Complement Inhibitor

    CDX-1135 (sCR1, TP-10) Current focus is renal disease and I know Celldex has no stated program for the this as a potential treatment for Alzheimer’s Disease, but based on the drug’s activity I suspect it may be being investigated. It may be worth considering since the FDA recently (early February) released a draft guidance on the development of drugs to treat early stages of Alzheimer’s that revealed a shift in the agency’s thinking. For patients with early Alzheimer’s disease, a potential treatment’s “effect on a cognitive measure alone may be sufficient to support approval under the accelerated approval mechanism, with a requirement that the sponsor demonstrate (in Phase IV) that the effect persists over time, or that an effect on global functioning emerges,” FDA

    This new FDA guidance smoothes the regulatory path for approving potential Alzheimer's disease treatments and encourages “sponsors to analyze the results of biomarkers independently with the understanding that these findings will be interpreted in the context of the state of the scientific evidence at the time of a future NDA filing for approval.

    This represents a potential huge market for complement inhibition (outside of renal disease) where the FDA is supporting novel approaches to prevent early disease progression with accelerated approval.

    With so many potential opportunities for CDX-1135 and new money to put to use, then perhaps Celldex will get CDX-1135 into the clinic for additional indication (Alzheimer's or one of several other possibile indicaition in addition to renal disease) this year. This new program coudl be a catalyst if it's in an area the FDA is supporting with accelerated approval, like early Alzheimer's disease progression.

    Sentiment: Strong Buy

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