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Biotech / Medical : Indications -- Sepsis/Acute Inflammation

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From: nigel bates6/8/2005 4:41:22 AM
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Interesting snippet (re TNF-alpha polyclonal) from Protherics' results statement -


CytoFab(TM) - treatment of severe sepsis

CytoFab(TM) is based on the same polyclonal antibody technology as CroFab(TM)
and DigiFab(TM) and binds TNF-alpha, a key molecule involved in inflammation.
It has been developed to treat sepsis, a disease that affects about 750,000
people per year in the US and which has a mortality rate in excess of 30%.
There is only one product approved for the treatment of sepsis, Xigris(R)
(Lilly), but its use is restricted to a small subset of patients because of its
safety profile. CytoFab(TM) has the potential to treat a much broader patient
population than Xigris(R) and we believe CytoFab(T)M could be the second product
to market, with FDA approval possible in 2009.

A Phase IIb study with CytoFab(TM) has shown significant reductions in the time
patients spent in the intensive care unit and on mechanical ventilation relative
to placebo, with a trend to improved survival. Two end-of-Phase II meetings
were held with the FDA, one to discuss the Phase III programme and the other
manufacture of the product. Agreements on how to proceed have been reached in
principle in both areas and work on the manufacturing process to improve the
costs of goods is ongoing.

The positive Phase IIb data and FDA agreement that CytoFab(TM) is ready to be
taken into Phase III has stimulated interest from a number of potential
licensing partners. Discussions with several companies are ongoing and we are
encouraged by their feedback to date....


I was under the impression that TNF-alpha was too far 'downstream' to be an effective target for sepsis, so wasn't allowing anything for this progam.

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