Ian:
As I see it, that phase Ib will enroll 20 healthy volunteers and is to test mainly the safety and “tolerability” of multiple oral doses of SCIO-469, although they also will be looking at the pharmakokinetics.As they mentioned this is just a preliminary study before they embark in the more extensive phase II which they are planning towards the end of the year.
No question that the inhibition of TNF and all the increasingly complex steps of the inflammatory “cascade” and cyclooxygenase cycle can be quite rewarding both for patients as well as for the companies coming out with those new, EXPENSIVE, wonderful drugs. Just look at what happened to IMNX after the FDA approved etanercept (Embrel) in Nov.98 or to a less degree the effect of the approval of celecoxib (Celebrex) to PFE. (That in spite of the fact that AHP which controls 54% of IMNX kept the marketing rights for etanercept, except for the USA and Canada. )(Of course not too many people can afford Embrel injections outside USA <g>)
The other TNF alpha inhibitor, infliximab (Centocor’s Remicade) has a limited value since for RA it has been approved only in conjunction with methrotexate and for Crohn’s only as one shot dose. It has apparently more risk of toxicity and risk of serious infections.
It is really interesting to see, how all these drugs have come into reality based on the discoveries that have taken place not only on the “inflammatory cycle” but also on the DNA field. Infliximab is made by use of a recombinant cell line and etanercept by “recombinant DNA technology in a Chinese hamster ovary mammalian cell expression system”. Things certainly have kept coming at a quantum pace for the last 100 years <g>
By the way, at the 64th meeting of the Am.College of Rheumathology last year, Maxine Dougados M.D. from Cochin Hosp. In Paris, presented a double blind study on 246 patients with ankylosing spondylitis which showed good results with celecoxib as far of controlling pain and inflammation. Those patients still require very long term treatment, (if they can afford the cost <g>)
As far as SCIO, to me another interesting part is the research collaboration with Lilly in Alzheimer’s disease and their announcement of their alliance with Quintiles for the commercialization of nesiritide (if they successfully complete the VMAC trial <g>)
They apparently still derive a good part of their income from the marketing of some psychiatric drugs, including SKB's Eskalith.
I don’t know the potential of the BNP test that they licensed to Biosite, as I mentioned in my previous comment:
Message 15286430
Bernard |