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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: William Partmann who wrote (988)	6/5/2000 8:19:00 AM
From: William Partmann	Read Replies (1) \| Respond to of 10345

News ________________ CARLSBAD, Calif., June 5 /PRNewswire/ -- OraSense(TM) Ltd., a joint venture of Elan Corporation, plc (NYSE: ELN - news; ``Elan'') and Isis Pharmaceuticals, Inc. (Nasdaq: ISIP - news; ``Isis'') announced today results of a Phase I study demonstrating that oral formulation of antisense drugs for man is achievable. Based on this proof of concept, OraSense will move rapidly into development of an oral solid formulation of ISIS 104838, a second-generation antisense inhibitor of TNF-alpha for rheumatoid arthritis and Crohn's disease. The data were generated in a Phase I study examining novel formulations of an antisense drug in healthy volunteers. At the joint meeting of the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Biochemistry and Molecular Biology (ASBMB) in Boston on June 4, 2000, OraSense presented results of a 16 volunteer dose escalation study that evaluated the impact of various absorption enhancers on the uptake of a solution formulation of ISIS 2503, a first generation antisense inhibitor of Ha-ras, delivered intrajejunally in humans. The proprietary formulations tested produced therapeutically relevant blood levels, a key step toward the creation of marketable oral forms of antisense drugs. ``We are extremely pleased with the outcome of this study, as this is the first time this magnitude of oral delivery with antisense drugs has been achieved in humans,'' said John Devane, Executive Vice President, Research Development, Elan. ``Our analysis of these initial human plasma data compared to extensive animal model data suggest that 10% - 15% bioavailability in human tissue is attainable. In addition, we are excited that plasma drug concentrations observed in this trial will be therapeutically useful in a variety of diseases. The speed with which we've produced bioavailability data of this caliber was unexpected. These data support our belief that OraSense will create a platform formulation technology that will make a tablet form of antisense drugs a commercial reality.'' ``This study represents an important breakthrough for our oral delivery program,'' said Greg Hardee, Isis' Vice President, Pharmaceutical Development. ``Extensive animal studies over the past few years have identified two principle barriers to oral delivery of antisense compounds: stability and permeability in the gastrointestinal tract. Chemistry modifications have addressed the first barrier, and now this study successfully demonstrates an approach to overcoming the second barrier. We will incorporate these findings as we create tablet formulations of these compounds in the very near future.'' ``We are clearly on track for oral delivery of antisense drugs,'' said Stanley T. Crooke, Isis' Chairman and CEO. ``Our ability to deliver antisense drugs in tablet form will have tremendous significance both for Isis, as it broadens our market potential, and for patients, who need convenient treatment for a wide range of diseases. ISIS 104838, an antisense inhibitor of TNF-alpha and the first drug to be formulated orally by OraSense, is an excellent example. TNF-alpha is a gene that has a validated role in inflammatory diseases such as rheumatoid arthritis and Crohn's disease. In tablet form, ISIS 104838 would have substantial delivery advantages over parenterally delivered medications marketed for rheumatoid arthritis and Crohn's disease. The market for these drugs is currently $500 million and growing. An oral drug would have the potential to treat a broader spectrum of patients.'' While OraSense proceeds with the development of antisense oral formulation technology, Isis is advancing its preclincal development of ISIS 104838. Isis expects to initiate Phase I clinical trials of an intravenous (IV) and subcutaneous formulation of the before the end of this year. Clinical studies of an oral formulation of ISIS 104838 are expected to follow closely behind the Phase I trial. Isis will conduct a live webcast conference call to discuss this data on Monday, June 5 at 11:30 am Eastern time. To participate over the internet go to www.streetfusion.com. A replay of the call will also be webcast at this address on an on-demand basis for up to 90 days