Quite a bit of discussion over here about Vasogen, including the new anti inflammatory liposome. You must ask the moderator for access to the talksite, and he/she wants you to post something about biotech once a month. Very good discussions on several companies and drugs.
stockhouse.ca
Here is a snippet,...
People often confuse orphan drug status with fast track status. Orphan drug status is for drugs addressing small markets, i.e. less common illnesses. There is zero chance that Alzheimer's would ever be considered such an illness. If VAS wants to get orphan drug status for their new synthetic IMT (SAB's), they would need to go after Lou Gehrig's disease (ALS). The other potential applications, such as Alzheimer's, Parkinson's, stroke, and MS, are all major illnesses. The possibility of fast track status, on the other hand is realistic for the SAB's. Fast track means the FDA will review the application to market the product more quickly, with the final review taking only about 6 months instead of 12+ months. I believe there are other short cuts along the way as well. Of course, this point is contingent on the SAB's being considered a drug therapy, as opposed to a device, which seems like the likely scenario. Although regular IMT qualifies as a device, the SAB's would seem to be a drug, and as such, would require the usual 3 Phases of clinical trials.
fid, the abstract about the SAB's is indeed very technical, but if you want a plainer description of the portion of the abstract which describes the product, they are liposomes, which is a fatty substance, shaped into a generally spherical shape, and filled with a substance, which I believe is called phosphatadylserine, which works through to the surface of the liposome. When certain immune cells engulf/ingest these phosphatadylserine-presenting liposomes, they react in the same manner as when they ingest the apoptotic cells produced by the regular IMT. In other words, they respond by increasing their release of anti-inflammatory cytokines and lowering their release of inflammatory cytokines. In effect, the SAB's mimic the apoptotic cells produced by regular IMT. Apparently, these liposomes are able to cross the blood-brain barrier, which is why this technique will be used for the neurological indications. Regular IMT will continue to be used for the cardiovascular indications. I have seen some slides of the brain inflammation results in rats, and they are quite impressive. Of course, it is an awfully long way from rats to humans. It will be interesting to see which indication VAS chooses for the SAB's, and whether they will work as well as regular IMT.
The above description may not be 100% exact, but it's pretty close. |
