The personalized cancer vaccine that recently wrapped up phase III trials for follicular lymphoma, BioVaxID, has now been given orphan drug status for a second indication, mantle cell lymphoma.
Can you put this in english please ross, what does that all mean?
'Orphan drug status' is really more beneficial to the drug maker than the patient, but it still helps the patient. when a drug in development is given orphan drug status by the FDA it kind of allows the drug maker to concentrate on the drug itself and not worry about having competition when it reaches market. the FDA sees in these drugs 'great potential' to help people, so they're given this status. of course the absence of competition in any market means the drug ain't gonna be cheap because the company can charge whatever the market will bear. and when it comes to cancer drugs, the market can bear almost any amount.
Biovest is a biopharmaceutical firm, meaning they design drugs that fall into the class of biological therapy (Rituxan is biological therapy because of its biological origins in mice; chemotherapy drugs like bleomycin are chemotherapy because of their origins as chemicals).
Anyway, BioVest has developed a 'vaccine' for follicular lymphoma. it's not a vaccine like varicella (chicken pox) or rotavirus or polio--- you don't get a few shots of it as a kid and enjoy lifelong immunity. but it's still a vaccine because the drug does for you what your body can't-- it alerts your immune system to attack cancer cells. it's a lengthy process, but it's wholly personalized--- meaning it's based on the molecular specifics of your cancer, no one else's. that vaccine isn't on the market but a company director told me they're preparing their FDA applications this year.
Anyway, the point of the post above was to say that the FDA agrees with the company that this vaccine-- rather, the process that goes into developing the vaccine--- will be effective for people with mantle cell lymphoma. that's a potentially big deal, because right now there's very little for mantle cell. what is available, frankly, sucks.
don't get me wrong, i understand that a lot of these interactions with drug makers and regulatory agencies are skewed-- i'm not so naive-- but everything I've read on this vaccine says it could mean a great deal to people with FL, and if the same is true for those with mantle cell, even better.
on the subject, vaccines like this are right now in clinical trials for many cancers. the next decade or so we could see big things in this area.
It just sucks that our immune systems can fight off all sorts of **** but can't distinguish between a healthy human cell and a lumpy, bloated cancerous one.
Ok I understand now, thank you for the english version.
Lets hope this new weapon gets some real hope on the
horizon and not just line their pockets for potential
hopes and dreams, for all mantle cells.