Re: New Drug? No! Same drug, higher dosage, different regimen.

Thanks Alex. I thought I seemed to remember talking about this drug with my
neuro, oh 7 years ago, as a possible treatment if I still seemed to be
progressing on Avonex. It's nothing new, just a bigger dose. Just finding
more ways to make money and screw the little guy (us). Oh, did I say that
out loud?? :))) Shelley

"Alex" <akfromak@xxxxxxxxx> wrote in message
news:Y5udnd-WGMY163TYnZ2dnUVZ_s6onZ2d@xxxxxxxxxx
Ross M. Greenberg wrote:

After consultation with the FDA, Accentia is preparing an IND for
severe refractory multiple sclerosis and is proposing to enter Phase
3 clinical trials to support licensure under the 505(b)(2) regulatory
pathway, which is an abbreviated regulatory process
available when dealing with approved active pharmaceutical ingredients.

Uh oh. I *really* don't like to see the words "abbreviated regulatory
process" when dealing with a new drug and especially a new drug
effecting the immune system.

The IND incorporates a novel risk management program to ensure
appropriate patient selection, supportive care, and tracking of
outcomes, which we believe will be critical to reimbursement coverage
and malpractice protection for healthcare providers."

Big, BIg, BIG RED FLAG!: "a novel risk management program ... which we
believe will be critical to ... malpractice protection for healthcare
providers."

Sorry, but my Medical Safety Early Warning Rad/Sat System just went into
hyperdrive and has recommended DEFCON 1.

Understand that this is a press release, not geared toward patients, but
investors. You can bet your last dollar that this language, referring
to malpractice, will not appear in any patient information that gets
distributed.


BACKGROUND ON REVIMMUNE

Multiple Sclerosis:

Revimmune treatment of 20 Multiple Sclerosis patients has resulted in the
following successful outcomes in 2 published studies from C. Krishnan, D.
Kerr et al.(2) and D. Gladstone et al.(3):


Now wait just a minute, here.

I just scrolled down and glanced at the references.

(2)"High-Dose Cyclophosphamide in the Treatment of Aggressive Multiple
Sclerosis;" and (3)"High-Dose Cyclophosphamide for Moderate to Severe
Refractory Multiple Sclerosis;"

The cited studies appear, at least in the case of (2), to refer only to
Cyclophosphamide (Cytoxan).

Apparently, what they are calling Revimmune, is nothing more than
Cyclophosphamide, administered at a higher dosage.

I have been receiving monthly, 1600mg Cyclophosphamide treatments. That
works out, at my weight, about 90kg, to approximately 18mg/kg in one day.

The study cited at (2) states, int the abstract:
"INTERVENTIONS: Patients received 200 mg/kg of cyclophosphamide over 4
days."
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=16908728&dopt=Abstract

That works out, at my weight to approximately 4500mg per day for 4 days,
apparently as a one-time treatment.

So, where do they get "Accentia Biopharmaceuticals Acquires Worldwide
Exclusive License to Revimmune for All Autoimmune Diseases"?

Ah, now it clicks: "Revimmune uses an approved drug in a new
patent-pending method to eliminate autoimmunity"

Um, ok, but the problem with that is that is that the requirement for
patents is that it is "not obvious to one skilled in the art".

"Multiple sclerosis: long-term remission after a high dose of
cyclophosphamide.

The objective of this case report is to document the possibility that
immunoablative doses of cyclophosphamide may provide a long-term
remission of multiple sclerosis (MS). We report the case of a
48-year-old woman with definite MS diagnosed in 1994 who has been in
complete remission since a dose of 3800 mg of cyclophosphamide was
accidentally given intravenously in early 1997. For 7 years there have
been no signs of disease activity on history, physical examination, or
on high-quality magnetic resonance imaging (MRI) with appropriate
contrast-enhancement methodology. This case includes information on the
possibility that less aggressive chemotherapy than that used with stem
cell transplantation may be effective in the long-term control of MS."
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15691289&query_hl=2&itool=pubmed_docsum

So, by accident, this woman was given a single high dose of
cyclophosphamide, back in 1997. At some point, it had to become obvious
that she was not progressing.

This article was published in March of 2005. It does, however,
demonstrate what the patent office calls "prior art". Generally, if a
patent claim can be shown to have "prior art", it cannot be granted.

Now this outfit comes along and decides that it wants to monetize this
"method".

Low-dose Cytoxan treatments have been going on for quite a while. My
neuro told me he has had patients on it for going on 10 years now.

Its not a great leap to think that if monthly low-doses help, that
*maybe* there would be a benefit from a pulse of a high-dose or even
some other dosing regimen.

There is *no way* this should receive a patent. There is nothing new,
nor innovative about the drug. This is, in my opinion, an attempt at
another "applesauce" patent.

What this will do is drive up the cost of the described treatment. So,
while the low-dose method of treatment will continue with its current
cost, the cost of the high dose treatment will skyrocket.

*This* is why health care costs are out of control.

This reminds me of the "thought process" patent:
http://docket.medill.northwestern.edu/archives/003172.php

Repeat after me: "The US patent system is horribly broken, as is the
FDA, and, well, most of the US gub'mint."

Alex


.

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