*MS Drug Articles*-New Copaxone?/LDN

[Guest guest]

Hi

I only know what is posted below:

New and improved Copaxone?

http://msnews.acceleratedcure.org/node/2515

Here is a story I ran into recently (strange that it wasn't more

newsworthy), about a company improving on Copaxone. Supposedly it

will

work more efficiently and only be needed to be injected

subcutaneously

only once a week--eliminating the other six injections (yea!).

Abstract from ECTRIMS 2006 below...

Immunomodulation of experimental autoimmune encephalomyelitis by the

novel copolymer PI-2301

B. Carrillo-Rivas, J.T. Kovalchin, J. Krieger, M. Augustyniak, I.

Dufour, K. , H.M. Genova, K. Rafuse, A. Ward, S. Baldwin, R.

Kolbeck, J-C. Gutierrez-Ramos, E. Zanelli (Cambridge, USA)

Years of clinical experience have shown that daily subcutaneous

administration of the peptide copolymer Copaxoneâ„¢ (Cop-1), a

mixture

of millions of peptides composed of the four amino acids YEAK in

random

order, is a safe and efficacious treatment for relapsing-remitting

multiple sclerosis (RR-MS).

Cop-1 was modeled to mimic myelin basic protein (MBP) and turned out

to

ameliorate experimental autoimmune encephalomyelitis (EAE) in mice,

most

likely by shifting the immune response away from an effector TH1 to

an

immunoregulatory TH2/TH3 immune response through presentation by MHC

class II molecules.

Recently, a series of new peptide copolymers have been synthesized

with

the goal to improve the in vivo efficacy of Cop-1. In the present

study,

we show that Copolymer PI-2301 produced by substituting E with F has

improved beneficial effects in a relapsing-remitting murine model of

EAE.

Unlike Cop-1, PI-2301 shows long-term therapeutic efficacy when

administered either daily or weekly at disease onset. In an adoptive

EAE setting, efficacy of PI-2301 administered daily at the time of

autoreactive lymph node cell transfer correlates with decreased serum

level of Metalloproteinase-9 and increased level of Metalloproteinase

Inhibitor-1.

Antibody production against PI-2301 and T-cell recall proliferation

assay using splenocytes from PI-2301-treated mice underscore the

induction of a TH2/TH3 immunity. Evidences of the expansion of T-

cells

with regulatory properties expressing Forkhead box protein P3 (FoxP3)

and producing Interleukin-10 following PI-2301 treatment are also

apparent.

We propose that PI-2301 is a potential novel immunomodulatory

compound

for the treatment of RR-MS. Clinical trials will soon be started to

test this hypothesis.

Also, here's a link [77] to the company developing the drug.

Interestingly though, it isn't Teva pharmaceuticals.

February 13, '07: MS Patients Fund First Human Trial Of LDN

Category: M.S. Research Study Reports Posted by: stuart

February 12, 2007

The first human clinical trial of Low Dose Naltrexone (LDN) for MS

will begin this March. The double-blind crossover study will involve

80 patients and will be conducted at the University of California,

San Francisco Multiple Sclerosis Research Center.

Over the last decade, anecdotal reports indicated that a very low

dose of naltrexone, an FDA-approved drug, provides effective symptom

relief for many individuals with MS. Frustrated by the absence of

scientific research, volunteers began raising money to fund a human

clinical trial of Low Dose Naltrexone (LDN) for MS. This effort

produced a $25,000 gift to the University of California, San

Francisco Multiple Sclerosis Research Center.

Twenty years ago, naltrexone was approved for treating addiction,

but researchers at Penn State University discovered its ability to

normalize a dysfunctional immune system when used in very low doses.

Dr Bernard Bihari, a Harvard trained neurologist in New York City,

observed positive results in his patients using LDN for MS and other

immune system disorders. His observations were published at

www.ldninfo.org, which is where SammyJo Wilkinson, a woman diagnosed

with MS in 1995 at the age of 30, learned of it.

Despite years of using the FDA-approved disease-modifying drugs for

MS, SammyJo's condition worsened. By the end of 2003, she was

falling so often that a motorized wheelchair was needed.

" In February of 2004 I took my first 4.5 mg capsule " recalls

Wilkinson, " and I have recovered without setbacks ever since. " In

2005 she attended the 1st LDN Conference, and in conjunction with

other patient advocates, formed a committee to raise funds toward

research for LDN treatment of MS.

Because naltrexone is an inexpensive generic drug, it seemed there

would be little commercial interest in research. Consequently, MS

advocates felt it was up to them to get LDN into a clinical trial

for MS. Besides SammyJo Wilkinson, Lester and Art Mellor,

founder of the Accelerated Cure Project, were also on the committee.

They created a website, www.LDNers.org, and received enthusiastic

support from others who had benefited from LDN. The finale of the

fundraising effort was a gala in California attended by over 250

people. The event organizer, Vicky Finlayson, had experienced

positive results after taking LDN, and felt passionately about

funding the research so that others with MS could also find relief.

To learn more, visit www.LDNers.org, To learn more about recruitment

for the clinical trial, contact Elena Kornyeyeva, M.D., Ph.D.,

Clinical Research Manager, at or

Elena.Kornyeyeva@....

*Please Note: During the 17-week clinical trial, participants will

be required to make three visits to the San Francisco MS Center and

must do so at their own expense.

This article can be found at:

http://www.msfocus.org/online_newsDetails.php?ID=111