This Is MS Multiple Sclerosis Community: Knowledge & Support

does anyone take this
my girlfriend asked me and i've never heard of it

Pipex Pharmaceuticals Announces Broadly Issued European Patent Covering Uses of Oral TRIMESTA for the Treatment of Autoimmune Diseases, Including Multiple Sclerosis 06 September 2007

Claims Covering Use of Estrogens Including TRIMESTA, in Combination With Popular Immunotherapies to Treat Multiple Sclerosis.

Pipex Pharmaceuticals, Inc, a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has received a broadly issued European patent which covers the use of estrogens in combination with other FDA-approved multiple sclerosis therapies for the treatment of autoimmune diseases.

The issued European patent, EP1286664 entitled, "Combination of Low Dose Estrogen and Immunotherapeutic Agent for Treating Immune Diseases," covers the use of estrogens and their derivatives at serum concentrations above basal and below pregnancy levels in combination with various immunotherapeutic agents, such as, Avonex®, Betaseron®, Copaxone®, Rebif® and Enbrel® for the treatment of Th1-mediated autoimmune diseases, such as, multiple sclerosis (MS), psoriasis and rheumatoid arthritis (RA). The corresponding U.S. and Japanese patents are currently pending.

"This patent issuance supplements our intellectual property estate which already includes U.S. Patent No. 6,936,599 which covers the use of TRIMESTA at pregnancy levels for the treatment of multiple sclerosis. This issued patent is an important addition to our leadership position in estrogen therapy for the treatment of autoimmune disease in women," said Steve H. Kanzer, Pipex's Chairman and CEO.

Through a wholly owned subsidiary, Pipex has obtained exclusive licenses to these patents from the University of California, Los Angeles (UCLA) and Oregon Health & Sciences University (OHSU).

About Oral TRIMESTA

TRIMESTA (oral estriol) is an orally active immunomodulatory and anti-inflammatory molecule that has been approved and marketed throughout Europe and Asia for the treatment of post-menopausal hot flashes for approximately 30 years, but has never been introduced in North America. Estriol, the active ingredient in TRIMESTA, is a weak estrogenic-based molecule that is produced in the placenta by women during pregnancy. Estriol is considered to play an important role in the immunologic privilege offered to the fetus during pregnancy and is also thought to be responsible for the spontaneous remission of Th1-mediated autoimmune diseases of women (such as multiple sclerosis and psoriasis) during pregnancy, especially during the third trimester. TRIMESTA has completed a 22-month crossover Phase II clinical trial for the treatment of MS and has recently entered a Phase II/III clinical trial under a $5 million grant from the National MS Society.

About the Phase II/III Clinical Trial

The clinical study is a double-blind, placebo-controlled trial that is currently taking place at seven sites in the U.S., enrolling up to 150 female MS subjects. Investigators are administering TRIMESTA to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. TRIMESTA is given in combination with subcutaneously injected Copaxone®, a standard of care treatment for MS. The team is evaluating effects of the treatment combination on relapse rates using several clinical and magnetic resonance imaging measures of disability progression.

The study sites include the University of California, Los Angeles (UCLA), Ohio State University (OSU), Rutgers University (UMDNJ), Washington University, St. Louis, University of Chicago, University of Utah and Wayne State University.

Source: Pipex Pharmaceuticals, Inc (06/09/07)

thank you

Hi Shell

I’m not taking the “patented” Trimesta but I have been on 8mg of compounded estriol (+ 500 mg of bioidentical progesterone) for about 3 years now and I’d basically say so far so good. Of course I’m sure you know given the unpredictable nature of MS that I have no idea if the hormones are what’s contributing to the “so far so good”. I'm 61 and was diagnosed about 4 years ago. I'm also on Copaxone, Swank diet (more or less), exercise and do some supplements.

And, while I don’t know if you might be concerned about the potential risks of estrogen, I sense many women are, so here are links to two full articles with lots of information on that topic. The first article, HRT: a reappraisal of the risks and benefits is pretty readable and there’s a great graph at the end.

Here’s the second article, A Comprehensive Review of the Safety and Efficacy of Bioidentical Hormones for the Management of Menopause and Related Health Risks , also quite readable. (Estriol is a "bio-identical hormone".)

And, if you consider estriol, I personally think you might also want to consider having your hormone levels tested. There’s a possibility, among others, that you might be low in progesterone and it seems to have lots of neuroprotective and remyelinating potential. Here’s a recent abstract on that:

Progesterone: Therapeutic opportunities for neuroprotection and myelin repair

Now, I’m curious too, is anyone else taking estriol (Trimesta)?

Ian Thanks for the patent info on Trimesta. There was another patent related to estrogen and neuroprotection in 1996. Here's the link. Unfortunately, most of it is very scientific and not easy to read.

Take care all

Sharon

I found this on pub med yesterday, and thought it might be of interest:

Differential neuroprotective and antiinflammatory effects of estrogen receptor (ER){alpha} and ER{beta} ligand treatment.

Proc Natl Acad Sci U S A. 2007 Sep 4;

Authors: Tiwari-Woodruff S, Morales LB, Lee R, Voskuhl RR

Treatment with either estradiol or an estrogen receptor (ER)alpha ligand has been shown to be both antiinflammatory and neuroprotective in a variety of neurological disease models, but whether neuroprotective effects could be observed in the absence of an antiinflammatory effect has remained unknown. Here, we have contrasted effects of treatment with an ERalpha vs. an ERbeta ligand in experimental autoimmune encephalomyelitis, the multiple sclerosis model with a known pathogenic role for both inflammation and neurodegeneration. Clinically, ERalpha ligand treatment abrogated disease at the onset and throughout the disease course. In contrast, ERbeta ligand treatment had no effect at disease onset but promoted recovery during the chronic phase of the disease. ERalpha ligand treatment was antiinflammatory in the systemic immune system, whereas ERbeta ligand treatment was not. Also, ERalpha ligand treatment reduced CNS inflammation, whereas ERbeta ligand treatment did not. Interestingly, treatment with either the ERalpha or the ERbeta ligand was neuroprotective, as evidenced by reduced demyelination and preservation of axon numbers in white matter, as well as decreased neuronal abnormalities in gray matter. Thus, by using the ERbeta selective ligand, we have dissociated the antiinflammatory effect from the neuroprotective effect of estrogen treatment and have shown that neuroprotective effects of estrogen treatment do not necessarily depend on antiinflammatory properties. Together, these findings suggest that ERbeta ligand treatment should be explored as a potential neuroprotective strategy in multiple sclerosis and other neurodegenerative diseases, particularly because estrogen-related toxicities such as breast and uterine cancer are mediated through ERalpha.

PMID: 17785421 [PubMed - as supplied by publisher]

_________________
Dom

thank you

Ironically, I went to my obn-gyn doc of 15+ years Friday and asked her about the estriol connection with Th1/Th2 balance. She said she did not know
anything about it. Now I can talk to her with literature support. Thank-you !

I was trying to figure out if the fumaric acid which I have been taking for 4 months, known to effect the Th1/Th2 balance was responsible for "bringing back" my monthly cycle. (Not that I am thrilled to have it back)

Compounded Estriol may help me in more than one way. What do you folks think?