This Is MS Multiple Sclerosis Community: Knowledge & Support

Name of drug/compound: Intranasal Interferon Beta
Manufacturer: Nastech Pharmaceutical
Location: Bothell, WA
Current FDA Phase: I
Treatment for: MS Progression
Intended for RRMS Sub-types
Mode of Action: A nasal form of interferon beta may provide increased patient compliance and an improved efficacy and side effect profile.
Mode of Application: nasal
Website for more information: http://www.nastech.com/

Name of drug/compound: NBI-5788
Manufacturer: Neurocrine Biosciences
Location: San Diego, CA
Current FDA Phase: II
Treatment for: MS Progression
Intended for RRMS Sub-types
Mode of Action: Neurocrine scientists have taken the same amino acids that comprise a portion of myelin basic protein and altered them to induce the pathogenic immune cells to shift to an anti-inflammatory response.
Mode of Application: Injection
Website for more information: http://www.neurocrine.com/html/clin_mul ... rosis.html

Name of drug/compound: BG-12 / Oral Fumarate
Manufacturer: Biogen Idec / Fumapharm AG
Location: Cambridge, MA
Current FDA Phase: II
Treatment for: MS Progression
Intended for RRMS Sub-types
Mode of Action: immunomodulatory
Mode of Application: oral
Website for more information: http://www.biogen.com/site/025.html

Name of drug/compound: Alpha Lipoic Acid
Manufacturer: n/a
Location: Oregon
Current FDA Phase: I/II
Treatment for: MS Progression
Intended for all MS Sub-types
Mode of Action: antioxidant
Mode of Application: oral
Website for more information: http://www.clinicaltrials.gov/ct/gui/c/ ... fbm6zyg6u1

A small, placebo-controlled safety study of alpha lipoic acid (an antioxidant) was conducted by Drs. Vijayshree Yadav, Dennis Bourdette and others (Oregon Health & Science University). Thirty volunteers with relapsing or progressive MS received one of two doses of alpha lipoic acid or inactive placebo for two weeks. This study did not test for a clinical benefit, but the treatment seemed to be well tolerated. By examining the blood of participants the investigators noted that some who took alpha lipoic acid had lower serum levels of an enzyme – matrix metalloprotease-9 – which is thought to aid the movement of disease-causing immune T cells into the brain and spinal cord. The investigators suggested that more clinical studies of alpha lipoic acid in MS are warranted.

Name of drug/compound: Inosine
Manufacturer: n/a
Location: Hospital of the University of Pennsylvania, Philadelphia
Current FDA Phase: II
Treatment for: MS Progression
Intended for RRMS Sub-types
Mode of Action: Uric acid is a natural inhibitor of certain chemistries associated with peroxynitrite, a product of inflammation. In animal models of multiple sclerosis (MS), these chemical reactions have been associated with breakdown of the blood-brain barrier and CNS tissue damage. In addition, MS patients have serum uric acid levels that are lower than age- and sex- matched healthy individuals.
Mode of Application: oral
Website for more information: http://www.clinicaltrials.gov/show/NCT00067327

What a wonderful thing to do...just a bit more on NeuroVax. I think it's also known as TCR Peptide

It is in an open label trial at OHSU for RRMS; SPMS; and PPMS.

Inclusion Criteria: 18-60 years old, able to walk 15 ft with walker; previous recipients of TCR peptide can be on A,B,C, R drugs; new participants in study will not be taking A,B, C, R drugs.

An April news release by the Immune Response Corporation on this was subtitled PhaseI/II Clinical Trial Discontinued Early After 94 Percent of Patients Show Response (16 patients got Neurovax; 15 saline; and 7 adjuvant alone).

I believe they also got some funding from the Immune Tolerance Network to support this research. The news release suggested it was well tolerated except for injection site reactions (1 x mo. for 6 mos. in completed trial)

Web site for more information: www.ohsu.edu/ms/drugtrials.html and also for information on:

Name of Drug: Ginkgo Biloba
Location: OHSU
Current FDA Phase: I (I think)
Treatment for: Symptomatic therapy for cognitive dysfunction in MS, all types.
Mode of Action: ???
Mode of Application: Oral

An article Future Immunotherapies in MS from 8/03, contains a summary of current clinical trials in MS. Web site: www.medscape.com/viewarticle/459968

Lastly, a comment, the Phase III Minocycline Trial for ALS that was noted is a great read in my opinion.

"Team work works" Let's go!

Sharon

I feel good! C'mon, the thread is ONLY two pages long... keep it going!

Name of drug/compound: Campath-1H (alemtuzumab)
Manufacturer: ILEX Oncology
Location: Addenbrooke's Hospital, Cambridge, UK, Croatia, Italy, US
Current FDA Phase: (I/II/III/IV) A Phase II, randomized, open-label, three-arm study comparing low- and high-dose CAMPATH® and high-dose Rebif®
Treatment for: (MS Progression/MS Fatigue/etc.) MS progression
Intended for early active RR MS Sub-types (Relapsing-Remitting, etc.)
Mode of Action: (how it works) To affect immune function
Mode of Application: (e.g., Injection/IV/etc.) infusion
Website for more information: http://www.ilexonc.com/CAMMS223.htm

Results expected late 2005/2006

Sorry, time to leave the board.

-finn

Name of drug/compound: BG-12 Oral Fumarate FUMADERM
Manufacturer: Biogen/ Fumapharm AG
Location: ?
Current FDA Phase: (I/II/III/IV) Phase 11 planned for this year
Treatment for: (MS Progression/MS Fatigue/etc.) MS progression
Intended for RR MS Sub-types (Relapsing-Remitting, etc.)
Mode of Action: (how it works) Immune-modulater
Mode of Application: (e.g., Injection/IV/etc.) oral
http://www.biogenidec.com/site/025.html

This is a table from the ING document I posted the link for earlier....I know this isn't formatted properly, oh well.

MS selected clinical development pipeline

Drug -- Description -- Phase -- Drug class -- Company

1. Zenapax -- Anti-IL-2 receptor antibody -- Phase I/II -- Biopharmaceutical -- PDL

2. 683699 -- VLA4 integrin antagonist -- Phase I -- Small Molecule -- GSK

3. Rituxan -- CD 20 antibody -- Phase I -- Biopharmaceutical -- Genentech

4. C 6448 -- Unknown -- Phase I -- Small molecule -- Merck

5. AZD 4750 -- Chemokine antagonist -- Phase I -- Small molecule -- AstraZeneca

6. ATL 1102 -- VLA-4 integrin antagonist -- Phase I -- Antisense -- ISIS/Antisense

7. CDP 323 -- Alpha 4 Integrin antagonist -- Phase I -- Small molecule -- Celltech

8. Genz-29155 -- Oral TNF inhibitor -- Phase I -- Small molecule -- Genzyme

9. Cladribine -- Purine analogue -- Phase I -- Small molecule -- Serono/Ivax

10. IFNAR-2a -- Recombinant human IFNAR-2a -- Phase I -- Biopharmaceutical -- Serono

11. ZK 811752 -- Chemokine antagonist -- Phase I -- Small molecule -- Schering AG

12. MLN 3897 -- CCR1 receptor antagonist -- Phase I/Iia -- Small molecule -- Aventis

13. Interferon tau -- Interferon tau -- Phase II -- Biopharmaceutical -- Pepgen

14. Fampridine-SR -- Potassium ion channel blocker -- Phase II -- Small molecule -- Acorda

15. Emfilermin -- Leukaemia inhibiting factor (hLIF) -- Phase II -- Biopharmaceutical -- AMRAD

16. SAIK-MS/laquinimod -- Immunomodulator -- Phase II -- Small molecule -- Active Biotech

17. E 2007 -- AMPA receptor antagonist -- Phase II -- Small molecule -- Eisai

18. J 695 -- Mab, interleukin-12 -- Phase II -- Biopharmaceutical -- CAT; Abbott

19. Mesopram -- PDE IV inhibitor -- Phase II -- Small molecule -- Schering AG

20. FTY720 -- T cell trafficking -- Phase II -- Small molecule -- Novartis

21. tiplimotide -- Altered peptide ligand (APL) -- Phase II -- Biopharmaceutical -- Neurocrine

22. MBP 8298 -- Synthetic myelin basic peptide -- Phase II -- Biopharmaceutical -- BioMS

23. Campath (alemtuzumab) -- Mab targeting CD52 -- Phase II -- Biopharmaceutical -- Ilex/Schering

24. teriflunomide -- Oral immunomodulator -- Phase III -- Small molecule -- Aventis

25. BMS 188667 -- CTLA4Ig -- cancelled? -- Biopharmaceutical -- Bristol-Myers

26. Antegren -- Integrin antagonist -- Phase III -- Biopharmaceutical -- Elan; Biogen

Source: ING

Name of the drug/compound: Avonex plus minocycline
Manufacturer: Teva pharmaceutics (Copaxone), Wyeth (minocycline is a generic drug, so there might be also other manufacturers)
Trial location: Creighton University, Omaha, Nebraska
FDA phase: II
Treatment for: Disease progression
Intended for RRMS
Mode of action: Immonomodulation, anti-inflammation, neuroprotection
Mode of application: Weekly injection (Avonex), oral (minocycline)
Other info: This is an open-label study lasting for one year.

(P.S. Thanks Finn for the template on minocycline plus an ABCR)

Sorry, time to leave the board.

-finn

Name of Drug: Rolipram (an existing antidepressant)
Manufacturer: Schering AG, Germany, but research for MS by National Institute of Neurological Disorders and Strokes (NINDS) in Bethesda, MD
Current FDA Phase: Phase II: Safety, Tolerability and Effects of Rolipram on Inflammatory Activity in the CNS in MS: Open Label Crossover Trial Using MRI as an Outcome Measure, has been completed.
Treatment: Novel immunomodulatory therapy in MS patients.
Intended for: RRMS, SPMS (i.e., Phase II study included 52 people with EDSS between 1.5 and 6.5)
Mode of Action: ? “..examine whether Rolipram can dampen the part of the immune response believed to lead to MS and reduce disease activity.”
Mode of Application: Oral
Website for more information: http://clinicaltrials.gov/ct/show/NCT00011375?order=18

Other: Some time ago Odd Duck submitted an article on the anti-depressant desipramine as a novel approach to MS treatment so I was fascinated to find the anti-depressant rolipram in a clinical trial for MS. Since this research was done by the NINDS, the results of the Phase II trial, when available, should be public and not proprietary.

For those who have a scientific background (that would NOT be me ), there is an abstract, PMID 7585041, entitled “The antidepressant rolipram suppresses cytokine production and prevents autoimmune encephalitis.” And another abstract, PMID 10430048, entitled, Differential effects of phosphodiesterase type 4-specific inhibition on human autoreactive myelin-specific T cell clones, that concludes: This profile suggests that rolipram differs from other currently used immunomodulatory drugs.

Sharon

Name of Drug: Testosterone Treatment for Men with MS

Where: University of California at Los Angeles (UCLA)

What: A 2 year study to determine if testosterone may be beneficial for RR or SPMS.

Criteria: Age 18-65 and cannot already be on MS-modifying drugs.

Web site with link to UCLA: www.centerwatch.com/patient/studies/stu40451.html


In the US, people can also go to the Centerwatch web site to find some of the larger MS studies in their state(s). Individuals can also sign up to be notified of trials.

Sharon