These have not been approved by the FDA however they are in the experimental stages for the Treatment of MS.
Cladribine: This drug is given orally for 4 - 5 consecutive days, ranging from once every 28 days to twice yearly, depending on the study regimen. This drug interferes with the proliferation of a specific class of T cells in the immune system. The ongoing 2 year, Phase III CLARITY extension study will assess the safety and efficacy of oral cladribine in RRMS as well as its effect on progession of disability.
Fingolimod (FTY720): Oral medication taken daily. Blocks T cells from leavng lymph nodes, lowering their number in the blood and tissues, may reduce damage to nerves and enhance nerve repair. Adverse events may include slowed heart rate, increased blood pressure, airway obstructions and infection.
BG00012 (BG 12; fumarate; fumaric acid esther): Oral medication taken daily. This drug is an immunomodulator with anti-inflammatory properties; may potentially have neuroprotective effects. This drug is being studies in RRMS. This drug was reported to be safe and tolerable.
Laquinimod: Oral medication taken daily. Laquinimod is being studied in RRMS and is an immunomodulator. The drug was well tolerated.
Teriflunomide: Oral medication taken daily. This drug is an immunomodulator, affecting the division of T cells. Treatment was well tolerated.
Statins: Statins are oral medications most commonly prescribed to lower cholesterol. Their anti-inflammatory properties make them of interest for possible use in MS. Atorvastatin (Lipitor) and Simvastatin (Vytorin, Zorcor) are among the statins presently being studies as potential treatments for RRMS. An initial pilot trial of Simvastatin in an uncontrolled study showed it was safe and reduced MRI activity at six months. The effects of statins combined with interferons are controversial. In one study, combination of Rebif with Lipitor increased MRI and clinical disease activity, suggesting that statins may block the therapeutic effects of interferons. However, two other studies did not support this, and more data are needed.
The following 3 drugs are "Experimental Monoclonal Antibody Medications"
Campath (alemtuzumab): Administered once yearly by intravenous infusion over 3 - 5 consecutive days. The drug is approved for the treatment of B-cell leukemia and targets T cells, B cells and macrophages. Side efforts include reduction in blood clotting, thyroid disorders, infusion reactions and infections. Patients need to be monitored closely due to risk of significant toxicities.
Rituxan (rituximab): Administered via intravenous infusion. Binds to molecule (CD20) on the surface of B cells and deplets them from the circulation for an average of nine months. Used in lymphoma, rheumatoid arthritis and lupus. Serious adverse events have been reports in Rituxan treated patients and must be closely monitored.
Zenapax (daclizumab): Administered via intravenous infusion every 4 weeks; also studied in subcutaneous injections. This drug is used to prevent renal (kidney) transplant rejection. It is a genetically engineered antibody against interlukin 2, a substance necessary for the growth of T cells, limiting their growth and reducing inflammation. Drug is wel tolerated, has been reported to improve or stablize 60% of patients; and reduce the number of active lesions in both RRMS and SPMS patients.
Other therapies being studied for MS:
MBP8298: Administered intravenously every 6 months. This peptide is a synthetic fragment of myelin basic protein (MBP). It replicates the site on the MBP molecule that is believed to be a target of attack by cells of the immune system, in 65 to 75% of all people with MS. It is believed to induce or restore immunologic tolerance to attack. Safe and tolerable.
Tovaxin: T cell vaccine given via subcutaneous injection every 4 weeks. T cells are removed frm a small amount of the patients blood, inactivated, then injected back into the patient; the immune system is stimulated to recognize and elminate the inactivated cells as well as active cells. Tolerable and safe.
Vitamin D3: There appears to be an inverse relationship between vitamin D3 status and the probability of developing MS, most likely due to its immunoregulatory effects. Vitamin D3 supplementation therefore appears to be a possible therapy in MS. Safe and tolerable.
Tetracycline Antibiotics: Have been shown to have immunomodulatory and neuroprotective activities. They appear to decrease the passage of leukocytes across the blood brain barrier.
BHT-3009: This is a DNA facdcine to myelin basic protein (MBP); it contains the gene for MBP and is administered by intramuscular injection. This therapy is designed to cause immune tolerance, by reprogramming the immune system to modulate the response of the antigen specific immune cells involved with MS and reducing the attack against MBP in the myelin sheath. Safe and well tolerated.
Approved Drugs for MS:
Avonex (interferon beta-1a): Taken via weekly intramuscular injections; dosage is 30 mcg. RRMS and individuals with clinically isolated syndrome (CIS), a single attack not yet dx'd as MS.
Betaseron (interferon beta - 1b): Administered by subcutaneous injectin every other day, dose is 250 mcg. Aproved for RRMS and individuals with CIS.
Rebif (interferon beta - 1a): Administered by subcutaneous injection 3 times weekly; dosage is 22 or 44 mcg. Approved for RRMS
Copaxone (glatiramer acetate - GA): Given through daily subcutaneous injections; dosage is 20 mg. Approved for RRMS.
Novantrone (mitoxantrone): Given via intravenous infusion once every 3 months for a maximum of 2 - 3 years. The total does that can be taken is limited to avoid the risk of damage to the heart. Careful monitoring both during and after treatment is necessary. Dose varies according to an individuals weight. It is approved for SPMS, PRMS or worsening RRMS and for people who are not responding favorably to standard therapies.
Tysabri (natalizumab): Administered via intravenous infusion every 4 weeks. Dose is 300 mg. It was approved for RRMS. Following a suspension of the drug after 2 patients developed Progressive Multifocal Leukoencephalopathy (PML), an often fatal viral infection of the brain, Tysabri was re-released in 2006. All patients now receive the drug through safety monitoring programs such as the TOUCH Prescribing Program and registered infusion centers and pharmacies...2 new cases of PML were recently reported. Nearly 31,800 patients are on the drug worldwide. In early 2008 the FDA mandated a label change to include the possibility of serious liver injury associated wth the drugs use.