Tovaxin®, a cellular immunotherapy has completed a Phase 2b clinical study for the treatment of multiple sclerosis (MS). Tovaxin is specifically tailored to each patient's disease profile and is designed to reduce the number of specific subsets of autoreactive T-cells known to attack myelin. Treatment will consist of donating blood and creating a vaccine using the patient’s own cells. The vaccine cells will be irradiated to render them unable to divide, but able to evoke an immune response.

Tovaxin is manufactured using Opexa Therapeutics’ proprietary method for the production of patient-specific T-cell vaccines, which comprises the collection of blood from the MS patient, the harvest and expansion of disease-causing T-cells from the blood, and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells, which comprise the Tovaxin vaccine, are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.

The vaccines will be administered in the doctor’s office as a subcutaneous injection in the arm given five times a year. The first four injections are administered a month apart with the fifth and final injection being administered two months after the fourth. For more information on Opexa and Tovaxin, please visit Opexa Therapeutics .

The FDA Approved Nuedexta ™ (dextromethorphan hydrobromide and quinidine sulfate). It is the first drug developed specifically to treat uncontrollable laughing or crying, also called pseudobulbar affect, or PBA.
Pseudobulbar Affect (PBA), which affects those who suffer from MS (as well as other neurological diseases and conditions). It is characterized by uncontrolled, inappropriate, and/or exaggerated episodes of crying, laughing, or other emotional display, occurring with only minimal or no stimulation to such a response.
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On September 22, 2010, The FDA, approved Gilenya (fingolimod), the first oral drug for multiple sclerosis (MS). Gilenya is used to treat  relapsing  and remitting form of MS. The drug has been shown to significantly reduces MS attacks. However, there can be serious side effects, with possible heart, lung, and eye toxicity and increased risk of infection. Side effect can include

Elevated liver enzymes

Macular edema (swelling of the central portion of the retina, causing distorted vision)

Elevated blood pressure

Shortness of breath

Bronchitis

Diarrhea

Bradycardia (slowing of the heartbeat, seen only upon first treatment. The FDA panel recommended that patients be required to receive their first dose under medical supervision).

 

 

In the last few years, researchers have been making strides in many areas to find a cure. My feeling is that stem cells transplant therapy is the most promising path to a cure. The technique involves using autologous non-myeloablative cells to reset your immune system.  

 

The intention of the procedure is to wipe out the immune system and then, with one’s own cells, reconstitute it with the hope that the new cells will not target myelin. The theory is to get rid of bad cells and reconstitute it with new cells from one’s own body so hopefully they haven’t been triggered yet to attach to myelin. Non-myeloablative autologous haemopoietic stem cell transplantation is intended for patients with relapsing-remitting MS.

 

Between January, 2003, and February, 2005, 21 patients were treated 17 of 21 patients (81%) improved by at least 1 point on the Kurtzke Expanded Disability Status Scale (EDSS), and five patients (24%) relapsed but achieved remission after further immunosuppression. After a mean of 37 months (range24—48 months), all patients were free from progression (no deterioration in EDSS score), and 16 were free of relapses.

 

Early results show Non-myeloablative autologous haemopoietic stem cell transplantation was able to reverses neurological deficits, but these results need to be confirmed in a randomized trial.

 

Studies were initiated by Richard K. Burt, MD, Associate Professor, Division of Immunotherapy Northwestern University Department of Medicine. Please Visit Disability Connections, New Treatment page to watch part 1 and 2 of Dr. Burt’s lecture on Non-myeloablative autologous haemopoietic stem cell transplantation or to learn more, contact Northwestern University Division of Immunotherapy.

Division Address
750 N. Lakeshore Dr., Suite 649
Chicago, IL60611
(312) 908-0059
(312) 908-0064 Fax

Contact Information

rburt@northwestern.edu

 

 

Source accessed June 21, 2010:

http://www.thelancet.com/journals/lancet/article/PIIS1474-4422%2809%2970017-1/abstract

 

We have posted some new videos about various treatments for Multiple Sclerosis. For those of you who have viewed the videos, please feel free to use this forum to discuss their content by adding a comment below. For those who have not yet viewed the videos, you may do so by clicking HERE .

I wanted to share an update on my previous post regarding the new drug, AMPYRA. I am excited to share this ground breaking news with you, my friends, and look forward to learning more about this medication. I would especially like to hear from anyone who may have some experience with it, and how it goes.

March 1, 2010 -- Acordia Therapeutics, Inc. announced that AMPYRA (TM) (dalfampridine) Extended Release Tablets, 10mg  is available by prescription in the United States and Puerto Rico. AMPYRA was approved on January 22, 2010 by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with Multiple Sclerosis (MS). This was demonstrated in clinical trials by an increase in walking speed in some patients. AMPYRA is indicated for use in all types of MS, and can be used either alone or with existing therapies, including disease-modifying agents. To learn more, please visit  Acorda Therapeutics . 

The most common adverse events (incidence ≥2% and at a rate greater than
the placebo rate) for AMPYRA in MS patients were urinary tract infection,
insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder,
multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation,
dyspepsia, and pharyngolaryngeal pain (6.1).
For a full list visit FDA.Gov

To report SUSPECTED ADVERSE REACTIONS, contact Acorda
Therapeutics at (800) 367-5109 or FDA at (800) FDA-1088 or
www.fda.gov/medwatch

***** Have you taken AMPYRA? *****

 

 

 

We want to wish everyone a safe and fun Memorial Day weekend. Sending out many thanks to our brave military who put their lives on the line for us and the freedom we all enjoy on a daily basis.

We want to hear from you. Since its FDA approval this year, many MS patients have taken AMPYRA. Others would like to know how it’s working, how it’s helping to relieve MS symptoms. Please come share your AMPYRA experience with us.

When AMPYRA was approved by the FDA for use in March of this year, it was unknown at that time how soon it would be prescribed for use by MS patients. However, much to our happy surprise, we have heard from many who have had success with it, saying that it significantly relieves their MS symptoms, and most importantly, say that it helps them walk. This is wonderful news!

If you are looking for more information and resources about Multiple Sclerosis (MS), you can find it on our web site. We encourage you to log on to Disability Connections, and ask you to please JOIN our membership. It's FREE and will enable you to connect to and interact with others who share your unique challenges.

LDN is a wonder drug for people with auto-immune disorders. << MORE >>

 I have been trying to find information on LDN to share with people who may not be aware of its usage in patients with Multiple sclerosis. Since my relapse in April I have been looking into other forms of treatment for MS, up to and including stem cell treatments. I have also been enrolled in an investigational study that involves a daily dosage of an oral medication called Fingolimod.

 

Given my recent experience, I thought it would be an interesting topic for a new column here on the blog. My idea is to create a venue where we can give feedback on the various medications and treatments for MS. Here is some information I found about Low-Dose Naltrexone, which I understand is prescribed to many MS patients. Have you taken it? How has it helped you? What can you tell us about it? If not, can you tell us what kind of treatment you have been undergoing, and how it’s going for you?

 
Low-Dose Naltrexone Finds Preliminary Benefit
for People with Multiple Sclerosis (MS)

Naltrexone was approved by the FDA in 1984 in a 50 mg dose for the treatment of addictions to opioids and alcohol. Naltrexone prevents the effect of such drugs by blocking opioid docking sites on the cells. In doing so, naltrexone also blocks the reception of the opioid hormones that our brain and adrenal glands produce. Many body tissues have receptors for these endorphins and enkephalins, including virtually every cell of the body's immune system.

 

At significantly lower doses, naltrexone has been prescribed as treatment for a variety of diseases, including various types of cancers, HIV/AIDS, Parkinson’s disease, Alzheimer’s disease, Amyotrophic Lateral Sclerosis (ALS; aka Lou Gehrig’s disease), emphysema, as well as MS and other autoimmune diseases. Until recently, there has been only limited information of Low Dose Naltrexone (LDN) and its benefit to treat MS.

 

LDN has been shown to provide symptomatic relief for MS, according to a number of recently published laboratory studies. Investigators cite the possibility that LDN increases levels of endorphins in the brain, which are the body’s natural pain relievers. Unfortunately, as noted by the investigators, due to study dropouts and incomplete data, they had complete data on only 60 of the 80 original participants, which weakened the statistical power of the trial results. It was suggested that their findings require confirmation in a larger, multi-center clinical trial.

 

 

 

Recent study of cholesterol drug Lipitor shows that it can be helpful in treating MS patients. A statin drug, Lipitor reduced the development of brain legions in 55.3 percent of MS patients during the course of a study, compared to 27.6 percent of those patients who took a placebo. Of the 81 individuals in the study, some were randomly selected to take either 80 milligrams per day of the Lipitor (atorvastatin), whereas the others were given a placebo.

This data is preliminary, according to study co-leader Dr. Emmanuelle Waubant, associate professor of neurology at the MS Center at the University of California, San Francisco. These findings were part of a phase II multi-center trial, also supported by drug manufacturer Pfizer, Inc. It was decided that a study of a larger magnitude would be necessary in order to confirm that the positive effects of Lipitor on MS patients, as well as long term results.

Dr. Waubant also added that we need to conduct further research and studies in order to better understand the impact Lipitor would have on the progression of multiple sclerosis, so that they can better inform the patients and physicians of the effect of this drug. Lipitor is broadly used throughout the US and the world, and is relatively inexpensive. So it is prudent to ensure proper administration of the drug in order for it to be used as protocol for MS patients on a routine basis.