Thursday, October 12, 2006

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MSnewsChannel.com Drug Alert #41: "DR. VOLLMER'S INFORMAL SYNOPSIS: NEW TREATMENTS FOR MS"
There are two parts to todays Alert...

The first is a MS news Channel exclusive..."Dr. Vollmer's informal Synopsis: New Treatments For MS"

Dr. Timothy Vollmer is Chairman of the Division of Neurology at Barrow Neurological Institute - St Joseph's Hospital & Medical Center.

Dr. Vollmer wrote the following informal synopsis for me...at my request...so that I could keep you informed of these wonderful new develoments!

I encourage you to forward ALERT #41: "Dr. Vollmer's informal Synopsis: New Treatments For MS" to everyone in your computer's address book who has been affected by MS!

But...Please forward this entire Alert: do not cut & paste. Plus...we will gladly approve of your using this Alert or part of it in all newletters, newspapers, etc....but...please contact me 1st for written approval.

The 2nd and last part of today's alert consists of 28 headlines that I have picked from the 188 that we have posted over the last 2 weeks on www.MSnewsChannel.com THE 28 HEADLINES INCLUDE 18 NEW MS TREATMENTS THAT ARE IN THE PIPELINE!
:-)

Stan L. Swartz
Founder

Swartz Neuroscience Foundation at
BARROW NEUROLOGICAL INSTITUTE
St Joseph's Hospital & Medical Center

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Copyright 2006 MS News Channel

DR. TIMOTHY VOLLMER'S EXCLUSIVE REPORT FOR MSnewsChannel.com: New treatments for MS



Dear Stan,
I am writing you a brief informal synopsis of recent events related to developing treatments for MS.

All of these agents are still “works in progress” but data to date is very encouraging.

It is also remarkable that we are not talking about one major advance but rather four treatments, each of which is significantly different from the others.

In addition, some of these treatments are being studied in the progressive form of MS and study results in progressive patients may be available within the next year.

I am very pleased with these recent reports but need to caution your readers that these are all relatively short term studies and results from longer term studies will be key to our eventual understanding of the potential use of these treatment strategies in MS.

However, such studies for these agents are either already
underway or about to start.

1....COMBINATION TREATMENT STRATEGIES:

As we all know certain other areas of medicine, such as AIDS and cancer, have seen major improvements in treatment effectiveness by using agents in combination.

Over the past several years there have been reports of small uncontrolled trials using chemotherapies such as cyclophosphamide and mitoxantrone in combination with interferons or glatiramer acetate. These reports have suggested that substantial increases in efficacy can be seen with such combinations.

This was supported by a recent report out of England concerning an ongoing study of the combination of glatiramer acetate (Copaxone) and mitoxantrone (Novantrone).

At an international meeting of MS researchers and clinicians (ECTRIMS) held in Madrid, we reported on our 5 center study of a short course of mitoxantrone (Novantrone) followed by long term treatment with glatiramer acetate (Copaxone).

The study was randomized and compared this treatment to standard glatiramer treatment alone.

Our study demonstrated a 90% decrease in new lesions seen by MRI after the induction treatment with mitoxantrone followed by glatiramer for up to 2 years. Safety was good.

The study is still ongoing and 3 year data will be available next year. A large study is now being planned. Other similar studies are demonstrating the same findings.

This may be an important option for patients with more active MS because there is no long term generalized immunosuppression. Other combinations are also being studied.

My personal belief is that these approaches are likely to lead to the most effective treatments with the best safety profile over the long term, but we will have to wait and see.

2....CAMPATH 1H:

This is a monoclonal antibody that deletes only immune cells which results in generalized immunosuppression.

Preliminary data from a phase II study suggests a marked reduction in disease activity as measured by MRI and reduction of relapse rate and possibly disability progression.

This is an IV injection given once or twice a year. There have been a few serious complications related to development of other autoimmune diseases and an increase in infections. Longer term studies are underway.

This therapy is already approved for treatment of certain cancers of the blood and may be useful for aggressive MS but the results of the longer term studies will be necessary before we know if this agent has a role in the treatment of MS.

3....FINGOLIMOD PREVIOUSLY KNOWN AS FTY 720:

This is an oral agent in a new class of medications that causes immune cells to stay in the immune organs such as the spleen and lymph nodes and prevents their migration into other organs such as the brain.

Phase II studies have reported a large treatment effect on MRI evidence of disease activity in MS with around a 80-90% decrease in new lesion formation and around a 60% reduction in relapse rate. There are increases in infections and effects on other organs. A phase III study is underway to evaluate longer term safety and efficacy.

The magnitude of the treatment effect is remarkable and if the safety holds up this may be a valuable treatment option in a few years.

4....RITUXUMAB (RITUXAN)

This is another monoclonal antibody like Tysabri and Campath.

However it targets B lymphocytes only. Over the last few years there have been three reports of rituximab treatment in MS including progressive MS which indicated benefit. They were small uncontrolled studies.

However, in the last few weeks there was a press release concerning the results of a larger phase II study in RRMS that stated the results were greater than expected. The actual results have not been released yet.

This molecule is of particular interest to many of us in the field because it attacks an immune cell that we think may be important to MS disease activity and possibly to the progressive phase of the disease.

In fact, there is a large phase III multicenter study of this agent in primary progressive MS, the results of which may also become available with in the next year.

Rituxumab is currently approved for use in B cell lymphoma and rheumatoid arthritis. So we already have a lot of safety data about this agent which is important in determining in whom to use the therapy.

If Rituxumab's treatment effect is comparable to or greater than current treatments, it may become an important therapy in MS and one with excellent tolerability by patients because it is an IV infusion done once each 6 months or so.

It does suppress a part of the immune system to a degree but current data does suggest good safety at least over two years. In my view this is an important therapy to watch as study results become available in part because it may tell us something important about the biology of MS.
There are a lot of other agents in the testing phase in MS many of which are oral.

The future looks very bright for better, more effective treatments for MS on the near horizon.

We are not talking the usual ten years before the next major advance, rather possibly the next 10 months.

These are not cures, but they appear to offer the potential of treatment effects much closer to that goal than we have ever achieved heretofore.

Best regards,
T. Vollmer, MD
Timothy Vollmer, M.D.
Chairman, Division of Neurology
Barrow Neurological Institute


Copyright 2006 MS NewsChannel
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HERE'S THE BEST OF THE 188 HEADLINES THAT HAVE BEEN POSTED DURING THE LAST 2 WEEKS ON: www.MSnewsChannel.com

READ THE STORIES BEHIND THE FOLLOWING 32 HEADLINES BY CLICKING HERE: www.MSnewsChannel.com


1...TYSABRI HELPS COGNITION: Tysabri reduced the risk of sustained cognitive worsening by 43 percent, compared to placebo.....

2...CAMPATH: "Genzyme Says MS Drug Works Better Than Serono's Rebif"

3...ORAL FINGOLIMOD - FTY720: Presented at ECTRIMS
Oral FTY720 (Fingolimod) for Relapsing Multiple Sclerosis Shows Sustained Benefits for Up to 2 Years

4....NEW REBIF AUTO-INJECTOR WHICH USES THE THINNEST NEEDLE OF ANY TREATMENT: ECTRIMS Presentation on new-improved Rebif PLUS It's new auto-injector. New Formulation Rebif for Relapsing Multiple Sclerosis Lowers Immunogenicity and Improves Tolerability

5...ORAL LAQUINIMODE BY TEVA: The NEW once-daily novel oral agent for relapsing remitting

6...ORAL CLADRIBINE BY SERONO: FDA fast-tracks Serono's oral MS drug Cladribine...

7...ORAL FAMPRIDINE-SR: Patients who took Fampridine-SR moved 25 percent faster ontimed 25-foot walk, while patients getting a placebo improved 4.7 percent, Hawthorne

8...FATIGUE AND FUNCTIONAL DEFICIT IMPROVEMENT: Four-week Rehab Significantly Improves Fatigue and Functional Deficit in Multiple Sclerosis Patients: Presented at ECTRIMS. Fatigue and functional deficits in multiple sclerosis (MS) patients were significantly improved during 4 weeks of inpatient rehabilitation, researchers reported here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)....

9...SATIVEX - CANNABINOID-BASED SPRAY APPEARS HELPFUL FOR SPASTICITY IN MS: Presented at ECTRIMS

10...SATIVEX: Cannabis-Based Spray Shows Positive Impact on Overactive Bladder Symptoms of MS: Presented at ECTRIMS

11...CDP323: NEW DRUG IN PIPELINE - Biogen Idec:
"Biogen Idec and UCB and to collaborate on oral multiple sclerosis therapy U.C.B. and BIIB announce a global collaboration to jointly develop and commercialize CDP323 for the treatment of relapsing-remitting multiple sclerosis...

12...TYSABRI: New Data on Demonstrate Significant Reduction in Steroid Use and Hospitalizations in Patients with MS

13...COPAXONE New Data Confirmed Antibodies to Copaxone® Do Not Impact Its Established and Sustained Long-Term Efficacy in Multiple Sclerosis

14...COPAXONE WITH MITOXANTRONE: Very Active Multiple Sclerosis Patients Benefited From COPAXONE(R) Treatment Following Short-Term Induction With Mitoxantrone

15...AVONEX PRESS RELEASE FROM ECTRIMS
....treatment with AVONEX (Interferon beta-1a) promoted a statistically significant recovery of T1-black hole lesion volume by almost 24%....

16...LYRICA: Pfizer's Lyrica(Pregabalin Capsules) Approved in Europe for Difficult-to-Treat Nerve Pain.

17...MBP8298: NEW DRUG IN PIPELINE shown to safely delay disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. BioMS Medical to present at the 22nd Congress of the European Com mittee for Treatment and Research in Multiple Sclerosis (ECTRIMS) :

18..."Testosterone gel proven to slow symptoms of MS...in small study": UCLA School of Medicine,

19...TYSABRI - Presented at ECTRIMS
Natalizumab (Tysabri) Reduces Brain Atrophy, Improves Cognition During Second Year of Multiple Sclerosis Treatment

20...TOVAXIN: New drug in the pipeline

21...REBIF: NEW FORMULATION: ONE-YEAR DATA FROM PHASE III TRIAL SHOW THAT NEW FORMULATION OF REBIF® OFFERS SUBSTANTIAL IMPROVEMENT IN TOLERABILITY AND IMMUNOGENICITY PROFILES...[click for full press release]:

22...BETAFERON: Causes Less Injection Site Pain and Injection Site Reactions Than Rebif in Patients With MS: Presented at ECTRIMS

23...SYMADEX...NEW DRUG ANNOUNCEMENT FROM ECTRIMS
Symadex Can Reverse Disease in Preclinical Multiple Sclerosis Animal Model

24...NICOTINAMIDE: "Daily Nicotinamide Shots May Protect MS Patients From Severe Disability"

25...Gene found that helps combat MS [MORE: BBC NEWS]
A gene that helps to stave off the effects of multiple sclerosis (MS) has been discovered by scientists. A Danish-UK team found that a known risk gene for MS, called DR2b, is always partnered by a twin gene - DR2a....

26...Novantrone (mitoxantrone)... Safety and Tolerability of Mitoxantrone for Worsening Multiple Sclerosis Appears Stable in Long Term: Presented at ECTRIMS...

27...Age Should Not Deter Multiple Sclerosis Diagnosis: Presented at ECTRIMS

28...MBP8298: New Drug in the Pipeline: "MBP8298 shown to safely delay disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes - Presented at ECTRIMS...A message from Ryan Giese

29...NovaDel Announces Two CNS Oral Spray Drug Candidates in its Development Pipeline; Oral Spray Formulations of Tizanidine for Spasticity

30...PPMS: Small Study Holds Hope For chronic progressive patients with MS [PPMS]

31...COPAXONE(R) Showed Sustained Benefit on Slowing Brain Tissue Damage in Multiple Sclerosis Patients - Data presented at ECTRIMS

32...Age Should Not Deter Multiple Sclerosis Diagnosis: Presented at ECTRIMS: In a new study of patients diagnosed with multiple sclerosis (MS) after the age of 60, nearly half of relapsing patients with relapsing-remitting multiple sclerosis (RRMS) and patients with clinically isolated syndrome presented with signs of inflammation on magnetic resonance imaging (MRI).

READ THE STORIES BEHIND THE 32 HEADLINES BY CLICKING HERE: www.MSnewsChannel.com

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