CCR2 antagonists

A board to discuss future MS therapies in early stage (Phase I or II) trials.

CCR2 antagonists

Postby carolew » Thu Dec 08, 2005 5:43 am

They are offering me a study on this now. Does anyone know of this category of meds. I read a bit on them on the net. They have one made by Pfizer called INCB3284. Apparently it stops the macrophages from causing too
much damage at the site of the inflammation. Little side effects reported.
Given by infusion.... My neurologist decided not to do the study on FTY720! (very upsetting)

so, they offer me this..Any info or input from someone who tried it would be great. Thanks. Carole
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Postby bromley » Thu Dec 08, 2005 9:18 am

Carole,

Never heard of this potential treatment - Dignan may know some more. At least your clinic is offering you options to the CRAB drugs. But, does the trial have a placebo arm? It's a difficult judgment call - do you start one of the CRABS which have fairly limited efficacy or opt for a treatment in trial but take the risk that you end up on a placebo.

Targeting macrophages seems sensible. Do you know what sort of trial this is - Phase II / Phase III?

Any idea why FTY720 is going forward at your clinic?

Good luck whichever you choose.

Ian
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Postby carolew » Thu Dec 08, 2005 11:12 am

Hi Ian,
I think I saw other names for it in another thread on here but now, I can't trace it. :?:
It is an open label study, 5 infusions given, frequency? I will receive more details by mail soon. It must be a phase ll trial just because of its design i.e. no placebo control arm.
The neurologist backed out of the FTY720 study because it had a placebo arm (one of three) and he didn't want patients to be on nothing for 2 years. I was ready to try it because I am only on Lipitor and vit D.
I will try to gwt in the study in Montreal which is 2 hrs away from here (Ottawa, Ont.) I will post again when I get more info.
Thank for the wishes. Take care, Carole
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Postby dignan » Thu Dec 08, 2005 1:23 pm

could be MLN1202...


July 11 - PRNewswire-FirstCall - Millennium Pharmaceuticals, Inc. today announced the initiation of a multicenter phase II clinical trial of MLN1202 in approximately 40 patients with relapsing-remitting multiple sclerosis (MS), the most common form of the disease. MLN1202, a novel humanized monoclonal antibody, is designed to block CCR2 chemokine receptors and prevent the infiltration of immune cells into inflammatory sites. The CCR2 chemokine pathway is believed to play a central role in a number of inflammatory conditions, including MS.
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Postby carolew » Fri Dec 09, 2005 3:31 pm

It is in that category all right. In your post, Dignan, under the general discussion. you posted a under the sticky with a list of drugs and you have some in there too. :D You guys seem to track them all. Good for us. I still have not received my documents on it. Carole
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Postby carolew » Mon Dec 12, 2005 6:23 pm

I received my info package. It IS the millenium study. I read the information. I need to have 3 MRI's before they decide if I am a candidate for the study. They want people where there is alot of inflammation going on. I may not fit but I will try.
The package doesn't say much else but on this site, some other people had heard about it.
I will need to take a chance. Carole
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Postby Jaded » Tue Dec 13, 2005 9:39 am

Good luck either way Carole.

Let us know how you get on.

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Postby carolew » Tue Jan 10, 2006 6:07 pm

Had my first MRI today, in a private clinic that the investigators pay for and,
guess what? They gave ME the CD with the pictures on it with the permission to look at it! I have to bring it to the neurologist! So, I looked at it. I am no expert but it seems to me that there are alot less plaques on it than the last one I had before I started Lipitor!!! I like it. I am all exited but it also means that they may not accept me in this study. Only the other MRI's will tell.... Carole
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Postby bromley » Wed Jan 11, 2006 2:42 am

Carol (and others),

Quite a few people say thay have had some success with statins such as Lipitor. I assume that you have to have high cholesterol to be prescribed a statin by your doctor, or are Neuros precribing them?

Is anyone on a statin trial for MS? Does anyone know if statins are being trialled for MS?


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Postby carolew » Wed Jan 11, 2006 5:24 am

There is a study going on in California with Dr Yussef (Zocor) and in South Carolina (Dr. Singh). No results on humans out yet. In the UK, you can buy over the counter your statins. I have access because of my job. I bet you can get some over the internet.
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Some more

Postby Melody » Wed Jan 11, 2006 9:30 am

John's cholesterol is fine at this point and actually when he was first started on it he hadn't had his checked. Ask your Doctor. If he says no look for another way. John is down to 10mg right now as we had some elevated numbers last time he was checked in Nov.

Trial Information

Summary: Statins to delay or prevent Multiple Sclerosis in patients experiencing a Clinically Isolated Syndrome
STAyCIS is a clinical research study for people with Clinically Isolated Syndrome (CIS). CIS is a condition that sometimes precedes Multiple Sclerosis (MS). This clinical research study is examining whether the drug atorvastatin (also known as “Lipitor”) can help in delaying or preventing the onset of MS in people who have experienced a CIS. Atorvastatin is one of a class of drugs commonly called 'statins' that are approved by the Food and Drug Administration (FDA) for lowering cholesterol. This is the first time a statin is being studied for this purpose, however, preliminary research has shown that this class of drugs has immunomodulatory properties that may be beneficial in the treatment of autoimmune disease. The study is taking place at 14 university and clinical centers and will enroll a total of 152 participants. Clinical sites are located in San Francisco, Los Angeles, Portland, Seattle, Phoenix, Dallas, St. Louis, Cleveland, Baltimore, Buffalo, Rochester, New Haven, New York and Montreal, Canada.

Eligibility:

This study is open to men and women aged 18-55 who have been diagnosed with at least 1 CIS (an acute or sub acute well-defined neurological event) lasting at least 48 hours, which is consistent with MS.
Patients with a definite diagnosis of MS according to McDonald criteria are not eligible for the study.
Those who have received therapy with interferon, glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis at anytime prior to study entry are also not eligible to participate.
For more information,

Contact:

Montreal Neurological Institute
Located in:
Montreal, QC, Canada,
Telephone: 1-866-STAYCIS (1-866-782-9247)





This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: August 4, 2005 at 2:53:57 PM
http://www.centerwatch.com/patient/stud ... 80890.html


Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis

This study is currently recruiting patients.
Verified by Bayhill Therapeutics February 2005

Sponsored by: Bayhill Therapeutics
Information provided by: Bayhill Therapeutics
ClinicalTrials.gov Identifier: NCT00103974


Purpose

This research study is being done to evaluate the safety of BHT-3009 alone and when combined with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).
Condition Intervention Phase
Multiple Sclerosis
Vaccine: BHT-3009-01
Phase I


MedlinePlus related topics: Multiple Sclerosis


Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety Study

Official Title: A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis

Further Study Details:
Primary Outcomes: Evaluate safety of BHT-3009 alone and when combined with atorvastatin in patients with multiple sclerosis.; Determine dose of BHT-3009 and regimen for phase II testing.
Secondary Outcomes: Describe effect of treatment on antibody and T cell responses to myelin basic protein (MBP).; Describe clinical course of treated patients.; Explore biomarkers of MS activity
Expected Total Enrollment: 30
Study start: July 2004; Expected completion: December 2006
Last follow-up: July 2006; Data entry closure: August 2006

This research study is being done to evaluate the safety of BHT-3009 alone and when combined with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).

Patients with MS are thought to have an immune response that attacks certain proteins in the brain, including myelin basic protein. (Myelin basic protein is a protein that makes up part of the outside layer of nerve cells.) BHT-3009 is an investigational immunotherapy product that is designed to alter the immune response to myelin basic protein and make the response less harmful. BHT-3009 contains the DNA (gene) for myelin basic protein.

Three different doses of BHT-3009 will be tested to determine if there are any differences in safety or effects on immunity. This is the first clinical research study of BHT-3009. Laboratory studies have shown that BHT-3009 and atorvastatin given together alters the immune response to myelin basic protein and makes the response less harmful.

Eligibility

Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:

Definite diagnosis of multiple sclerosis by the McDonald criteria.
Patients with relapsing remitting MS or secondary progressive MS are eligible.
1-5 gadolinium enhancing (Gd+) lesions on the first Screening MRI or relapse in the previous 2 years, or disease worsening in the previous 2 years
Clinically stable for > 1 month before screening evaluation and during screening. Patients who are stable on approved therapy are eligible only if they have intolerable side effects or other medical reasons for discontinuing approved therapy.
Off interferon for > 1 month before screening evaluation.
Off immunosuppressive and cytotoxic therapy (e.g. mitoxantrone, cladrabine) >12 months or > 6 months with CD4 count > 400.
EDSS ≥ 2.5 and < 7.0.
Female or male, age > 18 years.
Able to give informed consent.
WBC and platelets in normal range, hemoglobin > 10.0 g/dl.
AST, ALT, bilirubin < upper limit of normal.
Creatinine < upper limit of normal.
CPK < upper limit of normal.
Exclusion Criteria:

High-dose corticosteroids (e.g. >500 mg methylprednisolone or equivalent) within previous month.
>5 Gd+ lesions on the first Screening MRI.
Previous vaccine therapy, stem cell transplantation or total lymphoid radiation.
Glatiramer within previous 12 months.
Treatment with any statin in the previous 6 months or elevated cholesterol that requires treatment with a statin.
Pregnant or lactating women.
Unwilling to use a medically acceptable form of birth control.
History of positive test for HIV, hepatitis B or hepatitis C.
Clinically significant ECG abnormalities.
Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints.
Implanted pacemakers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
History of intolerable adverse events with statin therapy.
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00103974


Arizona
Barrow Neurology Clinics, Phoenix, Arizona, 85013, United States; Recruiting
Colleen Sweeney, MA, CCRC 602-406-6291
Timothy Vollmer, MD, Principal Investigator


California
USC, LAC & USC Medical Center, Los Angeles, California, 90033, United States; Recruiting
Patricia Rourke 323-224-5332
Pat Gutierrez 323-224-5333
Leslie Weiner, MD, Principal Investigator


Canada, British Columbia
University of British Columbia, MS Research, Vancouver, British Columbia, V6T 2B5, Canada; Recruiting
Wendy Morrison, RN, MSCN 604-822-7511
Joel Oger, MD, Principal Investigator


Canada, Quebec
Montreal Neurological Institute, Clinical Research Unit and MS clinic, Montreal, Quebec, H3A 2B4, Canada; Recruiting
Sherene Guindi 514-398-6052
Yves Lapierre, MD, Principal Investigator



Study chairs or principal investigators

Frank Valone, MD, Study Director, Bayhill Therapeutics
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John was diagnosed Jan 2005. On lipitor 20mg .On Copaxone since July 4,2005. Vitamin D3 2000iu-4000iu (depending on sunshine months)June 10 2005(RX::Dr. O'Connor) Omega 3 as well Turmeric since April 2005. Q10 60mg. 1500mg liquid Glucosamine Nov 2005.
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