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Dr. Timothy L. Vollmer
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MS NEWS ARCHIVES: by week
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Sunday

 
NEW DRUG IN THE PIPELINE FOR MS: Daclizumab for the treatment of MS:
"It's easy to understand the $800 million alliance forged between PDL Biopharma and Biogen Idec in August. The deal answers Biogen's pipeline needs and provides PDL a kindred biotech with experience in MS and cancer...The deal calls for PDL and Biogen to jointly develop, manufacture and sell three antibody products in mid-stage clinical trials. This includes PDL's drug Daclizumab for the treatment of MS......"

 
NEW MS DRUG: Biogen, Genentech See Solid Rituxan Data

NEW YORK (AP) - Drug makers Biogen Idec Inc. and Genentech Inc. said Monday a mid-stage study of Rituxan showed it was effective in treating MS.

The Food and Drug Administration originally approved the drug in 1997 for the treatment of cancer. It was developed by Cambridge, Mass-based Biogen and is co-marketed with South San Francisco, Calif-based Genentech in the United States.

The companies said the treatment reached its primary endpoint in reducing the number of gadolinium enhancing T1 lesions, or indicators of relapsing forms of MS, in a 104-patient study. The clinical trial compared Rituxan to a placebo and took place over 24 weeks.

Patients involved in the study will be followed for an additional 48 weeks as the companies monitor the long-term safety affects of the treatment.

MS, an autoimmune disease, is the leading cause of neurological disorders in young adults, the companies said, with the relapsing form of the disease accounting for 65 percent of all MS cases....."

Friday

 
Caraco gets FDA OK for generic MS drug - Pharmaceutical Business Review: "The FDA has granted final approval for Caraco Pharmaceutical's baclofen tablets, the company's generic version of Novartis' Lioresal, a muscle relaxant used for the alleviation of signs and symptoms of spasticity resulting from MS..."

Wednesday

 
FDA Approves Baclofen for Spasticity in MS: "Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Baclofen Tablets.

Caraco's Baclofen Tablet is a muscle relaxant and antispastic. It is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Caraco has two strengths available, 10 mg and 20 mg tablets....."

Tuesday

 
Tovaxin: Opexa Therapeutics T cell-based
therapeutic vaccine
: "...we achieved a very significant milestone with the initiation of our randomized, placebo-controlled Phase IIb trial to evaluate the effectiveness of our T cell-based therapeutic vaccine, Tovaxin, for treating MS. We believe that Tovaxin attacks the underlying cause of MS and has advantages over existing treatments for the disease, including lower relapse rates, quick onset of action, minimal side effects, less frequent injections and reduced patient fatigue.'....."

 
Chromos updates on progress with development of CHR-1103 for treatment of MS
"Chromos Molecular Systems Inc. (TSX: CHR) has taken several significant steps in the development of its lead product candidate, CHR-1103. A humanized monoclonal antibody, CHR-1103 is being developed for the acute treatment of relapsing forms of multiple sclerosis (MS). Its unique mechanism of action has the potential to reduce the severity of a relapse in patients with MS and also stem the residual neurological damage that often accompanies relapse and leads to progression of the disease.

Chromos recently completed its first meeting with officials from the U.S. Food and Drug Administration (FDA). The two parties discussed Chromos' clinical approach, proposed preclinical safety evaluation program and manufacture of CHR-1103. Chromos is now moving forward with preclinical safety evaluation studies in preparation for an Investigational New Drug (IND) application in Q3 2007.

Using its proprietary ACE System, Chromos engineered a stable clonal cell line expressing its product, CHR-1103 and transferred it to AppTec for process development, scale up and manufacture. The ACE System demonstrated the ability to perform well in large-scale manufacturing, validating the use of the platform for clinical and commercial scale manufacturing of biopharmaceuticals. The Company is now preparing to begin its preclinical safety evaluation studies with Charles River Laboratories.

Chromos has engaged two leading MS clinicians to act as clinical consultants for its CHR-1103 program. Lily Jung, M.D. is the Medical Director of the Seattle Neuroscience Institute at Swedish Medical Centre in Seattle, WA, and a clinical associate professor in Neurology at the University of Washington Medical School. Mariko Kita, M.D. is a clinical investigator and Director of the Virginia Mason Multiple Sclerosis Center in Seattle, WA. Drs. Jung and Kita will advise and assist with the clinical development of CHR-1103 as it enters clinical trials...."

 
An unlikely MS therapy: MS responds to high doses of chemotherapy in study, improving health of five subjects:
"Stony Brook University Hospital's Dr. Douglas Gladstone enrolled a dozen patients into the experimental drug trial with cyclophosphamide, a powerful drug used to treat leukemia and lymphoma. It wipes out the body's immune system, which is exactly why Gladstone suspected it would work in multiple sclerosis. In the disease process, T-cells of the immune system attack the myelin sheath, the insulation around the nerve cells......"

 

CHR-1103

Chromos updates on progress with development of CHR-1103 for treatment of MS:
" Chromos Molecular Systems
Inc. (TSX: CHR) has taken several significant steps in the development of its
lead product candidate, CHR-1103. A humanized monoclonal antibody, CHR-1103 is
being developed for the acute treatment of relapsing forms of multiple
sclerosis (MS). Its unique mechanism of action has the potential to reduce the
severity of a relapse in patients with MS and also stem the residual
neurological damage that often accompanies relapse and leads to progression of
the disease.
Chromos recently completed its first meeting with officials from the U.S.
Food and Drug Administration (FDA). The two parties discussed Chromos' clinical
approach, proposed preclinical safety evaluation program and manufacture of
CHR-1103. Chromos is now moving forward with preclinical safety evaluation
studies in preparation for an Investigational New Drug (IND) application in Q3
2007.
Using its proprietary ACE System, Chromos engineered a stable clonal cell
line expressing its product, CHR-1103 and transferred it to AppTec for process
development, scale up and manufacture. The ACE System demonstrated the ability
to perform well in large-scale manufacturing, validating the use of the
platform for clinical and commercial scale manufacturing of biopharmaceuticals.
The Company is now preparing to begin its preclinical safety evaluation studies
with Charles River Laboratories.
Chromos has engaged two leading MS clinicians to act as clinical
consultants for its CHR-1103 program. Lily Jung, M.D. is the Medical Director
of the Seattle Neuroscience Institute at Swedish Medical Centre in Seattle, WA,
and a clinical associate professor in Neurology at the University of Washington
Medical School. Mariko Kita, M.D. is a clinical investigator and Director of
the Virginia Mason Multiple Sclerosis Center in Seattle, WA. Drs. Jung and Kita
will advise and assist with the clinical development of CH"......

Monday

 
(Cytoxan): High-Dose Cyclophosphamide(Cytoxan) for Moderate to Severe Refractory MS:
[Arch Neurol -- Abstract] "Conclusions: High-dose cyclophosphamide treatment in patients with severe refractory multiple sclerosis can result in disease stabilization, improved functionality, and improved quality of life. Further studies are necessary to determine the most appropriate patients for this treatment. "

 
"interleukin 27 (IL-27)... ":
"Research May Bring New Hope for MS patients....A SIGNALLING molecule that seems to dampen inflammation may help scientists develop new treatments for MS. Two studies published in the journal Nature Immunology highlight the role of interleukin 27 (IL-27) in the brain. IL-27 is a protein belonging to a large family of molecules called cytokines which send signals between cells. Some cytokines are believed to trigger inappropriate immune system responses, resulting in inflammation and auto-immune diseases like MS. Two teams of scientists artificially induced MS-like reactions in the brains of mice......

Thursday

 
NeuroVax: Immune Response Corporation Receives $9.9 Million...Raising Aggregate $17.9 Million from 2006 Financing:
"Funding Will Support Continuation of Phase II Clinical Trials In MS. The Company's lead immune-based therapeutic product candidates are NeuroVax(TM) for the treatment of MS..."

Wednesday

 
Cannabis-Based Pain Treatment: SATIVEX
"European authorities asked for two phase III trials of Sativex against neuropathic pain in the same patient group, Salisbury, England-based GW said today. Phase III is the last of three stages generally required for approval. Sativex was delayed by U.K. regulators in June 2005 and has yet to gain approval for spasticity, or stiffness and spasms in multiple-sclerosis patients. GW said in March that it may ask European regulators to approve the medicine before the U.K....``One of the principal purposes of this study is to complete the regulatory package required for the approval in Europe of Sativex in the indication of neuropathic pain in MS,'' said Stephen Wright, the company's head of research.

Sativex was delayed by U.K. regulators in June 2005 and has yet to gain approval for spasticity, or stiffness and spasms in multiple-sclerosis patients. GW said in March that it may ask European regulators to approve the medicine before the U.K.

Shares in GW fell 5.5 pence, or 6.1 percent, to 84.5 pence by 8:45 a.m. in London trading. They rose 17 percent yesterday and have fallen 44 percent this year.

Canadian regulators approved Sativex, administered as a mist sprayed inside the mouth, for use in neuropathic pain caused by nerve damage, in April 2005."

 
SATIVEX: GW Pharmaceuticals :
"GW Pharmaceuticals Wednesday announces the start of a second pivotal Phase III trial in people with multiple sclerosis (MS) suffering from central neuropathic pain....This Phase III study is a double-blind randomised placebo-controlled study of Sativex in 218 patients with central neuropathic pain due to MS, who have achieved inadequate pain relief with existing therapies.....