MS: Promising therapies take new approaches
We know that about 400,000 people in the United States currently suffer from multiple sclerosis (MS), and it's more common in women and Caucasians. We also know that early treatment of the condition makes a difference. Recently, we've read that Biogen Idec and Elan Corp. were given the go-ahead to reintroduce natalizu-mab (Tysabri) for the treatment of relapsing forms of MS. But beyond that, we haven't heard too much lately regarding the treatment of this devastating disease. What, if anything, coming down the pipeline looks promising? Here are a few of the possibilities:
- Cladribine, from Serono, has just been granted fast-track designation by the FDA. The drug is an orally available purine nucleoside analog that interferes with the proliferation and behavior of lymphocytes involved in the pathological process of MS. A phase III trial in more than 1,200 patients over two years is evaluating endpoints, including assessments of clinical relapses, MRI brain scan, and disability progression. According to Serono, cladribine has the potential to be the first oral therapy to treat relapsing forms of MS.
- From Immune Response Corp., in collaboration with Oregon Health & Science University, is a new immune-based therapy called NeuroVax, currently in phase II trials as a potential treatment for relapsing forms of MS. The product works by stimulating a strong disease-specific, cell-mediated immunity and enhancing levels of FOXP3+ regulatory T-cells (Treg) that are able to down-regulate the activity of pathogenic T-cells that cause MS. According to the company, research has shown that low levels of FOXP3+ Treg cell responses are associated with the pathogenesis and progression of MS and other autoimmune diseases. Research has also shown that MS patients have abnormalities in FOXP3+ message and protein expression in peripheral Treg cells.
NeuroVax, administered by intramuscular injection, contains a combination of three T-cell receptor (TCR) peptides that represent immunogenic regions from TCRs that are expressed by the pathogenic T-cells in MS patients. The three peptides are BV5S2, BV6S5, and BV13S1. The firm has also developed a stable formulation of these three peptides (Incomplete Freund's Adjuvant) that, when injected, elicited a strong immune response in over 90% of the MS patients who received it. These responses to peptides are important, since clinical data show a correlation between the strength of T-cell response to TCR therapy and clinical benefit after one year of therapy.
- BHT-3009 is an antigen-specific treatment for MS from Bayhill Therapeutics. Currently in phase II trials, the drug is the first human-specific DNA plasmid for MS, according to the company. The plasmid has been designed to down-regulate rogue T cells specific for myelin basic protein (MBP). If left unchecked, these T cells shred the myelin sheath that insulates the nerve cells of the brain and spinal cord, resulting in MS. The down-regulation occurs only in the MBP-specific T cells, leaving the remainder of the immune system intact to fight infections. According to Bayhill, "BHT-3009 expresses full-length MBP, thereby encompassing all possible target autoantigens, rather than a single autoantigen, and allowing for broader possible population of responders to the drug."
MORE ARTICLES IN THIS ISSUE
CMS sued for its Part D marketing guidelines
A public interest law firm has sued the government over the restrictions placed on pharmacists and other healthcare providers in helping Medicare beneficiaries choose a Part D plan. The suit claims that the rules in the marketing guidelines are a violation of free speech.
Nobody does it better: This annual feature salutes independent pharmacies and the many special services they provide
Going the extra mile. Bending over backwards to serve. That's what sets some independent pharmacies apart. To learn who these standouts are, Drug Topics once again invited wholesalers across the United States to nominate their independent pharmacy customers that excel in four categories.
New product newswire: October 10, 2006
According to the company, this is the first FDA-approved orally disintegrating tablet form of prednisolone. The drug is used primarily for acute exacerbations of asthma in children and is also indicated for the control of severe, persistent asthma and to reduce the inflammation associated with various medical conditions, including arthritis and cancer. The drug will be marketed by Atlanta-based Alliant Pharmaceuticals.
Consumers happy with pharmacy experience
For the fifth consecutive year, consumer satisfaction with pharmacies has risen, according to the 2006 Pharmacy Satisfaction Digest. Ninety-eight percent of respondents reported that they were either highly satisfied or satisfied with their pharmacy, up from 95% in 2002. Moreover, the number of respondents indicating that they were highly satisfied rose to 58%, a gain of 5% over the 2005 results and 13% higher than the 2002 results.
R.Ph.s can help patients use anticoagulants safely
On behalf of the Senior Outpatient Medication Safety (SOS Rx) Coalition, the National Consumers League (NCL) recently commissioned Harris Interactive to conduct three surveys, one each of patients taking oral anticoagulants, their caregivers, and physicians who frequently prescribe these medications. The survey was made possible by an unrestricted educational grant from AstraZeneca.