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Last week Newstalk ZB reported Christchurch Neurologist, Dr Debbie Mason, as describing Tysabri® as a dream for MS sufferers who had trialled it in one of a number of safety trails around the world.
“She has four patients in the trial and says that they have all tolerated it very well. Dr Mason says there is mounting evidence Tysabri® has the potential to keep patients in the early stage of the disease from progressing. Her patients have all so far remained at the mild end of the disease spectrum.”
Tysabri® has been recently approved in New Zealand by Medsafe for relapsing remitting MS (see News RoundUp 29). It is a lab-produced drug called a monoclonal antibody administered by IV infusion once every four weeks. It is designed to hamper movement of potentially damaging immune cells from the bloodstream, across the "blood-brain barrier" into the brain and spinal cord. It works by blocking the receptors on white blood cells that allow these cells to enter the brain and spinal cord. Keeping these “nasties” out, leads to a decrease in inflammation.
Biogen Idec, its producer, says: “Tysabri® represents one of the most significant advances in MS treatment in nearly 10 years and provides people living with this disabling disease an important new therapeutic choice.”
In 2004, one year’s data showed that it slowed the progression of disability, has a positive effect on MRI scan results, and those taking the drug could experience a two-thirds reduction in MS relapse rate—double the benefits offered by all other MS DMDs. Typically, it has been used to treat people with relapsing-remitting MS who do not respond to other DMDs and who continue relapse and deteriorate physically.
Tysabri is also approved in Canada, USA, throughout Europe, in the UK and Australia.
The MS International Federation has awarded a further two Du Pré Grants to young MS researchers in the second round of the 2007 awards.
The researchers, Dr Jennifer Somerfield from New Zealand and Dr Ingrid van der Mei from the Netherlands, will undertake MS research projects in the UK and USA respectively.
The Du Pré Grant will enable Dr Jennifer Somerfield (featured in the August edition of MS Voice) to return to the University of Cambridge in the UK where, she spent the last year working as part of the Therapeutic Immunology Group in the Department of Clinical Neurosciences. Her two month visit in 2008 will provide her with the opportunity to continue working on three collaborative projects; the phase 3 trials of Campath-1H versus Rebif and investigations into the role of a T cell prostaglandin receptor in MS and techniques to induce tolerance to therapeutic monoclonal antibodies.
Dr Ingrid van der Mei will travel from the Menzies Research Institute, University of Tasmania, to the Harvard School of Public Health, Boston, USA. The visit will support Dr van der Mei’s aim of developing an International Consortium on Gene-Environment Interactions in MS.
The successful recipients were selected by the members of the MSIF International Medical & Scientific Board’s Du Pré Grant Work Group.
Du Pré Grants are offered twice a year but nominations can be received at any time.
The next nomination deadline is 15 February 2008; visit the Du Pré Grants page in the Research section of the MSIF website for more information, or contact Zoe Burr, International Programme Officer.
This year MSIF awarded five McDonald Fellowships to young MS researchers from Argentina, Brazil, Romania, Spain and Thailand.
The Fellowship enables the recipient to work with the world’s leading researchers in MS with a view to returning to their own country to establish a programme of MS research that involves the application of the newly learned techniques.
Find out about the researchers MSIF will be supporting over the next two years
Long-term administration of Sativex, an oral spray consisting of natural cannabis extracts, reduces neuropathic pain without inducing tolerance in MS patients, according to clinical trial data published in the journal Clinical Therapeutics.
Twenty-eight patients completed the two-year, open-label extension trial. Investigators reported that patients required fewer daily doses of Sativex and reported lower median pain scores the longer they took the drug.
Authors also reported that drug’s administration was not associated with an increase in patients’ use of other analgesics – noting that several of the study’s participants reduced or ceased their use of pharmaceutical pain medications while taking Sativex. It has been estimated that more than one out of four MS patients suffer from neuropathic pain.
“[Sativex] was effective, with no evidence of tolerance, in … patients with central neuropathic pain and MS who completed two years of treatment,” investigators concluded. “The use of [Sativex], per se, did not lead to a … major increase … in the use of new analgesics, which over at least two years is … a further indirect measure of sustained effectiveness in [this] population.”
Previously reported data on the long-term efficacy of Sativex has shown the drug to decrease spasticity and bladder dysfunction in people with MS.
In August, Canadian health officials granted regulatory approval to Sativex as an adjunctive treatment in adult patients with cancer pain. Canadian officials had previously approved the drug’s prescription use to treat MS-associated neuropathy.
Makers of the drug are seeking regulatory approval for Sativex in the United Kingdom, the European Union and in the United States.
Cannabis use in New Zealand is prohibited under the Misuse of Drugs Act 1975. Cannabis is a class C drug and cannabis preparations are class B drugs.
However, under the Misuse of Drugs Act and the Medicines Act 1981, a medical practitioner can—with the health minister's approval—access and prescribe controlled drug medication, such as cannabis-based medicine, for a patient under their care. So far, no applications have been successful.
Earlier this year, Labour MP Tim Barnett pressured his colleagues, writing to the then health minister, Hon. Pete Hodgson, to request an update on progress setting up a system to allow access to medical cannabis-related products.
Reported in the Dominion Post in February, he asked about clinical trials, and Mr Hodgson's response made the point that, regardless of the trial outcomes, there had not been at the time any applications to register medicinal cannabis products in New Zealand. Until such applications were made to Medsafe, the Health Ministry's drug regulator, they could not be considered.
The Ministry of Health, it is thought, believes pharmaceutical forms of cannabis would be more appropriate as a treatment than smoking leaf cannabis.
On the basis of a US survey of MS treatments, Copaxone® continues as a second-line treatment for MS, but use of Tysabri®® is increasing for refractory and aggressive cases. Teva Pharmaceutical Industries Ltd. makes Copaxone; Tysabri® is made by Biogen Idec Inc. and Elan Corporation. Analysts predict that Teva will "benefit from continued, though moderating, growth in Copaxone volumes and price."
Researchers state that: "Interferons are the mainstay as physicians overwhelmingly use them first. Of those, 34% of patients fail interferon. Interestingly, only 14% of interferon failures have been treated with Tysabri® compared with 35% with Copaxone. Of the 35% of patients who fail Copaxone, 16% get Tysabri®. All told, 15% of interferon and Copaxone failures go on to receive Tysabri®."
They also add that oral therapies could take a market share. "Physicians indicated that up to 65% of their patients could be switched to an oral therapy if it demonstrates comparable efficacy to injectable therapies. We believe that this could pose a threat to current interferon and Copaxone therapies, but it remains to be seen if their efficacy will be able to match those of the injectables."
Teva is developing an oral MS therapy laquinimod, which is in Phase III clinical trials for which the company hopes to recruit 1,000 patients.
The survey covered 50 US neurologists who treat 11,855 MS patients, 6% of all treated patients in the US.