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News RoundUp 36

as at 10 December 2007

Copaxone® treatment reduces risk of developing MS

The US National MS Society reported this week that Copaxone® (glatiramer acetate) has significantly reduced the risk of developing MS and delayed the development of MS in individuals with CIS (clinically isolated syndrome, a first event suggestive of MS) enrolled in the PreCISe study, according to a drug company press release dated December 3, 2007.

Based on these results, the company (Teva Pharmaceutical Industries) is stopping the study early and is giving all trial participants, including those who were taking inactive placebo, an opportunity to receive Copaxone for two years. The company also reports that it plans to file requests with regulatory authorities in the US, Europe and Canada to expand the labeling of Copaxone to include patients with CIS.

Read more at: http://www.nationalmssociety.org/site/PageServer?pagename=HOM_RES_research_2007dec6

and: http://www.reuters.com/article/health-SP/idUSN0341422420071203

A further report out this week suggests:

“Treatment of MS should start at the first onset of the disease. All patients, regardless of the type of MS, should receive adequate drug treatment after a first attack.”

This was one of the main conclusions at the international medical scientific conference on New Targets of Treatment in Multiple Sclerosis, organised by the independent European Charcot Foundation, November 29 - December 1, 2007, Italy. More than 320 scientists and clinicians in the field of MS from across Europe and abroad discussed the newest developments in treatment strategies.

Most current drug treatments are aimed at the suppression of relapses of Multiple Sclerosis. “In applying the available treatments, the neurologist has to know on which part of the immune system the therapy is aimed: the peripheral part of the immune system, the blood-brain barrier and/or the brain itself”, professor O.R. Hommes, chairman of the European Charcot Foundation stated.

During the congress, top level scientists in the field of MS thoroughly discussed a number of targets for new MS treatments and reliable measurement of clinically relevant effects. Today, medical science is increasingly supported by accelerating technical possibilities to analyse vast amounts of immunological samples in short time against low costs. The growing knowledge about a set of new biomarkers and the rapidly improving MRI imaging techniques were also mentioned as important developments to boost the search for accurate treatment.

“It is apparent that a promising line of new oral treatments is currently being developed, some of which are already being examined in phase III clinical trials. These drugs are all potentially 1st line treatments for MS and favour a high degree of tolerability for MS patients”, as was stated by Prof. G. Comi (Milan, Italy). Nowadays only injectable therapies are available.

“The enormous scientific efforts that are being undertaken throughout the world and the tremendous build-up of knowledge about the disease in recent years, give rise to an optimistic outlook at finding several curative treatments of MS in the next decade. Precise, predictive and personalised MS drugs against acceptable cost can be anticipated by 2020”, according to Prof. L. Steinman (Stanford University, USA) in his key note lecture.

 

Clinical study with the cannabis extract Sativex started in the USA

According to a press release by GW Pharmaceuticals, the British company and its Japanese partner Otsuka Pharmaceutical, began a phase III study of its cannabis spray Sativex pain-relief medicine for cancer patients. The five-week trial of 336 patients will test whether the drug reduces the pain of patients with advanced cancel who do not respond to opiates. The principal investigator of this study is Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City. The study will be conductet in approximately 40 centers primarily in the US. The primary objective of the study is to evaluate the potential role and dose of Sativex in these patients as an adjunct to their pre- existing pain medications.

GW Pharmaceuticals plans to report first findings from the study next year and expects to receive U.S. regulatory approval in 2011. Otsuka has exclusive rights to develop and market Sativex in the U.S. GW Pharmaceuticals estimates, that as much as 40 percent of cancer patients have severe enough pain to warrant a treatment with opiates.

Sativex is already approved in Canada for pain relief from advanced cancer and multiple sclerosis and restricted access to it is available in New Zealand.