Promising MS drug?

[cougarnurse]

This was too good not to post:
ScienceDaily (Apr. 19, 2008) — A drug that can be taken orally reduces the number of attacks people with multiple sclerosis (MS) have, according to new research.
"All of the current treatments for MS must be injected, so having a pill you can swallow with a glass of water would be a welcome improvement for many people," said study author Giancarlo Comi, MD, of Vita-Salute San Raffaele University in Milan, Italy.
The results reported are from an extension of a six-month study with 281 people with relapsing MS, two-thirds of whom took the drug FTY720 (fingolimod) and one-third of whom took a placebo. After six months, those taking FTY720 had more than 50 percent fewer relapses, or attacks, than those who took the placebo. At that point, all of the participants could enter an ongoing extension of the study where all would receive the drug.
A total of 173 people have finished three-years of the study. Continuous use of the drug led to sustained low relapses, with more than 67 percent of the participants remaining free of relapses after three years. In addition, the inflammatory activity associated with MS, as assessed by MRI scans, remained low, with 89 percent of patients free of disease activity and 75 percent of patients free of new or newly enlarged lesions.
"The first line treatments for MS, beta interferon and glatiramer acetate, reduce the relapse rate by only about 30 percent, so this is a significant development for people with MS," Comi said.
The most frequently reported side effects of the drug were headache, fatigue, flu, and cold symptoms.
FTY720 is an immune-modulating drug that binds to a receptor site on immune cells, sequestering them in the lymph nodes. As a result, FTY720 reduces their ability to cause damage associated with the symptoms experienced by people with MS.
This research was presented at the American Academy of Neurology 60th Anniversary Annual Meeting in Chicago, April 12--19, 2008.
The study was supported by Novartis Pharma AG, maker of FTY720.

Comments, anyone?

[klincos]

UPDATE 3-Novartis says FTY720 trial continues despite death
Thu Jun 5, 2008 1:47pm EDT

By Sam Cage

ZURICH, June 5 (Reuters) - Novartis AG (NOVN.VX: Quote, Profile, Research) said two patients taking its multiple sclerosis drug FTY720 in clinical trials had problems with infections and one died, but the role of the medicine in the cases was unclear.

Independent experts recommended that clinical trials with the drug -- which unusually for an MS medicine is taken orally -- should continue as planned, the Swiss drugmaker said on Thursday.

"Novartis was recently notified of two infection-related incidents among FTY720 patients, including one fatality," the company said in a statement.

Novartis shares closed 0.7 percent lower at 54.45 Swiss francs on Thursday, with traders citing rumours that FTY720 trials had been stopped on safety concerns. The Novartis statement was released after the Zurich bourse closed.

"The efficacy data looks good and comparable to existing agents," said Sanford C Bernstein analyst Tim Anderson, who sees a launch of the drug in 2010 and sales of $1.2 billion by 2015.

"Existing MS drugs also have safety issues. Investors very much appreciate the tenuous balance of efficacy-risk with FTY720, but clearly a termination of this programme would be likely to hurt Novartis's share price performance nonetheless," said Anderson.

Shares of U.S.-based biotechnology company Biogen Idec (BIIB.O: Quote, Profile, Research), which sells MS drugs Avonex and Tysabri, were up 4 percent.

"The read-through is it would be good for Tysabri, it would be good for all the other MS drugs," said Leerink Swann analyst William Tanner.

"FTY720 I think historically has been looked at as being kind of a category killer for some of the injectable agents. If there are some issues that are compromising the study then that's going to be a problem," Tanner said.

Novartis said it was in talks with health authorities and experts to try and improve awareness of the risks of infections and how these may be reduced.

"Both cases involved confounding factors, including the use of very high doses of steroids in the first patient and the delayed use of antiviral therapy in the second patient," it said.

The company said FTY720's role in the cases was unclear but could not be excluded, since its mechanism of action leads to suppression of the immune system, which can increase the risk of infection.

Novartis had previously said it expected to submit the once-daily therapy, currently in late-stage trials, for approval before the end of 2009. (Additional reporting by Lewis Krauskopf in New York; editing by Rory Channing)