Biogen reports 6 new cases of PML with Tysabri

The article below is taken directly from Reuters.

If you are taking Tysabri, made by Biogen, we urge you to please go and speak with your doctors as the total number of deaths reported is now at 16, while 69 people remain in varying states of disability from PML–on top of having Multiple Sclerosis. More information on what PML is here at WebMd and here at Wikipedia.

Good source for all MS drugs is: Drugcompare.destinationrx.com.

More Tysabri information here, here and here.

Everything below is taken directly from Reuters.

Biogen reports 6 new cases of PML with Tysabri

(Reuters) – Biogen Idec Inc said six patients taking its multiple sclerosis drug Tysabri developed a potentially fatal brain infection in December, bringing the total number of such cases associated with the drug to 85.

The biotechnology company said that as of January 7, the overall incidence of progressive multifocal leukoecephalopathy, or PML, was 1.06 per 1,000 patients, up from 1.0 in 1,000 last year.

Biogen, which makes the drug with Irish drugmaker Elan Corp Plc, temporarily withdrew Tysabri from the market in 2005 after it was first associated with the condition; it was brought back, with stricter safety warnings, in 2006.

The drug is widely considered the most effective on the market, but its sales have been crimped by concerns over PML. The risk of the condition increases with the length of treatment.

After two years of monthly infusions, the incidence of PML is now 2.13 per 1,000 patients.

The overall rate of PML in clinical trials was 1 in 1000, a benchmark that has now been exceeded.

Of the 85 cases of PML reported, 16 patients have died, while 69 are still alive with varying degrees of disability.

Biogen is developing a test that it hopes will allow doctors to screen patients to identify which might be more likely to develop PML.

Biogen shares were down $2.02 or 2.9 percent to $66.76 in afternoon New York trading, while Elan shares were down 10 cents or 1.5 percent to $6.37.

(Reporting by Toni Clarke, editing by Gerald E. McCormick)

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Keeping an eye on Tovaxin from Opexa Therapeutics.

Why are we keeping an eye on Tovaxin? Because Opexa seems to understand that not killing the patient is the best way to go about trying to treat Multiple Sclerosis. The only adverse effects reported in the clinical trials so far have been mild to moderate reactions at the site of injection. No one has died!

Although there was a random glitch with their trials in 2009, where the control group had a very low relapse rate and the treatment group a high relapse rate, the newest trials have been very positive:

The analysis produced encouraging results which showed that these patients, when treated with Tovaxin, had a 64% reduction in annualized relapse rate versus placebo (p=0.046, n=70). This statistically significant efficacy result, coupled with the superior safety profile of Tovaxin, was highlighted during the FDA meeting to emphasize what the Company believes to be a promising benefit-to-risk profile for Tovaxin.

Opexa Therapeutics announced that they are preparing to start the late-stage clinical trials for Tovaxin, a new MS drug that uses your own T-cells to make a “personalized T-cell vaccination for the treatment of MS.”

Let’s break this down into easy to understand terms about how a “personalized T-cell vaccination” would work. Taken directly from Opexa’s website is this graphic that explains the process:

The treatment will consist of donating blood and creating a vaccine using the patient’s own cells. The vaccine cells will be irradiated to render them unable to divide, but able to evoke an immune response. The vaccines will be administered in the doctor’s office as a subcutaneous injection in the arm given five times a year.

No brain melt as can happen with Tysabri. No compromised immune system, bradycardia or macular edema as can happen with Gilenya. Campath, not as yet approved by the FDA, has had deaths in their clinical trials.

What remains to be seen is the cost. Will Opexa go the way Novartis did and charge $48,000 per year? (and Gilenya is a pill) or will they find a way to satisfy themselves and their shareholders and charge a reasonable fee for what looks to be a very promising therapy? Time will tell.

You can read more useful information from those who were in the Tovaxin trials here, at the This Is MS Forums.