BG-12 trial

[Guest guest]

I may have a opportunity to participate in a clinical trial at the

University of Minnesota for BG-12 - an Immunomodulatory drug.

Wondering if anyone out there has any information or opinions on

this trial. I have been taking LDN since July, and doing well, I

think. Here is an article I found on BG-12.

BG-12 Psoriasis Study Meets Primary Endpoint; Oral Compound Also

Being Studied for MS in Phase II Trial

Business Wire, April 7, 2005

CAMBRIDGE, Mass., SAN DIEGO & LUCERNE, Switzerland -- Biogen Idec

(NASDAQ: BIIB) and Fumapharm AG today announced results from a Phase

III study designed to evaluate the efficacy and safety of BG-12, an

oral fumarate, in the treatment of moderate to severe psoriasis. The

trial met the primary endpoint and patients receiving BG-12

demonstrated a statistically significant clinical improvement as

measured by a lower median psoriasis severity score after 16 weeks

of treatment than patients receiving placebo.

" These data will be used to support a filing for market

authorization in Germany this year, " said Burt A. Adelman, M.D.,

Biogen Idec's Executive Vice President, Development. " We will work

with our partner, Fumapharm, to determine the next steps for the BG-

12 program. Additional Phase III studies would need to be conducted

for applications in the US and the rest of Europe. "

The trial, conducted by Fumapharm, was a multicenter, double-blind,

placebo-controlled Phase III study of 175 patients with moderate to

severe psoriasis. Patients were randomized to receive placebo (n=70)

or 720 mg of BG-12 a day (n=105) for 16 weeks. Patients were

evaluated using the psoriasis area and severity index (PASI), a

common measure of overall psoriasis severity. The primary endpoint

was the PASI score at 16 weeks.

At 16 weeks, the median PASI was 5.8 for the BG-12 group and 14.2

for the placebo group. Median percentage reduction from baseline

PASI was 68% for patients receiving BG-12 and 10% for patients

receiving placebo.

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In the study, the most commonly reported adverse events were

flushing and diarrhea. In addition, one patient was hospitalized for

pneumonia and one patient was hospitalized for kidney stones. The

data from the study will be presented at an upcoming medical meeting.

Biogen Idec also announced that a Phase II study of BG-12 in

patients with relapsing-remitting multiple sclerosis (MS) was

initiated in November 2004. The study, being conducted in Europe, is

a placebo-controlled, dose-ranging study designed to assess the

efficacy and safety profile of BG-12. The primary endpoint of the

study will be an MRI measurement of the amount of brain lesion

activity at six months. Approximately 250 patients are expected to

be enrolled in the study across 10 countries.

About BG-12

In October 2003, Biogen Idec licensed exclusive worldwide rights to

develop and market BG-12 from Fumapharm AG, a privately held

pharmaceutical company headquartered in Lucerne, Switzerland. BG-12

is an oral fumarate derivative with an immunomodulatory mechanism of

action. Biogen Idec is evaluating BG-12 in a range of diseases,

including psoriasis and MS.

About Biogen Idec

Biogen Idec (NASDAQ: BIIB) creates new standards of care in oncology

and immunology. As a global leader in the development,

manufacturing, and commercialization of novel therapies, Biogen Idec

transforms scientific discoveries into advances in human healthcare.

For press releases and additional information about the company,

please visit http://www.biogenidec.com.

Safe Harbor

This press release contains forward-looking statements regarding the

development of BG-12. These statements are based on our current

beliefs and expectations. They are subject to the risks inherent in

drug development, including the risks that the effects of the

product in larger clinical trials may not be as expected or that

there may be safety issues or other problems or delays that arise

during clinical trials, unexpected technical or manufacturing

hurdles, or intellectual property disputes. There is no certainty

that the risk/benefit profile of the drug will be acceptable to the

Company or to regulatory authorities for a particular indication.

Drug development involves a high degree of risk. Only a small number

of research and development programs result in the commercialization

of a product. Success in animal models or early stage clinical

trials does not ensure that later stage or larger scale clinical

trials will be successful. For more detailed information on the

risks and uncertainties associated with these forward looking

statements and Biogen Idec's other activities see the periodic and

other reports that Biogen Idec has filed with the SEC. Biogen Idec

does not undertake any obligation to publicly update any forward-

looking statements.

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