Myostatin Blocker to be Tested in Clinical Trial

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MYOSTATIN BLOCKER TO BE

TESTED IN CLINICAL TRIAL

TUCSON, Ariz., Feb. 27, 2005 — Wyeth Pharmaceuticals (Collegeville, PA) will

fund and conduct a clinical trial of MYO-029, a compound that blocks myostatin,

a natural protein that ordinarily puts a brake on the growth of muscles, the

Muscular Dystrophy Association (MDA) announced today.

MDA will further facilitate the conduct of the study by providing supplemental

research grant support to the clinical sites for this trial.

“This is one of the many approaches being pursued for muscular dystrophy, but we

are enthusiastic about its potential, in part because it relies upon

protein-blocking technology that has already reached the clinic for other

disorders,” said Sharon Hesterlee, MDA Director of Research Development.

Both MDA-funded investigations and Wyeth-conducted research have suggested that

blocking myostatin’s activities might improve muscle growth and survival and at

least partially offset the muscle degeneration associated with certain

disorders. MDA continues to fund research on the biological mechanisms

underlying myostatin’s effects.

Wyeth is developing MYO-029, which is a laboratory-engineered human antibody

(immune-system protein) that sticks to myostatin and interferes with its

functions.

The Wyeth trial will be a “prospective, randomized, placebo-controlled safety

study,” a company spokesperson said. “Prospective” means participants will be

followed through time. “Randomized” means participants will be randomly selected

to receive either the drug or a placebo (inactive substance), and

“placebo-controlled” means participants taking the drug will be compared with

those taking a placebo.

The study will be open to a small number of adults with facioscapulohumeral

muscular dystrophy (FSHD), Becker muscular dystrophy (BMD) and limb-girdle

muscular dystrophy (LGMD). Release of results is anticipated in late 2006.

Approximately twelve medical centers will participate in the trial, which is

slated to open this spring. Information about active sites can be found at

www.clinicaltrials.gov.

Almost all the U.S. investigators are directors of MDA neuromuscular disease

clinics.

Wyeth considers this a phase 1/2 study, which indicates that the compound has

already been tested for basic safety in healthy volunteers and that it will now

be tested to evaluate its safety in muscular dystrophy patients. In addition to

safety, the study will include preliminary assessments of MYO-029’s biological

activity.

The study is posted on the Web at www.clinicaltrials.gov, where details and

information about participation can be obtained.

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