February 25, 2005

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.

MDA is the nonprofit health agency dedicated to curing muscular dystrophy, ALS and related diseases by funding worldwide research. The Association also provides comprehensive health care and support services, advocacy and education.