Stamulumab (MYO-029Wyeth Product Pipeline

Wyeth Wyeth, LLC was an American pharmaceutical company. The company was founded in Philadelphia, Pennsylvania, in 1860 as ''John Wyeth and Brother''. It was later known, in the early 1930s, as American Home Products, before being renamed to Wyeth in ...

, Website accessed April 22, 2007) is an experimental

myostatin Myostatin (also known as growth differentiation factor 8, abbreviated GDF8) is a protein that in humans is encoded by the ''MSTN'' gene. Myostatin is a myokine that is produced and released by myocytes and acts on muscle cells to inhibit muscle ...

inhibiting drug developed by

Wyeth Pharmaceuticals Wyeth, LLC was an American pharmaceutical company. The company was founded in Philadelphia, Pennsylvania, in 1860 as ''John Wyeth and Brother''. It was later known, in the early 1930s, as American Home Products, before being renamed to Wyeth in ...

for the treatment of

muscular dystrophy Muscular dystrophies (MD) are a genetically and clinically heterogeneous group of rare neuromuscular diseases that cause progressive weakness and breakdown of skeletal muscles over time. The disorders differ as to which muscles are primarily af ...

(MD). Stamulumab was formulated and tested by Wyeth in

Collegeville, Pennsylvania Collegeville is a borough in Montgomery County, Pennsylvania, a suburb outside of Philadelphia on Perkiomen Creek. Collegeville was incorporated in 1896. It is the location of Ursinus College which opened in 1869. The population was 5,089 at ...

. NIH's

ClinicalTrials.gov ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database, holding registrations from over 329,000 tr ...

Study Evaluating MYO-029 in Adult Muscular Dystrophy
record last updated January 24, 2007 Myostatin is a

protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, res ...

that inhibits the growth of muscle tissue, stamulumab is a recombinant human

antibody An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of t ...

designed to bind to and inhibit the activity of myostatin. Stamulumab is a G1

immunoglobulin An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of th ...

antibody which binds to myostatin and prevents it from binding to its target site, thus inhibiting the growth-limiting action of myostatin on muscle tissue. Research completed in 2002 found that Stamulumab might one day prove to be an effective treatment for Duchenne muscular dystrophy.Blocking Myostatin Proves Beneficial in Mice with DMD
MDA Research News, 27 November 2002

Phase 1 and 2 trials

Wyeth undertook a Phase 1 and 2

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...

in 2005 and 2006 of stamulumab. The multiple ascending dose trial (36 patients per

cohort Cohort or cohortes may refer to: * Cohort (educational group), a group of students working together through the same academic curriculum * Cohort (floating point), a set of different encodings of the same numerical value * Cohort (military unit) ...

) contained some measures of efficacy. The trial's participants included people afflicted with Facioscapulohumeral muscular dystrophy, Becker's muscular dystrophy, and Limb-girdle muscular dystrophy. Through 2007 Wyeth had been analyzing the results but the hoped-for news and/or a publication in 2007 did not occur.Wyeth Analyzing MYO-029 Results

Muscular Dystrophy Association The Muscular Dystrophy Association (MDA) is an American 501(c)(3) umbrella organization that works to support people with neuromuscular diseases. Founded in 1950 by Paul Cohen, who lived with muscular dystrophy, it works to combat neuromuscular d ...

announcement, December 4, 2006FSH Watch Newsletter
pg 11, FSH Society, Summer 2007 On January 24, 2008, Wyeth announced that the study had been accepted by a peer-reviewed journal and publication was expected "in the next few months".Pharma Company Responds to WiSci on Muscle-Building Drug
Wired Science, Alexis Madrigal, January 24, 2008, 2008, 4:26:27 PM The publication appeared in Annals of Neurology in May 2008. On 11 March 2008, it was announced that Wyeth would not develop the drug further for MD, but would continue to explore myostatin inhibition along with other strategies.Wyeth Won't Develop MYO-029 for MD
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References

{{TGFβ receptor superfamily modulators Wyeth brands Abandoned drugs Monoclonal antibodies Myostatin inhibitors

Phase 1 and 2 trials

See also

References