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[Definitie:] "An ergogenic aid is any substance or phenomenon that enhances performance."
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2 6 - 0 3 - 2 0 0 5 Wyeth Initiates Clinical Trial with Investigational Muscular Dystrophy Therapy MYO-029
Wyeth: News & Announcements
Philadelphia, PA, February 23, 2005 – Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), will examine the safety of its novel investigational recombinant antibody MYO-029 in a phase one/two clinical trial in adult patients with muscular dystrophy (MD). The trial is open to adult patients with facioscapulohumeral MD (FSHD), Becker MD (BMD) and limb-girdle MD (LGMD); further details are available at www.clinicaltrials.gov. Results of the study are expected to be available in late 2006. “Presently there is no cure for muscular dystrophy. Although this trial represents an early stage of the drug development process, we are encouraged by the initiation of this trial, which could be a promising step toward a therapy for muscular dystrophy," says Robert Ross, President and CEO of the Muscular Dystrophy Association. The recombinant human antibody MYO-029 is designed to bind to and inhibit the activity of myostatin (growth and differentiation factor 8 or GDF-8), a protein that prevents skeletal muscle formation. Preclinical studies were conducted in a mouse model for muscular dystrophy contributing to the development of this clinical program. “This phase one/two trial will allow Wyeth to collect safety data that could lead to further, more advanced studies to investigate whether MYO-029 has any effect on treating muscular dystrophy. We are committed to moving forward in this critical therapy area and are developing other products that target GDF-8,” reports Robert R. Ruffolo, Ph.D., President, Wyeth Research and Senior Vice President, Wyeth. Twelve clinical sites will participate in this trial. Information on active sites is available at clinicaltrials.gov. This prospective, randomized, placebo-controlled study will include a total of 108 patients, including equal numbers of patients with FSHD, BMD and LGMD. About Muscular Dystrophy Muscular dystrophy is characterized by a progressive wasting and weakening of muscle fibers. The disorder can be classified into six major types, all of which are inherited. The common feature of these disorders is absence of one of several proteins involved in linking F-actin (a muscle fiber component) to the sheath of tissue surrounding the fiber. Breakdown of this link interferes with muscle tissue integrity and strength. In the late stages of muscular dystrophies, fat and connective tissue can replace muscle fibers. Wyeth estimates that muscular dystrophies affect more than 110,000 people in the United States. Facioscapulohumeral MD (FSHD) is the third most common genetic disease of skeletal muscle and affects about 20,000 people in the United States. A single abnormal gene can cause FSHD in either men or women. In this form of MD, the facial and shoulder muscles are always affected, causing difficulty in whistling, closing the eyes tightly, or raising the arms; in some, feet may drop or flop down. Many people are only mildly affected by FSHD, although some patients may become dependent on wheelchairs later in their illness. Becker MD affects the skeletal muscles of the arms, legs and trunk and occurs almost exclusively in boys. Becker MD results from the production of less dystrophin, or of a structurally altered version of dystrophin that does not function properly. Becker MD, passed from mother to son via a defective gene on the X chromosome, affects about 5,000 people in the United States and first appears at about age 12. Patients with Becker MD can survive into middle age and beyond. Limb-girdle MD is a collective term for at least a dozen disorders affecting voluntary muscles, mainly those around the hips and shoulders — the pelvic and shoulder girdles, also known as the limb girdles. About 20,000 Americans have a limb-girdle MD disorder. Limb-girdle MD usually begins during the first two decades of life, and the disease is usually progressive, causing patients to lose the ability to walk 10 to 20 years after onset. About Wyeth Pharmaceuticals Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade-buying patterns, wars or terrorist acts, product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and uncertainties, including those detailed from time to time in the Company’s periodic reports, including current reports on Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Clinical trials sites for Wyeth Ayerst myostatin inhibitor MYO-029 clinical trial on FSH Muscular Dystrophy
fshsociety.org
Sites for myostatin inhibitor MYO-029 clinical trial on facioscapulohumeral muscular dystrophy (FSHD) are listed below. This is for your information. Get the word out to your family members with facioscapulohumeral muscular dystrophy (FSHD) and those you know who live close to the clinical trial test sites. Contact the doctors below if you are interested in participating in the trials. Myostatin inhibitors have never been tried in human trials. This is the first drug and first trial. FSHD is the lead candidate and prospect thanks to the work of the FSH Society, Inc. Each site will enroll 12 patients. 4 FSHD, 4 LGMD, 4 Becker MD. Initial toxicity studies are done. There some side effects that are consistent with monoclonal antibody therapy. This next stage of the trial is to determine dosing at three different levels and clinical efficacy. Patients must be genetically confirmed. The MSTN-inhibitor drug is administered via intravenous infusion. Initial patient visit/transfusion may or may nor require an overnight stay. New infusion every other week for six months and three more months follow-up. Two muscle biopsies are optional. Patients should have average muscle strength grade of 3. As general rule patient should be able to walk 30 feet unaided except for use of orthotic braces e.g. AFOs. 9 sites U.S.. 2 or 3 sites U.K. are currently enrolling four FSHD patients and you may wish to contact the following. Most will request that you be within one hour of the hospital given the number of visits. Wyeth-Ayerst sites for myostatin inhibitor MYO-029 clinical trial:
List based on my best information to date.
My best,
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