Creatine and omega3s they will not be widely prescribed to treat HD until they are FDA approved drugs . Strangly the HDSA has not encouraged neurologists to prescribe these safe and effective treatments for HD.

The certainty that both omega3s and creatine are effective treatments for human HD goes to the the wonders of cell biology. Both omega3s and creatine are fundemental to basic cell processes. Omega3s are basic to cell synthesis and creatine is basic to cell energy production.

Scripts Biologist David Goodsell, author of "The Molecular Machinery of Life" says it well, "When interacting with the world, organisms must protect and isolate themselves, but at the same time, they must sense and respond to changing conditions. To perform these opposing functions, modern organisms have developed a bewildering variety of different molecular machines. The molecular machines of synthesis and energy production are nearly identical in all living organisms." [Emphasis added]

It is in protection and perception that humans differ from worms. Cell synthesis, related to omega3s, and energy production, related to creatine, are nearly identical in humans and worms. So if creatine and omega3s work for HD worms it is a sure bet that they will work for HD humans. --Jerry

Posted to HDLighthouse: 07-May-2002

FDA Grants Avicena Group Orphan-Drug Designation for Creatine for Use by ALS Patients The Avicena Group, Inc. announced that it has received Orphan-Drug Designation from the U.S. Food and Drug Administration for creatine to treat patients with ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig’s Disease). The company plans to submit an IND (Investigative New Drug Application) this year.

The Avicena Group, Inc. announced that it has received Orphan-Drug Designation from the U.S. Food and Drug Administration for creatine to treat patients with ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig’s Disease). The company plans to submit an IND (Investigative New Drug Application) this year.

Dr. Belinda Tsao-Nivaggioli, the company’s Vice President of Operations, said, “We are extremely pleased by the FDA’s action, which is a critical step in bringing this drug to market. Our extensive laboratory and clinical studies provide initial evidence of both creatine’s safety, even when used by seriously ill patients, and its efficacy.” She continued, “ALS is presently an incurable disease. Since initial results suggest that creatine can slow the disease’s progression and help maintain patient quality of life, we are excited about the prospect of eventually being able to deliver our product, controlled under the prescription drug regulations, to ensure that patients receive a drug-GMP product to aid in the management of their disease.”

Creatine is a critical element in cellular energy production and modulation. It is the substrate of the creatine kinase system which helps prolong cellular life and protect against cell injury and death.

Avicena is supporting three clinical studies on the effects of creatine among ALS patients. A pilot study was conducted at Cornell Medical Center in 1999. Ongoing Phase II/III studies, started in 1999, are being conducted at multiple centers coordinated by the Carolinas Neuromuscular ALS/MDA Center in Charlotte North Carolina and the North East ALS Consortium, consisting of over 300 patients at 29 sites. Preliminary data from three centers in the Carolinas Neuromuscular/ALS study are very encouraging.

Dr. Jeffrey Rosenfeld, Director of the Carolinas Neuromuscular ALS/MDA Center and lead investigator of the Carolinas Neuromuscular ALS study, commented, “We have seen, and continue to see, encouraging results among ALS patients, as measured by muscle strength and a decreased rate of deterioration. Additionally, creatine has a long history of safe use, and is well tolerated by patients in the study.”

These clinical studies build on Avicena’s extensive pre-clinical studies, 14 of which have been published, which demonstrate that creatine, in transgenic mouse models, has a neuroprotective effect in ALS, Huntington’s disease, and Parkinson’s disease.

ALS is a progressive and fatal disease that attacks motor neurons, the components of the nervous system that connect the brain with the skeletal muscles. More than 5000 people in the U.S. are diagnosed with ALS each year, with about 30,000 having the disease at any given time. Worldwide, ALS occurs in 1 out of every 100,000 people across racial, socioeconomic and ethnic boundaries. Among many notable persons to suffer from ALS are New York Yankee great Lou Gehrig and physicist Stephen Hawking.

Source: Avicena press release 26-Mar-02

	Read the HDAC/HDLighthouse Forum. Post your comments