Parkinson's Disease

Avicena is presently developing several novel drug candidates for the treatment of Parkinson's disease. In preclinical studies performed by Dr. Flint Beal of Cornell Medical Center, the compounds have shown significant neuroprotective properties against dopamine depletion and loss of affected nerve cells. One drug candidate recently completed Phase II efficacy trials at the University of Rochester. Data from the study, which was published in the journal Neurology, showed PD-02 to be safe and tolerable. Furthermore, findings demonstrated that the rate of disease progression for PD-02 was lower than the threshold for futility, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS). This indicates that further study of PD-02 is warranted as a treatment for Parkinson's disease.

What is Parkinson's Disease
Parkinson's disease is a progressive, neurodegenerative brain disorder that occurs when the neurons within the brain that are responsible for producing the chemical dopamine become impaired or die. Dopamine is essential for the transmission of signals within the brain that control the smooth coordination of voluntary muscle movement. Once approximately 80% of the dopamine producing cells no longer function, the symptoms of Parkinson's begin to appear.

Parkinson's disease typically develops on one side of the body initially and then gradually begins to affect the other side. Symptoms may initially include uncontrolled shaking of the hands or feet and may progress to a point where routine tasks such as shaving and eating become severely impaired.

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Types of Parkinson's Disease
While 90-95% of patients develop Parkinson's disease after the age of 60, there is a small group of individuals that demonstrate symptoms before the age of 40. Referred to as "young-onset," this type of Parkinson's disease affects only 5-10% of all patients.

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Symptoms of Parkinson's Disease
The symptoms of Parkinson's disease often develop gradually and typically start on one side of the body and gradually spread to the other side. Primary symptoms of the disease include uncontrolled shaking of hands, arms, feet and legs (tremors), difficulty with balance, slowness of movement, and stiffness.

Additional Parkinson's disease symptoms may include a shuffling walk, muffled speech, stiff or blank facial expression, and depression.

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Progression of Parkinson's Disease
It is important to note that the rate of progression of the disease, as well as the resulting level of disability, may vary dramatically from patient to patient. Symptoms may at first be restricted to one limb and gradually spread to the other limb on the same side. Regardless, the disease eventually progresses to the point at which it affects both sides of the body.

Initial symptoms are mild and may include shaking of the hand. Over time, slowness in movement may seriously interfere with routine tasks such as getting dressed or showering. General mobility will also be affected, and patients may have a hard time getting out of bed or a chair. Difficulty keeping balance may result in falls. Additional symptoms like a cramped, illegible handwriting, as well as a monotonous and muffled voice, may also develop throughout the progression of the disease.

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Diagnosis of Parkinson's Disease
The diagnosis of Parkinson's disease is difficult as there are no specific tests to confirm the presence of the disease. Instead, a physician must perform a thorough series of examinations that are designed to rule out conditions that present similar symptoms. To this end, the most commonly administered tests are blood scans and MRIs.

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Causes of Parkinson's Disease
Parkinson's disease is a progressive, neurodegenerative brain disorder that occurs when the neurons within the brain that are responsible for producing the chemical dopamine become impaired or die. The cause of this nerve cell damage and death is not completely understood, however scientists suspect that a combination of genetic and environmental factors contribute to the disease. With regard to genetics, it is estimated that a family history of Parkinson's disease is present in approximately 5 - 10% of the patients.

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Incidences of Parkinson's Disease
It is estimated that roughly 1.5 million Americans are affected by Parkinson's disease, making it the second most common neurodegenerative disease after Alzheimer's disease. Approximately 60,000 new cases are diagnosed each year in the United States.

Parkinson's disease typically develops after the age of 60, affecting 1 out of every 100 individuals. Both men and women are affected equally and the disease affects all racial and ethnic groups.

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Treatment of Parkinson's Disease
While there is no known cure for Parkinson's disease, several medications have shown the potential to ease the symptoms of the disease. The therapies most commonly used are designed to replace or mimic dopamine in the brain. While not a cure, certain surgical procedures may also ease the symptoms of the disease. However, surgery is recommended only as a last resort.

Avicena is presently developing several novel drug candidates for the treatment of Parkinson's disease. Avicena recently completed a Phase II multi-center futility trial of PD-02, Avicena's proprietary Parkinson's disease treatment, led by researchers at the University of Rochester. The results of the study were published in the journal Neurology and showed that the rate of disease progression for PD-02 was lower than the threshold for futility as measured by the Unified Parkinson's Disease Rating Scale (UPDRS). The compound was also found to be safe and well tolerated. Based on these results, Avicena intends to initiate a Phase III trial with PD-02 in Q1 2007.

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