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News In Brief
Promising Drug Trial Does Not Reach Hoped-for Endpoints
On July 2, Titan Pharmaceuticals, Inc., announced that Spheramine®, a treatment under investigation for use in advanced Parkinson’s disease (PD), did not meet its primary and key secondary endpoints in a Phase IIb clinical trial.
Spheramine is an experimental treatment derived from cells found naturally in the human eye — human retinal pigment epithelial cells (hRPE) — that have the ability to produce levodopa. Levodopa is the precursor to dopamine, the neurotransmitter needed by people with PD to improve movement. Researchers had theorized that if Spheramine were implanted in the brain, it would increase dopamine production and thereby reduce the symptoms of Parkinson’s. In 2004, the US Food and Drug Administration (FDA) granted the experimental treatment fast-track status, an expedited process reserved for drugs that are seen to have potential to treat serious disease.
The Phase IIb multi-center, double-blind, randomized study tested the safety, tolerability and efficacy of Spheramine in 71 people with PD between 2003 and 2007. Spheramine must be delivered through a surgical procedure that is performed on either one or both sides of the brain. In this case, the treatment was implanted in certain participants on both sides of the brain, while others underwent a “sham surgery.” Results from the study showed no difference in symptom relief between the two groups after 12 months of follow-up.
With this news, hopes about the treatment’s potential to be effective and to reach market, have diminished. Bayer Schering Pharma AG, Titan’s partner in developing and commercializing the treatment, has announced that it will no longer develop Spheramine
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Does Cholesterol Affect the Development of PD?
Recent scientific literature has provided conflicting evidence on the relationship between cholesterol and Parkinson’s disease (PD). Some studies have found that high cholesterol levels may signal an increased risk for developing PD, while others have determined that low cholesterol levels may lead to PD.
In a large prospective survey from Finland’s National Public Health Institute in Helsinki, published in the journal Neurology in May 2008, over 50,000 Finnish men and women were monitored for signs of PD for an average of 18 years. Gang Hu, M.D., Ph.D., the lead researcher, found that 321 men and 304 women in the group went on to develop Parkinson’s. Participants with a high blood cholesterol level who entered the study between the ages of 25 to 54 were more likely to develop PD than those with normal cholesterol levels. For older participants, aged 54 to 74 at baseline, high cholesterol had no bearing on whether they would someday develop PD.
Another large prospective study, published in the May 15 edition of Movement Disorders, produced very different findings. The Honolulu-Asia Aging Study, a survey that includes over three thousand men, indicated that individuals between 71 and 75 years of age with low cholesterol levels have an increased risk of developing PD.
While both studies were carefully designed and executed, it is not possible to account for every variable that might indicate a risk for developing PD. For example, both studies involved very restricted populations, whether in Hawaii or Finland, with distinctive environmental or other circumstances including dietary or lifestyle factors and genetic differences, that could influence PD or cholesterol levels.
So, should younger individuals with high cholesterol should be concerned about developing PD? Should these individuals take cholesterol-lowering drugs, called statins, to reduce their risk of PD? Right now, the relationship between cholesterol and PD requires further study to answer these questions.
Although the brain is rich in cholesterol, there is no clear scientific understanding of why cholesterol levels would directly affect the development of PD. But individuals with high cholesterol levels, of any age, should consult with their physicians about reducing their risk for heart attack and stroke.
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