May 8, 2013
Pharma Halts Alzheimer’s Drug Trials Due To Ineffective Results
Brett Smith for redOrbit.com - Your Universe Online
"We are currently re-evaluating our approach," he told reporters. “There is a lot of hypothesis but there are a lot of question marks here as well.”
According to the drugmaker, study participants with a moderate form of Alzheimer´s and those with a genetic mutation that increased risk of the disease who took elevated doses of the treatment didn´t see enough of a benefit to conclude that the drug is effective.
Gammagard is already on the market to treat certain blood conditions, and therefore already approved by the FDA for that use. The drug is an immune system treatment derived from natural antibodies that were taken from healthy blood donors. The therapy, also known as intravenous immunoglobulin (IVIG), is typically used to reduce infections in patients with lowered immune systems.
The 18-month clinical study that involved approximately 390 patients was expected to find that the treatment helped to reduce beta-amyloid plaques, which are associated with Alzheimer's and other neurodegenerative diseases. Hopes had been boosted by previous trials that showed the drug had successfully stabilized Alzheimer's in four patients who had received high doses over three years.
According to study leader Dr. Norman Relkin of Weill Cornell Medical College, there were "some significant findings" in another dementia screening test of the drug.
"There were also trends of significance looking at patients with moderate versus mild disease," he told Julie Steenhuysen of Reuters.
The doctor added that the study showed a "very different type of result" than seen in most other phase 3 trials of immunotherapies, which tend to show an effect in patients with a mild form of the disease.
Hantson said that the company is still evaluating the data from the trials and there were signs that the higher of two doses in the trial might benefit patients with a moderate case of the disease, as opposed to milder forms, and in patients with a risk-raising gene variant called ApoE4.
He added that the company wanted to at look data it did not yet have, including brain atrophy information measured by MRI scans and the amount of amyloid proteins in the blood and spinal fluid. Depending on the additional results, the company might decide to begin new trials for certain categories of patients and the company said it will probably make a decision about moving forward with trials of the drug by the end of the year.
The first signs of Alzheimer´s is typically attributed to stress or aging. Some neurophysical tests can reveal the disease in patients about eight years before the person fits the clinical definition. Once they fit the clinical definition of Alzheimer´s, patients usually die within eight years of their diagnosis.
Currently, no cure has yet been developed for the disease, which affects approximately 36 million people worldwide, including five million in the US alone. Some pharmaceutical treatments are capable of slowing the progression of Alzheimer's or treating its symptoms.