A drug developed by a University researcher that could potentially help patients stricken by amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, has been shown to be safe and is now being researched by a Pennsylvania-based drug development company.
Neurology Prof. James Bennett said his most recent research established the safety of his drug, called R-(+)-pramipexole, which he patented through the University Patent Foundation.
"We know that people can tolerate sizable doses," Bennett said.
The effectiveness of the drug in alleviating the struggles of ALS has not been fully determined, Bennett said, although research has found "a positive trend" when using the drug.
"What everyone is hoping for is that it will slow down the progression of the disease," Bennett said. "It could help people live longer and have a better quality of life."
Bennett said research has been ongoing for several years, and in spring 2004, he shifted the focus of the project from lab work to human testing.
The only drug currently available to treat ALS patients, Riluzole, is "minimally effective," Bennett said.
Now that the relative safety of the drug has been determined, Knopp Neurosciences has taken over the development and will continue researching the drug, according to Knopp spokesperson Thomas Petzinger, Jr.
"We became aware of the work by Dr. Bennett and were extremely intrigued by the rationale and the biological plausibility of Dr. Bennett's hypothesis," Petzinger said, noting that the additional research to be conducted by Knopp fits the company's focus on treating neurological disorders.
"We saw this compound as being highly worthy of testing," Petzinger said.
The version of the drug being tested by Knopp is a "high-purity formulation" of Bennett's developed drug, Petzinger said.
Petzinger added that Knopp has already completed Phase 1 of its study and will be entering Phase 2A in the next few weeks. Phase 1, according to Petzinger, tested the drug on healthy patients, while Phase 2A will study the effect of the drug on patients with ALS.
"We'll [now] be assessing safety and tolerability in ALS patients," Petzinger said.
Petzinger added that the study will be continue for several months.
"It's a complex study with the number of start and stop dates," he said.
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