Axonyx公司治疗 Alzheimer病的药物在Ii期试验
Hausman noted that the positive safety data could also help Phenserine's development as a potential agent to combat bioterrorism. Axonyx recently signed an agreement to test Phenserine and related compounds "against sarin gas and other toxic chemical agents," he said. "The safety data revealed in this phase II trial may be reassuring to the DOD in its efforts to validate the potential use of our compounds, including Phenserine, among our armed forces."
The drug, which the company describes as a third-generation acetylcholinesterase inhibitor, is believed to improve memory and cognition by prolonging signals between nerve cells in the brain. In addition, preclinical studies have suggested that it may slow production of beta amyloid precursor protein, which could help prevent a damaging build-up of beta-amyloid plaque in the brain, according to Axonyx.
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The drug is designed to have a short half-life with a strong uptake in the brain. "For any given dose of Phenserine, more of it will go to the brain, where it is needed to improve memory, than any other acetylcholinesterase inhibitor on the market today," Hausman told analysts during the conference call. "The enzyme binds in a very specific and tight manner that allows it to do what it is meant to do for a long period of time even while the blood levels of the drug are falling. These falling blood levels are more than likely the reason for the low rate of nausea and vomiting" found in study, he said.
, 百拇医药
Dr. Robert Burford, Axonyx's vice president of product development, said during the call that Phenserine, which is dosed twice daily, has a serum half-life of 90 to 120 minutes. "Compare that to Aricept, where the product is given once-daily, but has a half-life of approximately 70 hours," he said. "Exelon is also dosed twice a day, but has a half-life longer than ours, and we believe that's one of the reasons why it has such a high rate of nausea and vomiting," he added.
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The phase II trial was conducted at five US centers. Forty-eight patients were given 5 mg of Phenserine twice daily for two weeks and then 10 mg twice daily for 10 weeks--the maximum dose that was found to be well-tolerated in healthy phase I volunteers. The remaining patients were given placebo for 12 weeks, and all subjects then went through a four-week washout phase.
Dizziness, which occurred in 8 patients at the 10-mg dose, was the side effect reported most often. Company officials said that they will explore ways to manage dizziness during phase III. Possibilities include down-titrating the dose for some patients and making sure that the drug is taken with food, they said.
, 百拇医药
They also noted that, while relatively high, the rate of dizziness was still lower than that seen with some marketed Alzheimer's disease drugs.
Improvements in cognition were measured using the CANTAB test as well as the ADAS-cog memory and cognition test. The firm reported a 2.556-point improvement on the ADAS-cog test from baseline with Phenserine versus a 0.722 improvement for placebo.
Shares in Axonyx leapt more than 7% during Monday afternoon trading on the NASDAQ, but ended the day up only 2.34% at 4.60.
-New York Newsroom 212 273 1700, 百拇医药
The drug, which the company describes as a third-generation acetylcholinesterase inhibitor, is believed to improve memory and cognition by prolonging signals between nerve cells in the brain. In addition, preclinical studies have suggested that it may slow production of beta amyloid precursor protein, which could help prevent a damaging build-up of beta-amyloid plaque in the brain, according to Axonyx.
, 百拇医药
The drug is designed to have a short half-life with a strong uptake in the brain. "For any given dose of Phenserine, more of it will go to the brain, where it is needed to improve memory, than any other acetylcholinesterase inhibitor on the market today," Hausman told analysts during the conference call. "The enzyme binds in a very specific and tight manner that allows it to do what it is meant to do for a long period of time even while the blood levels of the drug are falling. These falling blood levels are more than likely the reason for the low rate of nausea and vomiting" found in study, he said.
, 百拇医药
Dr. Robert Burford, Axonyx's vice president of product development, said during the call that Phenserine, which is dosed twice daily, has a serum half-life of 90 to 120 minutes. "Compare that to Aricept, where the product is given once-daily, but has a half-life of approximately 70 hours," he said. "Exelon is also dosed twice a day, but has a half-life longer than ours, and we believe that's one of the reasons why it has such a high rate of nausea and vomiting," he added.
, http://www.100md.com
The phase II trial was conducted at five US centers. Forty-eight patients were given 5 mg of Phenserine twice daily for two weeks and then 10 mg twice daily for 10 weeks--the maximum dose that was found to be well-tolerated in healthy phase I volunteers. The remaining patients were given placebo for 12 weeks, and all subjects then went through a four-week washout phase.
Dizziness, which occurred in 8 patients at the 10-mg dose, was the side effect reported most often. Company officials said that they will explore ways to manage dizziness during phase III. Possibilities include down-titrating the dose for some patients and making sure that the drug is taken with food, they said.
, 百拇医药
They also noted that, while relatively high, the rate of dizziness was still lower than that seen with some marketed Alzheimer's disease drugs.
Improvements in cognition were measured using the CANTAB test as well as the ADAS-cog memory and cognition test. The firm reported a 2.556-point improvement on the ADAS-cog test from baseline with Phenserine versus a 0.722 improvement for placebo.
Shares in Axonyx leapt more than 7% during Monday afternoon trading on the NASDAQ, but ended the day up only 2.34% at 4.60.
-New York Newsroom 212 273 1700, 百拇医药