EndocrinologySafety And Cognitive Stability Are Key Findings In Phase IIA Trial Of New Alzheimer's Disease Treatment From Humanetics Corporation
The results of a preliminary clinical trial suggest that a new Alzheimer"s drug from Humanetics Corporation is safe for daily use and that cognitive performance in patients with mild to moderate disease remained stable during the six-week course of the trial. The lack of decline in cognitive performance was an encouraging finding to be further evaluated in a Phase IIB clinical trial.
Phase IIA clinical findings were presented in Vienna today at the 2009 Alzheimer"s Association International Conference on Alzheimer"s Disease (ICAD 2009) by investigators from The Mount Sinai School of Medicine (MSSM). The study was conducted at The Mount Sinai Alzheimer"s Disease Research Center in New York, a nationally renowned center of excellence since 1984 offering a comprehensive clinical program and research facility dedicated to the study and treatment of both normal aging and Alzheimer"s disease.
Study investigators Giulio Maria Pasinetti, M.D., Ph.D. and Hillel Grossman, M.D., both of Mount Sinai School of Medicine, each made a poster presentation on NIC5-15 at ICAD 2009. Dr. Pasinetti said his findings supported the conclusion that "NIC5-15 is a safe and tolerable natural compound that may alleviate Alzheimer"s disease dementia through multiple mechanisms including Abeta lowering activities. These early findings suggest the need for further investigation of NIC5-15 in the treatment of Alzheimer"s disease."
The Phase IIA trial was sponsored by Minneapolis, MN-based Humanetics Corporation which also has exclusive rights to develop and commercialize NIC5-15 to treat Alzheimer"s disease. The Mount Sinai School of Medicine has provided to Humanetics certain intellectual property rights related to these studies from which MSSM and Dr. Pasinetti, as Principal Investigator of the Phase IIA study, would be entitled to receive royalties from the sale of NIC5-15. Humanetics is currently seeking a pharmaceutical partner for FDA approval and commercialization of the product.
The double-blind placebo controlled pilot safety and efficacy study was conducted by Mount Sinai investigators on patients with mild to moderate Alzheimer"s disease. Patients, who had an average age of 70 years, were given escalating oral doses of NIC5-15 over a 45-day period. Investigators collected preliminary evidence of treatment efficacy including cognitive and global measures and secondary outcomes including activities of daily living, behavioral disturbances, pharmacokinetic parameters and a number of Alzheimer"s disease biomarkers including Abeta peptide levels.
"We are encouraged by these preliminary findings on NIC5-15," said Ronald Zenk, President and CEO of Humanetics Corporation. "The ability to identify new treatments that can modify the progression of Alzheimer"s disease is an important milestone that Humanetics and Mount Sinai are working towards in this research. We believe that intervention with NIC5-15 can make a significant difference in people"s lives, and we are hopeful that these preliminary learnings will be supported in subsequent clinical trials."
Phase IIB clinical trials on NIC5-15 will begin later this year under funding support from both the National Institutes of Health and the Department of Veterans Affairs.
Alzheimer"s: A Devastating Disease
Alzheimer"s disease affects 5.2 million Americans and another 5 million with early-stage disease. Nearly a half million new cases are reported annually. The cost of caring for the current Alzheimer"s population is estimated to be $100 billion per year.
There are no FDA-approved Alzheimer"s disease modifying drugs available today. Current drugs approved for use help maintain cognitive function, but only for a limited time. NIC5-15 is part of a new class of drugs known as gamma-secretase inhibitors that are thought to prevent the formation or increase of amyloid plaque in the brain, now recognized as an important biomarker for Alzheimer"s disease. The NIH is providing research support in this area.
NIC5-15 is different from many of the gamma-secretase inhibitors in that it is a natural compound, rather than a new chemical entity. Preclinical studies demonstrated that NIC5-15 worked directly to prevent accumulation of amyloid plaque in the brain. Preventing amyloid plaque formation may change the natural course of the disease, allowing Alzheimer"s disease patients to retain their current mental and physical abilities for a longer period of time.
Humanetics Corporation