Aphios® Corporation today announced that it was awarded Phase I of a Fast Track SBIR grant from the National Institute of Aging (NIA), National Institutes of Health (NIH) for Developing a Novel Alzheimer´s Disease Nanodrug.
Alzheimer´s Disease (AD) is the third largest cause of death in America and among the highest in the industrial world. AD is a significant neurological disorder that affects more than 4.5 million Americans and more than 10 million people worldwide. This problem will increase with the demographics of the aging populations in United States, Europe and Japan. Experts estimate that 22 million people around the world and more than 8 million Americans would be afflicted with AD by 2025. The total market for AD drugs in 2005 was over $2.7 billion. Due to the changing demographics, the market is expected to grow quickly. Because of the growing number of new cases each year, the market is expected to grow at a rate of 17.5%. The lack of a cure for AD will result in a demand for better and safer AD drugs.
Five prescription drugs are currently approved by the U.S. Food and Drug Administration to treat people who have been diagnosed with Alzheimer´s disease (AD). While these drugs may treat the symptoms of AD, none of these medications are a cure for the disease. Four of these medications, including Aricept®, are called cholinesterase inhibitors and are prescribed for the treatment of mild to moderate AD. They may help delay or prevent symptoms from becoming worse for a limited time and may help control some behavioral symptoms. The fifth approved medication known as Namenda® is believed to work by regulating glutamate, another important brain chemical that, when produced in excessive amounts, can cause excitotoxicity that leads to brain cell death. All of the drugs on the market today have serious side effects.
Recently, researchers have shown that sub-nanomolar concentrations of APH-0703, a potent PKC activator, can dramatically enhance the generation of non-amyloidogenic, soluble amyloid precursor protein (sAPP) in fibroblasts from AD patients. APH-0703 was effective in reducing brain amyloid plaques (A40 and A42 in AD) in double-transgenic mice while improving behavioral outcomes and the rate of premature death. APH-0703 not only produced a neuroprotective effect but enhanced cognitive memory in AD animal models and led to synaptic re-growth in stroke models.
Aphios manufactures pharmaceutical-grade APH-0703 following cGMP guidelines utilizing patented manufacturing technology. Aphios has also developed and patented improved methods for formulating the API into phospholipid nanosomes that can be utilized to enhance efficacy, reduce toxicity and improve quality-of-life, and polymer nanospheres for improving oral delivery and bioavailability. The grant will be utilized to develop and evaluate conventional and nanotechnology formulations of APH-0703; measure pharmacologic efficacy in the brain and plasma compartments; cGMP manufacturing of the active pharmaceutical ingredient and nanoformulated drug product at the pilot-scale level; establish a Drug Master File; design IND-enabling preclinical studies and Phase I/II clinical trials; and draft IND package for the US FDA.