Pharmaceutical Leaders Pave the Way to New Alzheimer's Treatments

NEW YORK, June 15, 2017 /PRNewswire/ --

Alzheimer's disease is a devastating brain disorder that now affects about 5.3 million Americans, accounting for one in nine people over the age of 65, according to the Alzheimer's Association. One in three seniors die with the disease or another form of dementia, and, while treatments to slow or stop the disease's progression have been lacking, several pharmaceutical companies are working to change that; India Globalization Capital, Inc. (NYSE: IGC) (IGC Profile), which has products that are backed by data of cannabis-based combination therapies to treat Alzheimer's, pain, seizures and a host of neurological and oncological issues, is lined up with Biogen, Inc. (NASDAQ: BIIB), Anavex Life Sciences Corp. (NASDAQ: AVXL), Axovant Sciences Ltd. (NASDAQ: AXON) and AC Immune SA (NASDAQ: ACIU) to develop medications they hope will yield promising results in treating a difficult and hard to treat illness.

The cost to the U.S. economy from Alzheimer's disease is estimated at $236 billion, including the costs of caring for individuals with the illness. Without effective treatments, the economic impact will continue to climb.

While industry behemoths like Pfizer and Novartis are obvious contenders, India Globalization Capital (IGC) is the first cannabis pharmaceutical company to focus on Alzheimer's disease. While there are more than a dozen publicly traded cannabis pharmaceutical stocks on the market, most of them with market caps much larger than IGC's $12 million, IGC is so far the only one to apply its cannabis-therapies to the treatment of Alzheimer's.

IGC is aggressively advancing its unique position, and earlier this week announced (http://nnw.fm/3QaWV) that it has acquired the exclusive rights to a THC-based treatment for Alzheimer's, moving the company one step closer to clinical trials for its Alzheimer's product.

Under a definitive license agreement with the University of South Florida, IGC is the exclusive licensee of a patent filing for the use of tetrahydrocannabinol (THC) as a potential therapeutic agent for the disease. The patent, entitled "THC as a Potential Therapeutic Agent for Alzheimer's Disease," claims discovery of a new pathway in which low doses of THC bind to amyloid beta plaques and prevent those plaques from aggregating on neurons, which is what occurs in Alzheimer's disease and causes cognitive decline.

Here's why the application of TCH (tetrahydrocannabinol), which is the psychoactive compound found in cannabis, is so exciting for the future of Alzheimer's treatment. THC has several known molecular pathways by which it interacts with the body. Numerous studies have shown that low doses of THC can slow the production of neural plaques (considered a key contributor to the progression of Alzheimer's), as well as decrease inflammation, prevent cell death and stimulate cell growth.

The acquisition of IGC's new patent filing provides another layer of protection for the company's proprietary formulation of IGC-AD1, which includes low-doses of THC and is intended to disrupt the buildup of amyloid beta plaques and relieve some of the worst symptoms of Alzheimer's.

If the patent is granted, and it works, IGC will become the owner of a major therapeutic pathway for THC interaction with the body, with significant potential in treating this condition.

"Securing this licensing agreement from the University of South Florida represents a major turning point for IGC as we now look to prepare several of our key products for clinical trials," IGC CEO Ram Mukunda stated in the press release. "We have worked hard to assemble a strong development team and a primary pipeline of four major products addressing large markets and possible blockbuster indications utilizing cannabis-based therapies. We are putting the finishing touches on our products, which may include filing additional patents, and we very much expect to start pursuing clinical trials for our Alzheimer's product and others this year."

IGC's drug development pipeline also includes cannabinoid therapy that targets human and veterinary epilepsy (http://nnw.fm/eW8gb). The company is developing numerous cannabis-based therapies, with a potential international market reach.

There are some other companies working on Alzheimer's with very large valuations, with IGC bringing the potential benefits of cannabis to bear on the disease.

Biogen (NASDAQ: BIIB) has developed and tested aducanumab, a drug that helps eliminate beta amyloid, a sticky plaque found in the brain of Alzheimer's patients. The antibody binds to the plaque, which has the potential to slow the progression of symptoms such as memory loss, confusion, trouble finding words, decreases in judgement, and changes in mood and personality. Phase 1 clinical trials included 165 patients, concluding that high doses of the drug decreased the level of amyloid plaque in the brain, as viewed using positron emission tomography. Scientists noted the slowing of the progression of memory loss in these patients as well.

Another company focused on the development of innovative therapies for Alzheimer's, other central nervous system diseases (CNS) and various types of cancer, is New York-based Anavex Life Sciences (NASDAQ: AVXL). The company's lead product candidate, ANAVEX™ 2-73, is an oral drug currently in phase 2a clinical trials for Alzheimer's, and is also being tested to Parkinson's and other CNS diseases. Phase 1 trials for ANAVEX™ 2-73 were completed with encouraging results attesting to the compound's potential to halt or even reverse the course of Alzheimer's, as well as with an indication of other anticonvulsant, neuroprotective and antidepressant properties. A phase 2 placebo-controlled trial is also underway to determine ANAVEX™2-73 effects on Rett Syndrome, while a separate trial is being conducted for Parkinson's disease. In addition to ANAVEX™2-73, the company is developing several other products targeting various symptoms and effects of Alzheimer's.

Clinical studies are also underway for Axovant Sciences' (NASDAQ: AXON) lead product candidate, Intepirdine (RVT-101), and its effects on Alzheimer's, dementia and Lewy Body Dementia. The Mindset study for Alzheimer's is a phase 3 international, double-blind, multi-center, placebo-controlled clinical trial that aims to assess the tolerability, safety and efficacy of the drug for mild and moderate cases of Alzheimer's. If the trials are successful, the therapy will be approved for commercialization across Europe and the United States. Phase 2 studies are being conducted to evaluate the product's performance for dementia. A novel glycopyrrolate and cholinesterase combination is also being developed for Alzheimer's and Lewy Body Dementia and is currently in phase 1 trials.

One of the world's largest Alzheimer's treatment pipelines is being developed by Swiss-based AC Immune SA (NASDAQ: ACIU). The company is working on seven therapeutic and three diagnostic products in various stages of clinical trials; with the potential to significantly improve treatment and even prevent Alzheimer's and other neurodegenerative diseases. All of AC Immune's therapies were discovered and developed via the company's proprietary Morphomer™ and SupraAntigen™ technology platforms. The lead product candidate, an anti-Abeta antibody called Crenezumab with treatment and prevention potential, is currently undergoing phase 3 clinical trials, in collaboration with Roche Holding AG (OTC: RHHBY) subsidiary, Genentech.  

The focus on Alzheimer's by so many biopharmaceutical companies is understandable, given the prevalence of this condition. In May 2017, Congress signed into law a $400 million increase for Alzheimer's research funding at the National Institutes of Health (NIH) in the fiscal year 2017 budget, marking the second consecutive year that Congress has approved a 'historic' funding increase for the disease.

This move demonstrates the urgency for the more than 5 million Americans living with the disease - a number that's forecast to increase to 16 million by 2050 - and highlights the value of the lineup of companies working to advance their efforts for a cure.

For more information on India Globalization Capital visit India Globalization Capital (IGC)

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