India Globalization’s Hyalolex Shows Promise in Treating Patients with Alzheimer’s Disease
February 8th, 2018
Exclusive, News, Top News
Alzheimer’s disease has already become the sixth leading cause of death in the United States and could cost the healthcare system upwards of $1 trillion by 2050. While pharmaceutical companies have spent billions of dollars trying to cure the disease, experts still aren’t sure exactly what causes the condition and how to go about treating it. The good news is that there are some therapeutics that act on multiple potential underlying causes.
India Globalization Capital Inc.’s (NYSE American: IGC) Hyalolex (IGC-AD1) is a cannabinoid-based therapy that appears to act on many different hypotheses of disease modalities. Investors interested in the AD space may want to take a closer look at the stock.
Elusive Alzheimer’s Treatments
Alzheimer’s disease affects over five million people in the United States and has become the sixth leading cause of death. Last year, the disease and related dementias cost the country $260 billion and is projected to cost about $1.1 trillion by 2050. It is America’s most expensive disease. About 10% of people over 65 are diagnosed with Alzheimer’s, and almost 66% of Alzheimer’s patients are women. At the same time, 35% of caregivers report that their health has gotten worse due to their care responsibilities, adding even further to the costs associated with the disease.
While there are several drugs that treat Alzheimer’s disease, the quest to cure the illness has frustrated even the largest pharmaceutical companies. The consensus for the past 25 years has been that the disease is caused by the build-up of a sticky plaque called beta amyloid in the brain. Billions of dollars were subsequently spent developing drugs to clear beta amyloid, but all of them have failed at various stages of clinical trials.
Some companies are shifting their focus to tau proteins, which get twisted and block the internal transport system of neurons. While one clinical trial focused on these proteins failed, the research remains in the early stages of clinical trials. Other researchers believe that over-reactive oxygen molecules are causing oxidative stress, which could lead to the build-up of beta amyloid plaque and other “symptoms” of the disease.
How Cannabis Could Help
India Globalization Capital’s Hyalolex (IGC-AD1) has been shown to act on many of these different pathways in early research studies. In addition to modulating beta amyloid production and inhibiting aggregation, the compound appears to inhibit hyperphosphorylation of tau proteins, enhance mitochondrial function, and modulate several endpoints of AD. The compound is also non-toxic to neurons and doesn’t product a “high” feeling.
Using an immunoblotting technique, Dr. Chuanhai Cao demonstrated that IGC-AD1 inhibits beta amyloid aggregation in a dose-dependent manner by increasing monomer levels. This addresses the “amyloid hypothesis” that states that the aggregation of amyloids into toxic oligomers is a key pathogenic event in the onset of AD. These plaques could also trigger other pathological events, such as oxidative damage and inflammation.
The same technique of using immunoblotting showed that IGC-AD1 reduced the expression of an enzyme that enables phosphorylation by as much as 53% to 62%, which reverses some of the pathological effects of overexpressed APP and tau proteins. This addresses the “tau protein hypothesis” that states that tau protein phosphorylation is three to four times higher than a normal brain, which could be the underlying cause of AD.
Finally, Dr. Cao showed that IGC-AD1 enhanced mitochondrial function by between 30% and 60%, which could address the “mitochondrial cascade hypothesis”. This hypothesis is based on the notion that mitochondrial dysfunction – which worsens with age naturally – could start a cascade that ultimately leads to the disease. Evidence has also shown that elevated beta amyloid levels contribute to these mitochondrial abnormalities.
Other than the evidence showing that Hyalolex may address the three disease etiological hypothesis as outlined above, Hyalolex at larger doses may reduce patient anxiety, patient aggression, sleep disorder and alleviate overall caregiver distress.
Hyalolex is a liquid formulation that comprises of cannabis extracts, including THC, along with other natural compounds. It will be prescribed in two different doses. The smaller dose for mild to moderate AD patients, and the larger dose for moderate to advanced patients. IGC plans to distribute its technology through licensed medical cannabis dispensaries in the United States. This process will include state-by-state sourcing, formula assembly, packaging, and distribution utilizing best practices to ensure quality control while complying with the current legal guidelines established by each individual state.
Management plans to begin the rollout in the first half of this year in Washington D.C., Maryland, and California dispensaries. To help facilitate the rollout, the company engaged The Medical Marketing Group inc., a provider of outsourced product-detailing, education, and outreach services. The company projects the rollout of Hyalolex in 10 of the 29 legal states in 2018.
In addition to its launch across dispensaries, the company is preparing the groundwork necessary for Phase 2B human trials with the U.S. Food and Drug Administration (FDA). The company’s most recent results showed compelling in vivo data from genetically engineered mice, including marked 50% improvement in spatial memory. If these results translate to humans, the drug program could be groundbreaking within the industry.
India Globalization Capital Inc. (NYSE: IGC) represents a compelling and potentially undervalued investment opportunity as compared to its peers in the group. By addressing multiple potential underlying causes of Alzheimer’s, the company’s lead drug candidate is unique among products including those undergoing clinical trials. Management’s dual plans, to launch the treatment in dispensaries over the near-term, while pursuing FDA clinical trials over the long-term, is unique with near term revenue generating potential. The firm SeeThruEquity recently issued a price target of $2.00 on IGC.
For more information, visit the company’s website at www.igcinc.us.
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