Seattle Washington, Feb. 26, 2018 (GLOBE NEWSWIRE) — CFN Media Group (“CFN Media”), the leading agency and financial media network dedicated to the North American cannabis industry, announces publication of an article covering India Globalization Capital Inc’s (NYSE MKT: IGC) pursuit of numerous pre-clinical studies involving cannabinoids, while developing Complementary Alternative Medicines in the near-term to help patients and drive revenue.
The cannabis industry has struggled with clinical trials due to the federal prohibition of cannabis and the difficulty in procuring cannabis plants for research. While the regulatory environment is showing signs of improvement, there are only a handful of companies that are pursuing rigorous clinical trials to prove the safety and efficacy of cannabinoids in treating underlying medical conditions. And, investors may want to take a closer look at these companies as they progress.
Importance of Clinical Trials
Clinical trials are research studies designed to explore if a medical strategy, treatment, or device is safe and effective for humans. By following strict scientific standards, clinical trials protect patients and help produce reliable study rather than relying on anecdotal evidence. The goal is to provide patients with higher quality medicine and protect them from unknown, unintended, or malicious side effects that may appear in unregulated drugs.
Clinical trials are carried out in several different stages:
• Phase I clinical trials are often healthy volunteers that are compensated for taking part in the trial or those that are ill and have exhausted other treatment options. The goal is to determine whether the new drug is safe for human consumption.
• Phase II clinical trials are designed to test the new drug in a larger group of people to measure safety and side effects, as well as see if there are any signs of positive effects in patients. They may or may not involve a comparison with another treatment option.
• Phase III clinical trials are large, randomized, controlled clinical trials that compare the effects of the new drug with standard treatments. One group receives the treatment, another receives a placebo, and the responses are compared.
Once new drugs have completed clinical trials, companies submit a new drug application to the Food and Drug Administration (FDA) or other regulatory bodies around the world for approval. These regulators review the new drug application and study results to determine if the drug is safe and if it has demonstrated enough efficacy to justify approval. Since governments are large payors in healthcare, there is an incentive to avoid approving drugs that don’t show efficacy.
Clinical Trials in Cannabis
Clinical trials of cannabis-related drugs have been sparse due to the federal prohibition of the drug around the world. Despite growing anecdotal evidence, only a handful of clinical trials have been completed by large companies like GW Pharmaceuticals plc (GWPH) in the United Kingdom. Researchers must take extensive steps before they’re allowed to research cannabis and approved cannabis for testing can be difficult to procure.
While many patients take medical cannabis, on a state-by-state basis, there’s very little standardization in terms of the cannabis plant genetics and the bioavailability of the compounds can vary tremendously between patients. That said, there’s growing evidence that cannabinoids could have beneficial effects in treating many difficult-to-treat conditions, including various cancers and neurodegenerative diseases.
India Globalization Capital Inc. (NYSE MKT: IGC) lead product, Hyalolex, is a cannabis-based drug for Alzheimer’s patients that’s designed to relieve anxiety, agitation, and sleep disorders – as well as alleviate caregiver distress. Early research has demonstrated that Hyalolex inhibits beta amyloid aggregation in a dose-dependent manner and addresses numerous other end points without showing any toxicity towards neurons.
“Our Alzheimer’s product, Hyalolex, an industry first, is progressing as planned,” said India Globalization Capital CEO Ram Mukunda. “Our work on formulation and packaging is complete and we expect initial commercialization as a Complementary Alternative Medicine sold via licensed medical dispensaries in select states in the near-term … we remain confident in the value of our phytocannabinoid therapy portfolio as we look to address key indications.”
India Globalization Capital Inc. (NYSE MKT: IGC) is advancing pre-clinical studies involving cannabinoids, while developing Complementary Alternative Medicines in the near-term to help patients and drive revenue. Investors may also want to take note of the company’s new efforts to develop blockchain solutions to resolve transactional difficulties, product labeling, product identification assurance, and product origin assurance issues. SeeThruEquity has set a $2.00 price target for the stock.
For more information, visit the company’s website at www.igcinc.us.