Connect with us

Science

The clinical trials roadmap: Everything you need to know about the trialing of new medicines

EuroCan’s chief technical officer, Miguel Fagundes shares his insight on the process.

Published

on

clinical trial
Carefully conducted clinical trials are the fastest and safest way to find effective treatments that help people.

Sponsored feature 

Established in 2018, with medicinal cannabis cultivation and processing facilities established in Lesotho and under construction in Portugal, EuroCan is in the vanguard of the fast-growing, legalised medicinal cannabis industry. 

In this article, EuroCan’s chief technical officer, Miguel Fagundes, a qualified pharmacist specialising in the pharmaceutical industry, gives his insight on the process of clinical trialing of new medical interventions, a topic which is of great relevance in the developing legal cannabis sector, from over-the-counter CBD products to pharmaceutical products prescribed by specialist medical professionals.

What is a clinical trial?

A clinical trial is a research study conducted in humans with the goal of answering specific questions about new therapies, vaccines, diagnostic procedures or new ways of using known treatments (together referred to as “interventions”).

Carefully conducted clinical trials are the fastest and safest way to find effective treatments that help people. Clinical trials are an integral part of the drug and diagnostics discovery and development process.

Before a new intervention can be made available, evidence of its safety and efficacy must be proved by well-designed, well-controlled, and carefully monitored clinical studies in consenting participants. Randomised controlled study is the most reliable medicine study design.

What is measured in a clinical trial?

Clinical trials are performed in human volunteers to provide answers to questions such as “does a treatment work?”,  “does it work better than other treatments?” and “does it have side effects?”

The plan/protocol for clinical trials will describe the results (“endpoints”) that will be measured and the type of information to collect; this is then shared with regulatory authorities to obtain marketing approval, which – when granted – allows a company to market its product for sale.

Clinical trials also provide important information on the cost-effectiveness of a treatment, the clinical value of a diagnostic test and how a treatment improves quality of life.

How many phases are needed in a clinical trial?

Clinical trials are conducted in phases. Each phase is designed to answer certain questions, while taking steps necessary to safeguard participants.

Every treatment is usually tested in three phases of clinical trials (conducted according to Good Clinical Practice (GCP) guidelines) before regulatory agencies consider the product to be safe and effective.

Clinical trials for the drug candidate commence only after pharmacokinetics and pharmacodynamics have been studied. An overview of the phases of clinical trials can be summarised as follows:

Phase 1: 

What happens to the compound in the body from a safety and tolerability point of view.

6-10 participants

Using a small number of healthy participants, the goal is to study what happens to the investigational compound in the body from a safety and tolerability point of view. Study participants are monitored for the occurrence and severity of side effects.

Phase 2: 

Safest and most effective dosing regimen for the medicine.

20-300 participants

Once the initial safety of the study drug has been confirmed in Phase I trials. Participants are given various doses of the

compound and closely monitored to compare the effects and to determine the safest and most effective dosing regimen.

Phase 3: 

Adequately confirm the benefit and safety of the medicine.

300 – 3,000 participants

These studies allow for the safety and efficacy of the new investigational drug to be compared to other available treatments or placebo. As well as being tested in combination with other therapies. Information obtained is used to determine how the compound is best prescribed to patients in the future.

Post-Marketing Surveillance Trials:

Anyone seeking treatment

Once the medicine has received regulatory approval (or market authorisation) – these studies are designed to evaluate the long-term effects of the drug (broader efficacy and safety information). Under these circumstances, less common adverse events may be detected.  

What’s the relevance to cannabinoids?

Until recently, despite the therapeutic qualities of cannabis which have been well known for many centuries, it has not been easy to carry out testing or research into medicinal cannabis products due to the prevailing legal restrictions.

With the liberalisation of legislative and societal attitudes towards cannabis we expect that growing scientific interest will further explore the clinical relevance of the various cannabinoids found within the cannabis plant, through clinical trials.

As these controlled and scientifically designed studies and trials progress, we anticipate a range of positive results which will demonstrate product safety, efficacy and the potential to improve quality of life for patients, whilst also further educating both scientists and the general public into the potential benefits of cannabinoids.

EuroCan is a division of Botanical Holdings PLC 

www.botanicalholdings.com

 

News

CBD and CBG have ‘significant’ anti-inflammatory effect in the lungs

The first results from a study into the impact of cannabinoids on respiratory diseases have been published

Published

on

CBD and CBG in combination were found to have ‘significant anti-inflammatory activity’ in the lungs.   

Researchers have found that the cannabinoids CBD and CBG, when used in combination, are beneficial for treating inflammation in the lungs.

Scientists at King’s College London, working in collaboration with Sativa Wellness Group have published the first results from a study into the impact of cannabinoids on respiratory diseases.

It aimed to investigate the anti-inflammatory effects of the two non-psychotropic cannabinoids alone and in combination, in a model of pulmonary inflammation. 

According to a statement released by the company, the results of the work suggest that the CBD and CBG in combination have ‘significant anti-inflammatory activity’ in the lungs.   

This builds on previous research suggesting cannabinoids are promising potential treatments for inflammatory diseases. 

The research also identified that the formulation for administering cannabinoids is critically important to obtain efficacy.

Concluding, the authors wrote: “This study has provided evidence that CBD and CBG formulated appropriately exhibit anti-inflammatory activity. 

“Our observations suggest that these non-psychoactive cannabinoids may have beneficial effects in treating diseases characterised by airway inflammation.”

Sativa Investments PLC announced that it had entered into a research agreement with King’s College London to study the impact of cannabinoids on inflammation and respiratory diseases in 2019.

Geremy Thomas, executive chairman said: “We have actively supported research now for over two years to identify the therapeutic benefits cannabinoids can have on medical conditions. Research is something we as a company believe is essential to inform the public and we are delighted to have seen such positive results identified.”

Continue Reading

News

Does CBD affect driving? Researchers aim to find out

Despite its widespread use, scientists don’t yet fully understand all of the ways CBD affects drivers. 

Published

on

Researchers are recruiting participants for a new study into whether CBD oil impairs driving ability. 

A US university is recruiting participants to study the effects that CBD oil has on driving. 

Sales of CBD have hit the gas of late, but despite its widespread use, scientists don’t yet fully understand all of the ways it affects drivers. 

Researchers with the West Virginia University School of Public Health are currently recruiting participants for a new study into whether and how CBD oil impairs driving ability. 

The study will involve 40 participants, half of which will be given 300 mg of pure CBD oil, the other half will receive a placebo.

The study is “double blind,” meaning neither the participants nor the researchers will know who has received the real or placebo doses.

“We don’t really know much about CBD,” said Toni Marie Rudisill, a research assistant professor in the Department of Epidemiology and Biostatistics.

Toni Marie Rudisill, a research assistant professor in the Department of Epidemiology and Biostatistics.

“There’s not a whole lot of research on it. But there were all these anecdotal reports of people using it to help them sleep or help them relax. And as an injury epidemiologist, my first thought was, ‘OK, then: if it’s making you tired, how does that impact your performance or make you more prone to injuries?’”

After taking their assigned dose, participants will complete a driving simulation that takes about half an hour.

The simulator can show how often a participant drifts out of their lane, whether they use turn signals appropriately and whether they stop at traffic lights.

If a participant is waiting to turn left at an intersection, it can reveal whether they properly judge the speed and distance of oncoming cars. If a pedestrian darts into the road, it can identify whether the participant brakes in time.

“The driving simulator doesn’t look impressive—it looks like a regular old computer game—but it’s amazing what it captures on the back end,” Rudisill said.

“What makes the simulator really great is that it provides a safe environment for people to drive in and where we can still assess performance.”

She and her colleagues will measure the participants’ driving performance and compare it between the two groups.

In addition, the researchers will assess the participants’ mood, drowsiness, sedation, reaction time and cognitive function, before taking the CBD oil or placebo and after finishing the driving simulation. 

“We’re looking to see if their mood changes. Do they feel more tired? Will we see any cognitive changes that are maybe due to drowsiness?” Rudisill said. 

“We’re interested to see how those variables relate to the driving measures.”

Last year a study led by the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney showed that CBD appears to be safe for drivers.

The research involved people inhaling vaporised cannabis containing different mixes of THC and CBD, before going for a 100-kilometre drive under controlled conditions on public highways both 40 minutes and four hours later. 

Cannabis containing mainly CBD did not impair driving while cannabis containing THC, or a THC/CBD mixture, caused mild impairment measured at 40 minutes later but not after four hours.

Continue Reading

News

Novel cannabinoid could treat cancer-related anorexia

Anorexia affects over 60 percent of later-stage cancer patients

Published

on

ART27.13 activates CB1 and CB2 receptors in the gut

A synthetic cannabinoid product could offer a new treatment for late-stage cancer patients with anorexia.

California-based pharmaceutical company, Artelo Biosciences is investigating the efficacy of its synthetic cannabinoid product, as a much-needed therapy for cancer patients experiencing anorexia and weight loss.

Anorexia affects over 60 percent of later-stage cancer patients, but there are currently no approved medicines for the condition.

A weight loss of more than five percent can predict a poor outcome for cancer patients and a lower response to chemotherapy.

Artelo Biosciences has developed the novel ART27.13, designed to target the endocannabinoid system’s (ECS) CB1 and CB2 receptors in gut, without crossing the blood barrier.

This means that despite being more potent, it causes fewer side effects than naturally occurring cannabinoids such as THC. 

The company announced last month that the first patient has been dosed in its Phase 1/2 Cancer Appetite Recovery Study (CAReS), taking place at the University of Edinburgh, in the UK. 

Professor of pharmacology and scientific advisor to Artelo biosciences, Saoirse O’Sullivan spoke to Cannabis Health about the significance of the study and its potential benefits for cancer patients and others with a range of conditions. 

Saoirse O’Sullivan, PhD, professor of pharmacology

Cannabis Health: What is cancer-related anorexia, and why is it in need of more awareness?

Saoirse O’Sullivan: Anorexia affects over 60 percent of late-stage cancer patients. Anorexia and the resulting weight loss in cancer patients compromises health, weakens the immune system, causes discomfort and dehydration, ultimately reduces the patient’s prognosis and quality of life. 

No medicines are currently approved for treating cancer anorexia, but Megace (Megestrol acetate), THC compounds (Dronabinol), and steroids (dexamethasone) are used off label with limited efficacy and often intolerable side effects. Therefore this remains a significant unmet need in a considerably vulnerable patient group.

CH: How could the drug being developed by Artelo Biosciences could help patients?

SO: ART27.13 is a CB1/CB2 receptor agonist that doesn’t effectively cross the blood brain barrier and therefore does not cause activation of the CB1 receptor in the brain. This means that there are potentially few central nervous system-mediated side effects like paranoia, memory loss and psychosis. 

ART27.13 was originally developed by Astra Zeneca as a pain medication, but the programme was terminated because it was not effective in people after a molar extraction. However, in otherwise healthy subjects who participated in a Phase 1 pain study it was observed that low doses of ART27.13 rapidly increased body weight of more than three percent that was not explained by fluid retention and without serious or persistent side effects. 

With the knowledge that activation of the CB1 receptor in the periphery can increase appetite and weight loss, ART27.13 represents a novel therapeutic strategy to stimulate appetite and weight gain known to arise from CB1 receptor activation that could significantly benefit patients with cancer-associated anorexia without CNS side effects.

CH: What makes it different from naturally occurring cannabinoids? 

SO: The major differences between ART27.13 and THC are that ART27.13 is more potent and it doesn’t easily cross into the central nervous system.

CH: ART27.3 is said to specifically target receptors in the gut, could you explain how it works?

SO: ART27.13 will activate CB1 receptors in the periphery which impacts the overall energy balance of mammals in a number of different ways; inhibiting satiety (feeling full) and nausea, increasing food intake, altering the levels hormone that control appetite, altering taste sensation, slowing gastrointestinal motility, decreasing lipolysis (fat break down) and increasing lipogenesis (fat generation). The combined effect of peripheral CB1 activation is to promote appetite, and energy storage and preservation.

CH: Could this potentially be helpful in other patients with anorexia, not related to cancer? 

SO: Yes it is possible that ART27.13 could positively impact other types of patients with anorexia by the same mechanisms of action. Positive data from our CAReS trial in cancer patients would help to support that idea.

CH: And what about its potential in other conditions?

SO: While oncology is the main focus of Artelo Biosciences, there are many other indications for which a peripherally restricted CB1 agonist could be beneficial, for example in muscle spasticity, neuropathic pain, anti-tumoural effects, and gastrointestinal disorders.

Continue Reading

Trending