Therapeutic Areas Cannabis

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UTT BioPharma is focusing attention in the development of appropriate formulations and method of delivery starting from cannabis derived compounds. The goal is to become world leaders in natural medicine and cannabinoid science. The aim is to researching synergic effects of different combinations chosen through a deep bioinformatics approach to address target diseases and specific symptoms.

The Company is developing proprietary and validated cannabinoid technology platforms, formulations and formed beneficial collaborations with prominent international scientists, universities and institutions in the field.

In addition to this expanding research network, UTT supports clinicians who approach the Company in seeking to explore the potential of cannabinoids in the clinic through investigator initiated studies.

With an extensive and well-planned clinical campaign and pre-clinical research, the R&D Department aims to produce new intellectual property and data to support safety and efficacy profiles of natural drugs prepared to target a range of therapeutic areas such as drug-resistant epilepsy, chronic and non-chronic pain, oncologic pain, cancer, schizophrenia, insomnia, obesity and anorexia.

Extensive in-house and outsourced (partner institutions such as University of Melbourne and University of Milan) proprietary research put UTT BioPharma in a strategic position and with the prospective to develop and license several new cannabis derived drug candidates.

UTT’s understanding of the chemical pathways, biology and applied pharmacology of cannabinoids and other molecules derived from high quality herbal material continues to be illuminated under the direction of luminars in the field of medicine and science.

Brief summary of therapeutic areas of interest:

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Drug-Resistant Epilepsy

Drug-Resistant Epilepsy, as the name suggests, is a condition characterized by the inability of AEDs (Anti-Epileptic drugs) to decrease the occurrence of seizures in patients.

The International League Against Epilepsy (ILAE) has defined Drug-Resistant Epilepsy as ‘the failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.” [1]

The prevalence of Drug-Resistant Epilepsy is about 5 per 1000 people in most developed countries, and 10 per cent of epileptic patients are thought to have drug-resistant conditions [2].

There is a large amount of anecdotal evidence which suggests that Cannabidiol rich cannabis extracts are effective in treating Drug-Resistant Epileptic conditions [2], and many trials are currently being conducted worldwide with various Cannabis derived medications.

UTT BioPharma aims to perform clinical development for its novel formulation, specifically designed to target various pathological characteristics of the disease.

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Chronic Pain

According to the National Institute of Health, any pain that last for more than 12 weeks is categorized as Chronic Pain. Pain can arise from either an injury or a certain disease. It can also be coupled with other health problems-often with great mystery surrounding its pathological basis. A WHO collaborative study predicted that the worldwide prevalence of chronic pain is approximately at 22%, where some countries exhibit higher rates than others [1].

In a few placebo controlled clinical trials, Cannabis and its derivatives have been tested in patients with chronic pain as conjunctive treatments with opioids, or as standalone treatments. There is a great deal of anecdotal evidence surrounding the effectiveness of cannabis treatments in pain.

Moreover the favourable side effect profile of certain Cannabis-derived compounds have been much acclaimed by patient groups who already have access to medicinal cannabis [2]. Compared with the safety profile of opioids, which present high risk of overdose [3], they present a much more viable treatment option. Mechanistically, the both the Cannabinoid receptors have shown to be effective targets for nociceptive (mainly CB2) and neuropathic pain (mainly CB1) states. The rationale behind UTT BioPharma’s formulation is to target the pathological states of pain, with Cannabis-derived compounds to bring about synergic analgesic effects.

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Schizophrenia is a psychotic disorder which is characterized by an onset of an impaired interpretation of reality. The symptoms of schizophrenia include delusional and disorganized thinking, hallucinations and abnormal motor behaviour [1].  Schizophrenia affects more than 21 million people worldwide, and it typically begins in late adolescence or early adulthood [2]. However it is considered to be a treatable disease, and choosing the right and effective therapy can have a significant effect on livelihood of the patient.

The use of Cannabis has been associated as a possible progressor or enhancer of schizophrenic symptoms, especially because of the effects of delta-9-tetrahydrocannabinol (THC), which is known for its psychoactive effects at low doses (generally >15-20 mg). However, recent research has shown that other specific compounds contained in cannabis such as Cannabidiol (CBD) may have have therapeutic properties for the disease whereas other compounds (THC) are contraindicatory.

UTT BioPharma aims to explore the safe and efficacious compounds present in Cannabis, and build a novel formulation for clinical development of a specific drug against schizophrenia. The right combination of therapeutic compounds with specifically calculated dosage levels, could provide a very effective treatment for this treatable disorder. This drug aims in becoming a substitute or a complement of drugs such as clozapine, thioridazine and lurasidone.

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Cancer can be of many different types, but is characterized by the development of abnormal cells which divide uncontrollably and have the ability to enter and disintegrate normal body tissue [1]. The estimated worldwide prevalence of Cancer is 206 per 100,000 people, with lung cancer being the most prevalent cancer type.

There is a lot of preclinical data which shows that Cannabis derived compounds can cause apoptosis, block angiogenesis, cause cell-cycle arrest and stop metastasis of cancer cells via multiple mechanisms. As well as this preclinical evidence, many anecdotal cases and herbal remedies have shown to have miraculous effects in decreasing the growth and spread of tumours, with little side effect profiles. One great anecdotal scenarios is the oil produced by Rick Simpson, which has shown to have incredible therapeutic effects in cancer patients [1].

The ideology of UTT BioPharma behind using Cannabis-derived compounds is to offer a possible adjunctive treatment (or perhaps even replace if clinically proven to be effective) to conventional anti-cancer medication, with targeted method of delivery.

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Insomnia is a disorder characterized by a difficulty to fall asleep or stay asleep, even if the opportunity presents itself (lying in bed awake) [1]. Insomnia can have a significant impact on one’s energy levels, concentration, mood and as well as the physical well-being. The prevalence of insomnia symptoms is thought to be 30%, whereas 5-10% prevalence is reported for specific insomnia disorders.

Anecdotal and preclinical data has shown that Cannabis-derived compounds have anxiolytic and somnolent properties, with minimal side effects, which are normally associated with many sleep medication.

UTT BioPharma aims to combine the somnolent compounds of Cannabis, with compounds derived from other herbal sleep remedies, which synergism may be effective to treat insomnia with minimal or no side-effects. An improvement of sleep will concordantly bring about significant enhancement in mood and the physical well-being of someone.

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Alzheimer’s Disease

Alzheimer’s disease is a neurodegenerative disorder which attacks the neurons of the brain and leads to cognitive impairment with decreased memory, thinking and language skills [1].   Alzheimer’s is characterized by the formation of plaques with certain brain regions, caused by abnormally folded amyloid beta and tau protein.

Although there are still no diagnostic tools to capture the onset and the specific mechanism of the disease pathology of Alzheimer’s still remains to be elucidated, it is thought that the formation of plaques trigger local inflammatory responses and consequent neurodegeneration occurs as a result [2]. Approximately 18 million people in the world suffer from Alzheimer’s disease, and it is the most common form of dementia [1]. There is a desperate need for novel treatment regimes for this disease, and Cannabis-derived compounds hold the potential to be additional, safe and effective treatments for Alzheimer’s. Specifically the Endocannabinoid System has been debated as a potential target for this disease, and the anti-inflammatory profile of compounds from Cannabis may hold they key to reduce the autoimmune degeneration [2].

The challenge of finding an effective treatment from Cannabis for Alzheimer’s disease, is one that UTT BioPharma wishes to undertake via Research and clinical development.

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A migraine headache is typified by intense throbbing or pulsing in one area of the head, which can cause significant pain for hours. Migraines are usually accompanied with nausea, vomiting as well as increased sensitivity to light and sound [1].

There are multiple factors which induce migraines:the environment (light and air quality), diet, physiological factors (stress, hunger, fatigue) as well as predisposition genetics. The exact mechanism of pain is highly debated, and a large amount of experimental evidence claims that the pain originates from the dilated extracranial terminal branches of the external carotid artery [2]. A WHO suggests that 47% of the adult population have headache at least once within last year in general [3], and recurring frequency of this disease can be extremely high in some.

The immense anti-inflammatory properties of Cannabis-derived compounds provide a potential for treating this disorder. Recent studies have also shown that the endocannabinoid system interacts with the  trigeminovascular nociceptive transmission, and consequently the pathology of migraines [4].

UTT BioPharma aims to build and clinically tested formulations of stemming from Cannabis and other botanical treatments, specifically designed to treat migraines. These formulations will be built with rationale to counter the pathophysiological mechanisms of migraines, using validated synergistic treatments.

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