Pipeline

Advancing Novel Therapies

Across Multiple Indications

Enveric Biosciences has a robust pipeline with multiple data points expected in 2021 for radiodermatitis, glioblastoma and chemotherapy-induced neuropathy.

  Discovery

    Preclinical

 Phase 1

Phase 2

Preclinical

45%

Enabling Partnership with Tikun Olam

Enveric Biosciences will leverage its proprietary treatment database, large-scale human data sets and resources it has acquired through its licensing agreements which includes databases of 15,000+ persons treated across a variety of conditions, with a primary focus on cancer care.

Between March 2015 and February 2017, researchers at the Soroka Medical Center in Beersheba, Israel, analyzed data for cancer patients who received medical cannabis palliative care.

The primary symptoms reported among the patients included:

  • Sleep problems (78.4 percent)
  • Pain (77.7 percent)
  • Weakness (72.7 percent)
  • Nausea (64.6 percent)
  • Appetite loss (48.9 percent)

Additionally, approximately 51 percent of patients reported an eight out of 10 on the pain scale.

17 percent of these patients received CBD. After six months, nearly all (95.9 percent) patients reported improved conditions.

Glioblastoma Multiforme (GBM)

Enveric Biosciences believes CBD has the potential to influence many of the key pathways involved in Glioblastoma pathogenesis, from tumor stemness and proliferation to angiogenesis and local invasion. Glioblastoma tumors express CB2 receptors, through which CBD and other cannabinoids are thought to exert their anti-cancer efforts (Ellert-Miklaszewska, Adv Exp Med Biol, 2013). The prospect of CBD used in combination with other pharmacologic interventions holds promise for the treatment of Glioblastoma.

As a result, CBD used in combination with other pharmacologic interventions holds promise for treating glioblastoma. Developing clinical trials to evaluate CBD combination therapies’ efficacy may represent an important next step toward improving the standard of care for treating glioblastoma for a population of patients with few effective therapeutic options available.

According to a Kenyon study in 2018
  • Seven out of seven patients with glioblastoma experienced a positive clinical response to CBD (although four ultimately succumbed to the disease).
  • CBD was hypothesized to reduce the growth and survival of glioblastoma cell lines by disrupting the normal function of the cell, or cell cycle arrest, and inducing programmed cell death, or apoptosis (Marcu, Mol Cancer Ther, 2010).
  • Cannabinoids promote cancer cell death through overproducing a lipid subset called ceramides, as an accumulation of ceramides in glioblastoma cells may prevent the cell from functioning normally.
  • Additionally, the generation of unstable oxygen molecules, or reactive oxygen species, can damage nearby molecules and trigger cell death (Dumitru, Front Mol Neurosci, 2018).

Radiation Dermatitis

Radiodermatitis (also called radiation dermatitis) is a condition caused by the high-energy X-rays delivered during radiation therapy. It affects nearly 95% of patients who receive radiation for cancer treatment, with approximately 85% of patients having moderate-to-severe skin reactions.

Radiodermatitis usually begins to occur within 1-4 weeks of treatment and persists for the duration of radiation therapy. It may require 2-4 weeks to heal after completion of treatment.  The severity of the skin reactions ranges from mild erythema (red rash) to dry desquamation (itchy, peeling skin) to the more severe moist desquamation (open wound) and severe ulceration. Radiodermatitis can be similar to the discomfort of a mild-to-severe sunburn: painful, difficult to move or wear clothing, itching, and peeling skin. In the most severe cases, ulceration can occur, disrupting the treatment.

Beginning with the initial dose of radiation can cause tissue damage to occur. Exposure to high-energy beams disturbs cell regulation, leading to electrolyte imbalance and fluid loss within the cells. The radiation also disrupts the natural wound healing within the skin. Inflammation can trigger several factors, including impairment of the skin’s endothelial cells, skin-cell necrosis resulting in cell dehydration and infection.

Clinicians generally believe that the ideal method for preventing and minimizing skin reactions to radiation treatment is to provide anti-inflammatory and anti-microbial solutions at the cellular level and moisturization of the irradiated area. The current standard of care involves using a simple topical product with petrolatum to provide moisturization and occlusivity to the irradiated area, yet this has left both patients and doctors searching for more effective medicine.

CBD and Radiodermatis

CBD therapy works by interacting with the body’s Endocannabinoid System, which plays an essential role in regulating skin health. When CBD and other cannabinoids interact with the skin receptors, they appear to play a role in controlling inflammation levels and bolster immune response.

The skin, the largest organ in the body, possesses all the elements of the endocannabinoid system. The various elements in the endocannabinoid system are engaged in crucial mechanisms of skin regulation, such as control of growth of the epidermis and skin annexes, cell survival, immune and inflammatory responses, the transmission of sensory stimuli to the central nervous system (pain, itching) and the synthesis of lipids, among other activities.

CB1R agonists inhibit the activation of mastocytes and the release of histamine. The topical application of CBD has been shown to reduce skin inflammation in animal models. Other research suggests that CB1R expression in keratinocytes plays a pertinent role in maintaining the epidermal barrier. CB2R inhibits the inflammatory skin reaction mediated by IgE and intense spontaneous pruritus. The antibacterial action of CBD is widely accepted and has shown to be effective against Gram-positive bacteria strains that cause skin infections.

Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Chemo-induced peripheral neuropathy (CIPN) is a set of symptoms caused by chemotherapeutic agents that damage the nerves outside the brain and spinal cord. These distant nerves are called peripheral nerves and carry sensations to the brain and control our arms and legs’ movement. The damage to these nerves typically results in persistent pain, abnormal sensations of tingling, numbness, pain pressure, and thermal hyperalgesia in a specific area. CIPN usually begins in the hands and feet but can move to other parts of the body. It is a serious issue affecting the quality of life of millions of patients receiving chemotherapy. Approximately 380 million people live with different types of neuropathy, the majority of them being peripheral and diabetic neuropathy, with an estimated 20 million Americans suffering from CIPN.

Evidence indicates that the onset of CIPN is closely related to oxidative stress, abnormal spontaneous discharge, ion channel activation, the up-regulation of various pro-inflammatory cytokines, and the neuro-immune system’s activation. Early studies show that CBD can have a beneficial effect diminishing the intense symptoms, reducing the neuropathic pain and other signs of CIPN affecting the quality of life.

CBD and Pain

CBD Therapy can be useful for treating neuropathic conditions like CIPN and other chronic pain. Specifically, when CBD is introduced in the endocannabinoid system, it creates positive responses within the peripheral nervous and central nervous systems, such as pain relief and inflammation.  This relief is noted with multiple types of pain, such as nerve pain (neuropathic pain) and other chronic pain conditions.

The pain only becomes pain once it’s signal is sent and then processed by the brain. CBD works to block pain pathways by slowing down the communication between nerve cells. CBD helps halt the inflammation response by causing the brain to think that the area to be inflamed is no longer injured. CBD treatments also inhibit the release of glutamate, which is an excitatory neurotransmitter. It directly activates serotonin receptors related to pain, depression/anxiety, addiction, appetite, nausea/vomiting, and sleep. Cannabinoids also work to eliminate excessive, immune-related, oxidative stress, resulting in the body’s ability to heal itself more efficiently.

When treated with CBD therapeutics, patients report significant improvement of pain and other disturbing sensations. Compared to other current therapies of treatment, research indicates that CBD treatments can significantly reduce intense pain, sharp pain, cold and itchy sensations, compared to other current therapies, without the adverse effects (such as potential opiate addiction).

We Are a Patient-Centric Biotechnology Company

Enveric Biosciences is a patient-centric biotechnology company focused on developing new-generation, naturally occurring chemical compounds, such as cannabinoids, to provide palliative care for targeted, unmet medical needs, both extending and enhancing patient quality of life.