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Science

Our pipeline of products in development are based on a foundation of breakthrough science and pharmaceutical innovation.

Andira Pharmaceuticals uniquely focuses on the synergistic properties of cannabinoids, meaning:

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Their ability to amplify the therapeutic effect of mainstay medical treatments
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Their ability to amplify the therapeutic effect of other cannabinoids

Harnessing cannabinoid synergy has allowed Andira to develop a patent-protected library of novel cannabinoid-drug and cannabinoid-cannabinoid formulations that are positioned to transform medical infection control and improve the treatment of cancer.

Therapeutic synergy explained

Synergy occurs when two or more active medicinal ingredients are combined together at specific dosages and the resulting therapeutic effect is far greater than the sum total effect of each ingredient acting alone. In the context of medical care, therapeutic synergy may result in a treatment having greater efficacy and potency, requiring a lower dosage, and having a lower risk of side effects.

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For example, if cannabigerol (CBG) kills 4 E. coli bacteria when administered at a certain dosage, and cannabichromene (CBC) kills 2 E. coli bacteria administered separately under the same conditions, one could expect that these dosages of CBG and CBC should kill approximately 6 bacteria if they are combined together. However, if CBG and CBC act synergistically at these dosages, the combination could result in the killing of 1,000,000 E. coli bacteria. This example is for illustrative purposes, however, the magnitude of this effect is reflective of Andira’s synergistic infection control technology, Silvanex™. For someone undergoing surgery, therapeutic synergy could make the difference between having a safe recovery and acquiring a dangerous infection.

Cannabinoids and Infection Control

Published scientific reports on the anti-bacterial properties of cannabinoids date back to the 1950’s (Krejci Z. Die Pharm. 1958, and Rabinovich A.S. et al. Mikrobiolohichnyi Zhurnal. 1959). A number of subsequent studies have been published illustrating that cannabinoids, as well as Cannabis sativa L. plant extracts, have anti-bacterial effects in vitro (in a test tube) against a specific family of bacteria, called “Gram-positive bacteria”. Members of the Gram-positive bacteria family include Streptococcus spp., Staphylococcus spp., Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococcus (VRE). Cannabinoids are indeed rapidly effective in killing MRSA and VRE in vitro (in test tube studies) in the right dosages. Importantly, published scientific research has demonstrated that cannabinoids do not have anti-bacterial effects against a separate family of disease-causing bacteria, called “Gram-negative bacteria,” which include common pathogens such as E. coli, Pseudomonas spp. and Acinetobacter spp. In addition, when it comes to their anti-bacterial effects against Gram-positive bacteria such as MRSA, cannabinoids cannot play a role in treating an infection by being administered into the body. In other words, cannabinoids cannot work to treat infections in the same manner as antibiotic drugs taken by mouth or intravenously. This is because the anti-bacterial effect of cannabinoids becomes eliminated when they enter the bloodstream, as shown by Andira Pharmaceuticals’ pre-clinical research. Furthermore, cannabinoids on their own cannot play a role in infection control (i.e., preventing infection) because they lack the ability to kill common Gram-negative bacteria such as E. coli, and their ability to inhibit other types of infection-causing microbes, such as fungi, is weak.

In spite of their limitations, cannabinoids have been found to act synergistically with other cannabinoids, and with several antimicrobial drug substances, which effectively amplifies antimicrobial killing power. While this may not be useful as an internally-administered treatment for infections (as mentioned above, the anti-bacterial power of cannabinoids is eliminated when they enter the bloodstream), Andira Pharmaceuticals has developed a broad-spectrum synergistic silver-cannabinoid technology that can be utilized for a wide range of infection control purposes, spanning topical drug treatments, medical devices, and consumer goods.

Silver is a standard antimicrobial agent used for medical infection control globally, however, antimicrobial resistance (AMR) limits its effectiveness. As a triple combination silver-cannabinoid-cannabinoid formula, Andira’s technology overcomes antimicrobial resistance (AMR) by amplifying potency against all major classes of healthcare-associated pathogens, including Gram-positive bacteria, Gram-negative bacteria and fungi.

Called Silvanex™, the silver-cannabinoid formula is the first of its kind in the world to have proven triple synergy both as an antibacterial and antifungal agent. Silvanex™ is an infection control breakthrough with amplified potency, proven efficacy against AMR microbes, faster onset of action, and ability to prevent future resistance from emerging with a unique cell-wall active mechanism of action. Silvanex™ antimicrobial technology is positioned for use in all the same commercial applications as standard antimicrobial silver, including, but not limited to: medical devices such as wound dressings and catheters, externally-applied antimicrobial drug products for topical use, medical supplies, surface coatings for high-touch areas, and integrated into fabrics, textiles, and other materials prone to microbial contamination, such as fitness equipment. Andira Pharmaceuticals is actively advancing Silvanex™ antimicrobial technology within a topically-applied drug product for the prevention of surgical site infections, and within a line of advanced wound dressings. Please contact us for partnership opportunities.

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Cannabinoids and Breast Cancer

Cannabinoids have been shown to have anti-cancer effects in scientific pre-clinical research studies, including those conducted by Andira Pharmaceuticals. In breast cancer specifically, cannabinoids have been found to have anti-cancer effects by inhibiting key cancer signaling pathways that promote cancer cell growth and invasion. The scientific research reports published on these findings are too numerous to mention here. However, the most groundbreaking research uncovering the pharmacologic actions of phytocannabinoids against breast cancer were published by the laboratory of Professor Cristina Sanchez at Complutense University in Madrid, Spain. Research from the Sanchez laboratory not only established that the effects of cannabinoids on breast cancer are mediated primarily by the CB2 cannabinoid receptor, the research also identified the specific cancer cell pathways that become affected following cannabinoid treatment, and further established that human breast cancer tumors have a very high number of CB2 receptors, while healthy surrounding breast tissue does not.

Building upon the foundational research from the Sanchez lab and numerous others, Andira Pharmaceuticals has confirmed the anti-cancer effects of cannabinoids in ductal carcinoma breast cancer are dose-dependent, and fall within a specific therapeutic window, meaning that a specific therapeutic concentration must reach the tumor in order to have a measurable anti-cancer effect. Achieving full therapeutic concentrations within a cancer tumor can be difficult when cannabinoids are administered using common dosing methods, such as oral ingestion or inhalation. In addition, the psychotropic effects of cannabinoids can significantly limit the dosages administered using the conventional dosing methods. Currently, targeted methods of administering cannabinoids more directly to tumors do not exist. Andira’s therapeutic candidate targeting ductal carcinoma in situ (DCIS), AND-259, makes use of a novel transdermal delivery technology which allows for direct, localized cannabinoid delivery to the primary tumor site.

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Cannabinoids and Pain

Cannabis has been utilized to treat pain for thousands of years. In surveys of cannabis usage, pain is the top indication in virtually all studies, in the range of 70%. The benefit of such use has been demonstrated in modern times with randomized controlled trials, most notably with Sativex®, which demonstrated efficacy in central and peripheral neuropathic pain, rheumatoid arthritis, and cancer pain unresponsive to optimized opioid treatment in two Phase II trials (1). Interestingly, one of those studies (2) showed a superior response to treatment with the lowest dose range. The need for better treatments for cancer pain is evident since 80% of people with advanced cancer are so afflicted. The efficacy of cannabis in chronic pain treatment in adults was endorsed in the 2017 report of the US National Academies (3) as demonstrating “conclusive or substantial evidence.” The way cannabis and THC affect pain is distinct from that of other analgesics (pain killers) and is more nuanced and multi-factorial. Whereas drugs like aspirin merely work on inflammation, and opioids kill pain at the risk of sedation, addiction and even death from overdose, cannabis-based drugs lack these drawbacks. Recent studies show a unique ability of cannabis to treat the affective (emotional) component of pain (4), so that while it is still felt, it is less problematic and disruptive to a patient’s ability to pursue successfully the activities of daily living. The more general usage of cannabis for pain has been problematic due to issues of its administration and adverse events (i.e., side effects) attributable to THC. Smoking is not a viable delivery vehicle that can attain regulatory approval by the US Food and Drug Administration. Oral usage is subject to great variability and may pose a greater risk of psychoactive effects, such as anxiety, as THC is metabolized (broken down) in the liver to a more potent molecule. The solution may rest in topical preparations, but previously these have been ineffective in breaching barriers in the skin. Andira’s innovative transdermal technology allows passage of cannabinoids through the skin, while the vehicle remains behind. The skin, subcutaneous tissues and associated sensory nerves are rich in CB1 cannabinoid receptors, which mediate analgesic effects, while inflammatory cells of the immune system are rich in CB2 cannabinoid receptors, which mediate anti-inflammatory and analgesic effects. Passage of cannabinoids through the skin and near the tumor site allows direct effects on the pain at its source with far less risk of anxiety or other central effects. The ease of administration will allow transdermal use in even the sickest patients who may not tolerate oral medication. The prospective advantages of this novel approach are clear.
  1. Russo EB, Hohmann AG. Role of cannabinoids in pain management. In: Deer T, Gordin V, editors. Comprehensive Treatment of Chronic Pain by Medical, Interventional and Behavioral Approaches. New York: Springer; 2013. p. 181-97.
  2. Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, et al. Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial. J Pain. 2012;13(5):438-49.
  3. National Academies of Sciences Engineering and Medicine (U.S.). Committee on the Health Effects of Marijuana: an Evidence Review and Research Agenda. The health effects of cannabis and cannabinoids : the current state of evidence and recommendations for research. Washington, DC: the National Academies Press,; 2017. Available from: https://dx.doi.org/10.17226/24625.
  4. Lavie-Ajayi M, Shvartzman P. Restored self: a phenomenological study of pain relief by cannabis. Pain Medicine. 2019;(in press):1-7.
  5. Hossain MZ, Ando H, Unno S, Kitagawa J. Targeting Peripherally Restricted Cannabinoid Receptor 1, Cannabinoid Receptor 2, and Endocannabinoid-Degrading Enzymes for the Treatment of Neuropathic Pain Including Neuropathic Orofacial Pain. Int. J. Mol. Sci. 2020; 21(1423). Available from: https://doi.org/10.3390/ijms21041423
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