Study finds up to one-quarter of cancer patients use marijuana

A new study conducted in a cancer center in a state with legalized medicinal and recreational marijuana found that approximately one-quarter of surveyed patients used marijuana in the past year, mostly for physical and psychological symptoms. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the study also revealed that legalization also revealed that legalization increased the likelihood for use among patients.

Eight states and the District of Columbia have legalized recreational marijuana, and over half the states in the U.S. have passed laws allowing for medical marijuana in some form. As availability and acceptance of marijuana use continue to increase, many cancer patients will have greater access to marijuana during their cancer treatment.

Marijuana is purported to alleviate symptoms related to cancer treatment, but patterns of use among cancer patients are not well known. To investigate, Steven Pergam, MD, MPH, of the Fred Hutchinson Cancer Research Center and his colleagues surveyed 926 patients at the Seattle Cancer Center Alliance.

The team found that most patients had a strong interest in learning about marijuana during treatment and 74 percent wanted information from cancer care providers. Sixty-six percent had used marijuana in the past, 24 percent used in the last year, and 21 percent used in the last month. Most current users smoked or consumed marijuana primarily for physical symptoms (such as pain and nausea) or psychological reasons (such as coping with stress, depression, and insomnia).

The study reports that random analysis of patient urine samples showed that 14 percent had evidence of recent cannabis use, similar to the 18 percent of users who reported use within the past week.

Although nearly all respondents wanted more information directly from their doctors, most reported that they were more likely to get information from sources outside of the healthcare system. “Cancer patients desire but are not receiving information from their cancer doctors about marijuana use during their treatment, so many of them are seeking information from alternate non-scientific sources,” said Dr. Pergam. He stressed that marijuana may be dangerous for some cancer patients or lead to unwanted side effects. “We hope that this study helps to open up the door for more studies aimed at evaluating the risks and benefits of marijuana in this population. This is important, because if we do not educate our patients about marijuana, they will continue to get their information elsewhere.”

New Arsenal Against MRSA: New Study Reports Cannabinoids Effective Against Antibiotic-Resistant MRSA

Researchers have found that cannabinoid-based therapies have unique anti-bacterial properties that fight MSRA and other infectious bacteria. In vitro studies demonstrated that bactericidal synergy was achieved against multiple species of methicillin-resistant Staphylococcus aureus (MRSA) utilizing a proprietary cannabinoid-based therapeutic platform. MRSA species tested included community acquired- (CA-MRSA), healthcare-acquired- (HA-MRSA), and mupirocin-resistant (MR-MRSA) strains of MRSA.

Researchers also found that using unique strategic cannabinoid-based cocktails, fractional-inhibitory concentration (FIC) levels demonstrating synergy between mixtures of individual cannabinoid-based components ranged from 0.06 to 0.28. FIC findings below 0.5 indicate significant killing potential of the mixture. The work was led by NEMUS BIoscience, Inc. and the company’s discovery and research partner, the University of Mississippi (UM).

Dr. Mahmoud ElSohly, professor at the National Center for Natural Products Research (NCNPR) at the University of Mississippi commented: “Historically, many types of anti-infective compounds are derived from plants so to have a series of cannabinoid-related compounds exhibit activity against this dangerous pathogen is in keeping with prior efforts of drug development. I believe that these compounds, in addition to the bacterial killing capability, could also offer benefits associated with anti-inflammatory and anti-fibrotic properties that could enhance healing, especially against an organism associated with skin and soft tissue infections. The University, in conjunction with Nemus, is looking to expand the anti-infective capabilities of this series of compounds.”

Recently, the World Health Organization (WHO) placed MRSA on their list as one of the top six organisms that pose a global public health threat. “This anti-infective platform will constitute the NB3000 series of Nemus molecules and formulations.  While there are a number of compounds in the development pipeline against MRSA, we believe that this family of drug candidates could possess an excellent safety profile in addition to efficacy in neutralizing this bacterium,” stated Brian Murphy, M.D., C.E.O. and Chief Medical Officer of Nemus. “These unique botanically derived components establish an anti-infective platform which could potentially be expanded into other types of bacteria, as well as viruses, and fungi.”

The University of Mississippi, the state’s flagship institution, is among the elite group of R-1: Doctoral Universities – Highest Research Activity in the Carnegie Classification. The university has a long history of producing leaders in public service, academics, research and business. Its 15 academic divisions include a major-medical school, nationally recognized schools of accountancy, law and pharmacy, and an Honors College acclaimed for a blend of academic rigor, experiential learning and opportunities for community action.

Nemus will work with Dr. Elsohly, the University lead researcher on this project, to have this data submitted to a future scientific meeting and anticipates performing further testing against a variety of other bacterial species. Commercially, the company looks to actively pursue partnering opportunities for these candidate molecules. “This work highlights the importance of Nemus’ relationship with the University which has significant experience and intellectual capital related to cannabinoid chemistry and physiology, dating back to 1968,” added Dr. Murphy.

Nemus Bioscience is a biopharmaceutical company, headquartered in Costa Mesa, California, focused on the discovery, development, and commercialization of cannabinoid-based therapeutics for significant unmet medical needs in global markets. Utilizing certain proprietary technology licensed from the University of Mississippi, NEMUS is working to develop novel ways to deliver cannabinoid-based drugs for specific indications, with the aim of optimizing the clinical effects of such drugs, while limiting potential adverse events. NEMUS’s strategy is to explore the use of natural and synthetic compounds, alone or in combination with partners. The Company is led by a highly-qualified team of executives with decades of biopharmaceutical experience and significant background in early-stage drug development.

For more information, visit http://www.nemusbioscience.com.

Cannabinoid-Based Therapeutics may present opportunity in Reducing Intraocular Pressure: Study

Data from a preclinical study presented last week at the 2016 AAPS National Meeting demonstrated significant data concerning the effects of a cannabinoid-based drug in lowering the effect of Intraocular Pressure (IOP).

The abstract, “Effect of single versus multiple day regimen of Δ9 -THC-valine-hemisuccinate (THCVHS) on the intra-ocular pressure (IOP) lowering activity in normotensive rabbits” (abstract # 30W0830), reports data comparing the prodrug of tetrahydrocannabinol (THCVHS) also known as NB1111 (Nemus Bioscience), to established glaucoma therapies of Pilocarpine and Timolol, as well as standard Δ9 -THC in both emulsion and solid lipid nanoparticle (SLN) eye drops. All studies were conducted in a normal, non-glaucomatous eye. The goals of the studies were to examine penetration and concentration of NB1111 in ocular tissues responsible for IOP regulation and to correlate that concentration to measurement of IOP. Additionally, the studies examined the effect on drug half-life by encapsulating NB1111 in a SLN with single- and multiple-day dosing for up to five days.

The data revealed:

  • NB1111 lowered IOP in a normal eye in a statistically significant manner with peak IOP decline of 32% versus 16% for Pilocarpine and 23% for Timolol (p< 0.05); prior experiments in a glaucomatous eye exhibited a 45% IOP reduction for NB1111
  • The experiments demonstrated that increased drug concentration of NB1111 in the ciliary body and retina/choroid plexus was correlated with a decline in IOP; these ocular organs help regulate IOP
  • Use of Δ9 – THC (parent molecule, non-prodrug), whether formulated in an emulsion or SLN eye drop solution, resulted in no significant tissue concentration nor decline in IOP
  • Formulation of NB1111 into an SLN produced a duration of activity that could be consistent with twice daily eye drop dosing in humans and successfully transported the drug into both the anterior and posterior compartments of the eye and was highly significant compared to both approved comparator drugs (p<0.001)
  • No safety issues were noted with the administration of NB1111 over five days dosing
  • No free THC was detected in the peripheral circulation of the test animals after repeated dosing NB1111 using an assay with nanogram detection sensitivity

“These findings are critical to our understanding on how this novel prodrug of THC can reduce IOP so effectively,” stated Soumyajit Majumdar, PhD, Professor of Pharmaceutics and Drug Delivery and Associate Dean for Research in the School of Pharmacy at the university and lead scientist of the ophthalmic studies of NB1111. “As important as the ocular findings were in these studies, we were also pleased to see that the plasma THC levels in these animals, even those undergoing repeated ocular dosing, did not have detectable levels of THC. This is a key safety finding for this drug.”

Dr. Mahmoud ElSohly, professor at the National Center for Natural Products Research at the University of Mississippi, commented: “Multiple experiments, including previously reported data, have clearly demonstrated a causal relationship between the drug’s tissue concentration and IOP lowering in both normal and glaucomatous eyes. This unique prodrug technology has enhanced treatment concentrations in the eye and could signal a new therapeutic class for the management of glaucoma.”

“NB1111 has performed above expectations in the ability to lower IOP in these animal models. We want to further explore the neuroprotective effects of cannabinoids upon the optic nerve and move the ophthalmology program into human testing. I am also happy to report that our colleagues at the University of Mississippi have been able to develop an early ocular formulation of our CBD analogue, and in doing so, expands our ocular program into a full-fledged ophthalmology platform that could address multiple eye diseases beyond glaucoma, including diseases of the retina,” noted Brian Murphy, MD, MBA, Nemus CEO and Chief Medical Officer.

A link to the abstract on the AAPS website can be found at https://annual.aapsmeeting.org/poster/member/66948.

New Class of Medicinals based on Cannabinoid Molecules, Spurs NEMUS Bioscience Inc. into Action

Q&A with Brian Murphy MD, CEO/CMO, NEMUS Bioscience

Humans produce a range of chemical compounds called cannabinoids that keep the human body stable by binding to receptors on cell membranes and controlling the release of chemical messengers that regulate everything from how humans experience pain to our moods. While most people’s endocannabinoid systems naturally help maintain a state of homeostasis, or stability, conditions such as multiple sclerosis or treatments for diseases like cancer can throw off that balance. Introducing cannabinoids made outside the body might help. Marijuana also contains cannabinoids – at least 66 of them.

Drugs based on cannabinoids, which could treat ailments ranging from arthritis to epilepsy, hold untold potential for the pharmaceutical industry.

The BioConnection.com recently spoke with Dr. Brian Murphy, NEMUS Bioscience’s CEO and CMO on the potential of cannabinoid research.

Q: What is NEMUS Bioscience working on?

Murphy: NEMUS Bioscience (OTCQB: NMUS) was formed to bring a new class of medicinals, based on the 100+ cannabinoid molecules in the Cannabis sativa plant, to a variety of therapeutic markets, especially those of unmet medical need.  Almost every organ in the body possesses cannabinoid receptors giving these compounds tremendous versatility in affecting the course of disease.

Q: What are the main diseases or symptoms you are attempting to target with cannabinoid research?

Murphy: The NEMUS developmental pipeline is currently focused on three therapeutic silos:

1) Palliative care addressing specific indications of chemotherapy-induced nausea and vomiting (CINV) and chemotherapy-induced peripheral neuropathy, a particularly severe pain syndrome associated with certain type of cancer chemotherapy.

2) Ophthalmology: the initial therapeutic indication being pursued is glaucoma, with initial animal studies in models of glaucoma exhibiting an average 45% reduction in IOP, exceeding current IOP reduction standards with currently approved medications and those in development using the same models.

3) Anti-infectives: Nemus is developing cannabinoid-based therapeutics against both bacterial and viral targets, with the initial therapeutic target in this silo being methicillin-resistant Staphylococcus aureus (MRSA). The current MRSA epidemic in the United States accounts for close to $4 billion in associated health-care costs as this bacterium has developed resistance to many antibiotics.  Newer therapies are needed.

Q: Describe your partnership with the University of Mississippi and how has the partnership benefited your research?

Murphy: The University of Mississippi (UM) is the only entity in the United States currently licensed by the federal government to grow, cultivate, and research cannabinoids autonomously.  The University has held that license since 1968 and has a tremendous amount of intellectual capital and experience in the chemistry and physiology of cannabinoid molecules.  That library of molecules and associated intellectual property helps distinguishes us from other companies in the cannabinoid therapeutic space.

Q: What difficulties have you encountered working with pharmaceuticals derived from cannabis?

Murphy: While marijuana is not a legal substance, drug companies are permitted to work with and develop derivatives from the plant and develop these molecules into drugs.  Many leading approved medicinals for cardiovascular disease, cancer, and anti-infectives are derived from plants or as is known in pharma development: botanically derived medications.  There is a designated regulatory pathway from both the DEA and FDA for cannabinoids and NEMUS works diligently to be in compliance with those requirements. To-date, we have not experienced any unexpected challenges outside the norm in developing a new class of compounds to address diseases.

Q: What is your opinion on people who smoke/ eat marijuana to relieve painful physical/ mental symptoms? In other words, why are cannabinoids better than the plant itself?

Murphy: For patients who use plant-derived cannabinoids, there are a number of challenges that “pharmaceuticalized” cannabinoids can hope to overcome:

  1. a) with an approved drug, you know what you’re getting- with the plant, random analyses performed by regulatory labs have shown that the advertised content doesn’t always reflect what is in the plant
  2. b) with an approved drug, the cannabinoid is specifically designed to combat a particular disease process both in formulation, route of delivery, and mechanism of action.  With plant-derived treatments, one-route of administration doesn’t always fit all diseases
  3. c) FDA approved medications are covered by insurance reimbursement; plant-derived cannabinoids have historically not been covered by insurance.  A month’s supply of plant-derived cannabinoids can run into the hundreds of dollars versus a $5-$10 monthly copay for FDA approved medications
  4. d) pharmaceuticalized cannabinoids undergo a rigorous testing process (randomized, double-blind, placebo controlled clinical trials),  Plant derived cannabinoids have not undergone this type of rigorous testing and in many cases, rely on anecdotal evidence where bias reporting can creep in; until this type of rigorous testing is conducted in plant-derived cannabinoids, marijuana dispensaries run the risk of violating FTC regulations if they make claims on the efficacy and safety of their products

Q: What has been your biggest success in your research so far?

Murphy: The biggest success has been validating our prodrug design in the molecular engineering of the cannabinoid molecule in animal studies that permit the therapy to enter the body with more predictable bioavailability and steady-state drug concentrations.  These proprietary molecules are designed to optimize safety and efficacy by permitting routes of administration that bypass first-pass metabolism in the liver.  We look forward to upcoming human testing to further validate the potential benefits of this drug design approach.

For more information, log on to www.nemusbiosciences.com