Zelira Therapeutics Archives - Green Market Report

StaffDecember 17, 2020
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Zelira Therapeutics Ltd (ASX:ZLD, OTCQB:ZLDAF), a leader in cannabis research and the development of clinically validated cannabis medicines, just announced its newest licensing agreement for its HOPE™ line of products, Zelira’s top-selling treatment developed for autism patients. Under the agreement with Alternative Solutions, a licensed grower, manufacturer and distributor of medical cannabis products in the District of Columbia (Washington DC), HOPE™ will be produced and distributed throughout the legal DC medical cannabis market beginning in Q2 2021.

“We are thrilled to have Alternative Solutions as a partner to launch HOPE™ in the nation’s capital,” says Dr. Oludare Odumosu, CEO & Managing Director USA for Zelira. “They are a leader in the DC medical cannabis market, and this partnership will allow legal access of HOPE™ to more patients across the country than ever before.”

Odumosu notes that this agreement with Alternative Solutions signifies HOPE’s largest expansion to date; because Washington DC has reciprocity with 32 other states in the US with approved medical cannabis programs, patients registered in those states are able to legally purchase medical cannabis products at an approved dispensary in Washington DC.

HOPE™ was formulated by Zelira Therapeutics and is the brainchild of Erica Daniels, founder of Hope Grows for Autism, a nonprofit aimed at improving the lives of families affected by autism through research, education and advocacy of medical marijuana. HOPE™ is currently available in the United States in Pennsylvania, through an exclusive license agreement with Ilera Healthcare, and in Louisiana, through an agreement with Advanced Biomedics LLC.


StaffDecember 2, 2020
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SprinJene and its partner Zelira Therapeutics (ASX: ZLD, OTCQB: ZLDAF) today officially launch their new CBD oral care line. In September, we reported on their partnership announcement and the future launch of their new hemp-derived CBD oral care line. The companies said their product would be available by Q4 of 2020. In a press release the companies announced the first product from its line will be available on Monday, December 7th at SprinJene.com.

This new launch already expands upon SprinJene’s premium natural oral care products which are Gluten-Free, Cruelty-Free, Vegan, Kosher, USDA Bio-preferred, and Halal oral care. The New Jersey based company which recently received its first ADA (American Dental Association) seal of acceptance for its Fresh Boost toothpaste. The formula for SprinJene products holds a patented formula of zinc and black seed oil, which together can provide relief from dry mouth, control tartar growth, and deliver long-lasting oral freshness. Black Seed oil and zinc have been shown to fight gingivitis (gum disease) and reduce gum inflammation. Their products are nationwide and can be found in such retails as Costco, Bed Bath & Beyond, and VitaCost and online at Walmart.com and Amazon.

Dr. Sayed Ibrahim, CEO of SprinJene said, “Our brand is built on harnessing the power of natural ingredients to protect and improve our oral health, and CBD, with its inherent anti-inflammatory, antibacterial and homeostatic properties are shown to be powerful tools in that fight.”

In its release, the company said research shows that incorporating CBD into oral/dental care results in health benefits such as: naturally eliminating decay-causing bacteria, reducing gum inflammation, restoring pH balance and increasing remineralization, reducing bone loss associated with gum disease, and helping to improve overall health.

SprinJene’s formulation was created with Zelira and uses hemp-derived broad-spectrum, THC-free CBD, unlike other brands that use hemp seed oil with no CBD. With their unique formulation which includes black seed oil as well, consumers will receive the benefits of CBD with no psychoactive “feeling of high” effects.

“We are thrilled to enter the national oral care market alongside our remarkable partner. SprinJene shares our values of aligning nature and science,” said Dr. Oludare Odumosu, Zelira’s CEO & Managing Director (USA).  “As you can see SprinJene continues to innovate and with this expansion, consumers will receive the benefits of the effectiveness of CBD and other cannabinoids improving our health from head-to-toe.”

 


StaffOctober 30, 2020
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Zelira Therapeutics Ltd (ASX: ZLD, OTCQB: ZLDAF) just announced that its proprietary cannabinoid medicines, HOPE 1 and HOPE 2are now available by prescription to patients in Australia. The HOPE™ forumations, developed by Zelira and noted autism advocate Erica Daniels, first launched in 2019 in Pennsylvania and this fall in Louisiana. 

“We have had great success with HOPE™ in the US and are thrilled to be able to offer it to patients as a treatment option through the Therapeutic Goods Administration’s (TGA) Special Access Scheme,” says Osagie Imosogie, Chairman of Zelira Therapuetics. “Zelira is proud of this latest achievement in our mission to bring cannabinoid medicine to patients around the world.”

The HOPE cannabinoid medicines were developed to support the needs of patients with Autism Spectrum Disorder (ASD) by Daniels and Zelira Therapeutics, which then licensed the proprietary formulas to Ilera Healthcare in Pennsylvania and Ilera Holistic Healthcare in Louisiana. HOPE has since established itself as one of the top selling formulated medicinal cannabis products in Ilera Healthcare’s portfolio. 

“Autism families are finally beginning to have access to a truly better alternative than the harsh pharmaceuticals of the past and I am so proud that HOPE is now available in Australia,” says Erica Daniels, founder of Hope Grows for Autism and co-creator of the HOPE forumalations. “What started off as a labor of love to find a way to treat my own son is now helping parents around the world.” 

HOPE is part of Zelira’s family of revenue generating medicinal cannabis formulations. The products consist of two pharmaceutical-grade proprietary formulations developed as pharmaceutical-grade products targeting Autism Spectrum Disorder (ASD) as a disease indication. 

“Following the success of the HOPE™ launches in Pennsylvania and Louisiana, we are excited to make these products available to patients and physicians in Australia,” says Dr. Richard Hopkins, Zelira’s global Managing Director. “This represents another key milestone in our commitment to bring the benefits of HOPE to patients in global markets.”


StaffSeptember 11, 2020
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Zelira Therapeutics (ASX: ZLD, OTCQB: ZLDAF) announced it has entered into a partnership agreement with New Jersey based oral care company SprinJene to launch hemp-derived CBD dental products. SprinJene says it will bring its CBD toothpaste to market by the end of Q4for  distribution across retail and other channels across the US. This will be the first CBD product for the brand. Dr. Sayed Ibrahim, CEO of SprinJene said “We are excited about the partnership with Zelira Therapeutics and look forward to the impact that our products will have in the oral care market.” The company’s current line of products are nationwide and can be found at Walmart, Costco, Bed Bath & Beyond, Amazon, and VitaCost. Ibrahim continues, “Our collaboration to commercialize the most advanced hemp-derived cannabinoid-based oral care products expands our reach into new oral care markets where every person can access the daily benefit of using our products.”
 
Dr. Oludare Odumosu, CEO and Managing Director (USA) of Zelira said, “This partnership with SprinJene will commercialize these new and advanced oral care cannabinoid-based products. Our firm remains focused on unlocking the benefits of cannabinoid-based applications as we continue to expand our company’s reach into new and lucrative markets. ”
 
Zelira is one of the global leaders in developing clinically validated cannabis medicines, this will be their first of five over-the-counter oral cannabinoid products they are on track to launch globally. will bring to market.  SprinJene® states it is a socially conscious brand dedicated to marrying the benefits of science and nature in the creation of Gluten-Free, Cruelty-Free, Vegan, Kosher, USDA Bio-preferred, and Halal oral care. The line is manufactured by New Jersey based Health and Natural Beauty USA Corp. where Zelira-SprinJene products will be manufactured. 

StaffJuly 20, 2020
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Zelira Therapeutics Ltd  ZLDAF 7.89%  has confirmed its phase one dose-escalation trial of ZTL-103 has successfully met its primary and secondary endpoints for safety and efficacy.

The Study:

The recent study was conducted at the St Vincent’s Hospital in Melbourne, Australia, and the Emerald Clinics (EMD) in Perth, suggests cannabis is a safe option for patients to integrate into their current pain treatment.

That includes patients who already consume high doses of opioids.

The company administered its ZTL-103, a 1:1 THC/CBD formulation to chronic pain (non-cancer) patients who used at least 60 milligrams of morphine or similar opioids daily. After a two-week dosing period, patients reported reduced levels of pain, stress, depression and anxiety, while experiencing no serious side effects.

“This study not only reinforces that cannabis can be safely administered in increasing amounts to treat pain, but can be safely taken concurrently with high daily doses of opioids,” says Zelira CEO Dr. Oludare Odumosu. “These promising results lay the groundwork for our further study on pain management among retired athletes.”

This trial aimed to assess the safety of Zelira’s cannabis formulation, ZTL-103, in patients with chronic pain who are already on long-term, high-dose opioid treatment. 

The downside of prescription opioid treatment is the links to serious side effects including physical dependence. In the U.S., an estimated 49,000 people died from an opioid overdose in 2017.

Nine patients were enrolled and seven completed the study. The average patient age was 58 years and the average Morphine Equivalent Daily Dose (oMEDD) was 93 milligrams per day. 

Patients were treated with a single dose of ZTL-103, containing five milligrams of total cannabinoids (2.5 milligrams THC and 2.5 milligrams CBD) on the first day. After seven days, patients received another single dose of the same amount. 

They then continued to take two daily doses of five milligrams for seven days before escalating to 20 milligrams per day for seven days. 

Following this, the dosage increased to 30 milligrams for another seven days before taking a single dose of 25 milligrams of total cannabinoids.

The Results:

Primary endpoints achieved

ZTL-103 has been confirmed as safe with no reports of serious adversity and the maximal dose was generally well tolerated.

Secondary endpoints achieved

ZTL-103 reportedly improved the patient’s measure of pain. The patient’s pain was assessed using a Brief Pain Inventory (BPI) questionnaire. The BPI measures pain severity and pain interference, which is how pain generally impacts daily function and activities.

The results showed patients were dose-responsive and a significant reduction at daily doses of over 10 milligrams of total cannabinoids.

Results also showed patients’ anxiety, stress and depression was reduced at daily doses of more than 30 milligrams. Overall, the ZTL-103 treatment reduced median scores from severe or moderate to mild or normal at over 10 milligrams.

“This trial showed that ZTL103 treatment was safe and well-tolerated in patients diagnosed with chronic pain who were also taking high oMEDD doses,” Associate Professor Yvonne Bonomo said.

“These results would certainly warrant further clinical investigation to assess the ability of ZTL-103 therapy to reduce opioid dependence and improve pain and quality of life in chronic pain patients,” Yvonne added.

Outlook:

The trial results have helped to inform the testing with privately-held medicinal cannabis company, Levin Growing, which will target retired athletes experiencing chronic pain.

“The data will also accelerate plans to expand Zelira’s portfolio of chronic pain products, supported by clinical trial data, we will be launching into global markets and progressing into clinical development,” Managing Director Dr Richard Hopkins said.

The chronic pain products include an aged-care product that is on track to be launched in the U.S. later this year. 

Company shares are up 3.64 per cent and are trading for 5.7 cents each at 10:23 am AEST.

 


Debra BorchardtApril 9, 2020
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Zelira Therapeutics Ltd (OTCQB: ZLDAF) has received the final report for its ZTL-101 medicinal cannabis trial for insomnia. Its findings represent a world-first clinical validation demonstrating that ZTL-101 cannabis treatment is safe and effective for chronic insomnia. Dr. Oludare Odumosu, Managing Director Zelira USA said, “This trial has yielded a comprehensive data-pack that supports our plans to launch the world’s first clinically validated cannabinoid-based insomnia medicine into global markets this year.”

Study Trial

The company said in a statement that the trial was undertaken at the University of Western Australia Centre for Sleep Science and was led by principal investigator Professor Peter Eastwood, and used a randomized, double-blind, cross-over design to evaluate the efficacy of Zelira’s proprietary cannabis formulation (ZTL-101) to treat patients diagnosed with chronic insomnia. Twenty three patients were treated for 14 nights with ZTL-101 and 14 nights with placebo, separated by a one-week washout period. After dosing commenced, each participant was able to take a single (0.5ml of 11.5mg total cannabinoids) or double (1 ml of 23mg total cannabinoids) their dose of the medication, delivered sublingually, according to their symptoms.

The analysis showed treated patients slept significantly longer, went to sleep faster and went back to sleep sooner after waking. Patients also reported significant improvement in the quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued and improved overall functioning.

Professor Peter Eastwood, Principal Investigator for the study, and Director at the Centre for Sleep Science at the University of Western Australia said, “This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia. The fact that ZLT-101 treatment achieved statistically significant, dose-responsive improvements across a broad range of key insomnia indices is impressive, particularly given the relatively short two-week dosing window.”

Patient Population

Zelira noted that an estimated 70 million Americans have insomnia and that the market for prescription and over-the-counter medications is forecast to be worth over $4 billion in annual revenue by 2022. Insomnia affects -30% of the US population and is a major risk factor for patients suffering from chronic pain, neurological disorders (Parkinson’s, dementia), mental disorders (anxiety, depression, anorexia) and cardiovascular disease.

Next Steps

Zelira said it will seek to supply its clinically validated insomnia formula in countries and states where medicinal cannabis has been legalized including Australia, the USA, Germany, and the United Kingdom. The company remains on track to launch in the Australian market by early Q3, 2020. The company is also evaluating undertaking further clinical development of ZTL-101 in order to achieve its goal of product registration in Australia.


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