Autism Archives - Green Market Report

Julie AitchesonJulie AitchesonSeptember 30, 2020
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5min18381

Autism is a developmental disorder characterized by communication and behavioral difficulties from minor to extremely severe. There is no medical cure for autism and much remains mysterious about the condition. There is no blood test or similarly straightforward means of diagnosis, and can often be missed for years or even a lifetime by a physician.  Autism can express differently in every individual, with a broad range of symptoms and gradients of severity that can make treating symptoms even more challenging than gaining a diagnosis. Conventional treatments for symptoms of ASD, which include a variety of drugs to relieve seizures or behavioral and anxiety issues, often come with serious side effects of their own. While interventions like cognitive behavioral therapy and speech-language therapy can have a positive impact on outcomes for those with ASD, those with more severe conditions may require some form of medication. Yet again, the adverse side effects that come with these medications create an untenable Catch-22 for ASD patients and caregivers alike. Enter HOPE.

HOPE tinctures are the creation of Zelira Therapeutics and 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 natural treatments. Daniels is a proud partner of Zelira Therapeutics, which formed through a merger of Zelda and Ilera Therapeutics in 2019. As the mother of a child with severe autism, Daniels responded to years of traveling the country in an exhaustive but fruitless search for treatments for her son by forging her own path, using diet and medical cannabis to ensure a high quality of life for her son and family.

Through partnerships within the state of Louisiana, HOPE tinctures (which are specifically formulated with Autism Spectrum Disorder in mind) will be available exclusively through state-licensed medical marijuana dispensaries in the state to all patients and families bearing a doctor’s prescription. The tinctures will be available in two formulations, “HOPE1”, which is a 1:1 THC: CBD tincture, and “HOPE2”, a 5:1 THC: CBD tincture. 

Louisiana ranks higher than the national average for the percentage of autism diagnoses per capita and recently passed legislation in the state allows all Louisiana patients and families to receive medical cannabis through a doctor’s prescription for any condition. This makes it a perfect staging ground for this new partnership between the HOPE line of medical cannabis tinctures, Lousiana’s Ilera Holistic Healthcare, and Southern University’s Agricultural Center, through which the tinctures are grown, cultivated, processed, and packaged. With the introduction of the specially formulated and research-based HOPE tinctures into medical marijuana dispensaries across Louisiana, Erica Daniels is excited to bring the benefits of cannabis to other constituents in the ASD community.

HOPE™ was formulated by Zelira Therapeutics a leading global therapeutic medical cannabis company with access to the world’s largest and fastest growing cannabis markets. The company’s focus is on developing branded cannabis products for the treatment of a variety of medical conditions including insomnia, autism and chronic non-cancer pain.

 


Kaitlin DomangueKaitlin DomangueJune 17, 2020
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4min24041

Zelira Therapeutics Ltd (OTCMKTS: ZLDAF) could be changing the way we approach autism. Zelira is a global therapeutic medicinal cannabis company headquartered in Australia. It works closely with leading researchers and organizations including Curtin University in Perth, Western Australia, the Telethon Kids Institute, the University of Western Australia, in Perth, St. Vincent’s Hospital in Melbourne, Australia, and the Children’s Hospital of Philadelphia (CHOP) in the United States.

Zelira is executing human clinical trials with medical marijuana, focusing on insomnia, opioid reduction, and autism. Subsequently, the company released a white paper detailing the survey results of 50 patients within the Hope Grows for Autism network in Pennsylvania. All of the patients used Ilera Healthcare’s HOPE product line. They were all residents of Pennsylvania and able to legally purchase medicinal cannabis. The findings were astounding.  

The white paper reads, “Respondents who used HOPE™ 1 tincture with a THC:CBD ratio of 1:1 with Eucalyptol, Valencene and Alpha-Pinene terpenes, HOPE™ 2 tincture with a THC:CBD ratio of 5:1 with beta-Caryophyllene, Myrcene and Alpha-Bisabolol terpenes or both products for a range of 5-133 days (average of 68 days of use) reported the following: Significant improvements in patient irritability (68%), meltdowns (60%), aggression (55%), anxiety (49%) as well as capacity to focus (38%); while 69% of participants reported an improved quality of life for the patient. In addition, 58% reported improved quality of life for the entire family.” In other words, a THC:CBD tincture of varying doses and a rich terpene profile produced significant improvements and quality of life for the patients. 26% of patients used only HOPE 1, 54% of patients used only HOPE 2, and 20% of patients used both HOPE 1 and HOPE 2. 

According to the data, 0% of patients reported the patient’s symptoms worsening. This is a great example of the cannabis plant’s gentle properties and minimal side effects. Additionally, less than 30% of participants reported no change in symptoms for anxiety, aggression, meltdowns, and irritability, with roughly 42% of participants reporting no change in the patient’s ability to focus. The majority of patients, however, noted significant improvement, with a small percentage noticing some improvement. 

The report acknowledges there are some limitations with the data. All of the survey responses were based on caregiver responses with no control group, nor did the survey collect information on the patient’s ASD history or associated symptoms. Nevertheless, “there is a strong and widely accepted belief that the main caregivers are the most reliable source of information to evaluate the status of a patient with ASD.”

“Our 5-year-old has been on HOPE™ for just over a year now, it has positively saved our lives!,” said a survey participant. “To think what our day-to-day was and what it is now is just remarkable… Within two weeks of Ilera HOPE™ the difference was night and day! Sleeping consistently, better appetite, better focus at school, much better overall behavior and mood.”

Dr. Richard Magill is the Medical Director at PA Green Med and said, “All physicians who treat patients with Autism Spectrum Disorder should be aware that HOPE™ represents a significant addition to the potential tools we have to improve the lives of ASD patients and their families.”


StaffStaffMay 27, 2020
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4min6630

Zynerba Pharmaceuticals, Inc. (ZYNE) announced positive top-line results from the exploratory, open-label Phase 2 BRIGHT study (An Open-Label Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Autism Spectrum Disorder) trial. Autism Spectrum Disorder is a developmental disorder that affects communication and behavior in approximately one million pediatric and adolescent patients between the ages of five and 17 in the U.S.

The stock was moving higher by over 8% at one point in early trading to lately sell at $6.69. Most of the analysts covering the stock have rated it a Hold according to Yahoo Finance. The average price target is $15.33.

The trial was designed to assess the safety, tolerability, and efficacy of the Zynerba drug called Zygel in pediatric and adolescent patients with autism spectrum disorder (ASD). Zygel was administered to patients with moderate-to-severe symptoms of ASD as add-on therapy to their standard of care utilizing a variety of efficacy assessments.

“We are very encouraged by the compelling top-line results of the BRIGHT trial and we expect to meet with the FDA to discuss the clinical pathway for developing Zygel for the treatment of behavioral symptoms of ASD in the second half of this year,” said Armando Anido, Zynerba’s Chairman and Chief Executive Officer. “Our goal is to develop Zygel for patients suffering from debilitating neuropsychiatric disorders including ASD, Fragile X syndrome, 22q and DEE. I want to thank the patients, families, physicians, clinical staff, and the Zynerba team for their support of this key study in ASD.”

Key findings from the trial disclosed today include:

  • All five subscales of the Aberrant Behavior Checklist – Community (ABC-C) as well as the Parent Rated Anxiety Scale – Autism Spectrum Disorder (PRAS-ASD) showed both statistically significant and clinically meaningful improvements at 14 weeks of treatment from baseline;
  • The results observed in other efficacy outcome measures, including Clinical Global Impressions – Improvement scale (CGI-I), support the subscale results observed in the ABC-C;
  • Zygel was well tolerated in this trial with no serious or severe adverse events reported.

“I am very impressed with the improvements my patients made over the 14-week treatment period while receiving Zygel; the reduction in irritability, communication deficits, and repetitive movements were especially noteworthy since some of these are core autistic behaviors,” said Helen Heussler, FRACP, Associate Professor at Children’s Health Queensland, Medical Director Child Development and principal investigator in the BRIGHT trial. “The magnitude of effect on autistic behaviors in this trial is significant, including hyperactivity and stereotypy, which are among the most difficult behaviors to improve with therapeutic intervention. The results of this study strongly suggest the potential of this drug as an important treatment for ASD and I look forward to participating in future clinical studies with Zygel.”



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