Tag Archives: cannabidiol

Watch Special TV Report: Trials Underway

NBC TV station WMGT 41in Macon aired a special report on this clinical trial that began in December at GRU.

The reporter interviewed Drs. Yong Park and Michael Diamond, as well as Valerie Weaver of Augusta, the mother of Preston – the first patient in the state to received the marijuana-based drug Epidiolex to find out if it will help is intractable epileptic seizures.

 

Update on Augusta boy in marijuana drug study

The Augusta Chronicle and WRDW-TV News 12 spoke briefly to Valerie Weaver about her son Preston, the first child in Georgia participating in the clinical trial of cannibinoid oil for the treatment of intractable seizures, during his first follow-up appointment at Children’s Hospital of Georgia on Jan. 27.

Read The Augusta Chronicle story: Augusta boy doing well in marijuana oil drug study

Watch Ch. 12 story below.

 

Cannabidiol trials begin this week

AUGUSTA, Ga. – Two clinical trials aimed at treating children with medication-resistant epilepsy with cannabidiol have been approved at Georgia Regents University. The first – a two-person compassionate use protocol that received authorization from both the Drug Enforcement Administration and the U.S. Food and Drug Administration – begins today at Children’s Hospital of Georgia. The second will allow for an expanded 50-person trial, initiated at GRU with planned expansion to Savannah and Atlanta.

The state, along with GW Pharmaceuticals (NASDAQ: GWPH), and officials at GRU have been working together since May to begin a study with GW’s investigational cannabidiol (CBD) product Epidiolex®, which has promising data for difficult to treat childhood epilepsies.

Georgia Governor Nathan Deal announced in April his support for clinical research that would investigate the use of CBD, a non-psychoactive component of the cannabis plant, and develop rigorous data that will inform and expand the scientific community’s understanding of potential treatments.

“No one with a heart could hear the stories of these children and their parents and not want to exhaust every possibility to provide them with the treatment they need to combat this debilitating condition,” said Gov. Nathan Deal. “I believe this initiative can have a meaningful and positive impact on the health of suffering children. Georgians have expressed overwhelming support for these endeavors, and I’m committed to finding solutions for these brave families.”

GW Pharmaceuticals is a world leader in the development of prescription cannabinoid medicines, and conducts scientific research in accordance with U.S. federal law with permission from the FDA and DEA. The FDA has already authorized physician-sponsored Investigational New Drug programs with Epidiolex at 20 sites around the U.S involving over 400 children. In parallel, GW is progressing a company-sponsored formal development program for Epidiolex that is focused on the treatment of two rare and severe forms of childhood epilepsy, Dravet syndrome and Lennox-Gastaut syndrome.

“We are pleased to be partnering with the State of Georgia and Georgia Regents University in response to the significant unmet needs of children with treatment-resistant epilepsies by providing physicians with access to our medicine Epidiolex,” said Dr. Geoffrey Guy, Chairman of GW Pharmaceuticals. “In parallel with this GRU program, GW is advancing a formal clinical trial program with the FDA and has commenced placebo-controlled clinical trials designed to gain approval for Epidiolex as a prescription medicine.”

“As the state’s public academic medical center, we should be on the leading edge in the treatment of these disorders,” said GRU President Dr. Ricardo Azziz. “Georgia’s children should not have to go elsewhere. We have a responsibility to bring the medicine of tomorrow to patient care today. We are excited to partner with GW Pharmaceuticals to study investigational cannabidiol and potentially change the lives of children with medication-resistant epilepsies.”

Families of children with difficult to treat seizure disorders who are interested in enrolling in the Epidiolex trial at Georgia Regents University can contact lead investigator Dr. Yong Park at (706) 721-3371.

About GW Pharmaceuticals:
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States. Sativex is also in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW is also advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex®, which is in Phase 2/3 clinical development for the treatment of Dravet syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Lennox-Gastaut syndrome. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type 2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.

About Georgia Regents University and Health System:
Georgia Regents University is one of four public comprehensive research universities in the state with nearly 10,000 students enrolled in its nine colleges and schools, which include the Medical College of Georgia – the nation’s 13th-oldest medical school – the nationally-ranked Hull College of Business and Georgia’s only College of Dental Medicine. The clinical enterprise associated with the university includes the 478-bed Georgia Regents Medical Center and the 154-bed Children’s Hospital of Georgia. GRU is a unit of the University System of Georgia and an equal opportunity institution. http://www.gru.edu

 

TIME: GA Gov. pushes trials of marijuana derivative

TIME Magazine featured coverage of Georgia Governor Nathan Deal’s visit to the Children’s Hospital of Georgia on July 8. Deal was on campus to discuss beginning clinical trials of a marijuana-derived oil that could help treat children with medication resistant epilepsy.

Read: Georgia Governor pushes trials of marijuana derivative

 

 

Finding the Medicine in Marijuana

Dr. Geoffrey Guy, Chairman of GW Pharmaceuticals, will talk about “Finding the Medicine in Marijuana: New developments in cannabinoid medications” at noon Tuesday, July 8, in the Natalie and Lansing B. Lee, Jr. Auditoria Center on Georgia Regents University’s Health Sciences campus.

The presentation is part of the company’s two-day visit to GRU to discuss the potential of clinical trials to use the company’s investigational cannabidiol (CBD) product Epidiolex® in the treatment of children with medication-resistant epilepsies.

Gov. Nathan Deal, who, in April, announced his support for clinical research that would investigate the use of CBD, will be also be on campus Tuesday to discuss the potential trials. GW Pharmaceuticals, GRU, and the state of Georgia, entered into a Memorandum of Understanding in May to study the drug. It is expected that details of the collaboration will be finalized in the coming months in order for research to commence later this year.

GW is a world leader in the development of prescription cannabinoid medicines, and conducts scientific research in accordance with U.S. federal law with permission from the U.S. Food & Drug Administration and the U.S. Drug Enforcement Administration. The FDA has already authorized, physician-sponsored Investigational New Drug programs with Epidiolex at 12 sites around the U.S involving over 300 children. In parallel, GW is progressing a company-sponsored formal development program for Epidiolex that is focused on the treatment of two rare and severe forms of childhood epilepsy, Dravet syndrome and Lennox-Gastaut syndrome.

 

Augusta Chronicle: Marijuana-derived drug shows promise

News about the first clinical trials of Epidiolex®, the marijuana-derived drug that might be tested on pediatric epilepsy patients at the Children’s Hospital of Georgia, was released by London-based GW Pharmaceuticals this week. 

About half of patients in the trial experienced a 50 percent reduction in their seizures, and 15 percent were seizure-free after the trial, the company reported Tuesday.

GW Pharmaceuticals, Georgia Gov. Nathan Deal, and Georgia Regents University, entered into a Memorandum of Understanding  last month to explore the possibility of Epidiolex trials at GRU.

Read about the trial results: Marijuana-derived drug Epidiolex shows promise; drug could be tested at Georgia Regents University

MOU signed to study investigational oil derived from marijuana

AUGUSTA, Ga. – A State of Georgia initiative making it possible to treat children with epilepsy with cannabidiol is moving forward. The state, GW Pharmaceuticals (NASDAQ: GWPH), and Georgia Regents University Augusta (GRU) announced today that they have entered into a Memorandum of Understanding to study GW’s investigational cannabidiol (CBD) product Epidiolex® in the treatment of children with medication-resistant epilepsies.

Georgia Governor Nathan Deal announced in April his support for clinical research that would investigate the use of CBD, a non-psychoactive component of the cannabis plant, and develop rigorous data that will inform and expand the scientific community’s understanding of potential treatments for difficult-to-treat forms of childhood epilepsies. Deal’s commitment to this research has led to this plan to form collaboration between GRU and GW Pharmaceuticals. It is expected that details of the collaboration will be finalized in the coming months in order for research to commence later this year.

“I have learned the stories of brave Georgia families desperately seeking treatment for their children’s debilitating condition,” Deal said. “As governor, it is my responsibility to address the needs of and protect our state’s most vulnerable citizens, especially when they are suffering. I’m grateful to Georgia Regents University and GW Pharmaceuticals for their leadership on this venture, and I’m confident that this public-partnership will deliver relief and improve quality of life for these children and their families.”

GW Pharmaceuticals is a world leader in the development of prescription cannabinoid medicines, and conducts scientific research in accordance with U.S. federal law with permission from the U.S. Food & Drug Administration and the U.S. Drug Enforcement Administration. The FDA has already authorized physician-sponsored Investigational New Drug programs with Epidiolex at 12 sites around the U.S involving over 300 children. In parallel, GW is progressing a company-sponsored formal development program for Epidiolex that is focused on the treatment of two rare and severe forms of childhood epilepsy, Dravet syndrome and Lennox-Gastaut syndrome.

“We are pleased that the State of Georgia has selected GW as their partner in this research program, and we look forward to working together to commence this important research. Georgia Regents University has the experience, expertise, and infrastructure to implement this research in accordance with the highest scientific and regulatory standards,” stated Dr. Geoffrey Guy, Chairman of GW Pharmaceuticals. “This collaboration is a great opportunity for stakeholders in Georgia to access true scientific data that should inform and expand their understanding of how CBD works in such a challenging and vulnerable patient population.”

“As the state’s public academic medical center, our primary missions are patient care, education, and research,” said GRU President Dr. Ricardo Azziz. “We have a responsibility to bring the medicine of tomorrow to patient care today. We are excited to partner with GW Pharmaceuticals to study investigational cannabidiol and potentially change the lives of children with medication-resistant epilepsies.”