The NSW Government has committed $3.5 million to fund clinical trials exploring the use of cannabis products to provide relief for children with severe drug-resistant epilepsy. Researchers at Sydney Children's Hospitals Network will lead trials of CBDV and Epidiolex, drugs manufactured by GW Pharmaceuticals that have shown promising anti-seizure effects. The first trial will evaluate CBDV for children with epilepsy, while a compassionate access scheme may also allow children to access Epidiolex. The goal is to develop a better understanding of how these cannabis-derived drugs can help reduce seizures.
Cephalexin - Useful for Treating Bacterial InfectionsDV Medical Supply
DV Medical Supply, Inc., offers medical and veterinary clients a range of supplies, including hard-to-find medications, at affordable wholesale prices. Among the pharmaceuticals available via DV Medical Supply’s website is cephalexin.
ACP Supports ACIP's Recommendation to the CDCWayne Macfadden
A former Assistant Professor of Psychiatry at the University of Pennsylvania School of Medicine, Wayne Macfadden, MD, brought over three decades of Clinical Psychiatric and research experience to his position as a psychiatrist with the Spirit Lake Reservation in North Dakota, where he focused on providing Psychiatric treatments to residents of the reservation who are suffering from mental illnesses and substance use disorder. In addition, Wayne Macfadden, MD, is a former fellow with the American College of Physicians (ACP).
The American College of Physicians (ACP) backs the Advisory Committee on Immunization Practices (ACIP) recommendation to the Centers for Disease Control and Prevention (CDC) to utilize an extra mRNA COVID-19 vaccine dosage in immunocompromised people. On Friday, August 13, ACIP unanimously recommended an extra (third) dose of Pfizer-BioNTech COVID-19 vaccine (for those 12 years and older) or Moderna COVID-19 vaccination (18 years and older) after the results of a preliminary study in immunocompromised individuals.
ACP previously said that it has an ethical obligation to assist others in reducing COVID-19 mortality and morbidity and that it supports the rapid ramping up of supplies for equitable distribution of COVID-19 vaccines across and within countries in need. According to ACP, countries facing a shortage of vaccines and a high incidence of COVID-19 mortality and severe illness require immediate assistance.
Cephalexin - Useful for Treating Bacterial InfectionsDV Medical Supply
DV Medical Supply, Inc., offers medical and veterinary clients a range of supplies, including hard-to-find medications, at affordable wholesale prices. Among the pharmaceuticals available via DV Medical Supply’s website is cephalexin.
ACP Supports ACIP's Recommendation to the CDCWayne Macfadden
A former Assistant Professor of Psychiatry at the University of Pennsylvania School of Medicine, Wayne Macfadden, MD, brought over three decades of Clinical Psychiatric and research experience to his position as a psychiatrist with the Spirit Lake Reservation in North Dakota, where he focused on providing Psychiatric treatments to residents of the reservation who are suffering from mental illnesses and substance use disorder. In addition, Wayne Macfadden, MD, is a former fellow with the American College of Physicians (ACP).
The American College of Physicians (ACP) backs the Advisory Committee on Immunization Practices (ACIP) recommendation to the Centers for Disease Control and Prevention (CDC) to utilize an extra mRNA COVID-19 vaccine dosage in immunocompromised people. On Friday, August 13, ACIP unanimously recommended an extra (third) dose of Pfizer-BioNTech COVID-19 vaccine (for those 12 years and older) or Moderna COVID-19 vaccination (18 years and older) after the results of a preliminary study in immunocompromised individuals.
ACP previously said that it has an ethical obligation to assist others in reducing COVID-19 mortality and morbidity and that it supports the rapid ramping up of supplies for equitable distribution of COVID-19 vaccines across and within countries in need. According to ACP, countries facing a shortage of vaccines and a high incidence of COVID-19 mortality and severe illness require immediate assistance.
Ongoing Clinical Trials at SanBio, Inc.BrianFrenzel
The president and chief executive officer of Tosk, Inc., Brian Frenzel oversees a company that creates drugs that reduce the side effects of prescription medications. Moreover, Brian Frenzel also serves as a director at the biotechnology firm, SanBio, Inc.
Clinical evidence for medicinal cannabis reportRoby Zomer
A Report Developed by the University of Sydney
Community Placement Program in Partnership with
MGC Pharmaceuticals, In recent years, medicinal cannabis has gone from being a niche and obscure area of medical scientific research into “one of the fastest moving frontiers in pharmacology”.
The potential value of cannabis as medicine has been demonstrated in relation to a number of serious conditions and symptoms including cancer, epilepsy, multiple sclerosis, chronic pain, muscle spasticity and nausea. The clinical evidence regarding medicinal cannabis has received less attention
than it merits, and scientists, clinicians, patients and carers seeking access to this evidence have found it difficult to separate good research from the wealth of anecdotal and less rigorously obtained experimental results. This report aims to summarise the strongest available scientific research on the use of cannabis as a
medicine for the treatment of epilepsy, cancer and multiple sclerosis; the symptoms of these conditions; and the side-effects of their current treatment.
When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval.
Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically.
GEMC: “Taming the Wild Child” - Pearls, Pitfalls and Controversies in Pediatr...Open.Michigan
This is a lecture by Dr. Jeff Holmes from the Ghana Emergency Medicine Collaborative. To download the editable version (in PPT), to access additional learning modules, or to learn more about the project, see http://openmi.ch/em-gemc. Unless otherwise noted, this material is made available under the terms of the Creative Commons Attribution Share Alike-3.0 License: http://creativecommons.org/licenses/by-sa/3.0/.
Trends is defined as the dynamic changes going on in the pediatrics community to achieve and uplift the already existing facilities .
The new development can be in the form of newer drugs , new diagnostic technique or treatment plan .
Ongoing Clinical Trials at SanBio, Inc.BrianFrenzel
The president and chief executive officer of Tosk, Inc., Brian Frenzel oversees a company that creates drugs that reduce the side effects of prescription medications. Moreover, Brian Frenzel also serves as a director at the biotechnology firm, SanBio, Inc.
Clinical evidence for medicinal cannabis reportRoby Zomer
A Report Developed by the University of Sydney
Community Placement Program in Partnership with
MGC Pharmaceuticals, In recent years, medicinal cannabis has gone from being a niche and obscure area of medical scientific research into “one of the fastest moving frontiers in pharmacology”.
The potential value of cannabis as medicine has been demonstrated in relation to a number of serious conditions and symptoms including cancer, epilepsy, multiple sclerosis, chronic pain, muscle spasticity and nausea. The clinical evidence regarding medicinal cannabis has received less attention
than it merits, and scientists, clinicians, patients and carers seeking access to this evidence have found it difficult to separate good research from the wealth of anecdotal and less rigorously obtained experimental results. This report aims to summarise the strongest available scientific research on the use of cannabis as a
medicine for the treatment of epilepsy, cancer and multiple sclerosis; the symptoms of these conditions; and the side-effects of their current treatment.
When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval.
Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically.
GEMC: “Taming the Wild Child” - Pearls, Pitfalls and Controversies in Pediatr...Open.Michigan
This is a lecture by Dr. Jeff Holmes from the Ghana Emergency Medicine Collaborative. To download the editable version (in PPT), to access additional learning modules, or to learn more about the project, see http://openmi.ch/em-gemc. Unless otherwise noted, this material is made available under the terms of the Creative Commons Attribution Share Alike-3.0 License: http://creativecommons.org/licenses/by-sa/3.0/.
Trends is defined as the dynamic changes going on in the pediatrics community to achieve and uplift the already existing facilities .
The new development can be in the form of newer drugs , new diagnostic technique or treatment plan .
Join Dr. Dan Sullivan for a fascinating look into the world of clinical research. In this video, you’ll learn the magnitude and complexities of the national and international clinical research community, the drivers of adverse outcomes related to clinical research and the types of resulting litigation, and suggestions for improving patient and practitioner safety in the clinical research process.
This presentation and our commentary and responses to your questions may contain forward-looking statements, including comments concerning drug development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of our technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our regulatory filings from time to time.
1. www.health.nsw.gov.au
MEDICINAL CANNABIS
CLINICAL TRIALS
FOR CHILDREN WITH
SEVERE EPILEPSY
These trials are part of the NSW Government’s
commitment to develop a better understanding
of how cannabis products can provide relief to
children with severe drug-resistant epilepsy.
NSW researchers at the Sydney Children’s
Hospitals Network, Dr John Lawson and Dr
Deepak Gill, will lead the development and
conduct of these trials using cannabis-derived
products that are manufactured and supplied
by GW Pharmaceuticals.
GW Pharmaceuticals
GW Pharmaceuticals is a world leader in the
development of prescription cannabinoid
medicines. The company has a pipeline of
cannabinoid products, including Epidiolex®
which is in Phase 3 clinical trial studies for the
treatment of certain types of severe childhood
epilepsy syndromes.
A world first partnership
A NSW partnership has now been established
with GW Pharmaceuticals to hold the world’s
first medicinal cannabis trial for children with
severe drug-resistant epilepsy using a new
cannabis-derived drug, CBDV (cannabidivarin).
The new partnership with GW may also allow
eligible children to be part of additional further
clinical trials using Epidiolex®. This drug is a
cannabidiol-based medicine currently used in
international clinical trials.
The new partnership facilitates four key
outcomes for NSW:
■ a world first phase 2 clinical trial for a novel
product, cannabidivarin (CBDV)
■ a compassionate access scheme for
Epidiolex®
■ provision for NSW to host future clinical trials
of GW products.
■ a phase 4 clinical trial of Epidiolex® (based on
success of phase 3 studies)
About Epidiolex®
Epidiolex® is a product developed by GW, which
contains the non-psychoactive cannabinoid,
CBD (cannabidiol). Epidiolex® is taken in the
form of an oral liquid and is currently in Phase 3
trials internationally. Epidiolex® has shown
positive results in a compassionate use scheme
in the United States. Epidiolex® contains CBD.
This drug is being investigated overseas for the
treatment of various rare childhood epilepsy
syndromes.
About CBDV
CBDV is a molecule in the cannabis plant that
has shown promising results as an anti-
convulsant, and for which GW Pharmaceuticals
already has phase 1 clinical trial results in adults.
CBDV does not produce the psychoactive
(mind-altering) effects associated with herbal
cannabis containing high levels of THC.
The NSW Government has committed $3.5 million to explore the use of
cannabis products in providing relief for children with severe drug-resistant
epilepsy.
2. About the trials
Each trial will have a specific number of
participants. This number will be carefully
calculated to ensure the study can achieve the
most accurate scientific result in the shortest
possible time. All trials will be conducted in
accordance with good practice for clinical trials
and be subject to regulatory approval including
review and approval by an appropriate Human
Research Ethics Committee. Researchers will be
designing the first of the trials over the coming
months and are expected to advertise for
participants in 2016.
Participating in the trials
The first trial is expected to commence in
2016 following ethics approval. At that stage
researchers will advertise for interested
participants and publish information on:
■ who can participate in the trial (eligibility
criteria)
■ reasons why some children would not be able
to participate (exclusion criteria)
■ how researchers will measure the outcomes
(eg: by tests or seizure diaries).
Once advertising for participants occurs it is
best to meet with your child’s doctor to discuss
their condition and whether they might be
suitable for participation in the trial.
This is a NSW based trial. Residents from other
states and territories in Australia will need to
await further information on potential study
hospital sites and local involvement. It is best to
talk to your local specialist doctor about whether
your child may be able to participate. Further
information will be available as the trials program
is developed.
Compassionate access scheme
for Epidiolex®
From 2016 the new partnership with GW
Pharmaceuticals allows compassionate access
for a small number of children to Epidiolex®. This
scheme would be for a small number of children
who are not able to participate in a clinical trial
due to the unrelenting nature of their epilepsy
which has not responded to proven treatments.
Details on this scheme will be publicised as soon
as available.
General information
For more information:
■ call the Cannabis Trials Help Line on
1800 217 257
■ write to Cannabis Trials, NSW Ministry of
Health, Locked Mail Bag 961, North Sydney,
NSW 2059
■ email the NSW Ministry of Health on
cannabistrial@doh.health.nsw.gov.au
Information about Epilepsy Services
in NSW:
Paediatric Epilepsy Network -
http://www.pennsw.com.au/
www.health.nsw.gov.au