Wednesday, October 22, 2014

Medical Cannabis Study November 12

AUGUSTA, GA (Anibal Ibarra) 11/12/2014 UPDATE - The General Assembly could have the votes in 2015 to pass legislation allowing cannabis oil treatment to patients with serious medical conditions. The Joint Study Committee met at Georgia Regents University (GRU) to hear experts and make their case during the next legislature session. Around $8 millions might cost to study 50 patients for a year. GRU would like to use Epidiolex in their investigations.

The Prescription of Medical Cannabis for Serious Medical Conditions Joint Study Committee public hearing took place at GRU November 12 and these were the experts:

Clinical Trial update by Dr. Michael Diamond, Interim Senior Vice President, Research GRU.
Panel Discussion by Dr. Diamond; Dr. Yong Park, Principal Investigator, Department of Neurology GRU; Dr. Cynthia Wetmore, Emory; Dr. Terry M. Hines, Medical Center of Centerra; Jason Cranford, CannLabs; Dr. Peter Buckley GRU.

State Representative (Democrat - District 127) Brian Prince and Republican District Attorney Ashley Wright were the only Richmond County officials presented during the public hearing.

Representative Allen Peake (Republican - District 141) co-chair of the joint committee expressed confidence that the bill to be introduced in January 2015 will have the votes necessary to pass.   

Epidiolex as a Potential Treatment for Epilepsy

(PR) - The results of our open-label trial of Epidiolex in children with Dravet syndrome have been very encouraging and we are excited to begin this important placebo-controlled clinical trial,” stated Orrin Devinsky MD, Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine, and Principal Investigator of the trial.

“As one of the largest epilepsy centers in the country, our focus has always been to find new and innovative ways to treat and cure children with various forms of epilepsy,” said Dr. Angus Wilfong, neurologist at Texas Children’s Hospital. “Initial trials of Epidiolex have shown promising signals of efficacy in children with treatment- resistant epilepsy, and we are pleased to have the opportunity to partner with GW Pharmaceuticals in the first worldwide trial for this group of patients with such a catastrophic form of epilepsy,” he continued.

“We are pleased to have advanced Epidiolex into the pivotal stage of clinical development. The start of this Phase 2/3 trial represents a significant milestone for children that suffer with Dravet syndrome for which there remains a substantial unmet medical need,” stated Justin Gover, GW’s Chief Executive Officer. “Epidiolex is the first plant-based CBD medicine to be studied in a FDA-authorized, placebo-controlled trial and we look forward to working with leading pediatric epilepsy centers across the U.S. to advance this clinical program as rapidly as possible.”

The Phase 2/3 trial is a two-part randomized double-blind, placebo-controlled parallel group safety, tolerability, pharmacokinetic and efficacy trial of single and multiple doses of Epidiolex to treat Dravet syndrome in children who are being treated with other anti-epileptic drugs. Part one comprises the pharmacokinetic and dose-finding elements of the trial in a total of 30 patients over a 3 week treatment period. Part two is a placebo-controlled safety and efficacy evaluation of Epidiolex over a 3 month treatment period in a total of 80 patients. All patients who complete the study will be eligible to receive Epidiolex under a long term open label extension study.

GW anticipates commencing an additional Phase 3 trial in Dravet syndrome in the first quarter of 2015 in parallel with part two of the first Phase 2/3 trial. The company also expects to commence two Phase 3 clinical trials in Lennox-Gastaut syndrome in the first quarter of 2015.

About GW

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 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) and is intended to support the submission of a New Drug Application for Sativex in cancer pain with the FDA and in other markets around the world. GW has a deep pipeline of additional cannabinoid product candidates, including Epidiolex in the treatment of childhood epilepsy, which has received Fast Track Designation from the FDA for Dravet syndrome as well as Orphan Drug Designations from the FDA in both the treatment of Dravet syndrome and Lennox-Gastaut syndrome and Orphan Designation from the European Medicines Agency for Dravet syndrome. GW’s product pipeline also includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type 2 diabetes, and schizophrenia.

State, Local Marijuana Legalization Measures Win Big On Election Day

WASHINGTON, DC (NORML) 11/5/2014 - Voters in Oregon and Alaska legalized and regulated the commercial production and sale of marijuana for adults, while voters residing in the nation's capitol and in numerous other cities nationwide similarly decided this Election Day to eliminate marijuana possession penalties.

Alaska and Oregon voters decided in favor of a pair of statewide measures to regulate the commercial production, retail sale, and personal use of marijuana by adults. Alaska and Oregon are the third and fourth states to enact regulations on the licensed production and sale of cannabis, joining Colorado and Washington. All four states have enacted their marijuana legalization laws via voter initiative.

Commenting on the new laws' passage, NORML Deputy Director Paul Armentano said: "The majority of voters in these states, like a majority of voters nationwide, agree that a pragmatic regulatory framework that allows for the legal, licensed commercial production and retail sale of cannabis to adults best reduces the risks associated with the plant's use or potential abuse. Elected officials in Alaska, Oregon, and elsewhere should welcome the opportunity to bring these common sense and long overdue regulatory controls to the commercial cannabis market."

Under the new Oregon proposal (Measure 91), adults who engage in the non-commercial cultivation of limited amounts of cannabis for personal use (up to four marijuana plants and eight ounces of usable marijuana at a given time) will not be subject to taxation or commercial regulations. Imposition of the new law will not "amend or affect in any way the function, duties, and powers of the Oregon Health Authority under the Oregon Medical Marijuana Act."

Under the Alaska measure (Ballot Measure 2), the adult possession of up to one ounce of cannabis as well as the cultivation of up to six-plants for personal consumption will be legal and untaxed. Commercial production and retail sales of cannabis will be subject to licensing and taxation. Since 1975, Alaskans have enjoyed personal privacy protections allowing for the possession and cultivation of small quantities of cannabis. However, state law has never before permitted a legal market for marijuana production and sales.

Some 55 percent of Oregon voters backed Measure 91 while 52 percent of Alaskans endorsed Measure 2.

In California, nearly 60 percent of voters backed Proposition 47, which defelonizes simple drug possession crimes, such as the possession of hashish. Under the measure, Californians with felony records for certain marijuana possession offenses will also be eligible to have their records expunged. Those serving time for felony drug offenses will also be able to petition for resentencing.

In the US territory Guam, 56 percent of voters decided in favor of Proposal 14A, the Compassionate Cannabis Use Act. The new law directs "the Department of Public Health and Social Services to regulate the use of marijuana as treatment for medical conditions." The Department has up to nine months to provide rules for the territory's medical marijuana program.

By contrast, a proposed Florida amendment (Amendment 2) fell shy of the 60 percent support threshold necessary in that state to amend the state's constitution. Fifty-eight percent of Florida voters endorsed the measure, including supermajorities in most every age group except for those voters age 65 and older.

Said NORML's Deputy Director: "This vote wasn't a rejection of medical marijuana in Florida, but rather an affirmation that most Floridians want patient access to cannabis therapy. NORML hopes that the Florida lawmakers will hear this message loud and clear and take action in 2015 on behalf of the will of the majority of the electorate."

Municipal voters overwhelmingly decided in favor of depenalizing cannabis on Election Day. In Washington, DC, some 70 percent of District voters approved Initiative 71, which removes criminal and civil penalties regarding the adult possession of up to two ounces of cannabis and/or the cultivation of up to six plants. Adults who engage in not-for-profit transactions of small quantities of cannabis or who possess marijuana-related paraphernalia are also no longer be subject to penalty under this act.

Unlike legalization measures in Alaska, Colorado, Oregon, and Washington, I-71 does not establish a regulatory framework for the regulation of a commercial cannabis market. However, members of the DC City Council are currently considering separate legislation to regulate the commercial production and sale of marijuana to adults. (Because Washington, DC does not possess statehood, all District laws are subject to Congressional approval prior to their implementation.)

Voters in several Michigan cities, including Saginaw (population 51,000), Port Huron (30,000), and Berkley (15,000) also decided in favor of local ballot measures depenalizing offenses involving the adult possession of up to one ounce of marijuana. Michigan lawmakers are anticipated to debate a statewide decriminalization proposal in 2015.

Likewise, voters in South Portland, Maine approved a municipal ordinance eliminating local penalties in regard to the adult possession of up to one ounce of cannabis. Voters in Lewiston, Maine rejected a similar measure.

In New Mexico, voters in Bernalillo and Santa Fe counties decided in favor of advisory questions in support of the decriminalization of one ounce or less of marijuana at a city, county and state level. Bernalillo and Santa Fe counties represent a third of the state's population.

Finally, in Massachusetts, voters in several state representative districts voted in favor of various nonbinding public policy questions calling on state officials to legalize and regulate cannabis-related commerce.

AUGUSTA, GA (Anibal Ibarra) 10/22/2014 - SR 981 creates the Joint Study Committee on the Prescription of Medical Cannabis for Serious Medical Conditions. The meeting number 4 of the committee will take place November 12 at 1pm at Georgia Regents University (GRU).

The committee will study the effects of the extracts and compounds of cannabis as a medical treatment to determine if it is appropriate to enact legislation that will allow for the prescription of medical cannabis.

Committee Members:

Rep. Allen Peake, Co-Chairman
Sen. Renee Unterman, Co-Chairman
Rep. Rich Golick
Sen. Dean Burke
Rep. Micah Gravley
Sen. Butch Miller
Rep. Margaret Kaiser
Sen. Curt Thompson
House Staff:
Roma Amin
Senate Staff:
Brad Vaughn
Elizabeth Holcomb

In the aftermath of the failed attempt by the Georgia General Assembly to legalize a form of medical cannabis, the joint committee has been selected to study the issue further. Medical staff, patients, relatives and other supporters are expected to tell their stories to the legislators.

HB 885 would have legalized a cannabis extract called CBD oil for people with epilepsy. The bill was supported overwhelmingly by the House and Senate but was killed when Sen. Renee Unterman attached the bill to another medical bill in an attempt to force its passage. Both bill died.

The 2015 session of the General Assembly might have a better chance to pass the medical cannabis.

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