Pubdate: Wed, 12 Nov 2014
Source: Augusta Chronicle, The (GA)
Copyright: 2014 The Augusta Chronicle
Contact: http://chronicle.augusta.com/help/contact
Website: http://chronicle.augusta.com/
Details: http://www.mapinc.org/media/31
Author: Tom Corwin

GRU HOSTS HEARING OF EVIDENCE FOR CLINICAL TRIALS FOR CANNABIDIOL USE

A legislative study committee on narrow uses of medical marijuana will
hold a hearing Tuesday at Georgia Regents University to hear about
potential medical evidence for use, according to the committee
co-chairman. GRU itself is on the verge of beginning clinical trials
into a purified cannabis oil drug for children with uncontrollable
seizures.

The Joint Study Committee on the Prescription of Medical Cannabis will
hold its fourth meeting in the ballroom of the Jaguar Student
Activities Center on the Summerville campus of GRU. Previous meetings
of the committee had heard from families with various medical
conditions that might benefit from marijuana-derived oil and concerns
from law enforcement about legalization, said Rep. Allen Peake,
R-Macon, the chief proponent of legislation that would allow its use
only under strict conditions.

The Augusta meeting is a chance to hear from the medical community,
and in particular from a pediatric neurologist in Colorado who has
been treating children with cannabidiol oil and has "some very
interesting findings," he said.

Cannabidiol is one of the main active ingredients in cannabis and
anecdotes about some of the remarkable progress in children with
severe seizure disorders have prompted some Georgia families to move
to Colorado, where they can legally receive it. Peake's bill is
focusing on products that are high in cannabidiol and very low in
tetrahydrocannabinol or THC, the psychoactive ingredient in marijuana
that produces a high.

GW Pharmaceuticals of London has already created a drug out of highly
purified cannabidiol. The company has an agreement with GRU and the
state of Georgia to begin clinical trials at GRU in children with
severe seizure disorders.

There have been two Investigational New Drug Applications filed with
the Food and Drug Administration for clinical trials, the first a
two-person expanded access trial of the drug, called Epidiolex. That
trial has been approved by the FDA and GRU's Institutional Review
Board and is hopefully in the "final stages" of approval by the Drug
Enforcement Administration, said Dr. Michael Diamond, interim Senior
Vice President for Research at GRU. That trial could commence as soon
as this month if GRU gets the DEA approval soon, he said.

"We're looking for it at any time," Diamond said. Because marijuana
and its products are considered Schedule 1 controlled substances, GRU
principal investigator Yong Park would need a Class 1 license from the
DEA to receive the cannabidiol products, he said.

The second, larger trial would be a multi-center trial in Augusta,
Savannah and Atlanta and GRU has asked initially to include 50
patients, although a smaller number might be approved. Diamond said he
believes GRU has the go-ahead from FDA on that trial but has yet to
see it in writing. There have already been discussions about whether
that trial might ultimately need to be expanded, he said.

"My expectation is that we will have greater demand than the 50
individuals," Diamond said.

While much of the early work has focused on children with severe
seizures, there has also been some "anecdotal evidence" that
cannabidiol could have a positive impact for those with muscle
spasticity, such as patients with multiple sclerosis, Peake said. When
the legislation is written, it will probably be focused on a limited
number of diagnoses but he could envision a medical advisory panel
that could weigh evidence cannabidiol is effective for other conditions.

"We're interested in seeing what other opportunities are out there for
this to provide some therapeutic benefit for citizens," Peake said.
"If there is an opportunity to help other citizens, we're all for it."
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MAP posted-by: Matt