Gw Pharm Pipeline Product Descriptions

[+washtenaut]

For me anyway, some new info in here as far as which cannabinoids they are using to target which conditions.

 

 

CANNABINOID PLATFORM PIPELINE

 

In addition to Sativex, GW is developing other product candidates based on the Company’s proprietary cannabinoid platform.

 

CBD for intractable pediatric epilepsy emerging as a new orphan development program

 

GW has carried out a significant amount of pre-clinical research into cannabinoids in the treatment of epilepsy over the last 5 years. GW’s activities in the field of epilepsy have significantly accelerated in 2013 with the emergence of a new epilepsy orphan development program featuring a liquid formulation of highly purified CBD extract for which the trademark Epidiolex ®  has been registered. This program has gained increasing momentum as a result of significant interest among U.S. pediatric epilepsy specialists and patient organizations in the potential role of CBD in treating intractable childhood epilepsy, with initial focus on two orphan conditions, Dravet and Lennox-Gastaut syndromes. The current status of this orphan program is as follows:

 

·                   GW’s pre-clinical research into cannabinoids in the treatment of epilepsy has yielded data on two highly promising cannabinoid product candidates, CBD and CBDV, both of which have reported significant anti-epileptiform and anticonvulsant activity using a variety of in vitro and in vivo models. These cannabinoids have also shown the ability to treat seizures in acute models of epilepsy with significantly fewer side effects than existing anti-epileptic drugs.

·                   In 2013, a total of seven expanded access INDs have been granted by the FDA to U.S. clinicians to allow treatment of approximately 125 pediatric epilepsy patients with GW’s Epidiolex. A small number of patients are already being treated and the majority are expected to commence treatment in the coming months after receipt of the necessary DEA site licenses. GW is aware of further interest from additional U.S. physicians to host similar INDs. GW’s ability to respond to these INDs results from the extensive pre-clinical and clinical safety information that GW has generated on CBD over several years.

·                   It is the Company’s expectations that these INDs will generate important clinical evidence in the near term to support the potential use of Epidiolex across a number of discrete pediatric epilepsy syndromes.

·                   GW has obtained orphan drug designation from the FDA for Epidiolex in the treatment of Dravet syndrome. We anticipate holding a pre-IND meeting with the FDA in the near future, following which we expect to conduct the first placebo-controlled trial of Epidiolex in Dravet syndrome during 2014.

·                   GW is preparing to submit further orphan designation applications to the FDA in the field of epilepsy.

·                   GW has nine patents or patent applications in relation to CBD and CBDV, and activity is ongoing to further enhance the Company’s proprietary position in this field

 

 

Separately, GW’s candidate GWP42006, which features CBDV as the primary cannabinoid, has now entered its first Phase 1 human clinical trial. CBDV has also shown significant promise in pre-clinical studies as a potential treatment for epilepsy.  GW believes that both CBD and CBDV represent important product candidates within the Company’s epilepsy franchise.

 

Combined, these two epilepsy product candidates represent a new development program that may yield a variety of individual orphan indications and which may provide the Company with significant new market opportunities. This development program is funded completely by GW and GW retains all rights to commercialize any and all products that evolve from this program.

 

Other Pipeline Programs

 

GW’s other lead pipeline programs are as follows:

 

·                   GWP42004, which features THCV as the primary cannabinoid, for the treatment of Type 2 diabetes, for which a Phase 2 dose ranging trial is expected to commence in early 2014. In late 2012, GW reported positive preliminary data reported from a Phase 2a exploratory clinical trial of GWP42004, administered as an oral capsule, in patients with type-2 diabetes which showed consistent evidence of anti-diabetic effects. These findings were consistent with pre-clinical data showing that GWP42004 protects the insulin-producing cells of the pancreatic islets, a highly desirable feature of a new anti-diabetic medicine, increases insulin sensitivity, and reduces fasting plasma glucose levels.

 

·                   GWP42003, which features CBD as the primary cannabinoid, for the treatment of ulcerative colitis (“UC”), for which a Phase 2 trial is ongoing, with data expected in the first half of 2014. This follows pre-clinical research that has shown GWP42003 to have anti-inflammatory properties in a number of accepted animal models of inflammation, notably of the gut and the joints. In particular, GW’s research has demonstrated potential in the treatment of UC in standard in vivo models.

 

·                   GWP42003, which features CBD as the primary cannabinoid, for the treatment of schizophrenia, for which a Phase 2 trial is expected to commence in the first half of 2014. GWP42003 has shown notable anti-psychotic effects in accepted pre-clinical models of schizophrenia and importantly has also demonstrated the ability to reduce the characteristic movement disorders induced by currently available anti-psychotic agents. The mechanism of GWP42003 does not appear to rely on the D2 receptor augmentation of standard antipsychotics and therefore has the potential to offer a novel treatment option in this therapeutic area.

 

·                   Combinations of THC and CBD for the treatment of glioma, for which a Phase 1b/2a trial in patients with Recurrent Glioblastoma Multiforme (GBM) commenced in November 2013. GBM is considered a rare, or orphan, disease by the FDA and the European Medicines Agency. This study follows several years of pre-clinical research which has demonstrated that cannabinoids inhibit the viability of glioma cells both in vitro and in vivo via apoptosis or programmed cell death, may also affect angiogenesis, and have demonstrated tumor growth-inhibiting action and an improvement in the therapeutic efficacy of temozolomide, a standard treatment for glioma.

[GregS]

I'm here to tell ya, the stuff is an effective garden home remedy. If we sit by idly while corporate interests chip away at that, and establish a front that intends to replace home grown cannabis altogether, we will be left with only pharmaceutical options. There are those who have conflated the simple and effective use of this medicinal garden herb, which is more like St. John's Wort for anxiety and depression or cayenne pepper for arthritis, into a drug to be feared because of some imagined dangers and side effects that do not exist and regulated. I have to wonder what the warnings are on these GW formulations.

Edited November 19, 2013 by GregS

[trichcycler]

what would you suggest we do ?

[GregS]

I suggest we more accurately describe cannabis as an effecive homegrown herbal medicine with little or no potential for negative side effects. That information is in the literature, but legislators, courts, and police work to demonize it as something dangerous. We know that is not the case. For instance, SB 0660 posits testing as not only pertinent, but absolutely necessary. We know that is not the case. It is more like the necessity to peel the shucks back on August sweet corn to see if it is good to consume. Lab testing and irradiation are little more than wiz bang distractions and are intended to make it more difficult to acquire and profitable for business interests because they add a lot of unnecessary cost that can be exploited for profit. I'll say it again, any number of us can put our product up against corporate grown cannabis and stomp it. Think Prairie Plant in Canada. Pharmaceutical preparations will have a place in medicine, but that is not reason  enough to withhold the relief that many of us derive from the stuff out of our gardens.

 

In short, I think it best to drive those points home with and shine the light on policy makers who serve the corpoatiban of plutocratistan. The MMA keeps things out of their hands, which is precisely why they are coming to stomp it out.

Edited November 19, 2013 by GregS

[t-pain]

I truly feel at this point that we should be focused on the MMMA, and making it work well for as many people as possible.

 

gregs is saying that the MMMA only says marijuana is medicine.

when more medicinal marijuana products become available in a pharmacy near you, the MMMA may seem redundant to pharma-bribed senators and represenatives.

 

what good is getting patients all set up and legal for home grows, when they decide to take away home grows?

like they just did in canada.

 

just how far off are any of these changes?

will cbd oil for epilepsy get fast-tracked? how fast can you fast-track something thru the FDA ?

how fast was 0660?

 

alternatively, if they decide to crush the MMMA, how far off would a legalization run be?

wouldnt killing off the MMMA just be the set up for legalization? how far off is canada's legalization?

[GregS]

The fact that pharmaceutical distribution seems to require a Federal change to schedule II (or below) indicates to me that there is still plenty of time.

There may very well be time, but it remains to be seen when it will happen. Changing its designation to schedule V is, to my mind, most appropriate. It would be best to insist on scheduce IV or even more accurately, V designation.

 

Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are:

 

cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin."

 

Schedule IV are those drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence.

 

Some examples of Schedule IV drugs are Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien

 

Whoinhell is going to tell me that cannabis is as dangerous and addictive as Darvon or Valium? Ambien puts people into mental health treatment facilities. I've seen that first hand.

Edited November 19, 2013 by GregS

[t-pain]

erm, thats only for 0660 cannabis.

 

gwpharma's tinctures can be in pharmacies as soon as the fda approves it.

[t-pain]

Whoinhell is going to tell me that cannabis is as dangerous and addictive as Darvon or Valium? Ambien puts people into mental treatment facilities. I've seen that first hand.

in every news article i read on oil it says cbd blah blah "without the high".

 

the "high" is what they dont like.

why dont they like the "high" ? i mean, aside from some motor skills, whats dangerous about the "high" ?

its the same racist answer, it makes white women date black men. there is no reason given. try looking for the danger of the high. maybe i missed it.

[GregS]

I don't think it should be a controlled substance at all, obviously.

THAT is something we can agree on. But to expect the government to let loose entirely its dominion over it is a mistake. There are plenty enough reactionaries that have influence and want no change at all. As a bargaining position, it is our best option.

Edited November 19, 2013 by GregS

[GregS]

gregs is saying that the MMMA only says marijuana is medicine.

when more medicinal marijuana products become available in a pharmacy near you, the MMMA may seem redundant to pharma-bribed senators and represenatives.

 

what good is getting patients all set up and legal for home grows, when they decide to take away home grows?

like they just did in canada.

 

just how far off are any of these changes?

will cbd oil for epilepsy get fast-tracked? how fast can you fast-track something thru the FDA ?

how fast was 0660?

 

alternatively, if they decide to crush the MMMA, how far off would a legalization run be?

wouldnt killing off the MMMA just be the set up for legalization? how far off is canada's legalization?

We have absolute control over quality and purity in our own gardens, just as we do our radishes and endive. Politicos like Rick Jones seek to perpetuate a war that is a boondoggle for the police state. He is, after all, a former sheriff with an obvious hard on for cannabis users. We need to slap it in the dirt.

Edited November 19, 2013 by GregS

[GregS]

If only we had a doctor around who would speak authoritatively regarding the safety of the drug...

 

If only we had a doctor around who would address our medical conditions and answer our questions...

Edited November 19, 2013 by GregS

[trichcycler]

whaddya mean, did Dr. Bob leave the forum ? 

[bobandtorey]

whaddya mean, did Dr. Bob leave the forum ? 

No

[bobandtorey]

in every news article i read on oil it says cbd blah blah "without the high".

 

the "high" is what they dont like.

why dont they like the "high" ? i mean, aside from some motor skills, whats dangerous about the "high" ?

its the same racist answer, it makes white women date black men. there is no reason given. try looking for the danger of the high. maybe i missed it.

Speaking of

[greenbuddha]

Big pharma means big money...

[GregS]

Dr. Bob has done none of those things. When asked.

[trichcycler]

huh ?

[Ms Chocolate]

The word from the FDA about Sativex is expected between now and January.