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marijuana stocks

Surprise! The Very First Marijuana Stock ETF Has Lost Investors Money

Surprise! The Very First Marijuana Stock ETF Has Lost Investors Money

The marijuana industry is growing like a weed, and marijuana stocks as a whole have been carried along in tow. Over the past year, a number of marijuana stocks have seen their valuations double, triple, or, in the case of AXIM Biotechnologies, rise by more than 3,600%. Both the 2016 Gallup poll and the more recent CBS News poll, both of which asked respondents whether they’d be in favor of legalizing recreational weed nationwide, have seen support for legalization climb to an all-time high (60% for Gallup and 61% for CBS News). Residents have voted to legalize recreational marijuana in eight states since November 2012, and over the past 21 years, 28 states have legalized the use of medical cannabis.

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GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences to Present Data on Epidiolex® (cannabidiol) at the 2017 American Academy of Neurology Annual Meeting

GW Pharmaceuticals plc (GWPH) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the Company will present results from three completed Phase 3 studies of Epidiolex® (cannabidiol or CBD) as adjunctive therapy – two in Lennox-Gastaut syndrome (LGS) and one in Dravet syndrome (DS) – at the American Academy of Neurology (AAN) Annual Meeting, April 22-28, 2017, in Boston. Company-sponsored activities at AAN will be conducted under Greenwich Biosciences, Inc., GW’s operating unit in the United States.

“We are very excited to share data from our Phase 3 epilepsy programs with the broader neurology community, particularly new results from the second of our two placebo-controlled studies in Lennox-Gastaut syndrome, which will be featured in the Emerging Science Program during the meeting,” said Justin Gover, GW’s Chief Executive Officer. “We are looking ahead to finalizing and submitting the NDA to the FDA for Epidiolex in the coming months, which will bring us one step closer towards our goal of making this much-needed treatment available to patients.”

Tuesday, April 25, 2017
Clinical Trials Plenary Session
9:15 – 11:30 a.m. (GW Presentation 10:45 – 11:00 a.m.)
Cannabidiol (CBD) reduces convulsive seizure frequency in Dravet syndrome: Results of a multi-center, randomized, controlled trial (GWPCARE1)

Epilepsy/Clinical Neurophysiology (EEG)
1:00 – 3:00 p.m. (GW Presentation 1:00 – 1:12 p.m.)
Presentation 001: Cannabidiol (CBD) significantly reduces drop seizure frequency in Lennox-Gastaut syndrome (LGS): Results of a multi-center, randomized, double-blind, placebo controlled trial (GWPCARE4)

Emerging Science Session
5:45 – 7:15 p.m. (GW Presentation 6:06 – 6:09 p.m.)
Poster 008: Cannabidiol (CBD) significantly reduces drop seizure frequency in Lennox-Gastaut syndrome (LGS): results of a dose-ranging, multi-center, randomized, double blind, placebo controlled trial (GWPCARE3)

Wednesday, April 26, 2017
Poster Session 4: Epilepsy/Clinical Neurophysiology (EEG)
11:45 a.m. to 12:35 p.m. (GW Presentation 12:20 – 12:25 p.m.)
Poster 108: A dose ranging safety and pharmacokinetic study of cannabidiol (CBD) in children with Dravet syndrome (GWPCARE1)

Sunday, April 23, 2017
Poster Session 1: Epilepsy and Clinical Neurophysiology: Basic Science
8:30 a.m. to 5:30 p.m. (GW Presentations between 4:00 – 5:30 p.m.)
Poster 224: Cannabidiol does not convert to Δ9- tetrahydrocannabinol (THC) in an in vivo animal model
Poster 228: The effect of cannabidiol on human CNS-expressed voltage-gated sodium channels

About GW Pharmaceuticals plc

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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in 31 countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. In the United States, GW operates as Greenwich Biosciences Inc. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release contains forward-looking statements that reflect GW’s current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of Epidiolex® and the safety profile and commercial potential of Epidiolex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission, including the most recent Form 20-F filed on 5 December 2016. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

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GW Pharmaceuticals Announces Epidiolex® Receives Orphan Drug Designation from the European Medicines Agency for the Treatment of Lennox-Gastaut Syndrome

GW Pharmaceuticals plc (GWPH) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to GW’s investigational product Epidiolex®(cannabidiol or CBD) in the treatment of Lennox-Gastaut Syndrome (LGS), a treatment-resistant, debilitating childhood-onset epilepsy.

“Following two positive Phase 3 trials of Epidiolex in patients with LGS, GW is committed to pursuing registration of Epidiolex in Europe in order to provide these patients access to an approved prescription CBD medicine,” stated Justin Gover, GW’s Chief Executive Officer. “In addition to preparing to submit a New Drug Application with the U.S. Food and Drug Administration in the middle of 2017, we are also planning a submission to the EMA shortly afterwards.”

In addition to this Orphan Drug Designation by the EMA in LGS, GW has also previously been granted Orphan Drug Designation by the EMA for Epidiolex in the treatment of Dravet syndrome. In the U.S., GW has received Orphan Drug Designation from the FDA for Epidiolex in the treatment of LGS, Dravet syndrome, Tuberous Sclerosis Complex, and Infantile Spasms, each of which are severe infantile-onset, drug-resistant epilepsy syndromes. Additionally, GW has received Fast Track Designation from the FDA for Epidiolex in the treatment of Dravet syndrome.

The EMA orphan drug designation is a status assigned to a medicine intended for use against a rare condition (prevalence of the condition in the European Union must not be more than 5 in 10,000) and allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a disease that is life threatening or a chronically debilitating rare disease.

About GW Pharmaceuticals plc

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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols),  which is approved for the treatment of spasticity due to multiple sclerosis in 31 countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release contains forward-looking statements that reflect GW’s current expectations regarding future events, including statements regarding the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products in development, the clinical benefits of Epidiolex® and the safety profile and commercial potential of Epidiolex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission, including the most recent Form 20-F filed on 5 December 2016. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

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Cannabis biotech bellwether, GW Pharmaceuticals (GWPH) announced positive top-line results from an exploratory Phase 2 placebo-controlled clinical study of a proprietary combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) in 21 patients with recurrent glioblastoma multiforme (GBM).

Concurrent with this announcement, the company also reported first quarter financial results for the period that ended on December 31st. GW Pharma continues to be a leader within the cannabis biotech sector and today’s announcement further solidify its position at the top.

About the Study

GBM is a particularly aggressive brain tumor, with a poor prognosis. GW Pharma was granted the Orphan Drug Designation from the FDA and the EMA for THC:CBD in the treatment of glioma.

The study showed that patients with documented recurrent GBM treated with THC:CBD had an 83% one-year survival rate compared with 53% for patients taking the placebo. The median survival for the THC:CBD group was greater than 550 days compared with 369 days in the placebo group.

The treatment was generally well tolerated with the patients in both groups. The study reported that emergent adverse events caused two patients in each group to discontinue the study. The most common adverse events reported were vomiting and dizziness.

From the Principal Investigator and the CEO

Professor Susan Short, PhD, Professor of Clinical Oncology and Neuro-Oncology at Leeds Institute of Cancer and Pathology at St James’s University Hospital and principal investigator of the study said, “The findings from this well-designed controlled study suggest that the addition of a combination of THC and CBD to patients on dose-intensive temozolomide produced relevant improvements in survival compared with placebo and this is a good signal of potential efficacy. Moreover, the cannabinoid medicine was generally well tolerated. These promising results are of particular interest as the pharmacology of the THC:CBD product appears to be distinct from existing oncology medications and may offer a unique and possibly synergistic option for future glioma treatment.”

2017 Outlook is Bright

Following the company’s earnings report, GW Pharma CEO Justin Gover said, “As we look forward to 2017, our primary focus is on completing the Epidiolex NDA, which we expect to submit to the FDA in the middle of this year. With three positive Phase 3 trials delivered in 2016, we remain confident in the prospects for Epidiolex’s approval and are accelerating our preparations for a highly successful launch. Beyond Epidiolex, the value of GW’s cannabinoid platform is further illustrated by promising new clinical data in the field of oncology and we continue to advance a number of additional clinical programs that will yield data this year.”

Trades on FDA Results, Not Earnings

Although GW Pharma reported a $19.3 million net loss on $2.5 million in revenue during the quarter, we remain very favorable on the company as biotech stocks tend to trade on FDA results, not earnings.

As of December 31st, the company reported to have $444.6 million in cash and cash equivalents. This should provide the company enough capital to execute on 2017 corporate initiatives.

We are favorable on this update and continue to view GWPH as one of the top investment opportunities for cannabis investors due to its deep pipeline of products that are in advanced stages of FDA testing. The company’s pipeline should create catalysts for years to come and this is a stock every investor should watch.

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GW Pharmaceuticals to Report Q1 Financial Results and Host Conference Call on 7 February, 2017

GW Pharmaceuticals plc (GWPH) (“GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, will announce on 7 February, 2017 its first quarter financial results for the period ending 31 December, 2016. GW will also host a conference call the same day at 8:30 a.m. EST. Conference call information will be provided in the financial results press release. A replay of the call will also be available through the Company’s website (www.gwpharm.com) shortly after the call.

About GW Pharmaceuticals plc

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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. 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 31 countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.

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GW Pharmaceuticals to Present at the 28th Annual Piper Jaffray Healthcare Conference on 29 November

GW Pharmaceuticals plc (GWPH) (GWP.L) (“GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that Justin Gover, GW’s Chief Executive Officer, will present at the 28th Annual Piper Jaffray Healthcare Conference on Tuesday, 29 November 2016, at 10:30 a.m. ET at the Lotte New York Palace, New York City.

A live audio webcast of the presentation will be available through GW’s corporate website in the investor relations section from the investor’s calendar of events page at www.gwpharm.com. A replay will be available soon after the live presentation.

About GW Pharmaceuticals plc

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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. 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 30 countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.

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GW Pharmaceuticals Announces Second Positive Phase 3 Pivotal Trial for Epidiolex® (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome

- Primary endpoint achieved in both Epidiolex doses with high statistical significance compared to placebo – 

- Today’s data represents the third positive Phase 3 pivotal trial for Epidiolex reported in 2016 -

- Data reinforce the potential of Epidiolex to be an important new medicine for patients who suffer from this treatment-resistant childhood-onset epilepsy -  

- Company to hold investor conference call today at 8:00 a.m. EDT/13:00 BST -

 GW Pharmaceuticals plc (GWPH) (GWP.L) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex® (cannabidiol or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. In this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint for both dose levels with high statistical significance. During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0047), and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0016).

This trial follows the announcement in June 2016 of positive results in the first pivotal Phase 3 trial of Epidiolex for the treatment of seizures associated with LGS, and the March 2016 announcement of positive results in the treatment of seizures associated with Dravet syndrome.  GW expects to submit a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in the first half of 2017.

“The positive outcome in this second trial of Epidiolex in patients with Lennox-Gastaut syndrome demonstrates the effectiveness of this product in this particularly difficult to treat, childhood-onset epilepsy,” stated Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center and principal investigator in the trial. “The data from the Epidiolex Dravet and LGS studies offers the prospect of an FDA-approved CBD medicine that shows both clinically meaningful seizure reduction and a consistent safety and tolerability profile. I believe Epidiolex has the potential to become an important new option within the field of treatment-resistant epilepsy.”

“Today brings great news for the Lennox-Gastaut Syndrome community,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation. “The announcement of a second set of positive results with Epidiolex is exciting as they offer much needed hope for patients and their families living with this debilitating condition where new treatment options are desperately needed.”

“The Epilepsy Foundation is thrilled to learn about the recent preliminary results for an innovative new therapy from GW for LGS. LGS in so many cases is extremely difficult to treat, and is an incredible challenge for children and families. We feel a tremendous sense of urgency to stop seizures, and believe that the pursuit of new therapies offers hope to individuals who have no currently available therapy to effectively stop their seizures. The Epilepsy Foundation will continue to be a champion for GW’s efforts to pursue this innovative new therapy as studies progress. We thank GW and all our partners who invest in a better tomorrow for people with epilepsy,” stated Philip Gattone, President and Chief Executive Officer of the Epilepsy Foundation.

“We are very pleased to report this second positive Phase 3 trial in seizures associated with Lennox-Gastaut Syndrome. This is the third positive Phase 3 trial for Epidiolex reported in 2016. All three trials provide GW with robust evidence to support the efficacy and safety of Epidiolex. This latest trial also shows that Epidiolex likely has an effective dose range, allowing for dose flexibility to address individual patient needs. These compelling results make us more determined than ever to make this important new medicine available to patients who suffer from these treatment-resistant childhood-onset epilepsies,” stated Justin Gover, GW’s Chief Executive Officer.

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Marijuana-Stocks-MJStocksImageTemplate

GW Pharmaceuticals (GWPH) soared in the last hour of trading Wednesday after Reuters reported that the company hired Morgan Stanley (MS) after it received unsolicited interest from other drug makers.
The news served as a catalyst to a number of cannabis stocks as share prices jumped 5% to 10% across the board. Does Not Come as a Surprise GW is in a league of their own when it comes to the cannabis industry and this news does not come as a surprise to us.

In an article published in July, we said, “We would recommend targeting companies like GWPH, INSY and ZYNE, as long-term investments. These companies would be very attractive takeout candidates for big pharma businesses that want to enter the legal cannabis industry.”

In March, GW changed the landscape of the cannabis industry when it reported positive data from its Stage 3 Clinical study on its Epidiolex product for the treatment of Dravet syndrome. GW reported similar results in May but this time it was for the treatment of Lennox-Gastaut syndrome (LGS) with its Epidolex product.
And we weren’t the only ones on the scent of Biotech Buyouts within the Cannabis Space as Jason Spatafora (@WolfofWeedSt) contributed to a piece in Forbes about Biotech Acquisitions with GWPH, CARA, ZYNE, & INSY all potential targets from ABBV. In the July 26th piece he stated:

“INSY would be the obvious first choice for ABBV because if they acquired INSY they get Syndros, which AbbV’s patients could switch over to due to the efficiency of the drug. My feeling is Abbv could acquire a few companies in this space such as Cara Therapeutics (CARA), Zynerba (ZYNE), and GW Pharmaceuticals (GWPH). Their purchase of Pharmacyclics for $21 Billion last year shows they aren’t scared to spend money and a move like this (if approved) would have them dominating the space.”

That article can be read here

Only Pure-Play Biotech Cannabis Stock Unlike Insys Therapeutics (INSY) and Zynerba Pharmaceuticals (ZYNE), GW actually utilizes the cannabis plant to derive its medicines.
Insys and Zynerba are focused on developing treatments with synthetic cannabis, which differs from GW’s approach.

Although ZYNE and INSY take a different approach, both shares rallied off of GW’s news. The shares rallied 8.5% and 5.7%, respectively and we were surprised by some of ripple effects created by this news.
What Stocks Benefited?

Terra Tech Corp (TRTC): After trading mildly higher for most of the day, TRTC jumped 10% following the GW news and the shares ended the day up 12.3%.

India Globalization Capital (IGC): The shares were trading at $0.45 for most of the day and then IGC jumped more than 12% after the GW news was reported. IGC ended the day up more than 20% and volume was 5x times higher than its monthly average. IGC is trading at $0.52 and the shares are now trading above its 20, 50, and 150 day moving average.

Cara Therapeutics (CARA): The shares were trading in the $5.70-$5.80 range for most of the day and then shares jumped above the $6 level after the news was reported. CARA rallied more than 6.1% yesterday and the shares are trading at $6.02 after this move.

By Michael Berger of Technical420.com

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GW Pharmaceuticals Announces Positive Phase 3 Pivotal Trial Results for Epidiolex® (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome

- Primary endpoint achieved with high statistical significance (p=0.0135) showing that Epidiolex treatment reduces drop seizures compared to placebo -

- Today’s LGS data follows successful Phase 3 trial in Dravet syndrome announced in March 2016 -

- Company to hold investor conference call today at 8:00 a.m. EDT/13:00 BST -

GW Pharmaceuticals plc (GWPH) (GWP.L) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the first randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex® (cannabidiol or CBD) for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. In this trial, Epidiolex, when added as an adjunct to the patient’s current treatment, achieved the primary endpoint of a significant reduction in the monthly frequency of drop seizures assessed over the entire 14-week treatment period compared with placebo (p=0.0135). This trial follows the announcement in March 2016 of positive results in a pivotal Phase 3 trial of Epidiolex for the treatment of Dravet syndrome. Epidiolex has Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LGS and Dravet syndrome.

“From a physician’s perspective, the positive outcome in this trial of Epidiolex in patients with Lennox-Gastaut syndrome is very exciting. Lennox-Gastaut syndrome begins in early childhood, is particularly difficult to treat, and the vast majority of patients do not obtain an adequate response from existing therapies,” stated Linda Laux, MD, Director of the Comprehensive Epilepsy Center at Ann & Robert H. Lurie Children’s Hospital of Chicago and assistant professor of pediatrics, Northwestern University Feinberg School of Medicine and an investigator in the trial. “These data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in this highly treatment-resistant population together with an acceptable safety and tolerability profile, which is consistent with my previous clinical experience with Epidiolex. I am excited about the prospect of Epidiolex being made available on prescription in the future and believe it has the potential to make an important difference to the lives of many patients.”

“We are delighted to announce positive results in this Phase 3 trial of Epidiolex in patients with Lennox-Gastaut syndrome, and particularly pleased that this result is consistent with our recent Phase 3 pivotal data for Epidiolex in Dravet syndrome. We believe that this result further demonstrates that Epidiolex offers the potential to be a new effective therapy within the field of treatment-resistant childhood-onset epilepsies,” stated Justin Gover, GW’s Chief Executive Officer. “We now look forward to advancing Epidiolex towards the submission of an NDA with the FDA in the first half of 2017.”

“Lennox-Gastaut syndrome is such a difficult form of epilepsy to treat. Additional safe and effective treatments are desperately needed for patients who continue to struggle with uncontrolled seizures,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation. “We are thrilled with these positive results, which offer much needed hope and promise to those living with this debilitating condition.”

Trial Overview and Result

Patients aged 2-55 years with a confirmed diagnosis of drug-resistant LGS currently uncontrolled on one or more concomitant anti-epileptic drugs (AEDs) were eligible to participate in this Phase 3, randomized, double-blind placebo-controlled trial. The trial randomized 171 patients into two arms, where Epidiolex 20mg/kg/day (n=86) or placebo (n=85) was added to current AED treatment. On average, patients were taking approximately 3 AEDs, having previously tried and failed an average of 6 other AEDs. The average age of trial participants was 15 years (34% were 18 years or older). The median baseline drop seizure frequency per month was 74.

The primary efficacy endpoint of this trial was a comparison between Epidiolex and placebo in the percentage change in the monthly frequency of drop seizures during the 14 week treatment period (2 week dose escalation period followed by 12 weeks of maintenance) compared to the 4 week baseline period before randomization. Drop seizures were defined as atonic, tonic and tonic-clonic seizures involving the entire body, trunk or head that led or could have led to a fall, injury, slumping in a chair or hitting the patient’s head on a surface. During the treatment period, patients taking Epidiolex achieved a median reduction in monthly drop seizures of 44 percent compared with a reduction of 22 percent in patients receiving placebo, and the difference between treatments was statistically significant (p=0.0135).

A series of sensitivity analyses of the primary endpoint confirmed the robustness of this result. The difference between Epidiolex and placebo emerged during the first month of treatment and was sustained during the entire treatment period. Results from secondary efficacy endpoints reinforced the overall effectiveness observed with Epidiolex.

Epidiolex was generally well tolerated in this trial. Overall, 86 percent of all Epidiolex patients experienced an adverse event compared with 69 percent of patients on placebo. The most common adverse events (occurring in greater than 10 percent of Epidiolex-treated patients) were: diarrhea, somnolence, decreased appetite, pyrexia, and vomiting.  Of those patients on Epidiolex who reported an adverse event, 78 percent reported it to be mild or moderate. Twenty patients on Epidiolex experienced a serious adverse event (nine of which were deemed treatment related) compared with four patients on placebo (one of which was deemed treatment related). Twelve patients on Epidiolex discontinued treatment due to adverse events compared with one patient on placebo. There was one death in the Epidiolex group, which was deemed unrelated to treatment. Of the patients who completed this trial, 100 percent have opted to continue into an open-label extension trial.

Further data will be presented in future publications and medical meetings.

In addition to this first Phase 3 trial of Epidiolex in LGS, GW is conducting a second Phase 3 dose-ranging trial of Epidiolex for the treatment of LGS, which is fully enrolled at 225 patients. This second trial has three treatment arms: Epidiolex 20mg/kg/day, 10mg/kg/day and placebo. GW expects to report top-line results from this trial towards the end of the third quarter of this year.

GW Clinical Trial Programs in Dravet Syndrome, Tuberous Sclerosis Complex and Infantile Spasms

In March 2016, GW announced positive results of the first pivotal Phase 3 trial of Epidiolex in Dravet syndrome. GW continues to enroll a second Phase 3 trial of Epidiolex in Dravet syndrome.

GW has commenced a Phase 3 trial of Epidiolex in Tuberous Sclerosis Complex and expects to initiate a Phase 3 trial of Epidiolex in infantile spasms in the fourth quarter of this year.

Investor Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast for analysts and investors to discuss the results from this initial Phase 3 trial today at 8:00 a.m. EDT /13:00 BST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada), or 0800-756-3429 (toll free from the UK) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website athttp://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free): 1-877-660-6853, (international): 1-201-612-7415. For both dial-in numbers please use conference ID # 13639965.

About Lennox-Gastaut Syndrome

The peak onset of LGS typically occurs between ages of 3 to 5 years and can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions. In up to 30 percent of patients, no cause can be found. Patients with LGS commonly have multiple seizure types including non-convulsive, convulsive and drop seizures, which frequently lead to falls and injuries. Drug resistance is one of the main features of LGS. Most children with LGS experience some degree of impaired intellectual functioning, as well as developmental delays and behavioral disturbances. It is estimated that there are approximately 14,000-18,500 patients with LGS in the United States and 23,000-31,000 patients with LGS in Europe.

About Epidiolex
Epidiolex, GW’s lead cannabinoid product candidate, is an oral pharmaceutical formulation of pure CBD, which is in development for the treatment of a number of rare childhood-onset epilepsy disorders. GW has conducted extensive pre-clinical research of CBD in epilepsy since 2007. This research has shown that CBD has significant anti-epileptiform and anticonvulsant activity using a variety of in vitro and in vivo models and reduced seizures in various acute animal models of epilepsy. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, Tuberous Sclerosis Complex and infantile spasms. Additionally, GW has received Fast Track Designation from the FDA and Orphan Designation from the European Medicines Agency for Epidiolex for the treatment of Dravet syndrome. GW is currently evaluating additional clinical development programs in other orphan seizure disorders.

About GW Pharmaceuticals plc
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 is advancing an orphan drug program in the field of childhood-onset epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, LGS and Tuberous Sclerosis Complex. GW successfully developed the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 28 countries outside the United States. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.

Forward-looking statements
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of the Company’s investigational drug Epidiolex, the development and commercialization of Epidiolex, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory submissions and approvals. Forward-looking statements involve risks and uncertainties.  Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex, if approved, and other products which we may commercialize by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

References:
LGS Foundation: http://www.lgsfoundation.org
Epilepsia. 2014 Sep;55 Suppl 4:4-9. doi: 10.1111/epi.12567., Lennox-Gastaut syndrome: a consensus approach to differential diagnosis., Bourgeois BF1, Douglass LM, Sankar R.

Contacts:

GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations (U.S.) 401 500 6570
FTI Consulting (UK Media)
Ben Atwell / Simon Conway + 44 20 3727 1000
FleishmanHillard (U.S. Media)  
Paddi Hurley / Adam Silverstein 212 453 2382 / 212 453 2493
Contact:

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GW Pharmaceuticals Announces New Planned Epidiolex (Cannabidiol or CBD) Development Program in Infantile Spasms (IS)

 

- Orphan Drug Designation Granted from FDA for Epidiolex for the Treatment of IS – 

- Phase 3 Trial Expected to Commence in Q4 2016 -

GW Pharmaceuticals plc (GWPH) (GWP.L) (“GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the Company has selected infantile spasms (IS) as the fourth target indication for its Epidiolex orphan pediatric epilepsy development program. In addition, the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Epidiolex (cannabidiol or CBD) for the treatment of IS. GW expects to commence a two-part pivotal Phase 3 study in the fourth quarter of 2016.

Epidiolex is already being developed in three other orphan indications within the field of pediatric epilepsy – Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC). In March 2016, GW announced positive results from the first Phase 3 trial in Dravet syndrome. Results of the first Phase 3 trial in LGS are expected in June 2016.

“We are pleased to add infantile spasms as a fourth target indication for Epidiolex, demonstrating GW’s ongoing commitment to addressing the significant unmet medical need within the field of pediatric epilepsy,” stated Justin Gover, CEO of GW Pharmaceuticals. “Currently, there are limited treatment options for children suffering from infantile spasms and outcomes for patients with the disorder include higher mortality, ongoing development of additional seizure disorders as the patient matures, and often severe cognitive and developmental delay.”

An infantile spasm is a specific type of seizure seen in an epilepsy syndrome of infancy and childhood known as West Syndrome. The onset of infantile spasms usually occur in the first year of life, typically between 4-8 months of age. The condition constitutes 2 percent of childhood epilepsies and 25 percent of epilepsies with onset in the first year of life. There are approximately 2,000 to 4,000 new cases in the United States each year. The long-term overall prognosis for patients with infantile spasms is poor. Cognitive and developmental delay is severe in 70 percent of patients, often with psychiatric problems such as autistic features or hyperactivity. It has been found that 50-70 percent of patients develop other seizure types and that 18 to 50 percent will develop LGS or some other form of symptomatic generalized epilepsy.

About Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition – generally a disease or condition that affects fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active moiety to treat a particular disease with FDA orphan drug designation is typically entitled to a seven-year exclusive marketing period for that drug and use except under a few exceptions.

About Infantile Spasms

According to the National Institute of Neurological Disorders and Stroke, an infantile spasm (IS) is a specific type of seizure seen in an epilepsy syndrome of infancy and childhood known as West Syndrome. West Syndrome is characterized by infantile spasms, developmental regression, and a specific pattern on electroencephalography (EEG) testing called hypsarrhythmia (chaotic brain waves). The onset of infantile spasms is usually in the first year of life, typically between 4-8 months of age. The seizures primarily consist of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs. Spasms tend to occur upon awakening or after feeding, and often occur in clusters of up to 100 spasms at a time. Infants may have dozens of clusters and several hundred spasms per day. Infantile spasms usually stop by age five, but may be replaced by other seizure types. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In some children, no cause can be found.

About Epidiolex

Epidiolex, GW’s lead cannabinoid product candidate, is an oral solution of pure plant-derived CBD, which is in development for the treatment of a number of rare pediatric epilepsy disorders. GW has conducted extensive pre-clinical research of CBD in epilepsy since 2007. This research has shown that CBD has significant anti-epileptiform and anticonvulsant activity using a variety of in vitro and in vivo models and reduced seizures in acute animal models of epilepsy with significantly fewer side effects than comparator anti-epileptic drugs. To date, GW has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Epidiolex in the treatment of Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex. Additionally, GW has received Fast Track Designation from the FDA and Orphan Designation from the European Medicines Agency for Epidiolex for the treatment of Dravet syndrome. GW is currently evaluating additional clinical development programs in other orphan pediatric seizure disorders.

About GW Pharmaceuticals plc

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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex. GW previously commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 28 countries outside the United States. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, type 2 diabetes, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.

To obtain information about this clinical trial or eligibility criteria, the treating physician should contact: medicaldirector@gwpharm.com

References:
1: http://www.ninds.nih.gov/disorders/infantilespasms/infantilespasms.htm
2: http://emedicine.medscape.com/article/1176431-overview
3: http://infantilespasmsproject.org/
4: http://www.epilepsy.com/learn/types-epilepsy-syndromes/infantile-spasms-wests-syndrome
5: http://misc.medscape.com/pi/iphone/medscapeapp/html/A1176431-business.html

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of the company’s investigational drug Epidiolex®, the development and commercialization of Epidiolex, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval. Forward-looking statements involve risks and uncertainties.  Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Epidiolex, and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Enquiries:

GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations (U.S.) 917 280 2424 / 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway + 44 20 3727 1000
FleishmanHillard (U.S. Media)
Paddi Hurley / Adam Silverstein 212 453 2382 / 917 697 9313

 

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