Navigation Links
GW Pharmaceuticals Commences Phase 1b/2a Clinical Trial for the Treatment of Glioblastoma Multiforme (GBM)
Date:11/11/2013

LONDON, Nov. 11, 2013 /PRNewswire/ -- GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW") a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced today it has commenced a Phase 1b/2a clinical trial for the treatment of Recurrent Glioblastoma Multiforme (GBM).

Glioma describes any tumor that arises from the glial tissue of the brain. GBM is a particularly aggressive tumor that forms from abnormal growth of glial tissue. According to the New England Journal of Medicine, GBM accounts for approximately 50% of the 22,500 new cases of brain cancer diagnosed in the United States each year. Treatment options are limited and expected survival is a little over one year. GBM is considered a rare, or orphan, disease by the FDA and the European Medicines Agency, or EMA.

This study follows several years of pre-clinical research conducted by GW in the field of glioma which has demonstrated that cannabinoids inhibit the viability of glioma cells both in vitro and in vivoi,ii 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. In addition, GW has shown tumor response to be positively associated with tissue levels of cannabinoids. GW has identified the putative mechanism of action for our cannabinoid product candidate, where autophagy and programmed cell death are stimulated via stimulation of the TRB3 pathway.

"We are very excited about moving this compound into further human study and the prospects of cannabinoids as new anti-cancer treatments. This is GW's first clinical study of cannabinoids as a potential treatment to inhibit tumor growth," stated Dr. Stephen Wright, Director of Research and Development at GW. "We believe this clinical program demonstrates the flexibility and broad application of GW's cannabinoid platform to treat significant, unmet therapeutic needs." 

This study is a 20-patient, multicentre, two part study with an open-label phase to assess safety and tolerability of GW cannabinoids in combination with temozolomide, and a double blind, randomised, placebo-controlled phase with patients randomised to active or placebo, and with a primary outcome measure of 6 month progression free survival. The study objective is to assess the tolerability, safety and pharmacodynamics of a mixture of two principal cannabinoids, THC and CBD in a 1:1 allocation ratio, in combination with temozolomide in patients with recurrent GBM. Secondary endpoints include additional pharmacokinetic and biomarker analyses and additional measurable outcomes of tumor response.

References:

i. Parolaro D, Massi P, Rubino T, Monti E. Endocannabinoids in the immune system and cancer. Prostaglandins Leukot Essent Fatty Acids 2002;66(2-3):319-32.
ii. Guzman M. Cannabinoids: potential anticancer agents. Nat Rev Cancer 2003;3(10):745-55.

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 commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 22 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional clinical-stage cannabinoid product candidates targeting epilepsy (including an orphan pediatric epilepsy program), Type 2 diabetes, ulcerative colitis, glioma and schizophrenia. 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 our clinical goals, our plans for a clinical trial, the ability to conduct clinical trials sufficient to achieve positive completion, and the therapeutic and commercial value of the company's compounds. To the degree we are able to conduct clinical trials, we may have difficulty in enrolling candidates for testing and we may not be able to achieve the desired results. 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® 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, including the prospectus related to the NASDAQ offering filed by GW with the SEC on May 1, 2013. 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.


'/>"/>
SOURCE GW Pharmaceuticals plc
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Keryx Biopharmaceuticals, Inc. Announces Upcoming Poster Presentations of Zerenex™ (Ferric Citrate) at the Upcoming American Society of Nephrology Kidney Week 2011 Annual Meeting
2. Convergence Pharmaceuticals Initiates Phase I Multiple Ascending Dose Study for CNV2197944
3. TetraLogic Pharmaceuticals Announces Initiation of a Phase 1/2 Clinical Trial of TL32711 in Patients with Acute Myelogenous Leukemia (AML)
4. Questcor Pharmaceuticals to Present at the Oppenheimer Healthcare Conference on December 13, 2011
5. Synergy Pharmaceuticals, Inc. Files Suit Against Ironwood Pharmaceuticals, Inc. and its Chief Scientific Officer and Senior VP of R&D, Dr. Mark G. Currie
6. Acumen Pharmaceuticals Regains Worldwide Rights to Anti-ADDL Antibody Therapeutics and Diagnostics for Alzheimers Disease From Merck
7. Inspiration Biopharmaceuticals Moves Corporate Headquarters to Cambridge, Massachusetts
8. Ampio Pharmaceuticals Awarded Canadian Composition of Matter Patent That Strengthens IP Protection for Its Key Drug Ampion™
9. Amylin Pharmaceuticals to Present at the 30th Annual J.P. Morgan Healthcare Conference
10. Inovio Pharmaceuticals Promotes Niranjan Sardesai to Chief Operating Officer
11. Keryx Biopharmaceuticals to Present at JP Morgans 30th Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/18/2017)... ... 2017 , ... G-CON today announced that it has received ... Patent Applications 14/858,857 and 13/669,785 both entitled Modular, Self-Contained, Mobile Clean Room. The ... protection of G-CON’s R&D investments and validate the G-CON platform as a novel ...
(Date:7/17/2017)... ... July 17, 2017 , ... Whitehouse Laboratories ... capabilities to encompass the full series of ISO 80369 standard test procedures. The ... medical device and drug delivery systems. With this recent expansion, Whitehouse Labs becomes ...
(Date:7/17/2017)... ... July 17, 2017 , ... Neurodevelopmental disorders (NDDs) ... of overlapping clinical features. The advancement of targeted next-generation sequencing (NGS) has been ... and testing. , However, designing a custom panel for disease research requires ...
(Date:7/16/2017)... ... July 16, 2017 , ... OHAUS Corporation, a leading worldwide ... its new line of Rocking and Waving Shakers today. , Five New Models ... and digital) for laboratory applications in a variety of environmental conditions. Rocking shakers ...
Breaking Biology Technology:
(Date:6/23/2017)... N.Y. , June 23, 2017  IBM (NYSE: ... dairy research, today announced a new collaboration using next-generation ... chances that the global milk supply is impacted by ... Cornell University has become the newest academic institution to ... a food safety initiative that includes IBM Research, Mars, ...
(Date:5/16/2017)... DALLAS , May 16, 2017   ... for health organizations, and MD EMR Systems ... certified development partner for GE, have established a ... Patient Portal product and the GE Centricity™ products, ... Centricity EMR. These new integrations ...
(Date:4/18/2017)... Calif. , April 18, 2017  Socionext Inc., a global ... of a media edge server, the M820, which features the company,s ... recognition software provided by Tera Probe, Inc., will be showcased during ... at the NAB show at the Las Vegas ... ...
Breaking Biology News(10 mins):