Navigation Links
Studies show novel device may enhance chemotherapy treatment in brain tumors
Date:11/24/2008

NovoCure Ltd. presented results yesterday evaluating the Novo-TTF device in vitro and in a pilot clinical trial that showed the device enhanced the efficacy of standard chemotherapy (temozolomide) treatment in newly-diagnosed glioblastoma multiforme (GBM) patients. When used in combination with standard chemotherapy, the Novo-TTF, a non-invasive medical device that uses low intensity alternating electric fields to destroy cancer cells, enhanced the anti-tumor effects of standard chemotherapy, thus prolonging time to disease progression and extending survival.

This pilot trial, which was presented during the Society of Neuro-Oncology (SNO) annual meeting yesterday in Las Vegas, NV, showed that combination therapy prolonged time to disease progression by nearly 31 months and increased survival by more than 25 months compared to historical results of patients receiving standard chemotherapy alone. Patients in the study did not experience any device-related, systemic, adverse events. The in vitro study, which was also presented during the annual meeting, mirrored these effects when applying both treatments together to GBM cells in culture.

"The pilot study further demonstrated that the NovoTTF device can be applied over an extended period of time without significant toxicity. These results are promising as NovoCure continues to evaluate the use of the device in combination with standard-of-care chemotherapies," said Eilon Kirson, MD, Medical Director, NovoCure Ltd. "This data adds to the growing body of evidence of Novo-TTF's potential to enhance standard therapy and potentially improve patient outcomes."

The Novo-TTF device disrupts cancer cell proliferation and tumor growth by generating low intensity, intermediate frequency, alternating electric fields within a tumor. These electric fields exert forces on polar structures within the dividing cancer cells that prevent tumor growth. In pre-clinical and clinical studies to date, the electric fields have shown no effect on non-dividing, healthy cells in the same region, suggesting that the device can treat cancer without harming surrounding tissue, unlike chemotherapies that are typically associated with high toxicity resulting in serious side effects. The Novo-TTF is currently an investigational medical device and is not yet FDA approved.

NovoCure recently published data from its human pilot study for patients with later stage GBM tumors that recurred after surgery and radiation. The results of this study preliminarily indicate that the Novo-TTF more than doubled the median overall survival rates for recurrent GBM patients relative to historical data.

NovoCure is currently conducting a Phase III clinical trial at more than 20 centers in the US and Europe for patients with recurrent GBM and is planning to launch a Phase III clinical trial to evaluate Novo-TTF treatment in combination with standard chemotherapy in patients with newly diagnosed GBM in 2009. Please refer to www.novocuretrial.com or call 1 (800) 978-0265 for more information on the ongoing trial.

SNO STUDY DETAILS

The in vitro study looked at the effects of TTFields alone and in combination with DTIC, a precursor of MTIC (the active metabolite of Temozolomide) in human GBM cells. The results demonstrated that, when applied together with DTIC, TTFields drastically increased the sensitivity of GBM cells in culture to DTIC.

The open-label, single-arm prospective pilot clinical trial evaluated the efficacy and safety of the Novo-TTF device in combination with standard chemotherapy (temozolomide) in 10 patients with newly diagnosed GBM. The results of the study were compared to concurrent and historical control outcomes of standard chemotherapy when given alone. All patients were followed on a monthly basis and received treatment with the device for up to 18 months. The primary endpoints were feasibility, toxicity, time to disease progression and overall survival. No device-related, systemic, adverse events were noted throughout treatment with the Novo-TTF device. A mild to moderate skin irritation appeared beneath the device electrodes in all patients.

Median time to disease progression was 155 weeks in patients treated with combined standard chemotherapy and the Novo-TTF device, compared to 31 weeks in concurrent control patients treated with standard chemotherapy alone. Half of patients were still progression-free at the end of the trial. Median overall survival was greater than 40 months in the combination trial, compared to 14.7 months reported for historical controls. Eight of the 10 patients were still alive at the end of this study.


'/>"/>

Contact: Marissa Green
marissa.green@edelman.com
323-202-1463
Edelman Public Relations
Source:Eurekalert

Related medicine news :

1. NxStage Applauds Array of Studies To Be Presented at American Society of Nephrology Meeting
2. Studies examine treatment for gout and the conditions protective effects
3. Center for Health Enhancement Systems Studies awarded $8.6 million NIH grant
4. Studies Reveal Every Homeowners Dream: You Can Dust Less and Have a Healthier, Cleaner Home
5. Town Hall Meeting on Inequities in Clinical Trials Documents Ongoing Tuskegee Effect When Recruiting Minorities for Research Studies
6. Battelle to Perform Verification Studies of IntelligentMDxs Proprietary Molecular Diagnostic Assay Process
7. American Council on Exercise (ACE) Studies Impact of Boot Camp-Style Workouts
8. Studies Ignite Hope for Long-Acting Allergy Vaccines
9. Groundbreaking cancer studies to be unveiled at ASTRO annual meeting
10. Post-marketing studies finding adverse events in drugs used in children
11. Studies refute common stereotypes about obese workers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... February 23, 2017 , ... Healthcare ... for those in the fight against cancer, has produced a seminal study that ... HRA will release top-line findings in a webinar, Defining Compassionate Care Through the ...
(Date:2/23/2017)... ... , ... CALNOC, the nation’s first and only nursing quality indicators database today ... Value and Collaboration – in Seattle, WA on October 23, 2017. , Dr. Gary ... in Seattle since 2000. In addition to his role at Virginia Mason, Dr. Kaplan ...
(Date:2/23/2017)... ... 23, 2017 , ... HealthPostures, the desk for standing designer headquartered in Prior ... to the Minneapolis Home and Garden Show which is being held February 24 through ... attention is the Minneapolis Convention Center. , From its broad line of sit ...
(Date:2/22/2017)... York (PRWEB) , ... February 22, 2017 , ... ... entrance and lobby of a new healthcare contact center in Georgia, PENETRON Specialty ... One of the nation’s largest healthcare systems recently invested $51 million to purchase ...
(Date:2/22/2017)... ... February 22, 2017 , ... Stem cell therapy ... The technology is so cutting edge, in fact, the U.S. Food and Drug ... procedures. However, successful patient outcomes in certain clinical stem cell procedures have shown ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... 2017 ... Research and Markets has announced the addition of the ... report to their offering. The Global Antifungal Drugs ... the next decade to reach approximately $12.8 billion by 2025. ... all the given segments on global as well as regional levels presented ...
(Date:2/23/2017)... Ga., Feb. 23, 2017  MiMedx Group, Inc. (NASDAQ: ... tissue and patent-protected processes to develop and market advanced ... Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, ... and full year ended December 31, 2016. ... Revenue is a 31% increase over full year 2015 ...
(Date:2/23/2017)... , Feb 23, 2017 Research and ... Devices Market Analysis & Trends - Industry Forecast to 2025" ... ... grow at a CAGR of around 9.2% over the next decade ... report analyzes the market estimates and forecasts for all the given ...
Breaking Medicine Technology: