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:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset ... of specialty vendors and unique items from across the nation, this holiday-themed event will ... services offered by the VNA. The boutique will be open Saturday, November 4 ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... be giving viewers the lowdown on sciatica in a new episode of "Success ... focuses on current events and innovation and investigates each subject in-depth with passion ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare Compliance (FHC), ... will showcase a range of technology and learning solutions at the 68th Annual ... Expo to be held October 14–18, 2017 at the Mandalay Bay Resort in ...
(Date:10/12/2017)... Fla. (PRWEB) , ... October 12, 2017 , ... IsoComforter, ... therapy products, announced today the introduction of an innovative new design of the shoulder ... pad so you get maximum comfort while controlling your pain while using cold therapy. ...
(Date:10/12/2017)... ... 12, 2017 , ... Dr. Parsa Mohebi, the Los Angeles ... to the newly revamped Cosmetic Town journal section, featuring articles written ... known as Follicular Unit Extraction (FUE). , Dr. Mohebi says “I ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... Oct. 12, 2017   Divoti USA will ... to the standard of the latest FDA requirements, which stipulates new ... Anyone in need of Medical ID jewelry such as Medical ... are engraved in terms of the new FDA requirements ... Divoti offers this dark ...
(Date:10/11/2017)... Oct. 11, 2017  Caris Life Sciences ® , ... the promise of precision medicine, today announced that St. ... Precision Oncology Alliance™ (POA) as its 17 th ... St. Jude Crosson Cancer Institute will help develop standards ... of tumor profiling, making cancer treatment more precise and ...
(Date:10/10/2017)... Calif. , Oct. 10, 2017  NDS received FDA 510(k) ... — a medical-grade battery-powered display stand specifically designed for endoscopy environments. ... transform technology into a clinical solution to support the improvement of ... Innovative Design ... Mobile Wireless Solution ...
Breaking Medicine Technology: