Optune is the first FDA-approved therapy in more than a decade to demonstrate statistically significant extension of survival in newly diagnosed glioblastoma patients
ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR), a commercial stage oncology company pioneering a novel therapy for solid tumors, announced today it will offer on demand Optune certification training for the radiation oncology community at the American Society for Therapeutic Radiology and Oncology (ASTRO) 57th Annual Meeting in San Antonio, Texas from October 18 through October 20, 2015. Optune was approved by the FDA on October 5, 2015 for the treatment of newly diagnosed glioblastoma (GBM) in combination with temozolomide. Optune’s Instructions for Use (IFU) require that prescribing medical personnel complete a training course provided by Novocure. Novocure is committed to making this training widely available for radiation oncologists, given their critical role in the treatment of newly diagnosed GBM patients.
Optune is the first FDA-approved therapy in more than a decade to demonstrate statistically significant extension of overall survival in newly diagnosed GBM. The two-year survival rate among patients treated with Optune in combination with temozolomide was 50% higher than in patients treated with temozolomide alone. No significant additive systemic toxicity was observed in the trial, and patients maintained stable quality-of-life, cognitive function and activities of daily living while using Optune.
“We are pleased to offer such a convenient training opportunity for radiation oncologists at ASTRO,” said Peter Melnyk, Novocure’s Chief Commercial Officer. “Novocure is committed to helping patients with glioblastoma and we know that the radiation oncology community will be an invaluable partner as we work together to bring this life-extending therapy to patients with newly diagnosed GBM.”
Certification training will be offered on location Sunday, October 18 through Tuesday, October 20, 2015. A sign-up sheet will be available at the Novocure exhibit, booth 1759.
Additional Novocure Activities at ASTRO
In addition to the certification training, Novocure will have four poster presentations describing the latest aspects of Tumor Treating Fields (TTFields) therapy at the meeting. Details on the poster presentations are as follows:
Modeling inter-subject differences in Tumor Treating Fields (TTFields) treatment of GBM patients
Presenter: Wenger C et al
NovoTTF™-100A system (Tumor Treating Fields) transducer array layout planning for glioblastoma: results of a NovoTAL™ system user study
Presenter: Chaudhry A et al
Optimizing the delivery of TTFields to the lungs by personalizing transducer array layouts on the torso
Presenter: Bomson Z et al
Tumor Treating Fields (TTFields) sensitize glioma tumor cells to radiation therapy by delaying DNA damage repair through homologous recombination
Presenter: Giladi M et al
Novocure will have an exhibit, booth 1759, where the radiation oncology community can meet with commercial and medical colleagues and learn more about Optune. Novocure will also host a company information session and sponsor an industry expert theatre to provide education on the newly diagnosed GBM indication for Optune, as detailed below:
Novocure Informational Session
Date: Sunday, October 18, 2015
Time: 6:30 p.m. to 8:30 p.m.
Location: Grand Hyatt, Bowie B, Second floor
Industry Expert Theatre: Tumor Treating Fields: Understanding Treatment with Optune
Faculty: Dr. Jeremy Rudnick, Cedars-Sinai Medical Center
Date: Tuesday, October 20, 2015
Time: 11:45 a.m. to 12:45 p.m.
Location: Theatre 1, Exhibition Hall, Henry Gonzales Convention Center
“We are thrilled to have a significant presence at ASTRO’s annual meeting and look forward to introducing Optune for newly diagnosed GBM to this important clinical community,” said Pritesh Shah, Novocure’s US General Manager. “Both Novocure and radiation oncologists treat glioblastoma with a physical modality and we believe there is a natural fit for us to work together to bring Tumor Treating Fields therapy to patients.”
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s US operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its prospectus dated October 1, 2015 filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Media and Investor Contact:
Ashley Cordova, 212-767-7558