SOURCE: TomoTherapy

TomoTherapy

October 29, 2009 09:03 ET

ASTRO Presentations Highlight Role of TomoTherapy® Technology in Combined Modality Approach to Treating Cancer

New Studies Explore Use of Helical TomoTherapy(SM) Treatments for Indications Previously Not Treated With Radiation Therapy

MADISON, WI--(Marketwire - October 29, 2009) - TomoTherapy Incorporated (NASDAQ: TOMO)announced today that several clinical presentations at the American Society for Radiation Oncology's 51st ASTRO Annual Meeting -- November 1-5, 2009 in Chicago -- will showcase the use of the TomoTherapy® radiation therapy platform as a vital component in the combined modality approach to treating cancer. Additionally, other presentations will explore how TomoTherapy technology is being employed to treat a growing array of challenging indications.

The TomoTherapy Hi·Art® treatment system is a CT scanner-based device that integrates image guidance and helical radiation therapy delivery for increased accuracy and enhanced tumor targeting. There are more than 250 Hi·Art systems in use around the world. More than 45 presentations will be made at ASTRO, detailing how TomoTherapy technology is helping cancer centers around the world improve cancer care through daily imaging and more precise delivery of radiation to targets throughout the body.

Some of the most compelling presentations focus on how the TomoTherapy Hi·Art system has been used to increase dosage to tumors while minimizing toxicity to patients. As a result, the TomoTherapy system is establishing itself as an effective radiation therapy solution for clinicians seeking to explore a combined modality approach that more effectively treats cancer by combining radiotherapy with chemotherapy and/or surgery. Presentations detailing such approaches include:

  • Hypofractionated TomoTherapy with Concomitant Chemotherapy in Pancreatic Adenocarcinoma: Preliminary Results of a Phase I Study -- Scientific Institute San Raffaele, Milan, Italy. This study evaluates the use of TomoTherapy technology to treat pancreatic cancer patients who have undergone chemotherapy and had limited options as a result. The TomoTherapy system's computed tomography (CT) imaging capabilities enabled better identification of target movement and resulted in toxicities that were acceptable. Researchers concluded that combining TomoTherapy treatment with chemotherapy provided a promising response rate and offered improvement in patient outcomes.

  • Prospective Phase I/II Trial of Helical TomoTherapy with or without Chemotherapy for Postoperative Cervical Cancer Patients and Prospective Phase I/II Trial of Helical TomoTherapy, Intracavitary Brachytherapy, and Concurrent Chemotherapy in Patients with Cervical Cancer -- both studies from researchers at Washington University School of Medicine, St. Louis. These presentations explore use of the TomoTherapy system as the external beam component of a treatment plan that included surgery and helical TomoTherapy, as well as evaluating the addition of chemotherapy. Researchers concluded that the TomoTherapy system's ability to reduce toxicities provides new options for clinicians in overall patient management.

  • Excellent Biochemical Control and Late Toxicity after Moderately Hypofractionated Adjuvant Helical TomoTherapy: Updated Results of a Phase I-II Study -- Scientific Institute San Raffaele, Milan, Italy; IBFM-National Research Council, Cefalù (Palermo), Italy; and Prostate Program, Fondazione IRCCS-Istituto Nazionale dei Tumori, Milan, Italy. A 45-month follow-up study showed positive results for patients classified as having high-risk prostate cancer who were treated with TomoTherapy radiation therapy following surgery. Researchers reported that local control and toxicity rates were acceptable and outcomes of patients who had TomoTherapy treatments and surgery were markedly better than those treated by conventional means.

  • Preoperative, Moderately Hypofractionated Radiotherapy with Image-guided TomoTherapy Concomitant to Chemotherapy in Rectal Adenocarcinoma: Early Results of a Phase II Study -- Scientific Institute San Raffaele, Milan, Italy. Similarly to those previously mentioned, this study evaluates the use of TomoTherapy radiation therapy as part of a combined modality approach in treating rectal cancer. Researchers concluded that a regimen of moderately hypofractionated TomoTherapy with concurrent chemotherapy seems to be effective and has an acceptable rate of acute toxicity, and believes that a Phase II study comparing this treatment with a conventional delivered bi-fractionated regimen is warranted.

ASTRO presentations also include investigation of the TomoTherapy Hi·Art system's use in treating indications that previously had limited applicability for radiation therapy. These new studies include:

  • Sparing of the Limbic Circuit and Pituitary during Whole Brain Radiation Therapy: A Dosimetric Study using Helical TomoTherapy -- Rush University Medical Center, Chicago. This study focuses on delivering radiation to the whole brain, while sparing the hippocampi and limbic circuitry, including the pituitary, to minimize impact on memory and regulation of heart rate and blood pressure through hormone production. This type of treatment can be accomplished by using complex conformal avoidance, which is an inherent unique capability of the TomoTherapy system. Results of the research showed that the calculated biologically equivalent dose for late toxicity of the hippocampi and limbic/pituitary were reduced by over 72 percent and 63 percent, respectively.

  • Helical TomoTherapy for Debulking Irradiation Prior to Stem Cells Transplantation in Malignant Lymphoma -- Institut Curie, Hospital Cochin and Hospital d'Instruction des Armées du Val-de-Grâce, all in Paris. This study shows that use of the TomoTherapy system resulted in better sparing of critical organs and may have contributed to improving tolerance to debulking irradiation prior to allograft. Research also concluded that patients' quality of life may be improved with less risk of subsequent heart disease as doses to the heart were decreased.

  • Radiotherapy in the Treatment of Solitary Plasmacytoma: New Technical Approaches and New Indications -- Institut Curie and Hospital Cochin, Paris. Researchers concluded in this study that TomoTherapy treatment serves as an effective local treatment for solitary plasmacytoma, and can be used to possibly decrease the early and late toxicity for patients through conformal avoidance with helical IMRT.

  • Brain Sparing Whole Skull/Scalp Radiotherapy: Unique Application of Helical TomoTherapy -- Tata Memorial Centre, Mumbai, India. Researchers here explored how complex cases involving the scalp and skull -- such as neuroblastoma metastases and non-Hodgkins lymphoma -- can be treated with helical TomoTherapy, limiting toxicity to only grade 1 and grade 2 dermatitis.

  • Pelvic Radiation in Patients with a Pelvic Kidney: No Longer Playing with Fire -- McGill University Health Centre, Montreal, Quebec, Canada. Researchers examined treatment options for prostate cancer patients who had previously received a kidney transplant. Typically, radiation therapy was not an option for these patients because of the transplanted kidney's proximity to the prostate. The study concludes that the high quality imaging and conformal radiation delivery possible with helical TomoTherapy can be safely utilized to treat this patient population.

"We are extremely pleased to see the breadth of presentations at ASTRO 2009," said Fred Robertson, M.D., CEO of TomoTherapy. "These presentations are representative of the tremendous clinical work performed by centers with the TomoTherapy Hi·Art system. With the introduction of the TomoHD™ treatment system at ASTRO, we look forward to delivering expanded offerings -- combined with greater efficiency and versatility -- to the global radiation oncology community."

About TomoTherapy Incorporated
TomoTherapy Incorporated develops, markets and sells advanced radiation therapy solutions that can be used to treat a wide variety of cancers, from the most common to the most complex. The ring gantry-based TomoTherapy® platform combines integrated CT imaging with conformal radiation therapy to deliver sophisticated radiation treatments with speed and precision while reducing radiation exposure to surrounding healthy tissue. TomoTherapy's suite of solutions include its flagship Hi·Art® treatment system, which has been used to deliver more than three million CT-guided, helical intensity-modulated radiation therapy (IMRT) treatment fractions; the TomoHD™ treatment system, designed to enable cancer centers to treat a broader patient population with a single device; and the TomoMobile™ relocatable radiation therapy solution, designed to improve access and availability of state-of-the-art cancer care. TomoTherapy's stock is traded on the NASDAQ Global Select Market under the symbol TOMO. To learn more about TomoTherapy, please visit TomoTherapy.com.

Forward-Looking Statements
Statements in this release regarding research, expectations, future products and other similar matters, including but not limited to statements using the terms "believe(s)," "will," "can," "expect," or "should" constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements contained in this press release are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated, including but not limited to factors such as our ability to gain customer acceptance, ability to complete development in a timely manner, ability to protect intellectual property, risks of interruption due to events beyond the company's control, and the other risks listed from time to time in TomoTherapy's filings with the U.S. Securities and Exchange Commission, which by this reference are incorporated herein. These forward-looking statements represent TomoTherapy's judgments as of the date of this press release. TomoTherapy assumes no obligation to update or revise the forward-looking statements in this release because of new information, future events or otherwise.

©2009 TomoTherapy Incorporated. All rights reserved. The following marks as used herein in italicized or stylized text are among trademarks, service marks or registered trademarks of TomoTherapy Incorporated in the United States and other countries: TomoTherapy, Tomo, TomoDirect, TomoHelical, TomoHD, TomoMobile, TQA, Hi·Art, and the TomoTherapy logo.

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