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Carl Zeiss Meditec AG (AFX.DE)'s INTRABEAM Targeted Intraoperative Radiotherapy System Demonstrates that Single-dose Radiation is Equivalent to Prolonged Courses of Post-operative Radiation for Early Breast Cancer Treatment


6/7/2010 11:57:22 AM

CHICAGO, IL--(Marketwire - June 07, 2010) -

Carl Zeiss Meditec announced that outcomes for the TARGIT-A multicenter clinical trial, which used the INTRABEAM® System to deliver a single dose of intraoperative radiotherapy (IORT) to the breast following breast conserving surgery, will be presented today at the American Society of Clinical Oncology (ASCO) meeting. The TARGIT-A study results, with up to 10 years maximum follow-up, have also been published as a fast-tracked peer-reviewed paper in The Lancet, now available at www.thelancet.com.

Professor Michael Baum, MD, co-principal investigator of the TARGIT-A multicenter clinical trial, will present the late-breaking abstract (ASCO abstract #LBA517) titled, "Safety and efficacy of targeted intraoperative radiotherapy (TARGIT) for early breast cancer: First report of a randomized controlled trial at 10 years maximum follow-up," today at 2 p.m. at the ASCO Meeting at McCormick Place in Chicago, IL.

"I am pleased to report these positive outcomes on behalf of the TARGIT group for what we believe is one of the most important studies to be conducted in the field of breast cancer to date," said Prof. Baum, who pioneered the TARGIT approach using the INTRABEAM® system along with Jayant S. Vaidya, MD, PhD and Jeffrey Tobias MD, PhD. "Now that the TARGIT-A trial has demonstrated that single-dose intraoperative radiation treatment using INTRABEAM is equivalent in efficacy and safety to traditional radiotherapy in the longest-running clinical trial of its kind, TARGIT treatment has the potential to become the new standard of care in breast cancer."

The INTRABEAM® system features a unique radiation delivery and dose distribution profile that allows targeted radiation to penetrate the tumor bed after breast conserving surgery while reducing exposure to the chest cavity and underlying organs. It is the only single-dose partial breast irradiation technology that has been studied in a randomized multicenter clinical trial. In the TARGIT-A multicenter clinical trial, which has achieved up to 10 year follow-up data, preliminary study results demonstrate the equivalency of single-dose targeted IORT in comparison to external beam radiation (EBRT) based on local recurrence.

"This is a critical breakthrough for women and a major advance in our ability to tailor treatments for women, depending on the biology of their tumors," said Laura Esserman, MD, MBA, Director, Carol Franc Buck Breast Care Center and Professor of Surgery and Radiology, University of California, San Francisco. "It is also an important step forward for patient-centered care and addresses the challenges and difficulty for women to return for daily radiation treatments over many weeks. It is wonderful to have the opportunity to offer women an appropriately tailored therapy that reduces their risk and diminishes the burden of cancer care."

The TARGIT-A trial is a randomized controlled study launched in 2000 in which 28 centers from 9 countries throughout Europe, North America and Australia participated with an accrual of 2,232 patients. The study was designed to assess the equivalence of targeted intraoperative radiotherapy with a single-dose using INTRABEAM® against standard three-to-six week external beam radiotherapy using linear accelerator technology after breast conserving surgery in women 45 years and over with invasive ductal carcinoma.

There are several potential benefits to INTRABEAM® single-dose TARGIT treatment, including:

  • A significant reduction in radiation treatment time for the patient.
  • Improved access to radiation therapy for patients in rural areas and developing countries.
  • Less toxicity related to external beam radiotherapy.
  • Minimized exposure to healthy tissues and organs.
  • No treatment delay for patients who must also undergo chemotherapy as part of their breast cancer treatment.
  • Cost savings to hospitals and breast cancer treatment centers.

"These impressive study results mean that we have passed a key milestone in breast cancer treatment with INTRABEAM," said Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG. "INTRABEAM has the potential to become the new global standard treatment for breast cancer. We will continue to invest in this field, to enable as many patients as possible to receive INTRABEAM treatment."

About the TARGIT-A trial
Since 1996, the international TARGIT research group has been researching a new method of delivering radiotherapy for breast cancer in which the treatment can be reduced to a single fraction at the time of surgery. The INTRABEAM® radiotherapy system from Carl Zeiss is the radiotherapy platform used in the TARGIT-A trial since its inception and it is the cornerstone technology for this new approach to radiation therapy. The TARGIT clinical trial evaluates whether a single dose of radiation can reduce the risk of recurrence in early breast cancer as effectively as the traditional, three to six week external beam radiation treatment. The TARGIT-A clinical trial randomized half of the study group to receive conventional external beam radiotherapy while the other half was randomized into the single treatment radiation intra-operatively with the INTRABEAM radiotherapy system. The results of the study will be presented for the first time during the 2010 American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago from June 4-8. Please visit www.targit-research.org or www.targit.org.uk for more information.

About The INTRABEAM® System
INTRABEAM®, Carl Zeiss Meditec's ground breaking radiotherapy system, offers the least disruptive treatment method available to patients diagnosed with early stage breast cancer. The radiation dose of INTRABEAM® is administered to the tumor bed in the operating room immediately following the surgical excision of the tumor. The system utilizes a miniature X-ray source, a highly flexible support stand and a full range of radiation applicator options. INTRABEAM has the advantage of delivering a precise radiation-dose to the tumor site at the time of surgery minimizing geographical miss and the associated side effects with external beam radiation. Afterwards, the applicator and miniature X-ray source are removed, the surgical site is closed, and the procedure is complete. In 1999, INTRABEAM® received both FDA clearance and CE mark to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments. The device is also cleared for use in most countries around the world. Please visit www.meditec.zeiss.com/intrabeam for more information.

US FDA-Cleared Indications for use:
The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments. The INTRABEAM® Balloon Applicator together with the INTRABEAM® System is intended to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy of breast cancer. The safety and efficacy of the INTRABEAM® System as a replacement for whole breast irradiation in the treatment of breast cancer has not yet been established.

References:
1. Vaidya JS, Baum M, Tobias JS et al. Protocol 99PRT/47, Targeted Intraoperative radiotherapy (Targit) for breast cancer. Lancet 1999; http://www.thelancet.com/journals/lancet/misc/protocol/99PRT-47
2. Vaidya JS, Baum M, Tobias JS et al. Targeted intra-operative radiotherapy (Targit): an innovative method of treatment for early breast cancer. Ann Oncol 2001; 12(8): 1075-80
3. Vaidya JS, Baum M, Tobias JS et al. The novel technique of delivering targeted intraoperative radiotherapy (Targit) for early breast cancer. Eur J Surg Oncol 2002; 28(4): 447-54
4. Baum M Michael Baum, David Joseph, Jeffrey S Tobias, Frederik K Wenz, Mohammed Keshtgar, Michael Alvarado, Max Bulsara, Wolfgang Eiermann, Norman Williams and Jayant S Vaidya on behalf of the TARGIT Trialists' group. Safety and efficacy of targeted intraoperative radiotherapy (TARGIT) for early breast cancer: First report of a randomized controlled trial at 10-years maximum follow up. Poster Presented at ASCO Annual Meeting; June 7, Chicago, 2010 (LBA517)
5. Vaidya Jayant S, Joseph David J, Tobias Jeffrey S, Bulsara Max, Wenz Frederik, Saunders Christobel, Alvarado Michael, Flyger Henrik L, Massarut Samuele, Eiermann Wolfgang, Keshtgar Mohammed, Dewar John, Kraus-Tiefenbacher Uta, Sutterlin Marc, Esserman Laura, Holtveg Helle M R, Roncadin Mario, Pigorsch Steffi, Metaxas Marinos, Falzon Mary, Matthews April, Corica Tammy, Williams Norman R, Baum Michael. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial., The Lancet, in press 2010

Brief profile
Carl Zeiss Meditec AG (ISIN: DE 0005313704), which is listed on TecDAX of the German stock exchange, is one of the world's leading medical technology companies.

The company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. It provides complete packages of solutions for the diagnosis and treatment of eye diseases -- including implants and consumable materials.

The company creates innovative visualization solutions in the field of microsurgery. Carl Zeiss Meditec's medical technology portfolio is rounded off by promising future technologies such as intraoperative radiation therapy.

In the financial year 2008/2009 (30 September) the 2,100 employees generated revenue of approximately EUR 640 million. The head office of Carl Zeiss Meditec is in Jena, Germany. The company has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France.

35 percent of Carl Zeiss Meditec shares are in free float. The remaining 65 percent are held by Carl Zeiss AG, one of the world's leading groups engaged in the optical and opto-electronics industry. Carl Zeiss offers innovative solutions for the future-oriented markets of "Medical and Research Solutions," "Industrial Solutions" and "Lifestyle Products." The head office of Carl Zeiss AG is in Oberkochen, Germany. In financial year 2008/09 (balance sheet date 30 September) the group posted sales of around EUR 2.1 billion. The Carl Zeiss Group has approximately 13,000 employees, including more than 8,000 in Germany.

Further information: www.meditec.zeiss.com


Contacts

United States:
Drew Avril
CoActive Public Relations
1 (718) 871-7117
+1 (718) 228-6553 fax
Email Contact
www.coactivepr.com

Europe:
Eva Sesselmann
Director Corporate Communications
Carl Zeiss Meditec AG
Göschwitzer Straße 51-52
07745 Jena, Germany
Phone: +49 3641 220-331
Fax: +49 3641 220-112
E-mail: Email Contact

Patrick Kofler
Director Investor Relations
Carl Zeiss Meditec AG
Göschwitzer Straße 51-52
07745 Jena, Germany
Phone: +49 3641 220-106
Fax: +49 3641 220-117
E-mail: Email Contact

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