A Medical Device Daily

RITA Medical Systems (Fremont, California), a medical device company focused solely on cancer therapies, reported that a presentation given at the 2006 annual meeting of the American Society of Clinical Oncology (ASCO; Alexandria, Virginia) in Atlanta featured pilot clinical trial data on the treatment of primary liver cancer using the company's radio frequency ablation (RFA) technology in combination with arterial embolization using DC Bead with doxorubicin, a product fromBiocompatibles International (Barnham, UK).

In a presentation titled “Approach and management of lesions detected in HCC surveillance programs,” Professor Riccardo Lencioni, medical director of the Department of Diagnostic and Interventional Radiology, University of Pisa (Italy), presented his first data on the sequential use of RFA and DC Bead in larger hepatocellular carcinomas (HCC), or primary liver cancer. RITA Medical RFA instruments were used in the study.

Lencioni concluded: “Preliminary data of this pilot clinical study show that arterial embolization with doxorubicin substantially increases the effect of RFA in the treatment of large HCC tumors.”

In May, RITA Medical reported a three-year agreement for the exclusive distribution of Biocompatibles LC Bead embolization bead in the U.S. and Canada (Medical Device Daily, May 3, 2006). The company noted that the product to be distributed in the U.S. is the same as the DC Bead, which is distributed in Europe.

Lencioni commented, “The ability to treat larger tumors through a combined therapeutic approach could open new prospects in the treatment of liver cancer by expanding the indication for RFA far beyond its current limits.”

In the pilot clinical trial 10 patients with HCC primary liver cancer tumors greater than 3 cms in size were first treated with RFA and then immediately scheduled for doxorubicin eluting beads arterial embolization. Arterial embolization was performed 24 hours after RFA using DC Bead.

On CT and MRI-scans, using this sequential treatment approach, the mean increase in the volume of coagulation necrosis was 64.2% (range: 5-134%), compared to tumors treated with RFA alone.

Also at ASCO, T.D. Yan, MD, from St. George Hospital (Sydney, Australia) presented long-term data on a series of 55 patients with inoperable lung metastases from colorectal cancer treated with RFA. The median survival following RFA reported in this group of patients was 33 months, with a 1-, 2-, and 3-year survival of 85%, 64% and 46% respectively.

Among other reports from ASCO:

• MacroArray Technologies (Atlanta) and GTx (Memphis, Tennessee) reported that MacroArray presented data from its development of a diagnostic test for prostatic intraepithelial neoplasia (PIN) in a general poster session. The poster provides details of MacroArray's development of a novel urine-based diagnostic for high-grade PIN, a premalignant lesion of the prostate.

GTx is supplying to MacroArray urine and serum samples from patients with high-grade PIN enrolled in GTx's Phase IIb and Phase III clinical trials to assist MacroArray in its development and future validation of a noninvasive test for high grade PIN. GTx is conducting a pivotal Phase III clinical trial of Acapodene (toremifene citrate) in a 20 mg dose for the prevention of prostate cancer in men with high grade PIN.

Currently, high-grade PIN can only be diagnosed by prostate needle biopsy. Usually patients undergo a prostate biopsy when they are found to have an elevated serum PSA. Between 8% and 10% of patients who undergo a prostate biopsy will be found to have high grade PIN. Men with high grade PIN have an approximately 50% chance of progressing to prostate cancer within three years and an 80% chance within five to seven years.

In the U.S., 1.1 million men have been diagnosed with high-grade PIN, and it has been estimated that 14 million men may unknowingly harbor the condition. Currently, there are no approved medical treatments for high-grade PIN.

GTx is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics for cancer and serious conditions related to men's health.

• Impac Medical Systems (Mountain View, California), an Elekta company that provides oncology information technology (IT) solutions, andRocket Communications (San Francisco), a professional user interface design studio, reported the release of Mosaiq, Impac's image-enabled oncology electronic medical record (EMR) featuring a new user interface designed in collaboration with Rocket.

With Microsoft's .NET and SQL database technology as its foundation, the Mosaiq platform is optimized for both local area and wide area network implementation and is structured to help users view and analyze image and textual EMR information in a “familiar” chart-based format, the company said.

Fundamental to Mosaiq's architecture is the ability to process DICOM and DICOM-RT images, plans, data sets, and services required to support image guided and adaptive therapy while providing the necessary foundation for scalable oncology image storage, retrieval, and archive.

With the ability to connect to multiple planning, imaging, and treatment devices, Mosaiq is designed to eliminate the dependency on any single equipment vendor, offering a user-defined total solution that improves productivity and return on investment while allowing more efficient, higher quality patient care.

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