Pilot Clinical Trial Data Using Rita Medical Systems Technology Presented at American Society of Clinical Oncology 2006 Annual
June 06 2006 - 7:30AM
PR Newswire (US)
Preliminary Research Shows Potential Benefit of Combining Arterial
Embolization with Doxorubicin Eluting Beads and Radiofrequency
Ablation to Treat Primary Liver Cancer FREMONT, Calif., June 6
/PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (NASDAQ:RITA),
a publicly-traded medical device company focused solely on cancer
therapies, today announced that a presentation given at the 2006
Annual Meeting of the American Society of Clinical Oncology (ASCO)
in Atlanta, Georgia, featured pilot clinical trial data on the
treatment of primary liver cancer using the Company's
radiofrequency ablation (RFA) technology in combination with
arterial embolization using Biocompatibles International plc's
(LSE:BII) DC Bead(TM) with doxorubicin. In his 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, presented his first data on the sequential use of
radiofrequency ablation (RFA) and DC Bead(TM) in larger
hepatocellular carcinomas (HCC), or primary liver cancer. RITA
Medical RFA instruments were used in the study. Dr. 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 of 2006
RITA Medical announced a three-year agreement for the exclusive
distribution of Biocompatibles LC Bead(TM) embolization bead in the
United States and Canada. 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. Dr. 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 centimeters 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. "We believe the ability to increase the size of tumors
that can be treated with existing RFA techniques is extremely
promising in the early data reported at ASCO," said Joseph DeVivo,
President and CEO of RITA. "We believe the strategic decision to
give our U.S. customers access to the Biocompatibles' embolization
technology will provide them with a powerful new tool to treat
patients. Our expectation is that the news from ASCO will help
increase the awareness of the potential benefit of combining RFA
and embolization when treating unresectable liver cancer patients."
Also at ASCO, Dr. T.D. Yan from St. George Hospital in 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. RITA Medical RFA instruments were used in
the study. (Abstract #3502) Jelle W. Kylstra, MD, Vice President
and Medical Director for RITA commented, "As we improve disease
control in the liver with a variety of liver directed therapies,
lung metastases are becoming an increasingly frequent late
complication of colorectal cancer. At this advanced stage of the
disease, median survival is typically less than 14-16 months. For
this difficult group of patients, we believe the Australian data is
particularly encouraging." About RITA Medical Systems, Inc. RITA
Medical Systems develops, manufactures and markets innovative
products for cancer patients including radiofrequency ablation
(RFA) systems for treating cancerous tumors as well as percutaneous
vascular and spinal access systems. The Company distributes the LC
Bead(TM) (Biocompatibles, UK) product which is used in arterial
embolization of hypervascular tumors and arteriovenous
malformations and has U.S. Food and Drug Administration (FDA)
marketing clearance in the U.S. The Company's oncology product
lines include implantable ports, some of which feature its
proprietary Vortex(R) technology; tunneled central venous
catheters; and safety infusion sets and peripherally inserted
central catheters used primarily in cancer treatment protocols. The
radiofrequency product line also includes the HABIB 4X resection
device which coagulates a surgical resection plane and is designed
to facilitate a fast dissection in order to minimize blood loss and
blood transfusion during surgery. The proprietary RITA RFA system
uses radiofrequency energy to heat tissue to a high enough
temperature to ablate it or cause cell death. In March 2000, RITA
became the first RFA Company to receive specific FDA clearance for
unresectable liver lesions in addition to its previous general FDA
clearance for the ablation of soft tissue. In October 2002, RITA
again became the first company to receive specific FDA clearance,
this time for the palliation of pain associated with metastatic
lesions involving bone. The RITA Medical Systems website is at
http://www.ritamedical.com/. The statements in this news release
related to the use of the Company's technology, including without
limitation the possibility of increasing the size of tumors that
can be treated with RFA and the possible benefits of using RFA and
embolization together are forward-looking statements involving
risks and uncertainties that could cause actual results to differ
materially from those in such forward-looking statements. Such
risks and uncertainties include but are not limited to: the
Company's ability to compete with companies offering alternative
therapies for solid cancerous and benign tumors; the Company's lack
of long-term data regarding the safety and efficacy of its RF and
embolization products; delay of product introductions or
modifications as a result of the FDA regulatory process; the
Company's limited experience as a distributor of embolization
beads; and the Company's success in its physician training efforts.
Information regarding these risks and other risks and uncertainties
is included in the Company's filings with the Securities and
Exchange Commission. CONTACT: EVC Group RITA Medical Systems, Inc.
Investors: Stephen Pedroff, VP Marketing Communications Doug Sherk
510-771-0400 Jennifer Beugelmans 415-896-6820 Media: Biocompatibles
International plc Steve DiMattia Crispin Simon, Chief Executive
646-277-8706 +44 (0) 1252 732701 DATASOURCE: RITA Medical Systems,
Inc. CONTACT: Stephen Pedroff, VP Marketing Communications, of RITA
Medical Systems, Inc., +1-510-771-0400, or ; or investors, Doug
Sherk, , or Jennifer Beugelmans, both of EVC Group,
+1-415-896-6820, for RITA Medical Systems, Inc.; or media, Steve
DiMattia of EVC Group, +1-646-277-8706, or , for RITA Medical
Systems, Inc.; or Crispin Simon, Chief Executive, of Biocompatibles
International plc, +44-0-1252-732701, or Web site:
http://www.ritamedical.com/
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