Pilot Clinical Trial Data Using Rita Medical Systems Technology Presented at American Society of Clinical Oncology 2006 Annual Meeting
Pilot Clinical Trial Data Using Rita Medical Systems Technology Presented at American Society of Clinical Oncology 2006 Annual Meeting
June 6, 2006 at 12:00 AM EDT
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™ 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™ 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™ 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™ (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® 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 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 spedroff@ritamed.com 415-896-6820 dsherk@evcgroup.com
Media: Biocompatibles International plc Steve DiMattia Crispin Simon, Chief Executive 646-277-8706 +44 (0) 1252 732701 sdimattia@evcgroup.com crispin.simon@biocompatibles.com
SOURCE RITA Medical Systems, Inc. 06/06/2006
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™ 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™ 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™ (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® 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 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 spedroff@ritamed.com 415-896-6820 dsherk@evcgroup.com
Media: Biocompatibles International plc Steve DiMattia Crispin Simon, Chief Executive 646-277-8706 +44 (0) 1252 732701 sdimattia@evcgroup.com crispin.simon@biocompatibles.com
SOURCE RITA Medical Systems, Inc. 06/06/2006