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Celsion Acquires Duke University's Breast Cancer Hyperthermia Treatment Technology.


Business Editors/Health/Medical Writers

COLUMBIA, Md.--(BUSINESS WIRE)--Aug. 7, 2003

Celsion has obtained exclusive rights to an advanced phased array radio frequency (RF) heating system designed specifically for use with chemotherapeutic drugs for the treatment of locally advanced breast cancer.

Celsion Corporation (AMEX AMEX

See: American Stock Exchange
:CLN) today announced that it has obtained exclusive rights to an advanced phased array radio frequency (RF) heating system designed specifically for use with chemotherapeutic drugs for the treatment of breast cancer. Duke engineer, Thaddeus Samulski, Ph.D, developed the technology, which uses RF energy to warm a woman's breast to approximately 42 degrees C to enhance the effectiveness of liposomal chemotherapeutic compounds. During the treatment the breast is immersed in a pool of distilled water, which helps distribute the heat evenly around the breast, thus preventing skin burns and "hot spots," which often create pain. Skin burns and hot spots have, up to now, limited the use of RF hyperthermia hyperthermia /hy·per·ther·mia/ (-ther´me-ah) hyperpyrexia; greatly increased body temperature.hyperther´malhyperther´mic

malignant hyperthermia
 as an effective means for treatment of breast cancer. Patients who have undergone the treatment describe their experience as like having their breast immersed in a Jacuzzi(R) (and sometimes refer to the machine as the "booby Jacuzzi").

The breast cancer treatment This article or section recently underwent a major revision or rewrite and needs further review. You can help!

The mainstay of breast cancer treatment is surgery when the tumor is localized, with possible adjuvant hormonal therapy (with tamoxifen or an aromatase
 system is currently being clinically evaluated at Duke. A Phase I trial has been completed and a Phase II trial is underway. The combination of trials was designed to demonstrate the system's ability to enhance the combined therapeutic effect of liposomal encapsulations of doxorubicin plus traditional paclitaxel (Taxol(R)) in the management of locally advanced breast cancer. Results of the Phase I study in 21 women were reported at the 2002 meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas.  (ASCO). The reported results indicated that tumor growth was halted in all women and that 50% of all tumors treated were reduced in size. In a press release dated May 18, 2002 Duke reported that, "11% of women have had complete pathologic responses, meaning no cancer was found in the breast tissue upon analyzing its surgical remains. 33% of patients had complete clinical responses, meaning visible signs of the tumor could no longer be detected, and 17% of patients were converted from mastectomy candidates to lumpectomy Lumpectomy Definition

A lumpectomy is a type of surgery used to treat breast cancer. It is considered "breast-conserving" surgery because in a lumpectomy, only the malignant tumor and a surrounding margin of normal breast tissue are
 candidates." The lead investigator during the trial was Kimberly Blackwell, M.D. of Duke University Medical Center. The Phase II trial to establish the efficacy of the system, also under Dr. Blackwell's direction, is ongoing.

Celsion and the Duke medical team believe that this technology will provide the ideal heat source for Thermodox(TM), Celsion's heat-activated liposomal encapsulation of doxorubicin, which is released from the liposome liposome (lī`pəsōm', lĭp`ə–), microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical to the phospholipids that make up cell membranes.  at 40-41 degrees C. Celsion has also licensed its heat activated liposome technology from Duke University. "As an established, successful partner with Duke University and a leader in the field of focused heating, Celsion was the ideal candidate to develop this technology," said inventor, Thaddeus Samulski. "I look forward to working with the team at Celsion and expanding the clinical trials to include the thermal sensitive liposomes developed by my Duke colleagues, Dr. David Needham and Dr. Mark Dewhirst."

Celsion believes that Dr. Samulski's system will complement the adaptive phased array technology it has licensed from the Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , which is currently in pivotal Phase II trials to treat both early and advanced stage breast cancer.

Dr. Augustine Cheung, Celsion's founder, Chief Executive Officer and Chief Scientific Officer added, "We are very excited to have acquired this technology, which has already shown great promise with non-temperature-sensitive liposomal chemotherapeutic drugs. Used in conjunction with our temperature-sensitive liposomes, we believe it has the potential to be even more effective. With the addition of Dr. Samulski's technology we now have heating technologies that will enable us to test Thermodox(TM) on three major cancers--prostate, breast and liver. We also believe that future adaptations of this technology could be used to heat other deep seated tumor sites to enable activation of other temperature-sensitive pharmaceutical and genetic therapies currently being developed by Celsion."

About Celsion: Celsion Corporation, based in Columbia, Maryland, is a research and development company dedicated to commercializing medical treatment systems for cancer and other diseases using focused-heat energy delivered by patented microwave technology.

In January 2003, Celsion entered into a strategic alliance with Boston Scientific Corporation (NYSE NYSE

See: New York Stock Exchange
:BSX) in which Boston Scientific will initially distribute Celsion's BPH BPH
abbr.
benign prostatic hyperplasia


BPH
Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men.
 product worldwide. Boston Scientific currently owns approximately 8% of Celsion's outstanding stock.

Celsion has research, license or commercialization agreements with leading institutions such as Duke University Medical Center, Massachusetts Institute of Technology, Harbor UCLA Medical Center UCLA Medical Center is a hospital located on the campus of the University of California, Los Angeles in Los Angeles, California. It is rated as one of the top three hospitals in the United States and is the top hospital on the West Coast according to US News & World Report. , the Center for Breast Surgery at Columbia Hospital in Florida, Montefiore Medical Center Montefiore Medical Center, in the Bronx, New York, is the university hospital of the Albert Einstein College of Medicine. The hospital, named after Moses Montefiore, is one of the 50 largest employers in New York State [1].  and Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New  in New York City New York City: see New York, city.
New York City

City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S.
, Roswell Park Cancer Institute The Roswell Park Cancer Institute is a cancer research and treatment center located in Buffalo, New York. Founded in 1898 by Dr. Roswell Park, it was the first dedicated medical facility for cancer treatment and research in the United States.  in Buffalo, New York, and Duke University. For more information on Celsion, visit our website: www.celsion.com.

Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 7, 2003
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