"Celsion Expands ThermoDox Prostate Cancer Study
Tuesday February 3, 10:01 am ET
FDA Allows Two Amendments to Enhance Enrollment in Celsion's Phase I Dose Escalation Study
COLUMBIA, Md.--(BUSINESS WIRE)--Feb. 3, 2004--CELSION CORPORATION (AMEX:CLN - News) announced today that the FDA has allowed two amendments to its Phase I Dose Escalation study of ThermoDox(TM). ThermoDox is Celsion's liposome-encapsulated formulation of doxorubicin for the treatment of prostate cancer.
The original Phase I protocol was limited to patients whose cancer had spread beyond the prostate (i.e. metastatic). Based upon safety data submitted by Celsion for the first two groups of patients in the study, the FDA has allowed expansion of the study to include patients with progressive prostate cancer in-situ (i.e. non-metastatic). In addition, the FDA has permitted the Company to add an additional site, Grand Strand Urology in Myrtle Beach, South Carolina, to its existing clinical sites at Roswell Park Cancer Institute in Buffalo, New York and Regional Urology in Shreveport, Louisiana.
Celsion's therapeutic approach to the treatment of prostate cancer combines focused-heat thermotherapy with its heat-activated drug ThermoDox, a formulation in which doxorubicin, a common anticancer drug, is encapsulated in a heat-activated liposome. In the treatment, the prostate is heated to 41 degrees C with Celsion's Microfocus(TM) BPH 800 Microwave Urethroplasty(TM) system, which enables the systemically administered ThermoDox to release its encapsulated doxorubicin in the prostate. Celsion believes that if the trial confirms the results achieved in pre-clinical animal studies, this approach may allow the direct delivery of high dose chemotherapy to the tumor, thus minimizing the need for invasive surgery, as well potentially reducing the severe systemic toxicities associated with currently available anticancer drugs.
Daniel Reale, President of Celsion's Oncology Division, said, "We anticipate that allowance of these amendments will add impetus to this study by giving us access to a much larger pool of potential patients, thereby enabling us to establish the safe dosage for ThermoDox expeditiously. We are also very pleased to add Dr. Neal Shore as an investigator at the Myrtle Beach practice. Dr. Shore was a significant participant in our recently completed BPH study and will be a valuable contributor to this study."
About Celsion: Celsion Corporation, based in Columbia, Maryland, is a biotechnology company dedicated to the development and commercialization of treatment systems for cancer and other diseases using focused-heat energy, either administered alone, or in combination with other therapeutic devices, heat-activated genes and heat-activated drugs.
In January 2003, Celsion entered into a strategic alliance with Boston Scientific Corporation (NYSE:BSX - News) in which Boston Scientific will initially distribute Celsion's BPH product worldwide. Boston Scientific currently owns approximately 6% of Celsion's outstanding stock.
Celsion has research, license or commercialization agreements with leading institutions such as the National Institute of Health, Duke University Medical Center, Massachusetts Institute of Technology, Harbor UCLA Medical Center, Montefiore Medical Center and Memorial Sloan-Kettering Cancer Center in New York City, Roswell Park Cancer Institute 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 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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Contact:
Celsion Corporation, Columbia
Tony Deasey, 410-290-5390
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