EXHIBIT 99.2
- ------------
NEWS RELEASE CELSION(TM)
- -------------------------------------------------------------------------------
For Further Information Contact:
Tony Deasey Steve Chizzik/ Richard Cooper/Jennifer Zimmons
Celsion Corporation Ira Weingarten Strategic Growth International, Inc.
410.290.5390 Equity Communications 212.838.1444
tony@celsion.com 973.912.0980 info@sgi-ir.com
chizz1@comcast.net ---------------
CELSION SUBMITS RESPONSE TO FDA WARNING LETTER
COLUMBIA, MD - JUNE 1, 2004: CELSION CORPORATION (AMEX: CLN) announced today
that its response to the warning letter issued to it by the Food and Drug
Administration (FDA) on May 7, 2004 was submitted to the FDA on Friday, May 28,
2004. As previously announced, the warning letter reflected certain matters that
arose in connection with the Phase I and Phase II clinical trials of Celsion's
Prolieve(TM) Thermodilatation system for the treatment of benign prostatic
hyperplasia. The FDA granted Premarketing Approval (PMA) to Celsion for the
Prolieve system earlier this year, and the system currently is being marketed
under a distribution agreement between Celsion and Boston Scientific
Corporation.
Tony Deasey, Celsion's Executive Vice President and Chief Operating Officer,
said, "We took, and continue to take, the FDA's letter extremely seriously and
have devoted significant attention and resources to our response. We believe
that we have responded to the FDA's immediate concerns and have initiated
actions necessary to address their longer-term comments on a schedule which,
based on discussions with the Agency, we believe will be acceptable. We are
putting processes in place to be fully compliant with FDA GCP regulations going
forward. Our actions in response to the FDA's findings should help us to meet
that goal and improve our clinical operations for the near and long term."
Carolyn Finkle, Celsion's Vice President, Regulatory Affairs, added, "We have
responded promptly to the findings raised by the FDA in its May 7, 2004 letter
and believe that we have addressed, or will address, all of the Agency's
concerns. So long as we do so and continue to work with the Agency, we do not
anticipate any further action by the FDA, including any actions that would
affect the Prolieve PMA." Ms. Finkle also indicated that the Company intends to
submit a redacted version of its response to the FDA shortly, with the request
that Celsion's response be posted for public review on the Agency's website at
www.fda.gov.
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) in which Boston Scientific will initially
distribute Celsion's BPH product worldwide. Boston Scientific currently owns
approximately 7% 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.