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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
__________________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 25, 2004
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Celsion Corporation
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(Exact Name of Registrant as Specified in Charter)
Delaware 000-14242 52-1256615
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
10220-L Old Columbia Road, Columbia, Maryland 21046-1705
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(Address of principal executive office) (Zip Code)
Registrant's telephone number, including area code: (410) 290-5390
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(Former Name or Former Address, if Changed Since Last Report)
ITEM 5. OTHER EVENTS
At its Annual Meeting of Stockholders on May 25, 2004, Celsion
Corporation (the "Company") made announcements with respect to the following:
(A) The Company has received a warning letter from the United States Food
and Drug Administration, or FDA, regarding the Phase I and Phase II
clinical trials of its Prolieve(TM) Thermodilatation system for the
treatment of benign prostatic hyperplasia, or BPH. The warning letter
reflects matters that arose during the course of an inspection
conducted by the FDA's Baltimore regional office from December 9
through December 18, 2003 under a program designed to ensure that data
and information contained in applications for Investigational Device
Exemptions, or IDEs, Premarket Approval, or PMA, applications and
Premarket Notification, or 510(k), submissions are scientifically
valid and accurate and to ensure that human subjects are protected
from undue hazard or risk during scientific investigations.
The warning letter addressed four general areas--monitoring,
investigational agreements, provision of information to certain
investigators, and FDA reporting--in connection with the Prolieve
studies, both of which were completed by January 2002. Subsequent to
the inspection, the Company took certain actions to address the
observations of the FDA inspector and on December 23, 2003, made a
written submission to the agency regarding those corrective and
compliance actions. In addition, since receipt of the warning letter,
the Company has spoken with representatives of the FDA regarding
compliance matters and has initiated short- and long-term corrective
and compliance measures to address fully the issues raised by the FDA.
In addition, the Company recently has added personnel, including a
Senior Vice President-Product Development who will be responsible for
oversight of the entire clinical process, a Vice President-Regulatory
Affairs and experienced clinical monitors.
Under FDA regulations, the Company must make a written submission in
response to the warning letter no later than 15 days following its
receipt, subject to extension in the discretion of the agency. The
Company is working to complete and submit its response in a timely
manner. The warning letter indicates that the Company's failure to
respond and take timely and appropriate corrective action could result
in regulatory action by the FDA without further notice.
(B) On Tuesday, May 18, the Company completed treatment of the fourth
cohort of prostate cancer patients in the dose escalation study for
Thermodox(R), the Company's liposome encapsulation of the cancer drug
doxorubicin. The study has now reached safe delivery of 30 mg per
meter squared and the Company anticipates that maximum safe dosage
should be reached some time during the summer of 2004.
(C) Effective May 25, 2004, the Company has suspended both branches of its
pivotal Phase II trials using the Company's advanced phase array
microwave technology in the treatment of small and late stage breast
cancer tumors. The decision to suspend was taken after preliminary
evaluation of interim (midpoint) data from
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the trials. In the small tumor study, the Company determined that it
was achieving the primary endpoint of reducing second incisions, but
that it was not consistently meeting its secondary endpoint of
reducing tumor burden as measured by tumor necrosis. The Company
believes that these inconsistent results may be due to inconsistent
delivery of an adequate thermal dose. In the late-stage study, the
Company was encountering difficulties in enrolling sufficient patients
in part due to a change in the prevailing standard of care specified
in the study protocol and in part due to a shortage of late-stage
tumor patients, due to earlier detection of breast cancer.
(D) Effective May 25, the Board of Directors has established a search
committee to recruit a new chief executive officer for the Company. At
such time as the Board retains a new chief executive officer, Dr.
Augustine Cheung, the Company's chief executive officer, will assume
the position of Vice Chairman of the Board of Directors. Dr. Cheung is
expected to retain his position as Chief Scientific Officer.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CELSION CORPORATION
Date: May 25, 2004 By: /s/ Anthony P. Deasey
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Executive Vice President and Chief
Operating Officer
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