Printer Friendly
The Free Library
14,651,469 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

CELSION Provides Update on Status of Special Protocol Assessment (SPA) Submission.


COLUMBIA, Md. -- CELSION CORPORATION (AMEX AMEX

See: American Stock Exchange
: CLN CLN Clean
CLN Community Learning Network
CLN Colon
CLN Celsion Corporation
CLN Class Library for Numbers
CLN Credit Linked Note
CLN Comitato di Liberazione Nazionale (Committee of National Liberation)
CLN Corn Lethal Necrosis
) today is providing an update to its SPA application for Primary Liver Cancer. As previously reported, the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 requested and received an update to the study's Radiology Charter. Although the FDA could take an additional 45 days from the time of receipt to issue a formal response, at that time Celsion was advised that the submission would be acted upon within a week to ten days. Subsequently, the FDA has advised the company that the review is still in progress, but did not indicate a definitive date for the agency's issuance of the formal response.

Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "We continue to have confidence in our submission and we are appreciative of the Agency's collaboration with Celsion. We will provide an update as soon as we have a formal response. In the meantime Adv. 1. in the meantime - during the intervening time; "meanwhile I will not think about the problem"; "meantime he was attentive to his other interests"; "in the meantime the police were notified"
meantime, meanwhile
 we are continuing our Phase III planning with the expectation that the SPA will be approved with a target of enrolling our first patient before the end of the year"

About Thermodox

ThermoDox is Celsion's proprietary heat-sensitive liposomal encapsulation of an approved and frequently used anti-cancer drug, doxorubicin which is used in the treatment of various cancers including breast cancer. Localized mild hyperthermia hyperthermia /hy·per·ther·mia/ (-ther´me-ah) hyperpyrexia; greatly increased body temperature.hyperther´malhyperther´mic

malignant hyperthermia
 (39-42 degrees C) releases the entrapped doxorubicin 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. . This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

About Celsion:

Celsion is dedicated to the development and commercialization of oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat activated drug delivery systems. Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong The University of Hong Kong (commonly abbreviated as HKU, pronounced as "Hong Kong U") is the oldest tertiary institution in Hong Kong. Its motto is "Sapientia et Virtus" in Latin, and " , Cleveland Clinic, North Shore Long Island Jewish Health System. Additional information about Celsion Corporation can be found on the Celsion web site at 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Oct 5, 2007
Words:408
Previous Article:Fitch Affirms Merrill Lynch's Ratings; Outlook to Negative.
Next Article:EA Acquires Super Computer International.



Related Articles
Best care everywhere: here's an idea: a civilian VA for the uninsured, and maybe the rest of us.(SPECIAL HEALTH CARE ISSUE)
Tennessee Awards grant money for tire recycling.(TIRES)
U.K. Group calls for recycling at building sites.(C&D NEWS)
Chinese officials increase inspections at ports.(BIR REPORT)
Best Mfg. and DuPont team up to make gloves.(Contracts, licenses)
Extrusion tooling.(Suppliers Showcase: Equipment)
Thermoplastic elastomer.(Suppliers Showcase: Materials)
Leasing strong at Overlook complex.(NEW JERSEY)
GHP handles Two Bridges Road sale.(NEW JERSEY)
A closer review of mortgage recording tax exemptions.(INSIDERS OUTLOOK)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles