Navigation Links
Celsion Receives Fast Track Designation for ThermoDox® Development Program to Treat Primary Liver Cancer
Date:8/24/2010

COLUMBIA, Md., Aug. 24 /PRNewswire-FirstCall/ -- Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, today announced that the U.S. Food and Drug Administration (FDA) has designated the HEAT Study of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), as a Fast Track Development Program.  ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is currently being evaluated under a Special Protocol Assessment (SPA) agreement with the FDA in a 600 patient global Phase III trial in patients with non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer.  With nearly 70% of patients enrolled in the trial, Celsion is targeting to complete patient enrollment by year end 2010.

"We are very pleased to receive the Agency's Fast Track Designation for ThermoDox," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer.  "Fast Track Designation is an acknowledgement that HCC is a significant unmet medical need representing a life threatening disorder.  It also recognizes the challenges facing pharmaceutical companies to develop effective new treatments for this difficult disease.  Together with the FDA's SPA agreement, granting accelerated review for the HEAT Study, the Fast Track status provides Celsion with the shortest time to approval.  Supported further by the National Cancer Institute's recent designation of the HEAT Study as a Priority Clinical Trial, it is clear that the major U.S. healthcare agencies and the liver cancer medical community recognize the potential of ThermoDox. We look forward to working with the FDA and other regulatory agencies around the world to make ThermoDox available to patients as soon as possible."

The FDA's Fast Track Development Program provides for expedited regulato
'/>"/>

SOURCE Celsion Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Celsion Announces CFO Departure
2. Quest Diagnostics Care360™ EHR Module Receives Preliminary ARRA IFR Stage 1 Certification
3. Hospira Japan Receives Approval for New Indication for Precedex IV™ 200ug
4. EntreMed Receives NASDAQ Listing Rule 5550(b)(2) Determination Letter
5. Renhuang Receives Patent for Product Package Design for Compound Honeysuckle Granules
6. KemPharm, Inc. Receives Notice of Issuance From USPTO on Patent Protecting Companys ADHD Prodrug Technology
7. PDL BioPharma Receives Letter from Genentech Relating to European Patents
8. Sigma-Aldrich® Receives National Institutes of Health Funding for Cardiovascular Disease Research
9. PolyGel® Receives SADMERC Approval for L-Code L3670 for ThermoActive™ Cold & Hot Mobile Compression Shoulder Orthosis
10. Accurays CyberKnife® G4 System Receives Shonin Approval
11. AdvanDx Receives FDA 510(k) Clearance for 90 Minutes Protocol for Yeast Traffic Light® PNA FISH®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/14/2014)... July 14, 2014  Remedy Informatics, the leading ... delivery and life sciences research, announced that it ... (NPF) to build the first-ever national patient registry ... and pancreatitis. "The National Pancreas Foundation ... that thoughtful and committed organizations can effect upon ...
(Date:7/14/2014)... DIEGO , July 14, 2014  More than any ... their smartphones and tablet computers -- but their eyes don,t. ... have never needed before, and the eye has not evolved ... and what our eyes can do comfortably often results in ... collectively known as Digital Eye Strain. Now ZEISS has invented ...
(Date:7/14/2014)... , July 14, 2014  Celsion Corporation (NASDAQ: ... today that the Company will ring the NASDAQ Stock Market ... New York, NY . ... of the Celsion and EGEN management teams will participate in ... pm ET.  A live webcast will be available at ...
Breaking Medicine Technology:Remedy Informatics Partners with National Pancreas Foundation to Build a National Patient Registry 2Remedy Informatics Partners with National Pancreas Foundation to Build a National Patient Registry 3New Eyeglass Lens Helps Our Eyes Keep Up with our Digital Lives 2New Eyeglass Lens Helps Our Eyes Keep Up with our Digital Lives 3Celsion Corporation to Ring the NASDAQ Stock Market Closing Bell on July 16, 2014 2Celsion Corporation to Ring the NASDAQ Stock Market Closing Bell on July 16, 2014 3
... Feb. 22, 2011 Delcath Systems, Inc. (Nasdaq: ... received a "refusal to file" letter from the U.S. ... Application (NDA) for its proprietary chemosaturation system used in ... liver through the percutaneous intra-arterial administration of melphalan hydrochloride. ...
... Va., Feb. 21, 2011 MicroAire ... endoscopic treatment for carpal tunnel syndrome.  MicroAire,s new ... and blade assembly that allows surgeons to treat ... the patient,s wrist – thereby avoiding full open-hand ...
Cached Medicine Technology:Delcath Systems Receives Refusal to File Letter From FDA 2Delcath Systems Receives Refusal to File Letter From FDA 3Delcath Systems Receives Refusal to File Letter From FDA 4MicroAire Introduces New SlimLine™ ECTR Cannula 2
(Date:7/14/2014)... 2014 Follow us ... chromatography or UPLC is a new and ... that involves the use of extremely small-sized ... chromatographic compounds. This highly sensitive qualitative and ... analysis of chromatography samples. UPLC functions on ...
(Date:7/14/2014)... Skin M.D. by ... on Monday, July 14th, located at 45 East ... last all week through Saturday, July 19th, with ... welcomed to attend. The business is owned by ... anti-aging, weight loss services, and sells high-end industry ...
(Date:7/14/2014)... KeyPoint Credit Union is teaming up with ... and one-mile family fun walk. The run begins inside ... finishes inside Levi’s® Stadium. , Over the past five ... Mission City Community Fund. All proceeds benefit education, seniors ... athletes, part-time pavement-pounders and walkers are invited to help ...
(Date:7/14/2014)... (PRWEB) July 14, 2014 T.E.N., ... relationship-marketing firm, announced today that nominations will be ... 2014 Information Security Executive® (ISE®) North America Awards. ... of the Year, which recognizes executives who have ... risk management, data-asset protection, regulatory compliance, privacy and ...
(Date:7/14/2014)... Many people are unhappy with their jawline. ... reduce a “double chin.” A new product that ... go under the knife. Jawflex is a double chin ... tightening the skin in that area and reducing the ... for facial exercise, double chin elimination and sagging jowls. ...
Breaking Medicine News(10 mins):Health News:Need for Faster Sample Analysis Drives Demand for UPLC, According to New Trend Report Published by Global Industry Analysts, Inc. 2Health News:The Cosmetic Medic Announces Grand Opening of New Skin M.D., a Physician-Administered Anti-aging, Skincare, and Weight Loss Practice 2Health News:The Cosmetic Medic Announces Grand Opening of New Skin M.D., a Physician-Administered Anti-aging, Skincare, and Weight Loss Practice 3Health News:T.E.N. Accepting Nominations for the 2014 Information Security Executive® North America Awards 2Health News:T.E.N. Accepting Nominations for the 2014 Information Security Executive® North America Awards 3Health News:Jawflex | Double Chin Exercise for Double Chin Reduction 2
... linked to hypertension years later, study finds , MONDAY, ... and Afghanistan who go into combat are more likely ... than those who serve in supporting roles, a new ... appeared to be a unique risk factor for newly ...
... Surging obesity rates have reversed gains, study finds , MONDAY, ... heart disease may be on the wane, experts say, with ... are now in the clear when it comes to heart ... bear much of the blame for the downturn, the researchers ...
... Analysis notes tamoxifen, raloxifene can up chances of other ... Medications given to women at high risk for developing ... drugs carry other health risks, a new analysis suggests. ... at numerous published studies, including randomized clinical trials and ...
... Global meeting ... ... Scientists and Technologists, , ,WHAT: 21st International Radon Symposium , , ,WHEN: September 20-23, ... Station, , ,WHY: Radon remains a serious, global health threat and remains the ...
... 14 Misonix, Inc. (Nasdaq: MSON ), a ... Europe is used for the ablation of tumors and worldwide ... who wishes to remain anonymous, donated the majority of the ... NM, to purchase a SonicOne(R) Ultrasonic Wound Cleansing and Debridement ...
... , LOS ALTOS, Calif., Sept. 14 ... Higgins, PhD has been named Chief Operating ... as InteKrin,s Chief Scientific Officer after joining the Company earlier ... has had increasingly broad operational and strategic responsibility in key ...
Cached Medicine News:Health News:Combat Exposure Tied to Chronic High Blood Pressure 2Health News:Most Adult Americans at Some Risk for Heart Disease 2Health News:Most Adult Americans at Some Risk for Heart Disease 3Health News:Medications That Lower Breast Cancer Risk Carry Other Dangers 2Health News:Medications That Lower Breast Cancer Risk Carry Other Dangers 3Health News:21st International Radon Symposium 2Health News:Misonix Equipment Funded By Anonymous Patient Donation 2Health News:Misonix Equipment Funded By Anonymous Patient Donation 3Health News:InteKrin Therapeutics Appoints Linda Slanec Higgins, PhD Chief Operating Officer 2
... Maxim knee system's curved-on-curved articulation maintains ... excellent sizing options for better patient ... alloy plasma spray porous coating, which ... own ArCom processed polyethylene is used ...
... posterior stabilized knee has an advanced ... flange mates with both resurfacing and ... precise, repeatable kinematics and fit with ... reduce wear. Constant cutting guide peg ...
... tricompartmental total knee prosthesis stems from many ... design and manufacturing technologies have been used ... as well as a favorable pressure distribution ... keep wear to a minimum. The inherent ...
The Balanced Knee System provides instrumentation designed to achieve proper tissue balancing and alignment with user-friendly instrumentation that provides reproducible results....
Medicine Products: