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:11/22/2014)... LONG BEACH, Calif. , Nov. 21, 2014   ... implants. Dental implants are often called the gold standard in ... teeth. They are a stable, long-lasting way to restore and ... use dental implants to replace a missing tooth or as ... to completely transform the look and feel of a smile. ...
(Date:11/22/2014)... 21, 2014 Many power shifts are ... influence of patients in the biopharmaceutical market is ... more than ever, understanding how to effectively acquire, ... is essential. According to recent ... companies spent about two-thirds of their patient-focused dollars ...
(Date:11/21/2014)... In September 2014, the staff at Medelita ... new product development plan that started with the launch ... lab coat , aptly named "Vera G.," after one ... world. The new women,s designer lab coat is a ... envelope collar, vertical princess and high waist seaming, and ...
Breaking Medicine Technology:Long Beach Dentist, Dr. Rassouli, is Now Offering Dental Implants 2New Report Details Importance of Adopting a "Patient Journey" Framework in Marketing 2Medelita Introduces Medical Industry's First Limited Edition Women's Designer Lab Coat 2
... AstraZeneca (NYSE:,AZN) today announced that the U.S. Food ... (quetiapine fumarate) Extended-Release,Tablets for maintenance treatment of schizophrenia ... approved SEROQUEL XR for the acute treatment of,schizophrenia ... rates of symptom relapse, and as,a result, there ...
... from Fort Point Channel to the Cyclorama mark 16th Annual,24-hour ... thousands of youth to process with black and copper buckets ... The Boston Center,for the Arts as part of the annual ... event was named Best Project in a Public Space by ...
Cached Medicine Technology:SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia 2SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia 3SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia 4SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia 5SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia 6SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia 7SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia 8Award-Winning Medicine Wheel Returns to the Cyclorama at the Boston Center for the Arts on Dec. 1 for 24-hour Vigil Recognizing World AIDS Day 2Award-Winning Medicine Wheel Returns to the Cyclorama at the Boston Center for the Arts on Dec. 1 for 24-hour Vigil Recognizing World AIDS Day 3Award-Winning Medicine Wheel Returns to the Cyclorama at the Boston Center for the Arts on Dec. 1 for 24-hour Vigil Recognizing World AIDS Day 4
(Date:11/23/2014)... Newport Beach, CA (PRWEB) November 23, 2014 ... founder of American Medical Aesthetics & Wellness was ... Dr. Asher Milgrom, Ph.D. is president and CEO of ... Skincare. Dr. Asher Milgrom received a full scholarship ... Sciences and the Medical School at the University of ...
(Date:11/23/2014)... BambooFlooringChina.com , the world’s leader in bamboo ... bamboo flooring collection. Now, the business is announcing big ... the promotion is valid until Dec. 20, 2014. , The ... and dust-free surface, which makes it very easy to maintain. ... company wants to make its website the best shopping platform ...
(Date:11/22/2014)... 2014 PrettyTailor , an outstanding ... new big promotion. Customers can buy new dresses at ... can visit its website. , As a matter of ... dresses. It mainly provides four types of wedding outfits, ... flower girl dresses. It also provides a variety of ...
(Date:11/22/2014)... 23, 2014 Today, Dylan Queen, a ... collection of wedding dresses; the business offers a wide ... accessories for ladies worldwide, allowing them to create multiple ... the company, this new collection of chic wedding dresses ... they are offered at discounted rates now. Dylan Queen ...
(Date:11/22/2014)... 22, 2014 Nocturia is defined ... complaint that the individual has to wake at ... report “Nocturia – Pipeline Review, H2 2014” provides ... complete with comparative analysis at various stages, therapeutics ... route of administration (RoA) and molecule type, along ...
Breaking Medicine News(10 mins):Health News:Asher Milgrom Is the Founding Doctor of AMA Skincare and Is Featured in the International Business Times 2Health News:Asher Milgrom Is the Founding Doctor of AMA Skincare and Is Featured in the International Business Times 3Health News:Asher Milgrom Is the Founding Doctor of AMA Skincare and Is Featured in the International Business Times 4Health News:Click Strand Woven Bamboo Flooring From Famous Bamboo Flooring Company BambooFlooringChina.com 2Health News:Customers Are Welcome to Shop at PrettyTailor.com 2Health News:Dylan Queen Introduces Its New Wedding Dresses 2Health News:Nocturia Therapeutic Pipeline Market Review by Drugs and Companies H2 2014 Report at RnRMarketResearch.com 2Health News:Nocturia Therapeutic Pipeline Market Review by Drugs and Companies H2 2014 Report at RnRMarketResearch.com 3Health News:Nocturia Therapeutic Pipeline Market Review by Drugs and Companies H2 2014 Report at RnRMarketResearch.com 4
... Reporter , MONDAY, Aug. 23 (HealthDay News) -- Another ... play a role in chronic fatigue syndrome, a poorly ... , Using blood samples collected in the mid-1990s from ... found evidence of gene sequences for murine leukemia virus ...
... In a Policy Forum published this week in ... Graham review different population strategies for preventing cardiovascular ... individuals may be ineffective and widen social inequalities. ... prevention strategies for screening and treating high-risk individuals ...
... receptor-positive breast cancer, but not necessarily invasive ductal carcinomas, ... The Journal of the National Cancer Institute., ... factor for overall breast cancer, few studies have looked ... risk by subtype of breast cancer. While some studies ...
... specific drugs can protect nerve cells in mice from ... are published in the August 22 issue of ... a protein that, when altered in people, leads to ... system that leads to tremors and problems with muscle ...
... plays a significant role in the survival of cells that ... (TUM) uncovered this protein,s mode of operation some time ago ... an unexpected pattern of motion. The results are published in ... and may help researchers discover specific cancer medication. Proteins ...
... University of Cincinnati (UC) analysis of 10 years ... that patients removed from a corticosteroid regimen shortly ... survival rates and fewer cardiovascular events than patients ... The analysis shows that, out of 904 ...
Cached Medicine News:Health News:More Evidence Virus Plays Role in Chronic Fatigue Syndrome 2Health News:More Evidence Virus Plays Role in Chronic Fatigue Syndrome 3Health News:Alcohol intake increases certain types of breast cancer 2Health News:A promising target for developing treatments against Parkinson's disease 2Health News:Munich researchers demonstrate rocking movement in the anti-stress protein Hsp90 2Health News:Decade-long trial confirms benefts of steroid withdrawal for transplant patients 2
... DAPII brain biopsy needle guide housing. ... Screw mount. Placed through a ... Non-sterile; sterilize via autoclave Guide sphere assembly ... with biopsy needles with barium sleeves. Sterile; ...
A complete system of cannulas, needles and rasps specifically designed for inside-out meniscal repair procedures....
Part of the GraFix® Cruciate Reconstruction System, which is designed to facilitate arthroscopic anterior cruciate ligament reconstructions....
... (KGTI) system offers the latest technology and ... The implant system is anatomically designed and ... KGTI is the most advanced reconstructive device ... the market today. The system consists of ...
Medicine Products: