Navigation Links
Fibrocell Science, Inc. Initiates Histology Study of azficel-T
Date:5/13/2010

EXTON, Pa., May 13 /PRNewswire-FirstCall/ --  Fibrocell Science, Inc. (OTC Bulletin Board: FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today the initiation of a small histology study (IT-H-001) of azficel-T, an autologous cell therapy currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles.  The study has a target enrollment of approximately 20 participants from the completed and statistically significant pivotal Phase III studies of azficel-T (IT-R-005 and IT-R-006).

The FDA requested the comparative histological data from this study in a Complete Response letter issued to the Company on December 21, 2009 related to the Biologics License Application (BLA) for azficel-T for the treatment of moderate to severe nasolabial fold wrinkles in adults.  

The histology study will evaluate tissue treated with azficel-T as compared to tissue treated with sterile saline (placebo).  The study will also provide information about the skin after treatment, including evaluation of collagen and elastin fibrils, and cellular structure of the sampled tissues.

"Over the past several months, we have worked closely with the FDA and our clinical investigators to design this study protocol," said David Pernock, Chairman and CEO, Fibrocell Science Inc.  "We intend to submit data from the study to the FDA in the fourth quarter of 2010."

According to milestones established in the Prescription Drug User Fee Act (PDUFA), the FDA will have six months to review the data submission once they deem Fibrocell's response to their le
'/>"/>

SOURCE Fibrocell Science, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Fibrocell Science, Inc. Enters Into Financing Agreement
2. Fibrocell Science, Inc. Names David Pernock Chief Executive Officer
3. Fibrocell Science, Inc. Receives FDA Complete Response Letter Regarding azficel-T for Wrinkles
4. Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles
5. Isolagen, Inc. Reorganizes as Fibrocell Science, Inc.
6. California Life Science, Business, and Economic Development Experts Discuss Californias Bioscience Future
7. FRC: NIH Stem Cell Guidelines Reflect Poor Science, Ignore Real Hope for Patients
8. Seahorse Bioscience, Inc. Acquires BioProcessors Corp.
9. Bert W. OMalley, M.D., Recipient of the 2008 National Medal for Science, Joins Bionovos Scientific Advisory Board
10. For creating new field of science, Texas chemist wins international prize
11. Todd R. Nelson Named Chief Executive Officer of eBioscience, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2014)... Incorporated (SPEX) -- an intellectual property development company committed to ... the United States Patent & Trademark Office (USPTO) issued a ... that is part of a standard essential family of patents. ... , Application number: US 13/728,867 , Publication date: Sep ... The listed inventors of the new patent, entitled ...
(Date:9/21/2014)... discovered how to produce ultra-thin "diamond nanothreads" that promise ... of today,s strongest nanotubes and polymers. A paper describing ... V. Badding, a professor of chemistry at Penn State ... issue of the journal Nature Materials . , ... intriguing because the threads we formed have a structure ...
(Date:9/20/2014)... (PRWEB) September 20, 2014 Entries are ... Prism Awards for Photonics Innovation . The international ... multi-billion dollar optics and photonics industry, and is sponsored ... photonics , and Photonics Media . , The ... versatility of photonics, said SPIE CEO Eugene Arthurs. , ...
(Date:9/20/2014)... Friesland, Netherlands (PRWEB) September 20, 2014 ... cell technologies to perform a groundbreaking surgery at the ... incident, the mare's superficial digital flexor tendon was ruptured ... this kind of injury is a death sentence for ... MediVet America stem cell treatments . This ...
Breaking Biology Technology:Spherix Notified by United States Patent & Trademark Office of New Standard Essential Patent Issued to Spherix 2Spherix Notified by United States Patent & Trademark Office of New Standard Essential Patent Issued to Spherix 3Smallest possible diamonds form ultra-thin nanothreads 2Smallest possible diamonds form ultra-thin nanothreads 3Smallest possible diamonds form ultra-thin nanothreads 4Entry deadline is 10 October for international photonics Prism Awards 2Entry deadline is 10 October for international photonics Prism Awards 3Entry deadline is 10 October for international photonics Prism Awards 4World’s first tendon replacement using Nanofiber and activated MediVet Stem Cell Fraction 2World’s first tendon replacement using Nanofiber and activated MediVet Stem Cell Fraction 3
... 4 ARCA Discovery Inc., a privately held,biopharmaceutical ... other cardiovascular diseases, today announced Richard B.,Brewer, President ... 26th,Annual JPMorgan Healthcare Conference on Tuesday, January 8 ... Conference will be held January 7-10, 2008 at,the ...
... REYKJAVIK, Iceland, Jan. 4 deCODE genetics,(Nasdaq: DCGN ... webcast of deCODE,CEO Kari Stefansson,s presentation at the JPMorgan ... at 11:30 am PST / 7:30 pm GMT on,Thursday, ... California.,The webcast can be accessed through the Investors page ...
... FRANCISCO, Calif., Jan. 4 Cerimon,Pharmaceuticals, Inc. announced ... Counsel, a newly established position, and Vice President ... global life sciences,executive and corporate attorney with broad ... in the US and,Europe. In the business development ...
Cached Biology Technology:ARCA Discovery, Inc. to Present at 26th Annual JPMorgan Healthcare Conference on January 8, 2008 2Cerimon Pharmaceuticals Names Matthew J. Meyer its General Counsel and Vice President of Business Development and Licensing 2
(Date:9/21/2014)... 2014The story of cowpea (black-eyed peas) is a fascinating ... problemseven more fascinating is the story of the scientist ... The Food Legume of the 21st Century to serve ... use. The book was recently published by the Crop ... of Tropical Agriculture (IITA). , Singh has devoted his ...
(Date:9/21/2014)... recent years, new strains of bacteria have emerged that ... superbugs, including drug-resistant forms of tuberculosis and staphylococcus, infect ... least 23,000. Despite the urgent need for new treatments, ... in the past decade. , MIT engineers have now ... a gene-editing system that can disable any target gene, ...
(Date:9/21/2014)... team of Stanford researchers has developed a protein therapy ... break away from original tumor sites, travel through the ... the body. , This process, known as metastasis, can ... "The majority of patients who succumb to cancer fall ... Cochran, an associate professor of bioengineering who describes a ...
Breaking Biology News(10 mins):Battling superbugs 2Battling superbugs 3Battling superbugs 4Stanford researchers create 'evolved' protein that may stop cancer from spreading 2Stanford researchers create 'evolved' protein that may stop cancer from spreading 3Stanford researchers create 'evolved' protein that may stop cancer from spreading 4
... Md. -- Later this week, the American Society of Plant ... plant science to chart the future of the field. The ... the broad plant science research community in a process that ... science research over the next decade. The summit will ...
... A University of Alberta research team has turned their ... and hopes to expand its use. U ... students produced a 3-D imaging system called Virtual Reflected-Light ... a light source, a platform that moves the objects ...
... woodland creatures, including woodlice, millipedes and worms, can help ... according to new research from Cardiff University. Huge ... compete with each other for space and resources and, ... woodland floor have the potential to govern the outcome ...
Cached Biology News:ASPB convenes leaders to chart future of plant science research 2Peacekeeping creatures help maintain woodland diversity 2
... dispenser combining the most versatile features for bulk ... existing Multidrop dispensers. , ,It is designed ... nl up to 2500 l with excellent precision ... for multiple plate formats (96, 384, 1536) including ...
... Multidrop Combi is a new generation bulk ... flexibility and simplicity for pharmaceutical and biotech ... reliable Multidrop range, Multidrop Combi has been ... volumes of 0.5-2500 l and multiple plate ...
Multidrop DW is a high-speed automated dispenser for Deep Well plates, 1.1 ml test tubes and 96-well plates. Designed for accuracy and precision, the Multidrop DW dispenses up to eight different reag...
Buckets for 2 racks of 5 tubes, type Stago/Hitachi...
Biology Products: