Navigation Links
Tengion Announces FDA Orphan-Drug Designation for Neo-Urinary Conduit
Date:6/9/2011

EAST NORRITON, Pa., June 9, 2011 /PRNewswire/ -- Tengion, Inc. (Nasdaq: TNGN) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to the Company's Neo-Urinary Conduit™, for treatment of bladder dysfunction requiring incontinent urinary diversion.  

"This designation is another important step in advancing the development of our Neo-Urinary Conduit, our lead clinical product candidate, currently being studied in patients with bladder cancer," said Sunita Sheth, M.D., Chief Medical Officer of Tengion.  

Orphan drug designation entitles Tengion to seven years of U.S. marketing exclusivity for the Neo-Urinary Conduit if and when it receives regulatory approval, as well as additional incentives in the form of tax credits for clinical research expenses and a waiver of the FDA's application user fee. Orphan-drug status is granted by the FDA to promote the development of new therapies for medical conditions affecting fewer than 200,000 individuals in the United States.

About Tengion

Tengion, a clinical-stage biotechnology company, has pioneered the Organ Regeneration Platform™ that enables the Company to create proprietary product candidates that are intended to harness the intrinsic regenerative pathways of the body to produce a range of native-like organs and tissues. Tengion's product candidates seek to eliminate the need to utilize other tissues of the body for a purpose to which they are poorly suited, procure donor organs or administer anti-rejection medications.  An initial clinical trial is ongoing for the Company's lead product candidate, the Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like bladder tissue for bladder cancer patients requiring a urinary diversion following bladder removal.  The Company's lead preclinical candidate is the Neo-Kidney Augment, which is designed to delay or prevent the need for dialysis or transplantation in patients at risk for kidney failure.  Tengion has also applied its technology in two Phase II clinical trials for Tengion's Neo-Bladder Augment for the treatment of neurogenic bladder.  Tengion has worldwide rights to its product candidates.

Forward-Looking Statements

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to the Company's: (i) plans to develop and commercialize its product candidates, including the Neo-Urinary Conduit and the Neo-Kidney Augment; (ii) expectations regarding the initial clinical trial of the Neo-Urinary Conduit and (iii) expectations regarding planned preclinical studies of the Neo-Kidney Augment. Although Tengion believes that these statements are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there are a number of factors that may cause actual results to differ from these statements. For instance there can be no assurance that: (i) the Company's Neo-Urinary Conduit clinical trial will not be placed on clinical hold by the Food and Drug Administration, or FDA; (ii) patients enrolled in the Company's Neo-Urinary Conduit clinical trial will not experience additional adverse events, which could delay clinical trials or cause the Company to terminate the development of the Neo-Urinary Conduit; (iii) the Company will be able to successfully enroll patients in its clinical trials, including its initial clinical trial for the Neo-Urinary Conduit; (iv) the results of the clinical trial for the Neo-Urinary Conduit will support further development of that product candidate; (v) data from the Company's ongoing preclinical studies will continue to be supportive of advancing its preclinical product candidates; and (vi) the Company will be able to progress its product candidates that are undergoing preclinical testing, including the Neo-Kidney Augment, into clinical trial and (vii) the Company will be able to obtain the capital it needs to develop its product candidates and continue its operations.  For additional factors which could cause actual results to differ from expectations, reference is made to the reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended.  The forward looking statements in this release are made only as of the date hereof and the Company disclaims any intention or responsibility for updating predictions or expectations in this release.


'/>"/>
SOURCE Tengion, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Tengion Presents New Data in Nine Posters and Two Oral Presentations at TERMIS North America Annual Meeting
2. Tengion Advances Clinical Trial for Neo-Urinary Conduit™ in Bladder Cancer Patients
3. Tengion Provides Business Update and Reports Third Quarter 2010 Financial Results
4. Tengion Reviews Pipeline Progress at First Analyst and Investor Meeting; Strategic & Clinical Updates Provided for Regenerative Medicine Programs
5. Tengion Announces First Implantation of Neo-Urinary Conduit™ in Initial Clinical Trial in Patients with Bladder Cancer
6. Tengion Presents New Data Demonstrating Functional Regeneration in a Diabetic Chronic Kidney Failure Model at the International Society for Cellular Therapy
7. Tengion Appoints Sunita B. Sheth, M.D., Chief Medical Officer
8. Tengion Scientists Publish Key Preclinical Findings Demonstrating the Benefits of Organ Regeneration Vs. Repair
9. Preclinical Data Demonstrate Ability to Regenerate an Entire Bladder With Tengion Neo-Bladder Replacement(TM)
10. Tengion Launches Third Phase 2 Clinical Trial of Regenerated Human Bladder
11. Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... Research and Markets has ... Myeloma Market and Competitive Landscape Highlights - ...      (Logo: http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ... Highlights 2016, provides comprehensive insights into Multiple ... Myeloma market valuations and forecast, Multiple Myeloma ...
(Date:5/3/2016)... 2016 Global Insulin Needles ... 09 key companies and supported with 272 tables ... study on the current state of the Insulin ... industry including definitions, classifications, applications and industry chain ... for the international market including development history, competitive ...
(Date:5/3/2016)... ACME Markets, Delaware County ... Councilman Dave White announced today the availability ... pharmacies across Delaware County . According ... has saved 26,463 lives nationwide over the past 20 years. Since ... were authorized to administer naloxone to overdose victims, 244 lives ...
Breaking Medicine Technology:
(Date:5/4/2016)... ... 04, 2016 , ... Momsense, Inc. has developed ... patented technology, The Smart Breastfeeding Meter, is designed to monitor and measure a ... now available for purchase at Target.com . , Breastfeeding is a ...
(Date:5/4/2016)... ... 04, 2016 , ... Recognizing that lifestyle medicine is essential to health and ... tapped David Katz, MD, MPH, president of the American College of Lifestyle Medicine, as ... is especially gratifying,” said Katz. “There is so much opportunity to add years to ...
(Date:5/4/2016)... ... 2016 , ... Natalie Jill is a well respected lifestyle mentor ... the launch of her new book: Natalie Jill’s 7 Day Jump Start: Unprocess Your ... jump start a new healthy lifestyle featuring simple recipes using MitoXcell’s raw cacao formula. ...
(Date:5/4/2016)... , ... May 04, 2016 , ... The preeminent surgical ... Janice Dickinson needed following breast cancer surgery. In March 2016, the 61-year-old model and ... of breast cancer that occurs in the milk ducts, according to an interview ...
(Date:5/4/2016)... ... ... Advanced Spine & Sport Medical Rehabilitation Center, which is renowned for its use ... on stem cell injections. The seminar is scheduled for Wednesday, May 18, from 6-8 ... 110, Ventura, CA. There are only 10 seats available. , “The purpose of ...
Breaking Medicine News(10 mins):