Navigation Links
Innocoll Announces Successful End-of-Phase 2 Meeting with FDA for XaraColl® and Agreement of the Phase 3 Program
Date:2/17/2012

ASHBURN, Va., Feb. 17, 2012 /PRNewswire/ -- Innocoll, Inc. announced that it has held an End-of-Phase 2 meeting with the FDA to present the results of the Phase 2 clinical studies completed for XaraColl® and to discuss the proposed safety and efficacy studies to be conducted in Phase 3. XaraColl® is being developed for postoperative analgesia and Innocoll plans to undertake its Phase 3 program in patients undergoing hernia repair. FDA agreed to the Phase 3 clinical studies that Innocoll proposed and confirmed that, if successful, those studies should be sufficient to support a future NDA submission.   

Commenting on the announcement, Dr. Michael Myers, Innocoll's President and CEO said, "We are pleased to announce yet another significant milestone for Innocoll.  With the recent EU approval of  CollaGUARD® Adhesion Barrier and with Cogenzia®, for diabetic foot infections, also ready to start Phase 3, Innocoll's portfolio of late stage assets is stronger than ever."  

About XaraColl®

XaraColl® is a biodegradable and fully resorbable collagen/bupivacaine matrix formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx®. This technology achieves a high concentration of drug at the target tissue, while maintaining low systemic levels.  XaraColl® is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery.  The product is available in several different strengths, and is designed such that multiple units can be used per patient, for optimum dosing flexibility and efficacy.  XaraColl® is easy to use and can be cut or rolled depending on the surgical setting and can be used laparoscopically. 

About Innocoll, Inc.

Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm®, DermaSil™, CollaPress™ and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.

Other products in clinical and regulatory development include: CollaRx® Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections and Cogenzia® in phase 3 for the adjuvant treatment of infected diabetic foot ulcers.  For more information, please visit www.innocollinc.com.


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

Related biology technology :

1. Innocoll Announces Appointment of Anthony H. Wild Ph.D. to Chairman of the Board
2. Innocoll Announces Provisional Findings From Its Three Phase 2 Clinical Trials Investigating CollaRx(R) GENTAMICIN TOPICAL for the Treatment and Prevention of Diabetic Foot Infections
3. Innocoll, Inc. Files 510 (k) Application for CollaRx Lidocaine Sponge
4. Baxter Announces Licensing Agreement for Innocolls Gentamicin Surgical Implant in the United States
5. Neuralstem Announces Closing of $5.2-Million Registered Direct Offering
6. Regeneron Announces Presentation at the Leerink Swann 2012 Global Healthcare Conference
7. Silence Therapeutics Announces Board Changes and Appointment of New Chief Executive Officer
8. Genomic Health Announces Year-End 2011 Financial Results, Provides 2012 Financial Outlook
9. Auxilium Announces Appointments to Enhance Leadership Team
10. Spherix Announces Registered Direct Offering of $1.15 Million
11. Sangamo BioSciences Announces Fourth Quarter and Full Year 2011 Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... , ... February 23, 2017 , ... ... Discovery Services portfolio to include an array of biochemical analyses critical for ... data to drive their hit-to-lead and SAR programs, including inhibitor potency and selectivity, ...
(Date:2/23/2017)... ROCHESTER, Minn. , Feb. 23, 2017 /PRNewswire/ ... a new product line of oncolytic vaccinia viruses ... Genelux Corporation as part of Genelux,s proprietary, vaccinia ... "We are excited to enter into a partnership ... time, selected oncolytic vaccinia viruses for use in ...
(Date:2/23/2017)... ... February 23, 2017 , ... The Greater Gift Initiative, Inc , (GGI) ... Compass Research . GGI's mission is to advance global health and highlight the greater ... in honor of each clinical trial volunteer. The vision of GGI is to serve ...
(Date:2/22/2017)... Feb. 22, 2017  Aratana Therapeutics, Inc. (NASDAQ: PETX), a ... of innovative biopharmaceutical products for companion animals, will host a ... a.m. ET to discuss financial results from the fourth quarter ... Interested participants and investors may access the audio webcast ... ...
Breaking Biology Technology:
(Date:2/1/2017)... IDTechEx Research, a leading provider of independent market research, business ... new report, Sensors for Robotics: Technologies, Markets and Forecasts 2017-2027 ... ... Revenues of ... for Robotics: Technologies, Markets and Forecasts 2017-2027: Machine vision, force sensing ...
(Date:1/26/2017)...  Acuity Market Intelligence today released the 2017 ...  Acuity characterizes 2017 as a "breakout" year for ... a new understanding of the potential benefits these ... identity are often perceived as threats to privacy ... of Acuity Market intelligence. "However, taken together these ...
(Date:1/23/2017)... latest mobile market research from Acuity Market Intelligence reveals ... average price of a biometric smartphone decreased from $849 ... are now 120 sub-$150 models on the market at ... a year ago at an average price of $127. ... Acuity Market Intelligence Principal, "Biometric Smartphones are a global ...
Breaking Biology News(10 mins):