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:3/23/2017)... 23, 2017  Northwest Biotherapeutics (OTCQB: NWBO) (NW ... therapies for solid tumor cancers, today announced that ... it announced last Friday, March 17, 2017. ... investors securities totaling 28,843,692 shares, comprised of 18,843,692 ... shares of Class C Warrants pre-funded at the ...
(Date:3/23/2017)... PARK, Calif., March 23, 2017  BioPharmX Corporation ... products for the dermatology market, today reported financial ... 31, 2017, and will provide an update on ... the year. "We are pleased to ... year for BioPharmX," said President Anja Krammer. "We ...
(Date:3/23/2017)... 2017 NetworkNewsWire Editorial Coverage  ... Cancer remains one ... on health care systems, in terms of costs and resources. ... does the development of innovative and efficient therapies that demonstrate ... many types of cancer treatments, a growing number of patients ...
(Date:3/23/2017)... In today,s pre-market research, Stock-Callers.com ... Biotech industry: Sangamo Therapeutics Inc. (NASDAQ: SGMO), Eyegate Pharmaceuticals ... and Regulus Therapeutics Inc. (NASDAQ: RGLS ). ... its rating on Pharmaceuticals/Biotechnology to "Overweight" from "Market Weight." Learn more ... ...
Breaking Biology Technology:
(Date:2/13/2017)... FRANCISCO , Feb. 13, 2017  RSA ... centralized platform that is designed to enhance fraud ... latest release in the RSA Fraud & Risk ... enable organizations to leverage additional insights from internal ... tools to better protect their customers from targeted ...
(Date:2/9/2017)... Feb. 9, 2017 The biomass boiler market ... the biomass boiler market globally in terms of revenue ... boilers. The market for biomass boilers has been segmented ... application, and country/region. The market based on feedstock type, ... residues, biogas & energy crops, urban residues, and others. ...
(Date:2/8/2017)... YORK , Feb. 7, 2017 Report Highlights ... The ... should reach $11.4 billion by 2021, growing at a compound ... Includes - An overview of the global markets for synthetic ... 2015, estimates for 2016, and projections of compound annual growth ...
Breaking Biology News(10 mins):