Navigation Links
Innocoll Announces Dosing of Last Patient in Second US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Colorectal Surgery Patients
Date:3/19/2009

ASHBURN, Va., March 19 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last patient has been dosed in the second of two ongoing U.S. phase 3 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the prevention of surgical site infections.

The trial is being conducted at approximately 45 hospital sites across the U.S. and has enrolled 600 patients undergoing open colorectal surgery, which is widely considered to be the most prone to surgical site infection (SSI). Patients in the treatment group have two Gentamicin Implants (260 mg total dose) implanted in the wound before abdominal closure and the primary endpoint is total incidence of SSI after 2 months post-surgery. The design of the trial is based upon an approved and well established use of GENTAMICIN SURGICAL IMPLANT for this indication in Europe. The results of several such studies have been published, including one prospective, randomized, controlled clinical trial in 221 patients which demonstrated a 70 percent decrease in surgical site infections from 18.4 percent in the control group to 5.6 percent in the patients treated with the implant.

Patient enrolment in the first phase 3 trial being conducted in diabetic and/or obese patients undergoing cardiac surgery closed earlier this month. Innocoll has appointed Duke University's Duke Clinical Research Institute (DCRI) as the Study Coordinating Center for both phase 3 trials.

Dr. Michael Myers, Innocoll's President and CEO commented, "Having recently completed patient enrollment in our first phase 3 trial in cardiac surgery, we are pleased to have now concluded enrollment in both trials, which FDA has confirmed are the only trials we need for NDA approval. As a well established product in Europe and other non-U.S. markets with proven safety, efficacy and pharmacoeconomics, we believe that a future launch of Gentamicin Implant in the U.S. market represents excellent commercial opportunity."

About Gentamicin Surgical Implant

GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold. The product was developed using Innocoll's proprietary collagen-based drug delivery technology, CollaRx, and (outside of the U.S.) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues. GENTAMICIN SURGICAL IMPLANT is already approved in 49 countries spanning Europe, Latin America, Middle East, Africa and Asia and there are more than 60 prospective clinical trials and published case reports totaling over 7,500 patients documenting its safety and efficacy over a broad range of orthopedic, colorectal, cardiothoracic, vascular, and neurosurgical procedures. The product is in phase 3 clinical trials in the U.S. for the prevention of surgical site infections and has received FDA fast-track designation for this indication.

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(R) and Liquicoll(R). Innocoll has licensed its US marketing rights to its lead product, CollaRx GENTAMICIN SURGICAL IMPLANT to a division of Baxter International Inc (NYSE: BAX). The product is currently in phase 3 development in the US for the prevention of surgical site infections. It is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia. Other late stage pharmaceutical products in Innocoll's development pipeline include CollaRx Gentamicin Topical for the treatment and prevention of infected diabetic foot ulcers and CollaRx Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit www.innocollinc.com.


'/>"/>
SOURCE Innocoll, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Innocoll Announces Dosing of Last Patient in US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Cardiac Surgery Patients
2. Innocoll Announces Dosing of Last Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-Operative Pain
3. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections
4. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Moderately Infected Diabetic Foot Ulcers
5. Innocoll Announces Dosing of First Patient in Second US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections
6. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain
7. Innocoll Announces Dosing of First Patient in US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections in Cardiac Surgery Patients
8. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Mildly Infected Diabetic Foot Ulcers
9. Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
10. XTL Biopharmaceuticals Announces the Acquisition of the Use Patent on Recombinant Erythropoietin (rHuEPO) for the Treatment of Multiple Myeloma
11. Alba Therapeutics Corporation Announces the Next Clinical Trial of Its Lead Compound, Larazotide Acetate and Promotions
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... 2, 2016 On Thursday, December ... excellence in research, development and innovation in the biopharmaceutical ... was held in the presence of Sergey Tsyb, Vice ... Russian Federation , Natalia Sanina, First Vice Chairman ... , Head of Roszdravnadzor, National Service of Control in ...
(Date:12/2/2016)... Dec. 2, 2016 CVS Health Corporation (NYSE: ... Day in New York City on Thursday, December 15, 2016, beginning at 8:00 ... team will provide an in-depth review of the company,s ... The company will also discuss 2017 earnings guidance during ... of the event will be broadcast simultaneously on the ...
(Date:12/2/2016)... YORK , December 2, 2016 ... the trading session in red, while the Dow Jones Industrial ... at the close of US markets, which prompted Stock-callers this ... stocks: NuVasive Inc. (NASDAQ: NUVA ), Smith & ... (NASDAQ: NXTM ), and Cesca Therapeutics Inc. (NASDAQ: ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... December 02, 2016 , ... Rijuven Corp launches rejiva ( http://www.rejiva.com ), a ... No other wearable health technology on the market can deliver all that rejiva can. ... meaningful insights about their health than the usual heart rate and steps taken”, adds ...
(Date:12/2/2016)... ... 02, 2016 , ... On November 24th, 2016, Thanksgiving morning, ... different sites throughout Miami-Dade and Broward counties. This is the largest meal delivery ... Thanksgiving morning by putting together individual meals via assembly lines and passing them ...
(Date:11/30/2016)... ... November 30, 2016 , ... ... that we have been designated as a Cigna Infertility Center of Excellence. The ... performance standards. , “It’s an honor to be designated a Cigna Infertility ...
(Date:11/30/2016)... Gardens, FL (PRWEB) , ... November 30, 2016 ... ... eating disorder and mental health treatment has announced the opening of a new ... specialized partial hospitalization and intensive outpatient treatment for adults and adolescents, both males ...
(Date:11/30/2016)... Austin, TX (PRWEB) , ... November 30, 2016 ... ... like to remind the clinical research community that the FDA Binding Guidance goes ... submit data in FDA-supported formats listed in the FDA Data Standards Catalog. The ...
Breaking Medicine News(10 mins):