Navigation Links
Innocoll Submits SPA for Cogenzia(TM) Phase III Clinical Trials for the Adjuvant Treatment of Diabetic Foot Infections
Date:7/13/2010

ASHBURN, Va., July 13 /PRNewswire/ -- Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd., has submitted a Special Protocol Assessment (SPA) for a proposed phase 3 clinical trial to support the U.S. approval of Cogenzia™:  Innocoll's topical antibiotic therapy for the adjuvant treatment of infected diabetic foot ulcers.

The protocol was developed following an End of Phase 2 meeting with FDA where the results of Innocoll's phase 2 clinical studies were presented and discussed. In the planned phase 3 randomized, placebo-controlled, double-blind clinical trial, patients with a moderate or severe diabetic foot infection will be treated with Cogenzia on a daily basis as an adjunct to standard-of-care, which includes systemic antibiotic therapy administered by the oral or intravenous route. Patients will be treated for a maximum of 28 days and the primary endpoint will be the percentage of patients who are clinically cured of infection 10 days after discontinuation of all antibiotic therapy. The study design is based on a highly encouraging phase 2 trial where 100% of Cogenzia-treated patients who completed the study achieved clinical cure, which was statistically significantly superior to 70% of patients in the control group (P = 0.024). Patients in the Cogenzia group also had a significantly higher rate of baseline pathogen eradication and a reduced time to pathogen eradication (P < 0.001).

Dr. Michael Myers, Innocoll's President and CEO commented, "Building on the strength of the phase II data, we continue to make great strides in the development of our lead product, Cogenzia.   We are particularly encouraged by the fact that the product will be developed as adjuvant therapy for use in conjunction with systemic
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
11. Advanced Life Sciences Submits Updated Special Protocol Assessment to FDA for Restanza in Community Acquired Bacterial Pneumonia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2014)...   3D Systems   (NYSE: DDD ) ... , a new robotic surgery skills and procedural training simulator, ... ERUS exhibition in Amsterdam, The Netherlands ... minimally invasive surgery represents a growing portion of overall surgical ... for robotic surgery has increased, and it is expected that ...
(Date:9/18/2014)...  Neurotrope, Inc. (OTCQB: NTRP) today announced the appointment ... the Company,s Board of Directors, effective September 12, 2014. ... the Board of seven members. Dr. Altstiel will also ... and a member of the Audit and Compensation Committees ... Scientific Advisory Board, a position he has held since ...
(Date:9/18/2014)... , Sept. 18, 2014 Australian biomarker discovery ... US trial of its MiStat™ prostate cancer screening test, ... regulatory approval upon completion. Minomic,s proprietary MiStat™ ... presence of a proprietary biomarker known as the MIL-38 ... prostate cancer cells. Researchers at 11 ...
Breaking Medicine Technology:3D Systems Introduces New Simbionix Robotics Training Platform 23D Systems Introduces New Simbionix Robotics Training Platform 3Larry D. Altstiel, M.D., Ph.D. Joins Neurotrope Board of Directors 2Larry D. Altstiel, M.D., Ph.D. Joins Neurotrope Board of Directors 3Larry D. Altstiel, M.D., Ph.D. Joins Neurotrope Board of Directors 4Minomic Launches US Pilot Study of MiStat(TM) Novel Prostate Cancer Screening Technology 2
... EATONTOWN, N.J. , Jan. 14 Osteotech, Inc. (Nasdaq: ... products for regenerative healing, today reported preliminary unaudited revenue for the ... $24.6 million for the same period in 2008.  During ... revenue from sales of its new innovative products all currently in ...
... and NORTH BRUNSWICK, N.J. , Jan. 14 ... that they have achieved the initial milestone of a research ... vitro test for potential allergic reactions to substances that could ... "Allergy Test on a Chip™," is intended to comprise a ...
Cached Medicine Technology:Osteotech Announces Preliminary Fourth Quarter 2009 Revenue 2Osteotech Announces Preliminary Fourth Quarter 2009 Revenue 3Osteotech Announces Preliminary Fourth Quarter 2009 Revenue 4L'OREAL and Hurel Corporation Announce R&D Collaboration to Develop a Non-Animal Alternative, Microfluidic Biochip 2L'OREAL and Hurel Corporation Announce R&D Collaboration to Develop a Non-Animal Alternative, Microfluidic Biochip 3
(Date:9/18/2014)... September 18, 2014 Companies in the ... carbon dioxide, selling it to downstream industries in either ... carbon dioxide are food and beverage manufacturers. Food producers ... fruits, vegetables or pizzas. The gas is also used ... the compound to carbonate soft drinks, beer and other ...
(Date:9/18/2014)... supplements of selenium or vitamin E don,t seem ... men, a new study indicates. Previous animal research ... cataracts. To investigate this further, William Christen, from Brigham ... and his colleagues examined data from a randomized, placebo-controlled ... initially designed to study prevention of prostate cancer. ...
(Date:9/18/2014)... TayganPoint Consulting Group, a leading ... and co-founder John Cassimatis was named as one ... 2014, recognizing the region’s top healthcare and life ... of the year. , The Innovation Awards celebrate ... continue to shape the medical industry in Greater ...
(Date:9/18/2014)... (PRWEB) September 18, 2014 Stealth ... and wellness advocate, and Frank Davis, founder of ... Whole-food Nutrition, are pleased to announce the new ... to make delicious, nutrition-packed meals using Activz whole-food ... the next step in the Stealth Health ...
(Date:9/18/2014)... expect to pay higher employee contributions for their health ... officers about the impact of the Patient Protection and ... conducted by the Darla Moore School of Business at ... Patrick Wright, a professor in strategic human resource management, ... Officers. The survey is distributed to more than 560 ...
Breaking Medicine News(10 mins):Health News:Carbon Dioxide Production in the US Industry Market Research Report Now Available from IBISWorld 2Health News:Carbon Dioxide Production in the US Industry Market Research Report Now Available from IBISWorld 3Health News:Vitamin E, Selenium Supplements Don't Seem to Prevent Cataracts 2Health News:TayganPoint Executive Receives Prestigious Award from Philadelphia Business Journal 2Health News:Montel Williams and Frank Davis Announce New Whole-Food Nutrition Recipe Book, The Simple Scoop, at Natural Products Expo East In Baltimore 2Health News:Montel Williams and Frank Davis Announce New Whole-Food Nutrition Recipe Book, The Simple Scoop, at Natural Products Expo East In Baltimore 3Health News:Survey: Fortune 500 employees can expect to pay more for health insurance 2Health News:Survey: Fortune 500 employees can expect to pay more for health insurance 3
... director of chemical and food safety programs with Pew Health ... response to the introduction of the Food Safety Modernization Act ... , "In the midst of an ongoing peanut product recall, ... not be more timely. The FSMA contains key improvements that ...
... The Greater Baltimore Committee is seeking nominations for ... Thursday, March 12, 2009. Those interested in nominating a ... . The four award categories are: Entrepreneurial, Best New ... Nominators will be asked to submit documentation and narratives ...
... Feb. 4 Speaker Nancy Pelosi and parents and children ... a photo opportunity this morning before the final House vote ... this afternoon. Below are the Speaker,s remarks and answer to ... in the House of Representatives and in the Congress of ...
... architect of BurrellesLuce 2.0, will be the featured speaker at the ... of America. , ... Livingston, NJ (PRWEB) February 4, 2009 -- Jeffrey ... , will be the featured speaker at the Feb. 11th luncheon ...
... Compuware Corporation (Nasdaq:, CPWR ) today announced ... Health,Initiative with a collaborative network for the secure ... The VIP Health,Initiative was formed by Scripps Mercy ... to enhance the quality of care,delivered while also ...
... Saturday, February 7 -- 8 a.m. - 3 p.m.DETROIT, Feb. ... more to smile about.With the help of dentists, dental hygienists, ... School of Dentistry will provide free oral health care ... Saturday, Feb. 7 from 8 a.m. to 3 p.m. on ...
Cached Medicine News:Health News:Statement From Pew Health & Human Services Policy Program on the Introduction of the Delauro Food Safety Modernization Act 2Health News:GBC Seeks Nominations for Fourth Annual Bioscience Awards 2Health News:Pelosi: 'Today is a Very Special Day for Us in the House; We Are Going to Help 11 Million Children' 2Health News:BurrellesLuce IT Expert to Explore Web 3.0's Potential PR Impact At February Luncheon Meeting of Westchester/Fairfield PRSA 2Health News:BurrellesLuce IT Expert to Explore Web 3.0's Potential PR Impact At February Luncheon Meeting of Westchester/Fairfield PRSA 3Health News:Compuware Covisint to Network VIP Health Initiative and Its Physicians, Enabling Improved Collaboration, Better Care 2Health News:Compuware Covisint to Network VIP Health Initiative and Its Physicians, Enabling Improved Collaboration, Better Care 3Health News:UDM School of Dentistry 'Gives Kids A Smile' 2
Used to negotiate tortuous vessels....
BiodivYsio stent with biocompatible coating (phosphorylcholine)...
... The CYPHER Sirolimus-eluting Coronary Stent ... drug, called "sirolimus", a controlled-release ... delivery platform. Upon placement, sirolimus ... and impedes the process of ...
PT wires combine the enhanced durability of a linear elastic nitinol distal core and a highly resilient polymer tip. This provides excellent access in difficult cases involving severe tortuosity, tig...
Medicine Products: