Navigation Links
Novagali Pharma Successfully Enrolls First Patient in U.S. Phase I Clinical Study with CORTIJECT(R) for Diabetic Macular Edema
Date:4/24/2008

EVRY, France, April 24 /PRNewswire/ -- Novagali Pharma, an emerging ophthalmic pharmaceutical company today announced that it has successfully injected the first patient in a Phase I clinical trial using CORTIJECT(R), an ophthalmic injectable emulsion based on EYEJECT(R) technology platform containing a corticosteroid prodrug for the treatment of Diabetic Macular Edema (DME). This trial, which will enrol a total of 15 patients, is designed to evaluate the safety and to observe the efficacy trend of CORTIJECT(R). The patients will be monitored for a period of twelve months following injection. Company's Investigational New Drug Application (IND) to conduct this Phase I clinical trial has been granted by the U.S. Food and Drug Administration (FDA) in January 2008 (cf. Novagali Pharma Press Release issued on January 18th, 2008).

"This first injection in patient is a crucial step toward the clinical development of our state-of-the-art technology for the posterior segment of the eye that can be used to develop new treatments for retinopathies" said Jerome Martinez, Pharm.D., Novagali Pharma Chief Executive Officer. "Thanks to EYEJECT(R) technology, CORTIJECT(R) is a major move with the optimized use of corticosteroids for the back of the eye expected to combine ease of use, sustained release and ocular safety. Administering this emulsion through a single injection can offer real medical value to both physicians and patients."

Investigators for this open-label, dose-escalation study will treat patients suffering from DME with a single intravitreal injection (inside the eye) of CORTIJECT(R) formulation. The trial will include 3 treatment arms with patients receiving one of three doses of Novagali Corticosteroid prodrug. Each administration of CORTIJECT(R) will provide the patient with exposure to the compound for approximately nine months.

About Novagali Pharma : http://www.novagali.com


'/>"/>

SOURCE Novagali Pharma
Copyright©2008 PR Newswire.
All rights reserved

1

GOOD

Page: 1 2

Related medicine technology :

1. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
2. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
3. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
4. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
5. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
6. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
7. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
8. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
9. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
10. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
11. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/20/2013)... , May 20, 2013  B. Braun ... clinician and environmental safety with products, services and ... will feature its innovative Outlook® 400ES and Space ... barcoding capabilities at the American Association of Critical-Care ... the Boston Convention Center. ...
(Date:5/20/2013)... Mass. , May 20, 2013 ... ("OSI")  whose subsidiary companies include OMNIlife science®, Inc., Enztec, ... directors to their Board.  Guy Mayer ... as the Chairman of the Board of Directors ... join as a director. Before joining ...
(Date:5/20/2013)... ALEXANDRIA, Va. , May 20, 2013   ... B. Douglas Hoey , RPh, MBA issued the ... Hart Research Associates regarding Medicare Part D "preferred ... pharmacies from offering patients the plan,s lowest advertised co-payments: ... "Officials with Medicare and MedPAC , ...
Breaking Medicine Technology:B. Braun Committed To Improving Patient Safety 2Orthopaedic Synergy, Inc. Announces Key Additions to the Board of Directors 2Orthopaedic Synergy, Inc. Announces Key Additions to the Board of Directors 3Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans 2Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans 3Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans 4
... Inc. (NYSE: HRC ) will release its fiscal ... company will host a webcast the following morning on Thursday, ... Earnings Release:   Hill-Rom,s Fiscal 2011 Third Quarter Earnings Release ... to the public after the close of the NYSE on ...
... N.J., June 29, 2011 Par Pharmaceutical Companies, Inc. ... of its branded division, Strativa Pharmaceuticals, as part of ... a workforce reduction of approximately 100.  The Company believes ... the near term. Patrick G. LePore, Chairman, ...
Cached Medicine Technology:Hill-Rom Holdings, Inc. Hosts Fiscal 2011 Third Quarter Earnings Webcast 2Par Pharmaceutical Companies Announces a Restructuring of Its Branded Division, Strativa Pharmaceuticals, to Maximize Profitability 2
(Date:5/21/2013)... Healthcare Solutions, the parent company of ... that it was honored to receive the Catamaran ... Conferred annually, the Innovation Award recognizes a client ... edge programs that improves cost and/or quality outcomes. ... its clinical and IT solutions that have helped ...
(Date:5/21/2013)... (PRWEB) May 21, 2013 The producers of ... May air dates for Peterborough, Ontario, Canada. The area is ... spot for Canadians and Americans. It is located an hour ... rivers. Peterborough is located in the Kawartha Hills, home to ... adds economic stability to the area. Residents and visitors to ...
(Date:5/21/2013)... 21, 2013 It’s nearly summer and millions ... or starting practice for summer or fall sports. In ... sporting activities can begin. , To help parents during ... youth sports or camp physicals at just $29. ... review a child’s medical history, perform a physical exam and ...
(Date:5/21/2013)... 21, 2013 Dallas-based TopMD™ Skin Care ... article testing the efficacy of their flagship product, ... clinical study results appear in the May/June 2013 issue ... “A Novel Sodium Hypochlorite Cleanser Shows Clinical Response and ... impressive findings seen after consistent use of the product ...
(Date:5/21/2013)... 2013 Dimensional Insight, a developer of ... Western Maryland Health System, a 275-bed hospital ... Solution™ (Diver) to help it analyze its data more ... to purchase Diver through Dimensional Insight’s recently announced ... hospitals, Western Maryland has massive amounts of data in ...
Breaking Medicine News(10 mins):Health News:Healthcare Solutions Receives Innovation Award From Catamaran 2Health News:Net Worth Business TV Announces May Air Dates for Peterborough, Ontario 2Health News:MedSpring Offers Camp and Sports Physicals For $29 2Health News:Peer-Reviewed Article Shows CLn® BodyWash an Effective Solution for Children with Eczema 2Health News:Peer-Reviewed Article Shows CLn® BodyWash an Effective Solution for Children with Eczema 3Health News:Dimensional Insight Announces Western Maryland Health System as First Customer Through Premier Healthcare Alliance 2Health News:Dimensional Insight Announces Western Maryland Health System as First Customer Through Premier Healthcare Alliance 3
... 3 Targeted Genetics Corporation,(Nasdaq: TGEN ) ... (NIH),Recombinant DNA Advisory Committee,s (RAC) assessment of the ... Phase I/II trial of,tgAAC94 for inflammatory arthritis., ... was a result of,complications from an opportunistic infection, ...
... ALBANY, N.Y., Dec. 3 AARP recently ... the state to,address three major issues that impact ... New Yorkers: prescription drug marketing reform and,affordability, housing ... are critical issues that help New Yorkers stay ...
... Dec. 3 Coherent, Inc.,(Nasdaq: COHR ) today ... of the Board of Directors of The Nasdaq Stock ... file its past due periodic reports,for the year ended ... 2007 with the Securities Exchange Commission ("SEC") in order ...
... ORLANDO, Fla., Dec. 3 A new study ... depressant effects in,patients (40 years and older) with ... measured by oxygenation or abnormal breathing,events relative to ... at the 53rd International,Respiratory Congress of the American ...
... that protect cells from the powerful, common chemotherapeutic agent ... how the drug also can destroy the heart., We ... for cell survival in the face of doxorubicin, says ... of Georgia Cancer Center. At the moment you start ...
... to lead can hinder the brains ability to recover ... The results have implications for the effects of environmental ... researchers at Jefferson Medical College, who led the work. ... increase the risk for cancer, renal disease, hypertension and ...
Cached Medicine News:Health News:Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Assessment of Its Phase I/II Trial of tgAAC94 for Inflammatory Arthritis 2Health News:Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Assessment of Its Phase I/II Trial of tgAAC94 for Inflammatory Arthritis 3Health News:Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Assessment of Its Phase I/II Trial of tgAAC94 for Inflammatory Arthritis 4Health News:AARP Urges Governor to Use Budget to Improve New Yorkers' Quality of Life 2Health News:Coherent, Inc. Reports Decision by the Nasdaq Stock Market 2Health News:Coherent, Inc. Reports Decision by the Nasdaq Stock Market 3Health News:New Study Demonstrates Ramelteon Does Not Exacerbate Respiratory Depressant Effects in Patients With Moderate-to-Severe COPD 2Health News:New Study Demonstrates Ramelteon Does Not Exacerbate Respiratory Depressant Effects in Patients With Moderate-to-Severe COPD 3Health News:New Study Demonstrates Ramelteon Does Not Exacerbate Respiratory Depressant Effects in Patients With Moderate-to-Severe COPD 4Health News:Genes identified that protect against heart damage from chemotherapy 2Health News:Jefferson neuroscientists find early lead exposure impedes recovery from brain injury 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: