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

Novagali Pharma is an ophthalmic pharmaceutical company based in the Genopole biocluster in Evry (France) that develops and commercializes innovative products. Thanks to its proprietary technology platforms Novasorb(R) and Eyeject(R), the company has developed a broad pipeline of 7 innovative products addressing main ocular conditions as well as orphan diseases. Most advanced products include Vekacia(R), an orphan product for treatment of vernal keratoconjunctivitis, Cyclokat(R), a product for the treatment of moderate-to-severe dry eye syndrome and Cortiject(R) for the treatment of diabetic retinopathies. Cationorm(R), indicated for dry eye symptoms is commercialized in France since April 2008. Founded in 2000, Novagali Pharma has 50 employees.


'/>"/>
SOURCE Novagali Pharma
Copyright©2008 PR Newswire.
All rights reserved

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:1/17/2017)... 2017  Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) ... in a Phase 3 clinical trial comparing the efficacy ... in the prevention of hepatic veno-occlusive disease (VOD) in ... (HSCT) who are at high risk or at very ... will be conducted across approximately 100 medical centers in ...
(Date:1/17/2017)... According to a new market research report "Neural Network Software Market by Type (Data ... - Global Forecast to 2021" published by MarketsandMarkets, the market to expand from ... Compound Annual Growth Rate (CAGR) of 33.2%. Continue ... ... ...
(Date:1/17/2017)...  OrthoAccel ® Technologies, Inc. announces that the ... "The Effect of Vibration on Molar Distalization," a study ... S. Jay Bowman , this prospective, peer-reviewed clinical study ... Technology ® speeds up molar distalization rates in ... of days to move the upper molars into a ...
Breaking Medicine Technology:
(Date:1/17/2017)... (PRWEB) , ... January 17, 2017 , ... SC&H Group, ... firm as a Principal in its IT Advisory Services practice . Rossi is ... months as market demand for strategic IT guidance grows, and the practice continues to ...
(Date:1/17/2017)... ... January 17, 2017 , ... Physicians Education ... Lee as keynote speaker for the 34th Annual Miami Breast Cancer Conference®, on ... announcement, PER® president, Phil Talamo, said, “We are delighted to have Sandra Lee ...
(Date:1/17/2017)... ... January 17, 2017 , ... Many people make New Year’s resolutions or renew their commitment to ... making it easier for people who want to kick off 2017 with better smiles. Dr. ... , These special offers include: , , A new patient ...
(Date:1/16/2017)... ... January 17, 2017 , ... ... an internationally recognized leader in the fast-casual category, announces a hearty and wholesome ... Good Egg Breakfast Sandwich, Turkey Mash-Up Sandwich, Cranberry Crunch & Honey Parfait, Slow ...
(Date:1/16/2017)... ... 16, 2017 , ... Gym Source, America’s leading retailer of premium residential and ... New Jersey. , “We are elated to be opening this new showroom,” explains Tom ... to give clients a seamless and motivating shopping experience.” , Every fitness journey is ...
Breaking Medicine News(10 mins):