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:6/23/2016)... -- The vast majority of dialysis patients currently receive ... usually 3 times a week, with treatment times averaging ... equipment preparation and wait time.  This regimen can be ... who are elderly and frail.  Many elderly dialysis patients ... for some duration of time. Residents in ...
(Date:6/23/2016)... 23, 2016  Experian Health, the healthcare ... the patient payment and care experience, today ... products and services that will enhance the ... offerings. These award-winning solutions will enable healthcare ... compliant in an ever-changing environment and redefine ...
(Date:6/23/2016)... -- The National Pharmaceutical Council (NPC) today announced that ... organization as its newest member.  ... and chief scientific officer, Mallinckrodt Pharmaceuticals, will serve ... of Directors. ... in support of our efforts to conduct research ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of indulgence ... high can result in disappointment, perhaps even self-loathing. However, those who set the bar ... from PsychTests.com reveals that behind the tendency to set low expectations is ...
(Date:6/24/2016)... ... , ... June 19, 2016 is World Sickle Cell Observance Day. In an ... of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a ... Cell Disease (SCD) is a disorder of the red blood cells, which can cause ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
(Date:6/24/2016)... ... ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for ... $12 an hour by 2020 and then adjusting it yearly to increase at the same ... wage, assure the wage floor does not erode again, and make future increases more predictable. ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty ... Barry M. Weintraub as a prominent plastic surgeon and the network’s newest partner. ... and the most handsome men, look naturally attractive. Plastic surgery should be invisible.” ...
Breaking Medicine News(10 mins):