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:9/7/2017)... 7, 2017 Caris Life Sciences, a ... the promise of precision medicine, today announced results ... of its molecular profiling approach in guiding therapeutic ... profiling plus (CGP+) with Caris Molecular Intelligence ® ... a molecular level, leading to more therapeutic options ...
(Date:9/6/2017)... TORONTO , Sept. 6, 2017 /PRNewswire/ ... new knowledge and skills while treating their ... for hands-on experience without involving patients. Simulation ... skills. Clinicians can carry out procedures, refine ... at risk. Integration of new technology, such ...
(Date:9/5/2017)... 5, 2017  Xyntek Inc. has announced another milestone in their continued growth ... to meet the growing demands of customer engagements regionally.  ... Xyntek's new Midwest office is located at 318 West Adams Street, Suite ... Xyntek's ... ...
Breaking Medicine Technology:
(Date:9/21/2017)... ... 21, 2017 , ... With ProSlideshow Portrait from Pixel Film Studios creating a ... select from up to two layers of subject matter along with fully customizable backdrop ... Final Cut Pro X. , With ProSlideshow Portrait each user are given ...
(Date:9/21/2017)... Falls Church, VA (PRWEB) , ... September 21, ... ... **An FDAnews Webinar**, Sept. 26, 2017 — 1:30 p.m. – 3:00 p.m. ET, ... exacting business. It’s easy to get things wrong, run afoul of The Quality ...
(Date:9/21/2017)... Angeles, CA (PRWEB) , ... September 21, 2017 ... ... a lunch and learn with Infinity Behavioral Health Services for professionals in the ... in a Commercial Payer Audit . , Insurance companies and state and ...
(Date:9/21/2017)... IL. (PRWEB) , ... September 21, 2017 , ... ... results released today of a new member survey conducted by the International ... restoration procedures performed from 2014 to 2016 rose 60 percent, with 635,189 procedures ...
(Date:9/21/2017)... ... September 21, 2017 , ... Bill Howe Plumbing’s mission is to create an ... to the community. For over 37 years, they have operated with their mission at ... in San Diego. They were chosen as the Best San Diego plumber in ...
Breaking Medicine News(10 mins):