Cordex Receives Special Protocol Assessment Approval from FDA for ... ( LA JOLLA Calif. June 2 /- Cordex Phar...)

Cordex Receives Special Protocol Assessment Approval from FDA for ATPace(TM)

Date:6/2/2009

LA JOLLA, Calif., June 2 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that the U.S. Food and Drug Administration (FDA) has approved the design of pivotal, Phase 2b/3 clinical trials evaluating its lead product ATPace(TM) as an antiarrhytmic drug for the acute treatment of patients with paroxysmal supraventricular tachycardia (PSVT) under the Special Protocol Assessment (SPA) process.

ATPace(TM) is a novel stable liquid formulation of adenosine 5'-triphosphate (ATP). It is being developed as a therapeutic and diagnostic drug for the management of patients with cardiac arrhythmias. ATP has been used in Europe for more than five decades as the drug of choice for the acute termination of PSVT. During this extended period of time, formulations of ATP have manifested an excellent safety and efficacy profile.

Cordex intends to initiate prospective, double-blind, placebo-controlled and randomized clinical trials with its lead product ATPace(TM) in approximately 200 patients aimed at demonstrating clinical safety and efficacy sufficient to support a New Drug Application filing of ATPace(TM) for the treatment of PSVT in emergency room patients.

"We are very pleased with the FDA's decision; we believe that data to be obtained in the proposed trials would constitute sufficient evidence to support the marketing approval of ATPace(TM) for the proposed indication," commented Amir Pelleg, Ph.D., Cordex's President and CSO. "Due to its unique mechanism of action in the heart, which involves a central vagal reflex and adenosine, the product of its rapid degradation, ATPace(TM) has the potential to be an important advance in the treatment of patients with PSVT," he added.

About PSVT

PSVT is an episodic, rapid, regular heart rate originating in the atria. The heart rate in PSVT can range from 150 to 250 beats per minute. There are approximately 57
'/>"/>

0

GOOD

Page: 1 2 3 4
Related medicine news :

1. Cordex Pharma to Collaborate with BG Medicine in a Clinical Study of Heart Failure Biomarkers
2. Cordex Pharma Files ATPace Formulation Patent
3. Cordex Pharma Submits to the FDA an Amended Special Protocol Assessment for ATPace
4. Cordex Pharma Sets Fourth Quarter 2008 Program Update Call
5. Respected Surgeon Receives Emmy Nomination
6. Edward Diehl Receives Outstanding Achievement Award From the American College of Addiction Treatment Administrators (ACATA)
7. LA BioMed researcher receives clinical teaching award
8. SAFC Pharmas St. Louis HPAPI Conjugates Facility Receives SafeBridge Certification
9. ALIMTA(R) (pemetrexed for injection) Receives Positive Opinion From CHMP as Maintenance Therapy for Nonsquamous Non-Small Cell Lung Cancer
10. Bausch & Lomb Receives FDA Approval of Besivance(TM), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis (Pink Eye)
11. Family Health International Receives $100,000 Grand Challenges Explorations Grant for Innovative Global Health Research Project Led by David Sokal, M.D.

Post Your Comments:

Cordex Receives Special Protocol Assessment Approval from FDA for ...( LA JOLLA Calif. June 2 /- Cordex Phar...),Health