Navigation Links
Ceregene Completes Enrollment of Phase 2 Clinical Trial for Parkinson's Disease
Date:11/14/2007

SAN DIEGO, Nov. 14 /PRNewswire-FirstCall/ -- Ceregene, Inc. today announced that the company has completed enrollment of its randomized, controlled, double-blind, Phase 2 clinical trial evaluating CERE-120, a gene therapy product in development for the treatment of Parkinson's disease. The trial enrolled 58 patients with advanced Parkinson's disease across nine medical centers in the United States. The company expects to announce results from the trial in late 2008. CERE-120 is designed to deliver the neurturin gene, a nervous system growth factor with the ability to maintain the growth and normal function of dopamine-producing neurons which deteriorate in Parkinson's disease.

The Phase 2 trial, which was supported in part by The Michael J. Fox Foundation for Parkinson's Research, was prompted by positive results from a Phase 1 study of CERE-120 which demonstrated a 36 percent (p<0.001) reduction in Parkinson's symptoms at 12 months after administration, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) motor "off" score ("motor off" meaning patients were off Parkinson's medication at evaluation time). CERE-120 was also shown to be well tolerated in the Phase 1 study. The Phase 2 study was designed to confirm these findings in a controlled trial by randomly assigning patients to receive either CERE-120 or a control treatment at a 2 to 1 ratio and is powered at 90 percent to demonstrate clinical efficacy. The patients in this Phase 2 study will be followed for 12 months for safety and efficacy.

"Completing full enrollment of this multi-center controlled trial represents an important milestone in CERE-120's development as well as in the development of Ceregene as an emerging biotechnology company," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "We are encouraged by the positive results from our Phase 1 trial and carefully designed this Phase 2 study as a controlled trial to confirm those results. With positive results from the Phase 2 study, we would expect to initiate a Phase 3 trial for CERE-120 in 2009."

"CERE-120 represents a truly revolutionary future treatment option for Parkinson's disease patients, given that a single treatment is not only intended to improve the symptoms of the disease, but also slow disease progression. We appreciate the courage of the patients and the efforts of the physicians who have participated in our Phase 2 trial and hope that CERE-120 may someday provide a meaningful difference in the lives of Parkinson's disease patients. We thank all trial participants for enrolling this study safely and within the projected time frame," stated Raymond T. Bartus, Ph.D., Ceregene's senior vice president of clinical and preclinical R&D and chief operating officer.

About CERE-120

CERE-120 is composed of an adeno-associated virus (AAV) vector carrying the gene for neurturin (NTN), a naturally occurring protein known to repair damaged and dying dopamine-secreting neurons, keeping them alive and functioning normally. NTN is a member of the same protein family as glial cell-derived neurotrophic factor (GDNF). The two molecules have similar pharmacological properties, and both have been shown to benefit the midbrain dopamine neurons that degenerate in Parkinson's disease and are responsible for the major motor impairments. CERE-120 is delivered by stereotactic injection to the affected area of the brain, providing stable, long-lasting expression of NTN in a highly targeted fashion. Genzyme Corporation (Nasdaq: GENZ) has licensed the ex-North American rights for the development and commercialization of CERE-120 from Ceregene, a deal which was announced in June 2007.

About Parkinson's Disease

Parkinson's disease is a progressive movement disorder that affects at least one million people in the United States. It is caused by a reduction in dopamine containing nerve cells of the midbrain. Dopamine is a neurotransmitter involved in controlling movement and coordination, so Parkinson's patients experiencing a reduction of dopamine-producing nerve cells exhibit the progressive inability to initiate and control physical movements. There is currently no cure for Parkinson's disease.

About Ceregene

Ceregene, Inc. is a San Diego-based biotechnology company focused on the delivery of nervous system growth factors for the treatment of neurodegenerative disorders using gene delivery. Ceregene's clinical programs include CERE-110, an AAV2 based vector expressing nerve growth factor that is currently in Phase 1/2 studies for the treatment of Alzheimer's disease, and CERE-120 (AAV2-Neurturin) which recently completed enrollment of a controlled Phase 2 study for Parkinson's disease. CERE-130 and CERE-140 are in preclinical development for ALS (Lou Gehrig's disease) and ocular disorders, respectively. Ceregene was launched in January 2001 and is a former subsidiary of Cell Genesys, Inc. (Nasdaq: CEGE). The company's investors include Alta Partners, MPM Capital, Investor Growth Capital and Cell Genesys as well as Hamilton BioVentures and California Technology Partners.


'/>"/>
SOURCE Ceregene, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Eligard(R) six-month formulation successfully completes European approval procedure
2. The ScottCare Corporation Completes Acquisition of Rozinn Electronics, a Leading Manufacturer of Cardiac Diagnostic Products
3. EaglePicher Corporation Completes Transaction to Sell EaglePicher Boron, LLC to Ceradyne, Inc. for $69 Million
4. Symmetry Medical Completes Acquisition Of Specialty Surgical Instruments
5. GSI Securitization Completes Merger and Domicile Transfer
6. Medical Services International Inc. Completes Testing for European Union (EU) Application
7. Inverness Completes Acquisition of Cholestech
8. Billians HealthDATA Completes Comprehensive Long Term Care Database Update
9. Synova Completes Sale of $3.3 Million in Senior Convertible Notes and Warrants
10. Explorer completes the map ... for the bodys blueprint
11. Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/13/2016)... City, Utah (PRWEB) , ... February 13, 2016 , ... When an Au Pair ... Parents aren’t always sure what they are in for and they are often worried things ... more than they were hoping for. This year’s Au Pair of the Year winner’s all ...
(Date:2/12/2016)... San Antonio, TX (PRWEB) , ... February 12, 2016 , ... ... of love, as expressed in Blue SKies Buddha, the biography of Rama - Dr. ... in fact a love story, the love of a Buddhist teacher for teaching and ...
(Date:2/12/2016)... ... ... Trends: , Back to the Future , Feb. 25, 2016 — 11:00 a.m. – 12:30 ... don’t learn from history are doomed to repeat it.” , An analysis of CDRH’s enforcement ... that takes time. , Take a close look at the warning letters the agency ...
(Date:2/12/2016)... ... ... Coco Libre, the maker of coconut water beverages with a purpose, is ... Coco Libre will offer musicians and celebrities the company’s signature Organic Coconut Water, a ... suite, held this year at the W Hollywood Hotel, has become a pre-show “must” ...
(Date:2/12/2016)... ... , ... Every winter, someone is killed, injured or loses a home in ... part of the Allegheny Health Network, has partnered with Etna Volunteer Fire Department, ... Space” campaign. , “Space Heaters Need Space” aims to bring awareness to ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... Feb. 12, 2016 /PRNewswire/ - Demers Ambulances announces its first delivery ... Okaloosa County Emergency Medical Services (EMS) ... and one LT2 van. Quality Emergency Vehicles in ... for the sale.  This is the latest in Demers, ongoing ... Vice President at Demers. --> Benoit LaFortune , ...
(Date:2/12/2016)... ALISO VIEJO , Kalifornien, 12. Februar 2016 ... es mit der Aufnahme von Patienten für eine ... Embolisation von Aneurysmen („WEB") speziell für die Behandlung ... Laurent Spelle , MD, Leiter der Neuroradiologie an ... , Frankreich, und Hauptprüfarzt der CLARYS-Studie hat den ...
(Date:2/12/2016)... and SEOUL, South Korea , ... and Macrogen, Inc. today announced they will form ... procedures for precision medicine in cancer. The goal ... DEPArray™ digital-sorting technology with Macrogen,s high-throughput Next Generation ... under the Clinical Laboratory Improvement Amendments (CLIA) of ...
Breaking Medicine Technology: