Navigation Links
Ceregene Announces Clinical Data From Phase 2 Clinical Trial of CERE-120 for Parkinson's Disease
Date:11/26/2008

SAN DIEGO, Nov. 26 /PRNewswire/ -- Ceregene, Inc., a biopharmaceutical company, today reported clinical data from a double-blind, controlled Phase 2 trial of CERE-120 in 58 patients with advanced Parkinson's disease. The trial did not demonstrate an appreciable difference between patients treated with CERE-120 versus those in the control group. Both groups showed an approximate 7 point improvement in the protocol-defined primary endpoint (Unified Parkinson's Disease Rating Scale- motor off score at 12 months), relative to a mean at baseline of approximately 39 points. Both groups had a substantial number of patients who demonstrated a meaningful clinical improvement from baseline. CERE-120 appeared to be safe and well tolerated.

"On behalf of everyone at Ceregene, I would like to personally express my gratitude to all the patients, physicians and staff who participated in this study. We share their disappointment. We also offer our heartfelt appreciation to the many talented and dedicated employees at Ceregene who continue to work extremely hard on this and Ceregene's other programs," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "We continue to believe in the multiple opportunities in our pipeline that target a range of serious neurodegenerative and ocular diseases."

"The medical research community has for several decades attempted to use the unique healing properties of neurotrophic factors to treat serious neurodegenerative diseases, and Ceregene's use of gene therapy as an essential enabling technology to translate this idea into an effective human therapeutic has consistently generated strong empirical support," stated Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer. "Thus, we are stunned by the results of this trial and will continue to analyze the data in order to gain greater insight into the factors that may have contributed to this negative outcome, not only to build upon this insight for our Parkinson's program, but also to help assure continued successful development of our product candidates for other diseases."

About Phase 2 Trial of CERE-120

Ceregene's Phase 2 trial was a double-blind, controlled clinical trial that completed enrollment of 58 patients with advanced Parkinson's disease in November 2007. This study was launched after successful execution of an extensive nonclinical program and preliminary evidence of safety and efficacy in advanced Parkinson's patients via an open-label Phase 1 trial in 12 patients. Patients in the Phase 2 trial were enrolled across nine leading academic medical centers in the United States, with two thirds of patients receiving CERE-120 and one third enrolled into a control group. Patients received a single administration of CERE-120 via stereotactic neurosurgery to deliver the drug into the putamen region of the brain and were followed for 12 months for safety and efficacy.

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 restoring normal function. 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 has licensed the ex-North American rights for the development and commercialization of CERE-120 from Ceregene, an agreement that was announced in June 2007. Ceregene gratefully acknowledges the financial support received from the Michael J. Fox Foundation for Parkinson's Research to help defray some of the costs of the CERE-120 Phase 1 and Phase 2 clinical trials.

About Parkinson's Disease

Parkinson's disease is a progressive movement disorder that affects a million people in the United States. Its main symptoms are 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 exhibit a 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 about to enter a Phase 2 study for the treatment of Alzheimer's disease, and CERE-120 (AAV2-Neurturin). CERE-135 and CERE-140 are in preclinical development for ALS (Lou Gehrig's disease) and ocular disorders, respectively. Ceregene was launched in January 2001. The company's investors include Alta Partners, MPM Capital, Investor Growth Capital and Cell Genesys, Inc. (Nasdaq: CEGE) as well as Hamilton BioVentures and California Technology Partners.


'/>"/>
SOURCE Ceregene, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Ceregene Appoints Joao Siffert, M.D. to the Position of Chief Medical Officer
2. Ceregene Announces Two Key Additions to Leadership Team
3. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
4. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
5. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
6. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
7. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
8. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
9. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
10. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
11. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... ... to bring innovative medical technologies, services and solutions to the healthcare market. The ... implementation of various distribution, manufacturing, sales and marketing strategies that are necessary to ...
(Date:6/27/2016)... -- Liquid Biotech USA , Inc. ... Research Agreement with The University of Pennsylvania ("PENN") ... patients.  The funding will be used to assess ... outcomes in cancer patients undergoing a variety of ... to support the design of a therapeutic, decision-making ...
(Date:6/24/2016)... 2016  Regular discussions on a range of subjects including ... two entities said Poloz. Speaking at a lecture ... , he pointed to the country,s inflation target, which is ... "In certain areas there ... common economic goals, why not sit down and address strategy ...
(Date:6/24/2016)... ... , ... While the majority of commercial spectrophotometers and fluorometers use the z-dimension ... are higher end machines that use the more unconventional z-dimension of 20mm. Z-dimension ... bottom of the cuvette holder. , FireflySci has developed several Agilent flow cell ...
Breaking Biology Technology:
(Date:4/13/2016)... 13, 2016  IMPOWER physicians supporting Medicaid patients in ... new clinical standard in telehealth thanks to a new ... higi platform, IMPOWER patients can routinely track key health ... mass index, and, when they opt in, share them ... to a local retail location at no cost. By ...
(Date:3/29/2016)... 29, 2016 LegacyXChange, Inc. (OTC: ... and SelectaDNA/CSI Protect are pleased to announce our successful ... a variety of writing instruments, ensuring athletes signatures against ... collectibles from athletes on LegacyXChange will be assured of ... DNA. Bill Bollander , CEO states, ...
(Date:3/22/2016)... and SANDY, Utah , ... which operates the highest sample volume laboratory in ... Genomics and UNIConnect, leaders in clinical sequencing informatics and ... launch of a project to establish the informatics infrastructure ... NSO has been contracted by the Ontario ...
Breaking Biology News(10 mins):