Navigation Links
Nobilon Advances First Vaccine Into Human Trials - Intranasal Influenza Vaccine Begins Phase I Clinical Development
Date:3/13/2009

BOXMEER, Netherlands, March 13 /PRNewswire-FirstCall/ -- Nobilon, the human vaccine business unit of Schering-Plough Corporation (NYSE: SGP), today announced that it has reached an important milestone with the initiation of its first-in-human clinical development program for SCH 900795, a new intranasal Live Attenuated Influenza Vaccine (LAIV) for annual seasonal use.

The candidate vaccine is composed of the three attenuated Influenza viruses recommended by the World Health Organization (WHO) for seasonal vaccine, in an intranasal device. The LAIV differs from most existing influenza vaccines, because it has been designed to offer (1) single-dose intranasal delivery, (2) advanced cell culture manufacturing technology and (3) potential earlier and broader protection against infection by influenza viruses.

The Phase I study consists of a randomized, double-blind, placebo-controlled, rising single-dose design and will include a total of 120 healthy volunteers. The primary objective of the Phase I program is to investigate the safety, tolerability and immunogenicity of escalating doses of SCH 900795 in adult men and women.

"I am pleased to announce the start of the first clinical development program of Nobilon," said Gelmer Leibbrandt, general manager of Nobilon. "This is an important milestone in the young history of our company." Han van den Bosch, Director R&D, stated: "We are encouraged by the positive results obtained in the pre-clinical development of our candidate vaccine so far and we believe that this vaccine has the potential to become an important tool in the prevention against seasonal Influenza illness."

The initiation of the clinical development program of SCH 900795 represents Nobilon's commitment to bringing innovative vaccines for human health to the market using state-of-the-art technologies.

About Influenza

Influenza (flu) is a contagious disease caused by the influenza virus. Influenza is a significant cause of morbidity and mortality and seasonal epidemics are responsible for approximately 40,000 deaths and over 100,000 hospitalizations annually in the US. Influenza infection in children causes a significant increase in both medically attended illness as well as hospitalizations. Mortality due to influenza generally affects aging adults. Inactivated, parenterally administered influenza vaccines have been available since the mid-1940s and effectively prevent influenza illness in healthy adults. Vaccination of elderly generally has a lower impact on prevalence, but is up to 80% effective in preventing death. Nevertheless, current inactivated influenza vaccines have limitations and are underutilized. Intramuscular vaccination with needles is an important barrier for the acceptance of annual influenza vaccination, which may be overcome by intranasal application. Moreover, Live Attenuated Influenza Vaccine (LAIV) is expected to be more effective in inducing local and cellular immunity and as such may be more efficacious in eliciting protection.

About SCH 900795

Nobilon acquired in 2004 the majority of rights to develop, commercialize and manufacture the LAIV technology from Australian company BioDiem, which had acquired these rights from the Institute of Experimental Medicine in St. Petersburg, Russian Federation. SCH 900795 could offer several improvements over most current vaccines such as single-dose intranasal spray delivery, improved convenience and earlier and broader protection. Moreover, SCH 900795 is manufactured using state-of-the-art cell culture technology. Cell-based vaccine production offers important advantages over egg-based production such as consistency and flexibility in production, reduced risk of microbial contamination, a more homogenous viral yield, and usability for subjects with egg allergies.

About Nobilon

Nobilon International BV, a part of Schering-Plough Corporation, was founded in 2003 and was acquired through the Organon BioSciences acquisition in 2007. It has production and R&D facilities in Boxmeer and Oss, the Netherlands. The biotechnology company is dedicated to develop, produce and market human vaccines, building on existing expertise within Schering-Plough. One of its core expertises is large-scale cell culture production of viruses, including influenza. For more information, go to the website www.nobilon.com.


'/>"/>
SOURCE Schering-Plough Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Mardil Inc. Advances Its Novel Cardiac Device to First-In-Human Trials for Mitral Valve Regurgitation
2. Advances in Science and Treatment of Pain Presented at 25th Annual American Academy of Pain Medicine Meeting January 28 - 31, 2009
3. Late-Breaking Data Highlighting Research Advances in Several Blood Disorders to Be Presented At the American Society of Hematology Annual Meeting
4. S*BIO Advances JAK2 Inhibitor SB1518 into Phase 1/2 Clinical Trial in Australia for the Treatment of Chronic Idiopathic Myelofibrosis
5. Bionovo Advances BZL101 to Phase 2 Clinical Trials After Positive Phase 1 Results for Metastatic Breast Cancer
6. MedImmune Advances Pediatric Disease Prevention Program With Start of Phase 1/2a Clinical Trial for Respiratory Syncytial Virus Vaccine
7. Anpath Group, Inc. Advances Relationship With the Washington Metropolitan Area Transit Authority (Metro)
8. Despite Advances in the Accuracy of CT Colonography in Detecting Polyps, Digestive Health Experts Urge Patients to Consider Risks and Realities
9. Anthera Pharmaceuticals Advances Global Development Strategy for Varespladib in Patients With Acute Coronary Syndrome With the Initiation of FRANCIS Trial
10. Ardea Biosciences Advances Lead Product Candidate for the Treatment of Gout, RDEA594, Into Phase 1 Clinical Trial
11. Idenix Pharmaceuticals Advances HCV Discovery Program to Clinic
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/12/2017)...  The China and Canada joint tech ... water, energy and detergent, and features a powerful disinfection process. ... washing machine that washes and sanitizes women,s panties or babies, cloth ... ... does not require an external water inlet. ...
(Date:5/10/2017)... Mass., May 10, 2017 Hologic, Inc. (Nasdaq: ... results for the fiscal second quarter ended April 1, ... of $1.84 increased 666.7% compared to the prior year ... resulted in a significant gain, while non-GAAP diluted EPS ... 3.2%, or 3.8% in constant currency terms.  Excluding the ...
(Date:5/10/2017)... , May 10, 2017  The Corporate ... or employees of sleep therapy clinics to call ... sleep therapy clinic is involved in a substantial ... interested in hearing from an employee of a ... in a kickback scheme to provide medical practice groups ...
Breaking Medicine Technology:
(Date:5/26/2017)... ... May 26, 2017 , ... Water damage to the flooring of several ... had left education officials with a number of critical issues to address before students ... to be accomplished with little or no disruption to class schedules. Second, the project ...
(Date:5/24/2017)... ... 24, 2017 , ... In modern research, success depends greatly ... for research and understanding the basic principles that were designed to drive that ... in stereo microscopy for brightfield and fluorescence typically used in laboratories working on ...
(Date:5/24/2017)... (PRWEB) , ... May 24, 2017 , ... Altec ... its participation in nVerge 2017 – a one-day technology conference in San Diego, CA. ... management solution, which allows users to fully utilize and enhance their Sage ERP solutions ...
(Date:5/24/2017)... ... May 24, 2017 , ... Drs. Nicholas Rallis and ... now spent 10 years as clinical instructors for the reputable Full Mouth Rehabilitation ... Through the program, private practitioners receive cutting-edge clinical training and learn how to ...
(Date:5/24/2017)... OH (PRWEB) , ... May 24, 2017 , ... Patients ... in Cortland, OH, can now meet with Dr. Joseph Bedich for a consultation, with ... while simultaneously improving their oral health and functionality. , Dr. Bedich offers ...
Breaking Medicine News(10 mins):