Dalton Pharma Services Supports Client Milestone in Dengue Treatment Clinical Trial
A Phase 1b clinical trial to evaluate Celgosivir as a treatment against Dengue Fever has opened for enrolment at the Singapore General Hospital. Dalton Pharma Services has successfully completed a comprehensive drug development program for the CELADEN trial, which included Celgosivir process development, cGMP API and capsule manufacturing in support of Duke-NUS´s translational clinical research program.
Toronto, Ontario (PRWEB) July 24, 2012
A clinical trial to treat dengue fever with a new antiviral medicine, Celgosivir, has been initiated in Singapore. The trial follows successful mouse model studies by researchers at the Duke-National University of Singapore (NUS) Graduate Medical School, who established its efficacy (1). Celgosivir, also known as butyl-castanospermine, is derived from the seeds of the Moreton Bay Chestnut tree.
The Phase 1b clinical trial to evaluate Celgosivir as a treatment Against Dengue (CELADEN) has opened for enrolment at the Singapore General Hospital´s Investigational Medicine Unit. This follows the successful completion of development of the active pharmaceutical ingredient (API) and manufacturing of the final dosage form by Dalton Pharma Services and subsequent approval for the clinical trial by the Health Sciences Authority of Singapore and the hospital´s Institutional Review Board.
Associate Professor Subhash Vasudevan who directs the Emerging Infectious Diseases Therapeutics Laboratory at Duke-NUS, is investigating Celgosivir as a potential treatment for dengue fever and also for its ability to prevent severe symptoms that are known to lead to Dengue Hemorrhagic Fever (DHF) and Dengue Shock Syndrome (DSS). According to estimates by the World Health Organization (WHO), about 2.5 billion people, or 40% of the world’s population, live in areas at risk of dengue transmission. About 500,000 cases of severe dengue (DHF/DSS) occur annually, resulting in about 24,000 deaths, predominantly amongst the young. There are no approved medicines to treat dengue fever.
Dalton Pharma Services, a leading provider of development and manufacturing services to the pharmaceutical and biotechnology industries, successfully completed a comprehensive drug development program for the CELADEN trial, which included Celgosivir process development, cGMP API and capsule manufacturing, as well as validations, analytical, and stability studies, in support of Duke-NUS´s translational clinical research program.
“We are pleased to have reached this important milestone with the support of Dalton Pharma Services,” remarked Dr. Cynthia Sung, project manager for the CELADEN trial. “They were able to develop the active ingredient and produce GMP clinical materials, which helped us to get it into the clinic for this important trial. Their integrated approach and experience in moving early stage projects forward really streamlined the process for us.”
“We are very grateful for the opportunity to contribute to the progress of this key project with our customer Duke-NUS. Dalton hopes to continue to support Duke-NUS in their ongoing efforts to bring important new medicines to the world,” said Peter Pekos, CEO of Dalton Pharma Services.
CELADEN is funded by The STOP Dengue Translational Clinical Research program grant obtained from the Singapore Ministry of Health´s National Medical Research Council and the National Research Foundation. Dr. Jenny G. Low, an infectious disease physician at the Singapore General Hospital (SGH), is Principal Investigator for this trial. More information on the CELADEN trial may be found at http://www.celaden.sg.
About Celgosivir (1)
Experiments at Duke-NUS have shown that Celgosivir inhibits all four serotypes of dengue virus and it also protects mice in an experimental lethal infection model system of dengue infection even after delayed treatment. Celgosivir is an oral drug and would therefore be suitable for wide use even in developing countries where dengue fever has a higher incidence and oral dosage forms can be more easily distributed.
About Duke-National University of Singapore:
The Duke-NUS Graduate Medical School Singapore (Duke-NUS) was established in 2005 as a strategic collaboration between the Duke University School of Medicine, located in N. Carolina, USA and the National University of Singapore (NUS). As a player in Singapore´s biomedical community, Duke-NUS has identified five Signature Research Programs: Cancer & Stem Cell Biology, Neuroscience and Behavioral Disorders, Emerging Infectious Diseases, Cardiovascular & Metabolic Disorders, and Health Services and Systems Research. For more information, please visit http://www.duke-nus.edu.sg.
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services, based in Toronto, Canada, supplies chemistry, analytical and formulation development services to the biotechnology and pharmaceutical industries in the areas of chemistry, medicinal chemistry and fine chemical manufacture. It´s modern, Health Canada approved facilities offer cGMP manufacturing of sterile aseptic liquids and solid dosage forms to its customers at any stage of the regulatory process (Phase I, II, III or commercial). Dalton conducts sterile fills in vials or syringes, either aseptically or terminally sterilized. Dalton also produces cGMP active pharmaceutical ingredients at the gram or kilogram scale. In addition, Dalton´s analytical chemistry laboratory offers method development, validation and ICH stability programs to its clients. Dalton Pharma Services is a privately held company. Further information can be found at http://www.dalton.com.
For More Information
Peter Pekos — CEO, Dalton Pharma Services
Lai Ming Wee — Communications, Duke-NUS Graduate Medical School Singapore
Phone: (65) 6516 7258
For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/7/prweb9729808.htm