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Dalton Supports Client Milestone in Dengue Treatment Clinical Trial

Published: Tuesday, August 07, 2012
Last Updated: Tuesday, August 07, 2012
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Completes API development and manufacture for Phase I trial.

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.

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 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.

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