Crucell, AERAS and SATVI Announce Start of Tuberculosis Vaccine Clinical Trial in South Africa six months after launching initial trial in the United States
2007 MAY 28 -- Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX), the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town today announced the launch of a new Phase I clinical trial of the unique AdVac(R)-based tuberculosis vaccine, six months after launching a similar study in the US. The trial will be conducted in the Boland-Overberg region of Western Cape Province in South Africa, which has one of the world's highest TB burdens. "We are very proud that Crucell's technologies are playing a key role in the search and development of a much-needed TB vaccine," said Dr. Jaap Goudsmit, Chief Scientific Officer at Crucell. "We also feel honored to collaborate with Aeras and SATVI on this important mission." Aeras and Crucell began jointly developing this vaccine candidate, called AERAS-402, in 2004 using Crucell's AdVac(R) vaccine technology and PER.C6(R) manufacturing technology. A Phase I clinical trial launched in October 2006 in the United States indicates that the vaccine candidate is safe in healthy adults in the US. The main parameters under examination in the current study will be safety, tolerability and immunogenicity of AERAS-402 in healthy adults in South Africa. "The world desperately needs a new TB vaccine, and this clinical trial, in a region severely impacted by TB, is an important step in Aeras' mission to develop these crucial vaccines," said Dr. Jerald C. Sadoff, President and CEO of Aeras. "Aeras is delighted to be working with the excellent researchers at Crucell and SATVI. We are grateful to the Bill and Melinda Gates Foundation and the Dutch Ministry of Foreign Affairs for their financial support of this trial and our vaccine development efforts." The trial will be conducted as a double-blind, randomized, placebo-controlled dose escalation study in three groups of healthy adults previously vaccinated with Bacille Calmette-Gu?rin (BCG). A total of 30 healthy adult volunteers will be enrolled. "We are pleased to be playing such an important role in the global effort to develop new vaccines against TB," said Dr. Gregory Hussey, Principal Investigator for the trial. "In the process of conducting this trial, we are advancing the development of a new TB vaccine, expanding scientific capacity, and building awareness of the need for new TB vaccines." Keywords: Biotechnology, Biotechnology Business, Biotechnology Company, Clinical Trial Research, Crucell Holland BV, Drug Development, Immunization, Infectious Disease, Mycobacteria, Mycobacterium Tuberculosis, Therapy, Treatment, Tuberculosis Vaccines, Vaccination, Vaccine Development, Tuberculosis Vaccine. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.
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