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iSBTc ArchivesArchives | Presidential Award | Young Investigator Travel Award  Published Documents | Richard V. Smalley, MD Memorial Award News ReleaseFor Immediate Release For more information, contact: CVCTWG DESCRIBES NEW CLINICAL DEVELOPMENT Milwaukee---The International Society for Biological Therapy of Cancer’s (iSBTc) joint initiative with the Cancer Vaccine Consortium (CVC) of the Sabin Vaccine Institute, the Cancer Vaccine Clinical Trials Working Group (CVCTWG), defines the cornerstones of a new clinical development paradigm for cancer vaccines and related biologics, as published in the January issue of the Journal of Immunotherapy. In its report titled A Clinical Development Paradigm for Cancer Vaccines and Related Biologics, the CVCTWG theorizes that the current clinical development paradigm used for oncology drug development revolves around criteria used specifically for developing cytotoxic agents. As such, the current guidelines are not representative of the heterogeneous group of complex biologics that make up the majority of therapeutic cancer vaccines. In an effort to better understand these unique characteristics of therapeutic cancer vaccines, the CVCTWG proposes the institution of more flexible and focused developmental guidelines. “The hope is that by employing ‘proof of principle’ trials that evaluate biological activity as the basis to make ‘go’ / ‘no go’ decisions on efficacy trials will result in faster development of effective new treatments for cancer patients,” says iSBTc Vice President and CVCTWG Core Member, Bernard A. Fox, PhD. The CVCTWG is comprised of over 50 experts from academia and pharmaceutical and biotechnology industries. The CVCTWG also includes additional participation from the United States Food and Drug Administration (FDA). From November 2004 – November of 2005, this comprehensive group of specialists focused on four distinct research components: 1) end points for clinical trials, 2) trial designs, 3) technical and developmental challenges, and 4) combination therapy. The original results of the CVCTWG findings were presented to over 200 attendees of the Cancer Vaccine Clinical Trials Workshop held in conjunction with the iSBTc 20th Anniversary Annual Meeting on November 10, 2005 in Alexandria, VA. In subsequent collaborative efforts, members of the CVCTWG summarized the official recommendations of the group culminating with publication in the Journal of Immunotherapy. The CVCTWG report suggests that the new paradigm provides more functional guidelines, thus aiding in the process of furthering the intended results of vaccine based therapeutics. “The goal of the paper is to shift the focus of cancer vaccine development from the ‘classical’ approach used for cytotoxic agents to one that takes into account the mechanism of action of these biological agents,” says Dr. Fox. Founded in 1984, the International Society for Biological Therapy of Cancer (iSBTc) is an organization of clinicians, researchers, students, post-doctoral fellows, and allied health professionals dedicated to improving cancer patient outcomes by advancing the development and application of biological therapy through interaction, innovation and leadership. ### |
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