Press Release

For Immediate Release
October 14, 2003

For more information, contact:
Laura Kalies at lkarec@isbtc.org

iSBTc to hold first Consensus Conference on
Patient Specific Biologic Therapy for Cancer

(Milwaukee)-The International Society for Biological Therapy of Cancer (iSBTc) will hold its first Consensus Conference on Patient Specific Therapy (PST), November 2, 2003 at the Hyatt Regency Hotel in Bethesda, Maryland.

PST such as cancer vaccines and T-cell therapy, stimulate cancer patients’ immune systems to recognize their cancer as an invader and attack it. These therapies are tailor-made from the patient’s own tumor tissue, proteins, or cells. PSTs have shown great promise as potential effective and nontoxic alternatives to more conventional systemic therapies such as chemotherapy. For example, monoclonal antibodies and cancer vaccines engineered by Dr. Ron Levy at Stanford in the 1980s put lymphoma patients into remission after chemotherapy had failed them. In some, those remissions have lasted many years and may represent a cure. Subsequent trials have yielded even more positive results, culminating in a dramatic 1999 trial by Drs. Maurizio Bendandi, Larry Kwak and their colleagues, which extended remissions of lymphoma patients far beyond what is normally delivered by chemotherapy. In a recent follow-up report, the median time to relapse of these patients had exceeded 7 years since the start of the trials. In addition, a team led by Dr. Steven A. Rosenberg of the National Cancer Institute reported positive results using PST. Rosenberg’s team used amplified T-cells (lymphocytes – the body’s white blood cells) to attack melanoma tumors in 13 patients. Ten of those patients are still alive, four are “virtually cancer free” and two others have experienced “substantial” shrinkage of their tumors.

The development of PSTs also poses many challenges, including several that go well beyond the scientific issues inherent in the development of any cancer drug.

Regulatory and development hurdles, in particular, have hindered their development. Many of the companies who have the capital to complete the required testing and bring a drug to market have no interest in treatments that must be tailor-made for each patient. Unfortunately, many smaller biotech companies that specialize in PST cannot afford the cost of development (up to $800 million per drug). Consequently, no PST has been approved for cancer treatment under current FDA rules. “The goal of this conference is to foster a better understanding of the problems and opportunities in developing PSTs in the context of current FDA regulations and drug development costs. This conference will present a forum for Government, Academic, Industry and Lay Organizations to discuss the current state of the art in PSTs and discuss positive ways to move the field forward.” said Robert Oldham, MD; Program Chair and Past President of the iSBTc.

Co-Chairs of the Consensus Conference include Dr. Larry Kwak of the National Cancer Institute; Kenneth Foon of the University of Pittsburgh Cancer Institute, and Dr. Robert Oldham of Cancer Therapeutics. Additional speakers and panelists include: Steven Rosenberg, MD, PhD (National Cancer Institute), Theresa Whiteside, PhD (University of Pittsburgh Cancer Center), Kristen Hege, MD (Cell Genesys), John Lewis, MD, PhD (Antigenics), Howard Streicher, MD (National Cancer Institute), Raj Puri, PhD (Food and Drug Administration), and Bob Bennett, a representative of the patient advocate community.

This half day conference will follow the 18th Annual Meeting of the iSBTc being held October 30-November 2, 2003 and will provide a forum for discussing issues related to PST and personalized medicines. PST includes forms of therapy developed from the patient’s own cells and tissues such as T-cell therapy, whole cell and protein cancer vaccines as well as certain tissue transplants. This program will include presentations by the National Cancer Institute (NCI), Food & Drug Administration (FDA), industry leaders from pharmaceutical and biotech and will conclude with a panel discussion which will include these groups and lay organization representatives (patient advocates).

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The Society for Biological Therapy was founded in 1984 with 40 charter members. The Society currently has over 450 members consisting primarily of MDs, PhDs, RNs, and corporate representatives. The purpose and mission of the International Society for Biological Therapy of Cancer (iSBTc) is to bring together those individuals actively involved in the preclinical and clinical investigation of biological agents in the treatment of cancer. Scientific and business meetings have been held annually since the first Annual Meeting of SBT in 1986. At the 2002 business meeting held November 9, 2002, the SBT membership voted to officially change the name of the Society and it thus became the International Society for Biological Therapy of Cancer (iSBTc).