DALLAS, June 4, 2014 (GLOBE NEWSWIRE) -- Gradalis Inc., a late stage clinical company, today announced that Scott Gottlieb, MD has joined its board of directors. Dr Gottlieb, MD is a practicing physician and Resident Fellow at the American Enterprise Institute. From 2005-2007, Dr. Gottlieb served as the Deputy Commissioner of the Food and Drug Administration and before that, from 2003-2004, as a senior medical technology advisor to the FDA Commissioner and as the FDA's Director of Medical Policy Development. He left FDA in the spring of 2004 to work on implementation of the new Medicare Drug Benefit as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services.
Dr. Gottlieb is regular contributor to leading medical journals as well as The Wall Street Journal, The York Times, and Forbes magazine. He has held editorial positions on the British Medical Journal and the Journal of the American Medical Association, and is currently an editorial board member of the journal Value Based Cancer Care, the Food and Drug Law Institute's Policy Forum, and is a member of the board of advisers of Cancer Commons. Dr. Gottlieb also serves as an advisor to the National Comprehensive Cancer Network, and the National Coalition for Cancer Survivorship. He is a member of the policy boards of the Leukemia and Lymphoma Society and the Society of Hospitalist Medicine. In 2013 Dr. Gottlieb was appointed by the Senate to serve on the Federal Health Information Technology Policy Committee.
"We are pleased that Dr Gottlieb has joined our board and we look forward to his advice and guidance as we initiate our Phase 3 program in ovarian cancer for our personalized cancer immunotherapy." said Joseph M. Limber, President and Chief Executive Officer of Gradalis. "I look forward to this exciting time in the advancement of novel immunotherapies for the treatment of patients with cancer. We are clearly on the leading edge of medicines to help even more patients with this deadly disease".
The Gradalis personalized immunotherapy Phase 3 program will focus on the adjuvant treatment of patients with stage III/IV ovarian cancer after surgical debulking and six weeks of chemotherapy. There are currently no therapies approved for this setting. The ovarian cancer program is the first of several development directions employing this personalized immunotherapy. The other planned programs will be in the treatment of hepatocellular carcinoma, colorectal cancer with liver metastases, and Ewing's sarcoma.
Gradalis is a fully integrated biotechnology company based in Dallas, Texas that focuses on the development, manufacturing, and commercialization of novel personalized immunotherapies to treat cancer. Gradalis has its own GMP manufacturing facility along with highly skilled technical leadership and staff and a strategic partnership with Mary Crowley Cancer Research Centers for clinical development of Gradalis products.
For more information about Gradalis, Inc. please visit www.gradalisinc.com .
Beth Kriegel Vice President, Finance (214) 442-8156