Northwest Biotherapeutics recently announced that the University of Texas MD Anderson Cancer Center in Houston, Texas will be conducting a Phase I/II clinical trial of DCVax-Direct on 60 patients with a history of inoperable solid tumors.
DCVax-Direct is a potential treatment option for inoperable solid tumors, as suggested by the results of pre-clinical animal studies. Tumors in the head and neck, lung, ovarian, melanoma, colon, pancreatic, liver, and other sarcomas generally have a poor prognosis due to site, area of involvement, distant metastasis or histological pattern of tumors.
Northwest Biotherapeutics is focused on developing innovative immuno-therapies that are safer and more effective when compared to traditional therapies. The company chose MD Anderson for phase I/II clinical trials of its product because of the institution’s vast research experience, as well as MD Anderson’s previous handling of a variety of cancer-related clinical trials.
Linda Powers, CEO of NW Bio commented:
“We are very pleased to be teaming up with an institution with the depth, caliber and reputation of MD Anderson to initiate our highly novel, first-in-man Phase I/II trial of DCVax-Direct for all inoperable solid tumor cancers. After years of painstaking development, we could not ask for a better clinical partner to explore the potential of DCVax-Direct to achieve some tumor regression in patients with inoperable tumors.”
Details of the human trial being conducted at University of Texas MD Anderson Cancer Center:
DCVax-Direct is a form of personalized immune therapy that targets solid inoperable tumors. As part of the clinical trial, patients with different types of cancers like pancreatic, colon, liver and melanoma, will be enrolled in the study. During phase I, researchers will evaluate the safe dose of administration in the study participants, and during phase II, researchers will ascertain the efficacy and potential benefits of the therapy. The efficacy of this combined phase I/Phase II clinical trial will be measured by the shrinkage or elimination of tumor. As per the standard protocols, the study will not be blinded and it is hoped that early results will be available in the later part of 2013.
Dr. Vivek Subbiah, the prime investigator and Assistant Professor in the Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, commented:
“Dendritic cell cancer vaccine therapy is a new and innovative therapeutic approach in our battle against cancer. Dendritic cell technologies have been advancing, and prior studies have shown encouraging results. Patients with inoperable tumors face very bleak prognoses, and have an urgent need for new treatment options. This innovative first-in-human study of NW Bio’s DCVax-Direct for inoperable tumors in multiple types of cancer is a crucial step forward for a new approach.”
Details of the pre-clinical animal studies:
The pre-clinical studies that were conducted in laboratory mice suggested that regression or elimination of tumor can be achieved by administration of partially mature dendritic cells in injectable form. In addition, when tumor cells were reintroduced after the elimination of primary tumor, the malignant cells failed to grow or produce any response suggesting immune memory.
The principle of DCVax-Direct is to utilize partially matured dendritic cells that are capable of picking up tumor antigens (or tumor biomarkers) after intra- tumor injection. In addition, the dentritic cells also invade immune tissues and glands to promote the immune mediated killing of tumor cells expressing the antigens. NW Bio currently holds strong patents for using and manufacturing the partially matured dendritic cells.