Clinical Trials
HyperAcute Pancreas cancer immunotherapy
In May 2010, we initiated our Phase 3 clinical trial for our HyperAcute Pancreas cancer immunotherapy. This trial is an open label, randomized, controlled, multi-center, Phase 3 clinical trial evaluating approximately 700 Stage I and Stage II surgically-resected pancreatic cancer patients, according to the American Joint Committee on Cancer classification system, or AJCC system, who have no detectable disease by a CT scan. The primary endpoint of the clinical trial is overall survival, with secondary endpoints of disease-free survival, safety, toxicity and immunological responses.
For information on eligibility criteria, study specifics, and contact information, click here. (This link will take you out of NewLink's website to an independent website)
D-1MT
We currently have two Phase 1B/2 clinical trials enrolling patients to evaluate d-1-methyltryptophan, or D-1MT, in combination with other approved therapies. The clinical trials are being co-sponsored by the National Cancer Institute’s Division of Cancer Treatment and Diagnosis under a Cooperative Research and Development Agreement and letter of intent and are taking place at the Moffitt Cancer and Research Institute in Tampa, Florida.
The first clinical trial has primary endpoints that assess safety and efficacy of D-1MT in combination with an Ad-p53 autologous dendritic cell vaccine for solid malignancies with p53 mutations, such as lung, breast and colon cancers. The Phase 2 clinical trial portion of the D-1MT/Ad-p53 study will expand primarily to enroll patients with metastatic breast cancer.
The second clinical trial has primary endpoints that assess safety and efficacy of D-1MT in combination with Taxotere for patients with advanced stage solid tumors for which Taxotere is the standard-of-care, such as metastatic breast, prostate, ovarian and lung cancers. The Phase 2 clinical trial portion of the D-1MT/Taxotere study will expand primarily to enroll patients with metastatic breast cancer.
For information on eligibility criteria, study specifics, and contact information, click here. (This link will take you out of NewLink's website to an independent website)