Cerulean Pharma Inc., a leader in dynamically tumor-targeted nanopharmaceuticals, today announced that researchers will present both pre-clinical and clinical data on Cerulean's Phase 2 candidate, CRLX101, in sessions at the American Association for Cancer Research (AACR) Annual Meeting.
Among the findings, Cerulean will share clinical data from a study evaluating synergy between CRLX101 and Avastin® (bevacizumab).
In multiple animal models, CRLX101 inhibits hypoxia-inducible factor 1a (HIF-1a), which is involved in cancer survival mechanisms, and which is up-regulated in the hypoxic conditions created by anti-angiogenic drugs. Animal models suggest that CRLX101 is synergistic with multiple anti-angiogenic drugs, and this hypothesis is being tested in a clinical trial combining CRLX101 with Avastin, the leading anti-angiogenic medicine.
Dr. Stephen M. Keefe , the Ann B. Young Assistant Professor in Cancer Research at the Perelman School of Medicine at the University of Pennsylvania, will present a poster entitled A Phase Ib-2a Study Evaluating the Nanopharmaceutical CRLX101 in Combination with Bevacizumab (April 9, 8:00 am – 12:00 pm) on a clinical trial studying synergy between CRLX101 and Avastin when combined to treat patients with advanced renal cell carcinoma. Dr. Keefe, who practices at the Abramson Cancer Center of the University of Pennsylvania, will present data showing that the CRLX101-Avastin combination has been well tolerated in six patients treated to date with no dose limiting toxicities observed. Additional patients are being enrolled in the study to confirm combinability and to assess efficacy.
"The pre-clinical data for CRLX101 in combination with anti-angiogenic agents are very impressive. I am excited that we can bring this combination hypothesis into the clinic, and I am encouraged by the results of this trial to date," said Dr. Keefe. "CRLX101's favorable safety profile is encouraging, and its ability to provide durable inhibition of HIF-1a could increase the benefit that anti-angiogenic agents provide to patients."
In addition, Cerulean scientists will participate in the following sessions at AACR:
- CRLX101, a nanopharmaceutical in phase 2 clinical trials, is synergistic with antiangiogenic treatment through HIF-1a inhibition in an ovarian cancer xenograft model (April 7, 1:00 – 5:00 pm): Douglas Lazarus , director of biology at Cerulean, will present a poster on the improved efficacy of antiangiogenic drugs when combined with CRLX101.
- Nanotechnology Approaches to the Treatment of Cancer (April 7, 1:00 – 3:00 pm): Dr. Scott D. Eliasof , vice president of research at Cerulean, will participate in a panel discussion led by Mark Davis of the California Institute of Technology on the advantages of using nanoparticles such as CRLX101 for the treatment of cancer, including how nanotechnology enabled the creation of the first clinically relevant HIF-1a inhibitor.
CRLX101 is an investigational anti-cancer agent that is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1α. CRLX101 is a dynamically tumor-targeted nanopharmaceutical designed to concentrate in tumors and release its payload, camptothecin, over an extended period of time, prolonging drug exposure at the site of action. Anti-tumor activity has been observed across a wide range of cancers in animal models and in seven clinical trials. CRLX101 is currently in Phase 2 clinical development. More information on CRLX101 clinical studies can be found at www.clinicaltrials.gov.