Cerulean Pharma Presents Final Data from Phase 1/2a Clinical Study of CRLX101 at AACR-NCI-EORTC
November 14, 2011 08:00 AM Eastern Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cerulean Pharma Inc., a leader in designing and developing tumor-targeted nanopharmaceuticals, today announced the presentation of clinical and non-clinical data on its lead product candidate, CRLX101, at the 2011 AACR-NCI-EORTC International Conference taking place from November 12-16 in San Francisco, California.
"We are very encouraged by these progression-free survival time results. Most impressive is that these patients had already seen their tumors progress through an average of greater than three prior regimens of chemotherapy."
On Sunday, Nov. 13, Edward Garmey, M.D., Cerulean's chief medical officer, presented a poster reporting key findings from the combined data of the Company's 62 patient Phase 1/2a study of CRLX101. The 38 patient Phase 2a study at the maximum tolerated dose (MTD) confirmed that the MTD was well-tolerated. In addition, encouraging progression-free survival times were observed among many of these heavily pretreated patients. Of particular focus were 21 of the 38 Phase 2a patients with non-small cell lung cancer (NSCLC). Among the 21 NSCLC patients receiving CRLX101, median progression-free survival time was 4.4 months for all patients and 4.8 months among patients with non-squamous histology.
"We are very encouraged by these progression-free survival time results. Most impressive is that these patients had already seen their tumors progress through an average of greater than three prior regimens of chemotherapy." said Dr. Garmey.
On Tuesday, Nov. 15, the Company will also be presenting non-clinical data highlighting the activity of CRLX101 in xenograft tumor models of highly treatment refractory sub-types of lung cancer. These include squamous cell histology NSCLC and lung cancers harboring KRAS or EGFR mutations. The presentation will further highlight immunohistologic data indicating that CRLX101 is achieving anti-tumor activity by localizing and penetrating deep into tumor tissue and releasing its cytotoxic payload inside the tumor cells. This presentation will take place from 12:30 to 2:30 p.m. in the West Hall of the Moscone Center West.
Based on these encouraging Phase 1/2a clinical data and non-clinical findings, the Company is presently enrolling patients in a randomized Phase 2 clinical trial in NSCLC patients who have progressed through one or two prior regimens of chemotherapy. The primary endpoint of this Phase 2 clinical trial is overall survival. Patient accrual is now well underway and the Company expects to enroll 150 patients from clinical trial sites in Russia and Ukraine. Further details on this study are available at http://www.clinicaltrials.gov.
"We are very pleased with the safety profile observed from the Phase 1/2a study of CRLX101 and the rapid progress being made toward developing CRLX101 as a novel therapy for advanced lung cancer patients who otherwise have limited therapeutic options," said Oliver Fetzer, Ph.D., chief executive officer of Cerulean. "Because these early findings have generated such intense interest among key opinion leaders across many different types of cancer, the Company plans to initiate investigator sponsored studies in several additional tumor types in 2012."
CRLX101 is a tumor-targeted nanopharmaceutical designed to inhibit topoisomerase 1 and hypoxia-inducible factor-1 alpha (HIF-1α). CRLX101 is also designed to concentrate drug in tumor tissue and tumor cells, prolonging drug exposure at the site of action. More information about clinical studies of CRLX101 can be found at http://www.clinicaltrials.gov.
About Cerulean Pharma Inc.
Cerulean Pharma Inc. is a clinical-stage company specializing in the design and development of tumor-targeted nanopharmaceuticals. Cerulean is applying its proprietary nanopharmaceutical platform technologies and specialized capabilities to advance a new class of therapeutic agents for diseases with unmet medical needs. With an initial focus in oncology, the Company's technology platform can be readily applied to a wide range of drug molecules, ranging from small molecules to peptides and RNAs. Cerulean is privately financed and funded by experienced healthcare investors, including Polaris Venture Partners, Venrock, Lilly Ventures, Lux Capital, and Bessemer Venture Partners. Cerulean is located in Cambridge, Massachusetts. For more information, please visit the Company's website at http://www.ceruleanrx.com.
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