US-based Cerulean Pharma has dosed the first patient in a phase 2 clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab) for the treatment of relapsed ovarian cancer.

The open-label single-arm phase 2 combination therapy trial is being carried out at Massachusetts General Hospital (MGH) and the affiliated Harvard teaching hospitals under the direction of principal investigator Dr Carolyn Krasner.

The trial is designed to investigate the rate of progression-free survival at six months (PFS6) using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria in relapsed ovarian cancer patients treated with a combination of Avastin and CRLX101.

The company said that neither CRLX101 nor Avastin is approved for the treatment of ovarian cancer.

In a 29-patient single-arm phase 2 monotherapy trial at the same hospitals, CRLX101 showed single-agent activity in previously treated late-stage ovarian cancer patients with multiple RECIST partial responses and the satisfaction of the primary efficacy endpoint of at least four of 29 patients achieving PFS6.

The adverse events observed in the CRLX101 monotherapy trial were generally low grade and manageable.

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Krasner said: “When ovarian cancer recurs, it can be very difficult to treat because of increasing resistance to chemotherapy.

“Based on our experience with CRLX101 in monotherapy, we are excited to transition into a CRLX101-Avastin combination trial to assess if pre-clinical synergies observed with the two agents translate into meaningful benefit for platinum resistant patients.”

“The adverse events observed in the CRLX101 monotherapy trial were generally low grade and manageable.”

The investigational tumour-targeted nanopharmaceutical, CRLX101, is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1a (HIF-1a), which releases its payload, camptothecin, over an extended period of time.

In an ongoing phase 1b/2a clinical trial at the University of Pennsylvania, the combination of CRLX101 and Avastin at their respective maximum tolerated doses appears well-tolerated in late-stage renal cell carcinoma (RCC) patients, while demonstrating signals of efficacy.

Safety data secured from the RCC trial were considered by the MGH institutional review board in approving use of the combination for ovarian cancer patients treated in this clinical trial.

Cerulean chief medical officer Edward Garmey said: “In the past few months, preliminary results from an ongoing clinical trial in renal cell carcinoma suggest synergies between CRLX101 and Avastin.

“We are pleased to collaborate with Dr Krasner to investigate this promising potential treatment for relapsed ovarian cancer.”

Image: Neither CRLX101 nor Avastin is approved for the treatment of ovarian cancer. Photo: courtesy of freedigitalphotos.net.