BioEclipse Announces First Patient Dosed in CRX100 Trial for Refractory Solid Tumors

BioEclipse Therapeutics™ announced the administration of the first dose of CRX100 to a volunteer in the ongoing Phase 1 clinical trial in patients with refractory solid tumors. The trial is a first-in-human study for CRX100, BioEclipse's lead investigational drug candidate, an intravenously delivered, multi-mechanistic therapy designed to target and destroy multiple cancer types and address disease recurrence.

The trial volunteer was administered a single dose of CRX100 at the HonorHealth Research Institute in Scottsdale, Ariz., one of two trial sites participating in a Phase 1, open-label, dose-escalation study exploring the safety, tolerability, and pharmacokinetic (PK) properties of CRX100 in patients with advanced solid tumors not responding to standard of care therapy. The study will enroll up to 24 participants ­18 years or older and specifically target six potential cancer indications, including: triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer. As secondary endpoints, the trial will also investigate the effect CRX100 has on a participant's tumor progression and overall immune response.

"With the first patient now dosed in our Phase 1 trial, we have crossed an important milestone in furthering the clinical development of CRX100, which we believe has enormous potential as a single therapeutic designed to launch a multi-mechanistic attack against multiple cancer types," said Pamela Contag, Ph.D., President and CEO of BioEclipse. "The need for more effective treatment options, especially for patients with cancers refractory to standard therapies is both urgent and unmet. With enrollment now underway at three clinical trial sites, we look forward to reporting top line data later this year."

BioEclipse is currently focused on the treatment of recurring cancers. CRX100 was developed with technology exclusively licensed from Stanford University that combines activated immune cells, known as cytokine-induced killer (CIK) cells, with an oncolytic virus. As stand-alone agents, these two components have previously been assessed in human studies. When combined to create CRX100, the CIK cells are expected to protect the oncolytic virus and deliver it to cancer cells throughout the body. The two components are intended to work together to attack primary tumors and metastatic disease. Data from preclinical studies shows that this combination approach may also trigger a long-lasting immune response that protects against relapse and disease recurrence.

BioEclipse will collaborate with Seattle-based C3 Research Associates, a contract research firm providing clinical trial management, clinical monitoring, medical monitoring, biostatistics and data management, pharmacovigilance, as well as data monitoring for the clinical trial.

"We at C3 Research are excited to be part of this incredible study team," said Ron Carozza, CEO and Director of Clinical Operations for C3 Research. "The dosing of the first patient is an important milestone in the clinical development of an exciting new potential therapy for cancer patients. None of this would be possible without the hard work of the project team, the clinic staff and, of course, our study participants."