Cerus Corporation (NASDAQ: CERS) announced its Phase 2 clinical trial of red blood cells treated with the INTERCEPT Blood System met its primary endpoint, with preliminary analysis demonstrating that greater than 75 percent of treated red blood cells continued to circulate 24 hours following transfusion. The investigators plan to submit data from the study for presentation at an upcoming scientific congress.
“We are pleased with the results of this study, which support the future advancement of the INTERCEPT red blood cell program into a Phase 3 study in the United States,” said Dr. Laurence Corash, Cerus' Chief Medical Officer. “The data from this study met recommended criteria for a successful red cell recovery study and demonstrate that INTERCEPT red cells behave similarly to untreated red cells when infused into healthy volunteers.”
The randomized, single-blind, controlled, multi-center Phase 2 clinical trial of the INTERCEPT red blood cell system evaluated 26 healthy subjects at two United States clinical trial sites. Each subject received two transfusions of the subject's own red blood cells, one INTERCEPT-treated, and the other a control not treated for pathogen inactivation. Red blood cell units were stored for 35 days prior to transfusion. The primary endpoint of the clinical trial, a mean INTERCEPT red blood cell recovery of greater than 75 percent at 24 hours post-transfusion, was met. The INTERCEPT red blood cells had a recovery of 83% compared to 85% for control red blood cells, and both INTERCEPT-treated and control red blood cells met the criteria for red blood cell recovery recommended by the U.S. Food and Drug Administration.
In Europe, Cerus recently completed a Phase 3 clinical study of the INTERCEPT red blood cell system in patients with acute anemia and plans to file for CE mark approval.
VBL Therapeutics (NASDAQ: VBLT), a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory disease, announced positive results from its exploratory Phase 2a study of VB-111 in patients with recurrent, iodine-resistant differentiated thyroid cancer. VB-111 demonstrated disease stabilization and safety in the study, which was designed to assess the compound's safety and signal of efficacy.
“We are pleased by the results of this study, which suggest that VB-111 is active in patients with advanced thyroid cancer and provide further proof-of-concept support to the unique mechanism of VB-111 and its potency in recurrent cancer indications,” said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. “We are excited to see that VB-111 provided disease stabilization for patients who previously progressed after receiving several lines of treatment, and are encouraged by the compound's continuously favorable safety profile. Going forward, we plan to focus our efforts and resources on our pivotal Phase 3 study of VB-111 in recurrent glioblastoma (rGBM), which we plan to initiate in the first half of 2015.”
Thirty patients enrolled in the open label, dose-escalating study, most of whom had failed on several therapeutic lines, including tyrosine kinase inhibitors, prior to enrollment. Thirteen patients received a sub-therapeutic single dose of VB-111 at 3X10e12 VPs and seventeen received VB-111 at 10e13 VPs every two months until disease progression. Six patients (35%) in the therapeutic dose cohort (n=17) met the primary endpoint of 6-month progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST), compared to three patients (23%) in the low dose cohort (n=13). VB-111 was well-tolerated in both stages of this study, with no signs of clinically significant safety issues.
