Israel’s VBL Therapeutics announced that it does not plan to continue development of its VB-201 for treatment of patients with psoriasis and ulcerative colitis (UC).
The company said that its Phase II studies evaluating its lead Lecinoxoid compound VB-201 in patients with psoriasis and UC did not meet their primary endpoints. The news sent the company’s stock down 45 percent.
VB-201 aims to treat chronic immune-inflammatory diseases by mimicking the body’s natural anti-inflammatory response. The company said that it can now focus on VB-111, its lead candidate for brain cancer.
In a separate news release, the company announced that the US Food and Drug Administration (FDA) has removed a clinical hold on its Phase III trial in patients with recurrent glioblastoma (rGBM), and VBL can now move ahead with the trial under a previously agreed upon special protocol assessment (SPA).
The agency placed the clinical hold on the late-stage study in July, pending additional data. VBL said that it expects to initiate the Phase III trial in mid-2015 and interim data is expected in the second half of 2016.
“We continue to focus on VB-111 into Phase III for recurrent glioblastoma (rGBM). We believe that this drug candidate has significant potential as an anti-angiogenic agent for the treatment of cancer and we look forward to initiating the trial,” said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. “We are disappointed by the outcome of these Phase 2 studies in psoriasis and ulcerative colitis. Immune-inflammatory conditions are difficult-to-treat diseases with a limited array of effective treatments. We were honored to work with an excellent team of clinical investigators and would like to thank the patients who participated in the clinical studies for these drug candidates.”
VBL is also studying VB-111 in thyroid cancer and ovarian cancer. The company has received fast track status for the drug in the US for prolongation of survival in patients with recurrent rGBM and orphan drug designation in both the US and Europe.
Source: VBL Therapeutics