Vical stumbles with latest vaccine failure
- Vical and partner Astellas said Monday morning their Phase 2 cytomegalovirus (CMV) vaccine failed to meet its primary endpoints in a trial of kidney transplant patients.
- ASP0113 did not meet the primary endpoint of the proportion of patients having CMV viremia defined as a plasma viral load of ≥ 1000 IU/mL. The endpoint was determined by a lab test one year after the study drug was given.
- Secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy were similar in both the drug and placebo groups.
CMV is a form of herpes that affects nearly half of all adults in the U.S. under the age of 50. The disease is generally harmless and most people go their whole lives without having signs or symptoms. Yet certain populations with compromised immune systems, like kidney transplant patients who have to take immune suppressive medications, are susceptible to the infection and can develop it after receiving an organ from a CMV-seropositive donor.
"The unmet medical need in addressing CMV infection in transplant patients remains high. Although we had hoped for a different outcome, we look forward to further analyzing these data in hopes of contributing knowledge to the future development programs in this patient population," said Bernhardt G. Zeiher, president of development at Astellas.
The company plans to continue to develop the vaccine in patients with hematopoietic cell transplant recipients. A Phase 3 study is currently fully enrolled. Results are expected in the fourth quarter of 2017.
Vical has several flops in its past: the biotech announced a failed Phase 3 trial for its cancer vaccine several years ago and then had a herpes simplex virus vaccine fail in an early-stage study in 2015.
Shares in Vical fell by nearly 25% in early trading Monday.
- Vical Statement
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