Clinical studies on Stimuvax (BLP25 liposome vaccine) intended to stimulate immune response in breast cancer has been suspended following brain infection in trial patients.
Stimuvax is a BLP25 liposome vaccine that belongs to a class of cancer drugs known as therapeutic vaccines which targets molecules that are unique to or found in abundance on tumor cells into the body to provoke an immune response. Therapeutic vaccines attack the tumor cells without harming healthy tissue, a drawback of traditional cancer therapies.
A patient participating in a Phase II exploratory clinical trial with the therapeutic cancer vaccine in patients with multiple myeloma developed encephalitis, Merck KGaA reported.
The patient was randomized to an experimental arm of Stimuvax in combination with an intensified schedule of low-dose cyclophosphamide, which is not used in the other Stimuvax studies.
Merck has suspended recruitment into and treatment of patients already enrolled into the recruiting Stimuvax clinical trials, following this report.
The Phase III clinical program, consisting of the non-small cell lung cancer (NSCLC) studies START and INSPIRE and the breast cancer study STRIDE, is impacted as well as the other recruiting studies.
Merck KGaA started its global Phase III clinical study of the therapeutic cancer vaccine Stimuvax (BLP25 liposome vaccine, L-BLP25) in patients with advanced, inoperable breast cancer in November last year.
The STRIDE(a) study was to determine if Stimuvax can extend progression-free survival in patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
STRIDE was to enroll more than 900 patients with advanced breast cancer at an estimated 180 sites in over 30 countries – within North America, Europe, Asia and Australia.
Merck was also planning to seek approval for Stimuvax for treating lung cancer in 2012 based on studies in that disease begun in 2007.
Stimuvax was the first investigational cancer vaccine to enter Phase III clinical testing in non-small cell lung cancer (NSCLC) with the February 2007 launch of the STARTb study, which involved more than 1,300 patients with unresectable stage III NSCLC, who were stable or responding after chemoradiotherapy.
Stimuvax was expected to rake in sales upto 350 million euros by 2017,Merck estimates.
Stimuvax trials have been expanded to breast tumors comes as Merck’s only marketed cancer drug, Erbitux, was unexpectedly denied approval for use in lung malignancies in July.
Merck may still broaden the Stimuvax studies to include still more tumor types, reports quoting Merck sources said.
Merck is testing the product for use as a potential first- line treatment for women with inoperable cancer, recurring tumors or metastases.
Merck bought rights to Stimuvax from Seattle-based biotechnology company Oncothyreon Inc. in 2001.