On November 20, 2015 GenSpera Inc. (OTCQB: GNSZ), a biotech company developing a novel prodrug therapeutic for the treatment of cancer, reported results from the Phase II study investigating the use of mipsagargin (G-202) for the treatment of glioblastoma multiforme (Filing, 8-K, GenSpera, NOV 23, 2015, View Source [SID:1234508334]). The results will be presented today in a poster entitled, "Phase II study of mipsagargin (G-202), a PSMA-activated prodrug targeting the tumor endothelial cells, in adult patients with recurrent or progressive glioblastoma," at the Society for Neuro-Oncology (SNO) Annual Scientific Meeting in San Antonio, Texas. The poster is available on the company website.
"We are seeing disease stabilization in a subset of patients and, importantly, clinical benefit appears to be correlated with PSMA expression, which offers enrichment strategies to enroll only potential responders in future clinical trials," said David Piccioni, M.D, Ph.D., the study’s Principal Investigator. "These results demonstrate mipsagargin’s potential to treat a patient population with few therapy options."
In addition to Dr. Piccioni, the two-stage, single-arm, open-label study (NCT02067156) is led by neuro-oncologist Santosh Kesari, M.D., Ph.D., and is being conducted at the UC San Diego Moores Cancer Center in La Jolla, Calif. The Phase II results indicate that mipsagargin appears to confer clinical benefit in a subset of patients and is well tolerated by glioblastoma patients. The results are as follows:
• Three of 11 efficacy evaluable patients demonstrated at least stable disease at the first disease assessment (2 stable disease, 1 partial response), one of which has met the primary endpoint of six-month progression-free survival.
• No dose-limiting toxicities have occurred. Preliminary evidence suggests that mipsagargin is well tolerated and may induce disease stabilization or treatment response.
• PSMA (Prostate-Specific Membrane Antigen) staining of tumor tissues shows variability of expression but all three responders have >2+ staining. Biomarker evaluation is ongoing.
"We are very encouraged with the positive results from this interim Phase II trial that demonstrate the tolerability and indications of effectiveness of mipsagargin in advanced brain cancer patients," said Craig Dionne, Ph.D., chief executive officer at GenSpera. "Mipsagargin is a first-in-class agent with a novel mechanism of action that is unlike any other drug being tested in patients with advanced brain cancer."
Potential Advantages of Mipsagargin in Glioblastoma Patients
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Glioblastoma is the most common and most aggressive malignant primary brain tumor in humans. There are approximately 10,000 new cases of malignant glioblastoma diagnosed each year in the United States and, despite optimal treatment, the median survival for these patients is only 12 to 15 months. Treatment commonly consists of surgery followed by radiation and the drug temozolomide. A few drugs have been approved in patients that have recurrent tumors, but none have been shown to promote long-term tumor stabilization or survival. Glioblastomas are particularly resistant to conventional chemotherapy drugs as most cannot cross the blood-brain barrier. This disadvantage of conventional chemotherapy does not apply to mipsagargin because mipsagargin directly attacks the PSMA-expressing cells of the tumor-associated blood vessels that comprise the blood-brain barrier.