BERG LLC has initiated a phase 1/phase 2 clinical trial to evaluate BPM 31510-IV as monotherapy for patients with glioblastoma multiforme.
The open-label, nonrandomized clinical trial will evaluate the safety and tolerability of BPM 31510-IV in patients with glioblastoma that recurred during treatment with a regimen that contained bevacizumab (Avastin, Genentech).
The trial also will assess the compound’s pharmacokinetics and pharmacodynamics.
The principal investigators will be Seema Nagpal, MD, and Lawrence Recht, MD, both of Stanford University.
“Glioblastoma is one of the deadliest and most insidious forms of cancer, and we are working to make a much-needed difference in the lives of patients with glioblastoma to improve survival and quality of life,” Niven R. Narain, co-founder, president and CEO of BERG, said in a company-issued press release. “The initiation of this [phase 1/phase 2] trial marks the continued advancement of BPM 31510-IV, and further demonstrates BERG’s interrogative biology platform.”
BPM 31510-IV has demonstrated the potential to slow or stop cancer cell growth by reversing the compromised metabolism of cancer cells, according to the press release.
In a phase 1 trial, the compound exhibited a safe profile in patients with solid tumors.
Preclinical studies suggested the compound may be effective as monotherapy, as well as in combination with temozolomide.
A phase 2 trial of BPM 31510-IV as part of a combination regimen has been initiated for the treatment of advanced pancreatic cancer.