Spectrum Pharmaceuticals, a biotechnology company, has launched a Phase 2 study evaluating lucanthone in primary therapy for glioblastoma multiforme (GBM).
Lucanthone is an orally administered small molecule that inhibits topoisomerase II and AP endonuclease, and was shown to sensitise tumour cells to radiation and chemotherapy by inhibiting DNA repair.
The international, multicentre, randomised trial is designed to evaluate the safety and efficacy of lucanthone administered in combination with temozolomide (TMZ) and radiation treatment.
Spectrum Pharmaceuticals chairman, president and CEO, Rajesh Shrotriya, said the earlier-stage clinical findings for lucanthone included an impressive safety profile in earlier studies, supported by the track record of use of the agent in another indication.
"Additionally, we have seen early clinical evidence that lucanthone's distinctive mechanism of action can help potentiate the activity of anti-cancer treatments, including radiotherapy," Shrotriya added.
"Based on these initial findings, we decided to make the additional investment in mid-stage studies and now are commencing our second Phase 2 trial for this promising product candidate."
The double-blind, placebo-controlled trial is being conducted at multiple sites in the US, as well as in India through OncoRx, Spectrum's subsidiary.
The study will enrol approximately 140 patients, who will be randomised in a 1:1 ratio to one of two groups, including a six-week treatment of focal radiation plus TMZ and lucanthone (active arm) or focal radiation plus TMZ and placebo (control arm).
The maintenance phase of lucanthone (active arm) or placebo (control arm) administered with TMZ on days one to five of a 28-day cycle for six cycles will follow the concomitant treatment phase.
Progression-free survival (PFS) at nine months is the study's primary endpoint while secondary endpoints include PFS at one year and overall survival (OS) at one year.
Image: Histopathological image of cerebral glioblastoma with a haematoxylin and eosin stain. Photo courtesy of: KGH.