Spectrum Pharmaceuticals Launches Lucanthone Phase 2 Clinical Trial For The Treatment Of Primary Glioblastoma Multiforme (GBM)

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced the initiation of an international, randomized, placebo-controlled Phase 2 study evaluating lucanthone in primary therapy for Glioblastoma Multiforme (GBM). An orally administered small molecule, lucanthone inhibits topoisomerase II and AP endonuclease and has been shown to sensitize tumor cells to radiation and chemotherapy by inhibiting DNA repair.

"We have been very encouraged by our earlier-stage clinical findings for lucanthone,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Those findings include an impressive safety profile in earlier studies, supported by the extensive track record of use of this 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. 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. This speaks to the strategic control and flexibility Spectrum gains through conducting all our trials ourselves, allowing us to make the go/no go decision for each program only when we feel we have sufficient foundations to do so.”

The international, multicenter, randomized, double-blind, placebo-controlled, Phase 2 study is designed to evaluate the safety and efficacy of lucanthone administered in combination with temozolomide (TMZ) and radiation treatment, the current standard of care in primary therapy for GBM. The study is expected to enroll approximately 140 patients, who will be randomized in a 1:1 fashion to one of two groups: 6-week treatment of 1) focal radiation + TMZ + lucanthone (active arm) or 2) focal radiation +TMZ + placebo (control arm). This concomitant treatment phase will be followed by a maintenance phase of lucanthone (active arm) or placebo (control arm) administered with TMZ on days 1-5 of a 28-day cycle for 6 cycles. The Phase 2 study primary endpoint is progression free survival (PFS) at 9 months, and secondary endpoints include PFS at 1 year and overall survival (OS) at 1 year. The trial is being conducted at multiple sites in the U.S., as well as in India through Spectrum’s subsidiary, OncoRx.

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