(By Balaseshan) Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it has initiated a placebo-controlled phase 2 clinical trial evaluating lucanthone in primary therapy for Glioblastoma Multiforme (GBM) or brain tumors.
An orally administered small molecule, lucanthone inhibits DNA repair (topoisomerase 2 and AP endonuclease) and has been shown to sensitize tumor cells to radiation and chemotherapy by inhibiting DNA repair.
The 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 about 140 patients, who will be randomized in a 1:1 fashion to one of two groups: 6-week treatment of focal radiation + TMZ + lucanthone (active arm) or 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 unit, OncoRx.
Lucanthone crosses the blood-brain barrier, and lucanthone has been shown to act preferentially on cycling cells (most of the normal brain cells are non-cycling).
In preclinical tests, lucanthone has been demonstrated to enhance sensitivity to an anticancer agent or radiotherapy in a time-dependent and reversible manner. Lucanthone has structural and biochemical similarities to Actinomycin D, but has shown no hematological or GI toxicity at clinically tolerated doses.
SPPI closed Monday's regular session up 2.83% at $16. The stock has been trading between $6.94 and $16 for the past 52 weeks.