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First Patient Injected With Novel Radiotherapy in Phase 2b Trial for Brain Cancer

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The treatment previously demonstrated significantly improved overall survival for patients with recurrent glioblastoma in a phase 1 study.

The first patient has been dosed in a phase 2b clinical trial evaluating rhenium (186Re) obisbemeda, a novel injectable radiotherapy, for the treatment of recurrent glioblastoma, a type of brain cancer.

Researchers conducting the ReSPECT-GBM trial will evaluate the safety, tolerability, distribution and efficacy of rhenium (186Re) obisbemeda, according to a press release from Plus Therapeutics, the drug’s manufacturer. The treatment will be infused directly to the tumor via catheters after conventional treatment.

The trial is expected to enroll up to 31 additional patients with small to medium sized tumors (20 milliliters or less) in approximately 24 months, according to the release.

It was previously reported that results from the phase 1 study, which evaluated the rhenium (186Re) obisbemeda in 24 patients with recurrent glioblastoma, demonstrated a statistically significant improvement in overall survival (time from diagnosis or treatment start when patients are alive). Additionally, the treatment was safe and well tolerated.

“In the phase 1/2a dose-escalation trial, we showed that a rhenium (186Re) obisbemeda radiation dose … can be safely administered and that there is a statistically significant correlation between overall survival and both absorbed radiation dose to the tumor and percent tumor volume in the treated volume,” said Dr. Andrew J. Brenner, lead author on the study and professor of medicine in neurology and neurosurgery at The University of Texas Health Science Center in San Antonio, in the release. “The strength of this correlation is unusually positive for a phase 1/2a trial, and we are optimistic that these safety and efficacy signals will be confirmed in the ongoing phase 2b trial.”

Moreover, the Food and Drug Administration granted the treatment orphan drug designation for this patient population. In particular, this designation is given when a pharmaceutical company developing the drug is eligible for certain incentives including tax credits for qualified clinical trial. This also grants the company a fast-track designation, which is given to a drug which has potential to treat a serious condition or fulfill an unmet need with purpose to expedite the development and review process, according to the Agency.

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