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Rocky Road To Glioma Approval: BNCT Firm Stella Redesigns Japan PII Trial

 
• By Lisa Takagi

Japanese bioventure Stella Pharma is re-designing a Phase II trial for its glioma candidate Steboronine after it was determined the original primary endpoint was not robust enough to prove efficacy, a challenge faced by some others working in the difficult indication. The drug was approved for head and neck cancer in Japan in 2020 and Stella has already announced a new collaboration which may be key to moving forward. 

BNCT for head and neck cancer
Stella's BNCT drug already approved for head and neck cancer • Source: Shutterstock

Stella Pharma Corporation, a Japanese bioventure focused on Boron Neutron Capture Therapy (BNCT) in oncology, has taken the decision to redesign a Phase II trial for its lead candidate Steboronine (borofalan; SPM-011) for recurrent malignant glioma, more than two years since the original trial ended.

The Osaka-based firm with 45 employees received the first approval for what is its only clinical pipeline asset in Japan in 2020, for head and neck cancer

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