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Clinical Trials

Date: 2011-07-14

Type of information:

phase: 1-2

Announcement: results

Company: Biotec Pharmacon (Norway)

Product: SBG Soluble Beta-Glucan

Action mechanism:

Disease: neuroblastoma

Therapeutic area: Cancer Oncology

Country: USA

Trial details:

Latest news: Biotec Pharmacon has announced the final results from an early phase (I/II) study on combining Soluble Beta-Glucan (SBG) with anti-cancer antibodies in treatment of neuroblastoma in children. The study, performed at Memorial Sloan-Kettering Cancer Center, showed that the combined treatment with SBG and 3F8 antibodies was well tolerated and the combined treatment gave promising activity against resistant neuroblastoma. Improvement was demonstrated in 14 of 30 patients showing metastasis to the skeleton, whereof 6 of 15 patients showed complete remission of neuroblastoma in bone marrow.
The patients included in the study had high-risk metastatic neuroblastoma and a history of recurrent or refractory disease. Patients that are more than one year old, as in this study (>18 months of age), having disseminated disease (described as \"stage 4\" in the International Neuroblastoma Staging System Criteria) have very poor prognosis. In the present study only patients with a history of heavy pre-treatment and recurrent or refractory stage 4 neuroblastoma were included.
When the current study was initiated, Biotec Pharmacon agreed to support a follow up phase II study at Memorial Sloan Kettering Cancer Center (MSKCC). However, the company will not immediately move onto the next clinical phase. Biotec Pharmacon said that it needs to secure a correct formulation of the product before entering into new clinical studies.

Is general: Yes