Biotec Pharmacon ASA is announcing 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.
"Neuroblastoma is a very serious form of cancer in infants and young children,
with high mortality rates. Given the progressed stage of disease (high-risk
stage 4) in the children in the study and the limitations of alternative
treatment regimes, we consider these results promising," says CEO Svein Lien in
Biotec Pharmacon ASA.
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.
"We are glad to see confirmation of the positive effects of SBG within the
cancer immunotherapy area, and have in co-operation with Memorial Sloan-
Kettering Cancer Center secured a very broad and worldwide patent platform
protecting this combined treatment," says Lien.
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.
"Based on the experience from our earlier clinical studies with SBG, we need to
secure a correct formulation of the product before entering into new clinical
studies. This work is currently ongoing." says Lien.
For further information:
CEO Svein W. F. Lien - +47 92289323
CSO Rolf Engstad - +47 95941542
Study details:
The objective of the study was to define the clinical toxicity of the combined
treatment and to assess the biological effects of the treatment regimen. The
study was a dose escalating study, where groups of patients were treated with an
increasing amount of SBG given per orally combined with a fixed amount of
monoclonal anti-neuroblastoma antibodies (3F8) given intravenously. SBG was
given in increasing dosing steps from 10 mg/kg, increasing to 20 mg/kg and
subsequently up to 200 mg/kg per day, each increasing interval of 20 mg. The
treatment was scheduled to be given in 4 cycles of 27 days, and increased up to
a total of 8 cycles when allowable, with treatment free periods between each
cycle. A total of 45 patients were entered into the study, whereof 44 of the
patients treated with the combination of the anti-cancer antibody 3F8 and SBG
were evaluable for toxicity. A total of 37 patients could be evaluated for
treatment response according to the International Neuroblastoma Staging System
Criteria.
Of the 30 patients showing metastasis to the skeleton, 14 patients demonstrated
improvement in skeletal MIBG during the treatment period, and 6 of 15 patients
showed complete remission of neuroblastoma in bone marrow. Overall, 2 patients
had complete response to the tumor and was diagnosed symptom free after the
treatment period, 3 had partial response, and 20 patient showed stable disease,
whereas 12 developed progressive disease already at start of the first treatment
cycle and did not receive the intended subsequent cycles of treatment.
About Biotec Pharmacon:
Biotec Pharmacon is a biopharmaceutical company that develops and manufactures
new immunomodulatory products and cold adapted marine enzymes. The wholly owned
Biotec BetaGlucans AS focuses on identifying, developing and commercializing
innovative products to meet unmet medical needs in wound treatment, cancer and
gastroenterology. The company's technology is protected by a large patent
portfolio covering amongst others applications of yeast beta glucans as
adjuvants in conjunction with monoclonal antibodies. The subsidiary ArcticZymes
AS (96% owned) aspires to become a leading supplier of novel enzymes for
diagnostics and genetic research.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
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Source: Biotec Pharmacon ASA via Thomson Reuters ONE
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