Preliminary results from the immunotherapeutic cancer study at Memorial Sloan-Kettering Cancer Center show a very good safety profile for SBG. Furthermore, encouraging responses on cancer development have been observed among several patients that have been treated with SBG in combination with the monoclonal antibody against neuroblastoma.
In line with the timetable described in the company's report for the 1st quarter 2007, all 24 patients have now been included in the clinical study at Memorial Sloan-Kettering Cancer Center (MSKCC). In this study, SBG is tested in combination with a monoclonal antibody (3F8) against the cancer form neuroblastoma. The patients are children that have developed metastatic neuroblastoma and are non-responders to previous conventional chemotherapy. These patients therefore maintain a very poor prognosis for survival, but earlier clinical studies at Sloan-Kettering have demonstrated positive effects in a similar patient population when treated with the cancer antibody 3F8. By using immune-stimulating adjuvants such as beta-glucans, the effects of the antibody treatment could be improved. The purpose of the present study was primarily to investigate if SBG leads to side effects in this particular combination treatment, but also to obtain the first indications whether SBG has a role together with monoclonal antibodies in the treatment of cancer patients.
Patients in the study have been treated at escalating dose levels of SBG from 10 and up to 120 milligram per kilo per day at the highest level. Of 24 patients that have been included in the trial, 23 patients are evaluable for safety, whereas 20 patients are evaluable for response. Sloan-Kettering has now reported preliminary data for these patients. It should be noted that the results are not considered definitive.
With a possible exception of one single incident, there are no adverse events reported from the trial that are related to SBG. A preliminary assessment of available safety data indicates that oral administration of SBG is very well tolerated in combination with the 3F8 antibody. At the highest dose level one event was reported of elevated liver enzymes (ALT) in one patient undergoing treatment, but for the time being it is not certain whether this is drug related or not. Due to this single incident it has been decided to extend the study with one additional dose level, i.e. 140 mg/kg/day in 6 patients. The purpose of the extension is to evaluate whether such dose level is near the maximum tolerated dose (MTD) level for SBG in combination with this particular monoclonal antibody.
Of the 20 patients that can be evaluated for response, the investigator has observed an objective response in 8 patients. The response was primarily observed as a reduction in cancer development in skeletal sites based on results from scans and responses on bone marrow testing. The preliminary data is considered to be an improvement compared to what would be expected if the monoclonal antibody was given alone. MSKCC has earlier shown that the effectiveness of the antibody could be improved by the use of intravenous injection of the recombinant cytokine GM-CSF, however, one has not yet data to assess whether one adjuvant is better than the other or if the two treatment regimes with immune stimulating adjuvants possibly can be combined to increase the effect even more. The investigator has emphasized that the indications of response are preliminary and that additional analysis will be carried out before the results can be confirmed. The preliminary data is however considered to be promising.
Biotec Pharmacon will give additional information from the study when the final results are reported from Memorial Sloan-Kettering Cancer Center in New York.
For further information, please contact:
CEO Lars Viksmoen, tel.: 40 62 08 70
CSO Rolf Engstad, tel.: 95 94 15 42
CFO Finn Samuelsen, tel.: 95 14 87 51
SBG (soluble beta-1,3/1,6-glucan) is Biotec Pharmacon's patented pharmaceutical compound. SBG binds to certain types of immune cells and initiates mechanisms that enhance the ability of the immune system to attack and destroy cancer cells, repair wounds, and fight infections. Immunotherapy of cancer is one of the priority therapeutic areas for Biotec Pharmacon. In addition to the study at Memorial Sloan-Kettering Cancer Center i New York, the company is also about to conduct two studies at Ullevaal University Hospital and Rikshospitalet-Radiumhospitalet in Oslo. The other therapeutic area covered by Biotec Pharmacon is treatment of wounds which include chronic diabetic ulcers and oral mucositis in cancer patients. Biotec Pharmacon has recently announced that the company enters clinical phase III within these indications.
About Biotec Pharmacon
The biopharmaceutical company Biotec Pharmacon was founded in 1990 and develops pharmaceutical products for treatment of immune related diseases. The company has developed the bioactive compound SBG, which initiates mechanisms that strengthen the ability of the immune system to destroy cancer cells, repair wounds and fight infections. In addition the company manufactures and markets non-pharmaceutical health- and diagnostics products. Biotec Pharmacon maintains comprehensive collaborations with renowned institutions such as for example Memorial Sloan-Kettering Cancer Center in New York. Biotec Pharmacon today has 56 employees and offices in Tromsø, Oslo and Long Beach, USA. Further information can be found on www.biotec.no