Navigation Links
Biotec Pharmacon Announces Preliminary Results from the,Sloan-Kettering Clinical Study

TROMSØ, Norway, June 29, 2007-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

About SBG

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.


'"/>




Related medicine technology :

1. Generex Biotechnology to Make Presentations At 46th Annual Meeting of the European Society of Pediatric Endocrinology
2. Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at ESMO Conference
3. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
4. Beike Biotechnology Study Suggests Adult Stem Cells Show Promise for Peripheral Vascular Disease
5. ConjuChem Biotechnologies Reports PC-DAC:Exendin-4 Albumin Conjugate Data Presented at American Diabetes Association Annual Meeting
6. Active Biotech presents new pre-clinical data for the 57-57 project at the 8th World Congress on Inflammation
7. New Positive Pre-clinical Data for Active Biotechs RA Project I-3D
8. Prana Biotechnology Presents New Key Findings on PBT2
9. Oncolytics Biotech Inc. Announces Positive Clinical Data from U.S. Phase I REOLYSIN Trial
10. News from the Battlefield of Metastatic Cancer: Epeius Biotechnologies Draws the Sword of Targeted Gene Delivery (Rexin-G) from the Stone of Chemistry and Physics
11. Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at ASCO Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... -- Research and Markets has announced the ... (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, ... Global Forecast to 2021" report to their offering. ... pharmaceutical excipients market is projected to reach USD 8.1 ... the forecast period 2016 to 2021. ...
(Date:6/23/2016)... June 23, 2016 Capricor ... ), a biotechnology company focused on the discovery, ... that patient enrollment in its ongoing randomized HOPE-Duchenne ... exceeded 50% of its 24-patient target. Capricor expects ... third quarter of 2016, and to report top ...
(Date:6/23/2016)... and INDIANAPOLIS , June 23, ... a Lilly Diabetes Tomorrow,s Leaders Scholarship is any indication, ... winners, announced today online at www.diabetesscholars.org by ... 1 diabetes stand in the way of academic and ... the Foundation,s scholarship program since 2012, and continues to ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe ... from the David Geffen School of Medicine at UCLA. He trained in Internal Medicine ... his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... A ... procedures that most people are unfamiliar with. The article goes on to state that ... but also many of these less common operations such as calf and cheek reduction. ...
(Date:6/24/2016)... Texas (PRWEB) , ... June 24, 2016 , ... ... International Conference and Scientific Sessions in Dallas that it will receive two significant ... of the grants came as PHA marked its 25th anniversary by recognizing patients, ...
(Date:6/24/2016)... ... ... of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum Wage’ ... 2020 and then adjusting it yearly to increase at the same rate as the median ... floor does not erode again, and make future increases more predictable. , The company is ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Grove Investment Group (TGIG), has initiated cultivation and processing operations at its production ... and Pahrump, Nevada. , Puradigm is the manufacturer of a complete system of ...
Breaking Medicine News(10 mins):