* Presentation of preliminary data of a multicenter Phase I Study in Multiple Myeloma at the 51st Annual Meeting of the American Society of Hematology
* Further development in more intensive dosage programme
Dreieich, GERMANY | December 7, 2009 | At the Annual Meeting of the American Society of Hematology in New Orleans, Biotest presented preliminary data from a US Phase I clinical trial with its immunoconjugate BT-062 in the lead indication of Multiple myeloma (MM). This is an aggressive cancer of certain blood cells, for which there is, so far, no permanent cure., Biotest is pursuing an innovative therapeutic strategy, which aims to allow the tumour cells to be combated more effectively. Pre-clinical investigations had already shown significant anti-MM activity by BT-062 in vitro and in vivo 1.
Preliminary data from this Phase I clinical trial show an acceptable toxicity profile for BT-062. The most frequently reported adverse events relate to the underlying disease. Some adverse events have been observed involving skin and mucosa at higher doses. Grade 4 toxicities were not reported. The trial showed the first evidence for efficacy of BT-062: in the case of two patients, a reduction of more than 50% in the M-protein values in urine or reduced serum FLC values were observed. In the case of a further seven patients, stable disease was monitored by early stabilisation of the M-protein level in serum or urine over several cycles. For 53% of patients, time to progression was more than six weeks and for one patient even 30 weeks.
The prospective, open-label, dose-escalation multicenter trial is currently being conducted in patients with relapsed or relapsed/refractory multiple myeloma, where previous treatment with the group of IMiD(R) agents and/or proteasome inhibitors has failed. The aim of the trial is to determine the maximum tolerable dose, dose-limiting toxicities and the pharmacokinetics as well as anti-MM activity . During a 21 day cycle, patients received 10mg/m2 to 200mg/m2 BT-062 on day 1. Treatment over additional cycles took place until disease progression was observed. From a regulatory viewpoint, this treatment programme is described as repeated single dose. The clinical response was determined in accordance with internationally recognised and standardised criteria² .
To date, 25 patients have been treated with one of seven different dosage levels. The dose-limiting toxicities (DLT) were observed at 200mg/m². To extend the safety and efficacy data, the recruitment of patients will be continued at the current maximum tolerated dose level of 160mg/m².
On the basis of the encouraging results on the efficacy and the acceptable tolerability observed to date, Biotest will pursue the development of BT-062 with a trial involving a more intensive dosage programme.
BT-062 is an immunoconjugate, which is manufactured from a monoclonal antibody and the highly effective cytotoxic agent DM4 using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen [Nasdaq: IMGN]. The antibody binds to the antigen CD138, which appears in particularly high concentrations on the surface multiple myeloma and certain other cancer cells. Only after it is absorbed into the target cell, DM4 is released, which effectively destroys the rapidly growing cancer cells. This combination of accuracy and great efficacy distinguishes BT-062 from the treatments currently used as a matter of choice against multiple myeloma.
References
1 Ikeda et al. The Monoclonal Antibody nBT062 Conjugated to Cytotoxic Maytansinoids Has Selective Cytotoxicity Against CD138-Positive Multiple Myeloma Cells In vitro and In vivo. Clin Cancer Res 2009;15(12):4028-4037.
2 Durie BGM et al. International uniform response criteria for multiple myeloma. Leukemia (2006):1-7.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic drugs as well as reagents and systems for diagnostics and microbiology. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of application of immunology and haematology. In its Plasma Protein segment, Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. The products of the Microbiological Monitoring segment are primarily used in hygiene monitoring, while those of Medical Diagnostics are used, for example, in blood transfusions and transplants. Biotest has more than 2,000 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest AG
Post Views: 564
* Presentation of preliminary data of a multicenter Phase I Study in Multiple Myeloma at the 51st Annual Meeting of the American Society of Hematology
* Further development in more intensive dosage programme
Dreieich, GERMANY | December 7, 2009 | At the Annual Meeting of the American Society of Hematology in New Orleans, Biotest presented preliminary data from a US Phase I clinical trial with its immunoconjugate BT-062 in the lead indication of Multiple myeloma (MM). This is an aggressive cancer of certain blood cells, for which there is, so far, no permanent cure., Biotest is pursuing an innovative therapeutic strategy, which aims to allow the tumour cells to be combated more effectively. Pre-clinical investigations had already shown significant anti-MM activity by BT-062 in vitro and in vivo 1.
Preliminary data from this Phase I clinical trial show an acceptable toxicity profile for BT-062. The most frequently reported adverse events relate to the underlying disease. Some adverse events have been observed involving skin and mucosa at higher doses. Grade 4 toxicities were not reported. The trial showed the first evidence for efficacy of BT-062: in the case of two patients, a reduction of more than 50% in the M-protein values in urine or reduced serum FLC values were observed. In the case of a further seven patients, stable disease was monitored by early stabilisation of the M-protein level in serum or urine over several cycles. For 53% of patients, time to progression was more than six weeks and for one patient even 30 weeks.
The prospective, open-label, dose-escalation multicenter trial is currently being conducted in patients with relapsed or relapsed/refractory multiple myeloma, where previous treatment with the group of IMiD(R) agents and/or proteasome inhibitors has failed. The aim of the trial is to determine the maximum tolerable dose, dose-limiting toxicities and the pharmacokinetics as well as anti-MM activity . During a 21 day cycle, patients received 10mg/m2 to 200mg/m2 BT-062 on day 1. Treatment over additional cycles took place until disease progression was observed. From a regulatory viewpoint, this treatment programme is described as repeated single dose. The clinical response was determined in accordance with internationally recognised and standardised criteria² .
To date, 25 patients have been treated with one of seven different dosage levels. The dose-limiting toxicities (DLT) were observed at 200mg/m². To extend the safety and efficacy data, the recruitment of patients will be continued at the current maximum tolerated dose level of 160mg/m².
On the basis of the encouraging results on the efficacy and the acceptable tolerability observed to date, Biotest will pursue the development of BT-062 with a trial involving a more intensive dosage programme.
BT-062 is an immunoconjugate, which is manufactured from a monoclonal antibody and the highly effective cytotoxic agent DM4 using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen [Nasdaq: IMGN]. The antibody binds to the antigen CD138, which appears in particularly high concentrations on the surface multiple myeloma and certain other cancer cells. Only after it is absorbed into the target cell, DM4 is released, which effectively destroys the rapidly growing cancer cells. This combination of accuracy and great efficacy distinguishes BT-062 from the treatments currently used as a matter of choice against multiple myeloma.
References
1 Ikeda et al. The Monoclonal Antibody nBT062 Conjugated to Cytotoxic Maytansinoids Has Selective Cytotoxicity Against CD138-Positive Multiple Myeloma Cells In vitro and In vivo. Clin Cancer Res 2009;15(12):4028-4037.
2 Durie BGM et al. International uniform response criteria for multiple myeloma. Leukemia (2006):1-7.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic drugs as well as reagents and systems for diagnostics and microbiology. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of application of immunology and haematology. In its Plasma Protein segment, Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. The products of the Microbiological Monitoring segment are primarily used in hygiene monitoring, while those of Medical Diagnostics are used, for example, in blood transfusions and transplants. Biotest has more than 2,000 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest AG
Post Views: 564
