- Efficacy and tolerability data from monotherapy studies 969 and 975 presented at 53rd annual conference of the American Society of Hematology
- Clinical benefit already seen in more than 50 % of patients receiving repeat single-dose regimen
- Good tolerability confirmed with multi-dose regimen at doses up to at least 100 mg/m2
- Application for phase I/IIa combination therapy study (no. 983) in multiple myeloma will be submitted to FDA
DREIEICH, Germany I December 12, 2011 I Biotest AG is pursuing an innovative therapeutic strategy using the antibody drug conjugate BT-062 to treat multiple myeloma, an aggressive malignant hematologic disease.
New clinical data with BT-062 in the indication multiple myeloma were featured in an oral presentation at the 53rd annual meeting of the American Society of Hematology (ASH) in San Diego.
The clinical data were obtained from two ongoing studies assessing BT-062 as monotherapy: A phase I repeated single-dose trial (study no. 969) and a phase I/IIa multiple-dose trial (study no. 975). In both trials, patients suffering from multiple myeloma receive repeated treatments with BT-062 until progression of the underlying disease or occurrence of unacceptable toxicities.
In study 969, 32 patients with relapsed or relapsed/refractory multiple myeloma were treated with BT-062 administered once every three weeks. Preliminary findings reveal that more than 50 % of the treated, heavily pretreated patients benefited from the therapy. Among these is a patient who achieved a sustained clinical benefit for more than one and a half years and is still under treatment with BT-062. Data show that BT-062 is well tolerated at doses of up to 160 mg/m², even when administered over a long treatment period of currently 26 treatment cycles.
Based on these results study 975 is underway to treat about 50 patients with relapsed or relapsed/refractory multiple myeloma in an intensified dose schedule. BT-062 is given on days 1, 8 and 15 of 4-week cycle. At the first 5 dose levels of up to 100 mg/m² per dose tested so far, BT-062 was well tolerated and initial evidence of efficacy was observed. To date, no dose limiting toxicities have been observed and escalation towards higher doses is ongoing.
Based on the promising clinical results from these two monotherapy studies and supported by the preclinical combination studies, Biotest will submit its first clinical
BT-062 combination study in multiple myeloma to the FDA. The phase I/IIa study (study no. 983) will investigate BT-062 in combination with lenalidomide and dexamethasone in relapsed or relapsed/refractory patients.
Combination therapies are widely used in oncology to improve overall response rates, in particular in multiple myeloma. Preclinical studies using in vitro und in vivo model systems show a strong increase of efficacy when combining BT-062 with widely used multiple myeloma drugs such as lenalidomide and bortezomib, suggesting a synergistic effect of such combinations in human.
About BT-062:
BT-062 is an antibody drug conjugate consisting of a monoclonal antibody and a highly potent cytotoxic maytansine derivative (DM4) using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen, Inc. The antibody binds specifically to the antigen CD138, which is over-expressed on multiple myeloma cells and a variety of solid tumors.
Once the conjugate is internalized into the target cell, the DM4 is released from the targeting molecule, thereby restoring its original cytotoxic potency. This combination of high efficacy and specificity with low systemic toxicity sets BT-062 apart from most therapies currently used to treat multiple myeloma.
SOURCE: Biotest
Post Views: 46
- Efficacy and tolerability data from monotherapy studies 969 and 975 presented at 53rd annual conference of the American Society of Hematology
- Clinical benefit already seen in more than 50 % of patients receiving repeat single-dose regimen
- Good tolerability confirmed with multi-dose regimen at doses up to at least 100 mg/m2
- Application for phase I/IIa combination therapy study (no. 983) in multiple myeloma will be submitted to FDA
DREIEICH, Germany I December 12, 2011 I Biotest AG is pursuing an innovative therapeutic strategy using the antibody drug conjugate BT-062 to treat multiple myeloma, an aggressive malignant hematologic disease.
New clinical data with BT-062 in the indication multiple myeloma were featured in an oral presentation at the 53rd annual meeting of the American Society of Hematology (ASH) in San Diego.
The clinical data were obtained from two ongoing studies assessing BT-062 as monotherapy: A phase I repeated single-dose trial (study no. 969) and a phase I/IIa multiple-dose trial (study no. 975). In both trials, patients suffering from multiple myeloma receive repeated treatments with BT-062 until progression of the underlying disease or occurrence of unacceptable toxicities.
In study 969, 32 patients with relapsed or relapsed/refractory multiple myeloma were treated with BT-062 administered once every three weeks. Preliminary findings reveal that more than 50 % of the treated, heavily pretreated patients benefited from the therapy. Among these is a patient who achieved a sustained clinical benefit for more than one and a half years and is still under treatment with BT-062. Data show that BT-062 is well tolerated at doses of up to 160 mg/m², even when administered over a long treatment period of currently 26 treatment cycles.
Based on these results study 975 is underway to treat about 50 patients with relapsed or relapsed/refractory multiple myeloma in an intensified dose schedule. BT-062 is given on days 1, 8 and 15 of 4-week cycle. At the first 5 dose levels of up to 100 mg/m² per dose tested so far, BT-062 was well tolerated and initial evidence of efficacy was observed. To date, no dose limiting toxicities have been observed and escalation towards higher doses is ongoing.
Based on the promising clinical results from these two monotherapy studies and supported by the preclinical combination studies, Biotest will submit its first clinical
BT-062 combination study in multiple myeloma to the FDA. The phase I/IIa study (study no. 983) will investigate BT-062 in combination with lenalidomide and dexamethasone in relapsed or relapsed/refractory patients.
Combination therapies are widely used in oncology to improve overall response rates, in particular in multiple myeloma. Preclinical studies using in vitro und in vivo model systems show a strong increase of efficacy when combining BT-062 with widely used multiple myeloma drugs such as lenalidomide and bortezomib, suggesting a synergistic effect of such combinations in human.
About BT-062:
BT-062 is an antibody drug conjugate consisting of a monoclonal antibody and a highly potent cytotoxic maytansine derivative (DM4) using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen, Inc. The antibody binds specifically to the antigen CD138, which is over-expressed on multiple myeloma cells and a variety of solid tumors.
Once the conjugate is internalized into the target cell, the DM4 is released from the targeting molecule, thereby restoring its original cytotoxic potency. This combination of high efficacy and specificity with low systemic toxicity sets BT-062 apart from most therapies currently used to treat multiple myeloma.
SOURCE: Biotest
Post Views: 46
