– Phase I clinical study completes patient recruitment
– Encouraging results concerning efficacy and tolerability
– Phase I/IIa clinical trial in multiple myeloma has started
Dreieich, Germany | August 11, 2010 | Biotest AG is pursuing an innovative therapeutic strategy to treat multiple myeloma using the monoclonal antibody BT-062. The current prospective, open label, dose-escalation phase I trial includes a total of 32 patients with relapsed or relapsed/refractory multiple myeloma who have failed several previous treatments. The patient recruitment for this study has now been completed. The patients are treated with BT-062 once every three weeks (repeated single dose). Treatment is only discontinued if the underlying disease progresses.
In the present phase I trial, BT-062 shows good tolerability across several cycles with seriously ill patients in the different dose ranges and dosage schedule addressed.
Results so far show that the progression of the disease can be delayed by BT-062 with lasting effect in seriously ill myeloma patients. In 13 out of 30 patients (43%) the disease was stabilised for up to 30 weeks, two patients demonstrated a partial clinical response with reduction of the tumor load. These data are very encouraging because the patients had up to 15 pretreatments with currently available drugs. Further two patients are still undergoing treatment. Biotest will be presenting details of the clinical trial at international conferences.
Based on the encouraging efficacy results and the good tolerability observed in the phase I trial, a further phase I/IIa clinical trial was initiated in which BT-062 is now, as planned, being tested using a more intensive dosage schedule. In this trial, recruitment of patients has started.
For the phase I/IIa trial approved by the US Food and Drug Administration (FDA) patients are undergoing treatment with BT-062 at several clinical centres in the United States. In this dose escalation trial patients are treated with repeated infusions of BT-062 in shorter intervals. Therefore, an optimisation of efficacy and tolerability is expected. In this trial patients with relapsed or refractory multiple myeloma for whom previous treatments, including the group of IMiD(R) agents and proteasome inhibitors, have been ineffective are treated with BT062. The results will be used as a basis to plan the trials that are relevant for approval.
Multiple myeloma is a malignant and aggressive bone marrow disease for which no cure has been developed so far. BT-062 is an immunoconjugate consisting of a monoclonal antibody and the highly effective cytotoxic agent maytansinoid (DM4) using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen. The antibody binds specifically to the antigen CD138, which is overexpressed on malignant plasma cells. Once the immunoconjugate is internalized into the target cell, DM4 is released from the targeting molecule, thereby restoring the original killing potency of The drug. This combination of high potency and specificity, while exhibiting low systemic toxicity and damage to healthy tissue sets BT-062 apart from the other therapies that are mainly used at present to treat multiple myeloma.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic drugs as well as reagents and systems for 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. Biotest has more than 1,900 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest AG
Post Views: 32
– Phase I clinical study completes patient recruitment
– Encouraging results concerning efficacy and tolerability
– Phase I/IIa clinical trial in multiple myeloma has started
Dreieich, Germany | August 11, 2010 | Biotest AG is pursuing an innovative therapeutic strategy to treat multiple myeloma using the monoclonal antibody BT-062. The current prospective, open label, dose-escalation phase I trial includes a total of 32 patients with relapsed or relapsed/refractory multiple myeloma who have failed several previous treatments. The patient recruitment for this study has now been completed. The patients are treated with BT-062 once every three weeks (repeated single dose). Treatment is only discontinued if the underlying disease progresses.
In the present phase I trial, BT-062 shows good tolerability across several cycles with seriously ill patients in the different dose ranges and dosage schedule addressed.
Results so far show that the progression of the disease can be delayed by BT-062 with lasting effect in seriously ill myeloma patients. In 13 out of 30 patients (43%) the disease was stabilised for up to 30 weeks, two patients demonstrated a partial clinical response with reduction of the tumor load. These data are very encouraging because the patients had up to 15 pretreatments with currently available drugs. Further two patients are still undergoing treatment. Biotest will be presenting details of the clinical trial at international conferences.
Based on the encouraging efficacy results and the good tolerability observed in the phase I trial, a further phase I/IIa clinical trial was initiated in which BT-062 is now, as planned, being tested using a more intensive dosage schedule. In this trial, recruitment of patients has started.
For the phase I/IIa trial approved by the US Food and Drug Administration (FDA) patients are undergoing treatment with BT-062 at several clinical centres in the United States. In this dose escalation trial patients are treated with repeated infusions of BT-062 in shorter intervals. Therefore, an optimisation of efficacy and tolerability is expected. In this trial patients with relapsed or refractory multiple myeloma for whom previous treatments, including the group of IMiD(R) agents and proteasome inhibitors, have been ineffective are treated with BT062. The results will be used as a basis to plan the trials that are relevant for approval.
Multiple myeloma is a malignant and aggressive bone marrow disease for which no cure has been developed so far. BT-062 is an immunoconjugate consisting of a monoclonal antibody and the highly effective cytotoxic agent maytansinoid (DM4) using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen. The antibody binds specifically to the antigen CD138, which is overexpressed on malignant plasma cells. Once the immunoconjugate is internalized into the target cell, DM4 is released from the targeting molecule, thereby restoring the original killing potency of The drug. This combination of high potency and specificity, while exhibiting low systemic toxicity and damage to healthy tissue sets BT-062 apart from the other therapies that are mainly used at present to treat multiple myeloma.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic drugs as well as reagents and systems for 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. Biotest has more than 1,900 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest AG
Post Views: 32
