To NASDAQ OMX Copenhagen A/S
Announcement no. 17-12 / Copenhagen, October 3, 2012
Initial results from the first stage of the phase II part of the phase I/II clinical trial of belinostat in combination with doxorubicin in patients with soft tissue sarcomas (PXD101-CLN-14) met predefined protocol criteria to continue into the further clinical development.
Study design This study, conducted by Topotarget, is an open-label, multicenter, dose-escalation phase I/II study to evaluate safety and efficacy of the combination of belinostat with doxorubicin in patients with advanced solid tumors (phase I part) and soft tissue sarcomas (phase II part). The phase I dose escalation part of this study showed that belinostat at a recommended dose of 1000 mg/m2 days 1-5 in combination with 75 mg/m2 doxorubicin on day 5 in a three-week schedule is well-tolerated. Therefore, this dose was used for 20 patients with soft tissue sarcoma in the phase II part of the study. The protocol states that if three or more responders (complete response or partial response) are observed the trial can continue to accrue 40 soft tissue sarcoma patients in total.
Trial results Fifteen out of 20 patients (75%) achieved disease control and all 15 patients remained in disease control at the three-month time point. The objective response rate was 15% (three objective responses) including one complete response and additionally 12 patients achieved disease stabilization. The preliminary results show a median duration of disease control of 7.9 months in the group of responders and 5.9 months in the patient group obtaining stable disease. These are encouraging data since patients suffering from sarcomas have a very dismal prognosis and a paucity of treatment options.
About soft tissue sarcoma Sarcomas are a group of solid tumors in the connective tissue of the body that are treated with surgery, chemotherapy, and/or radiation. Reported objective response rates are very low with complete responses being rare or absent in the trials that have led to registration of anticancer treatments in this indication over the past five years. Doxorubicin as a single agent or in combination with ifosfamide is the most commonly used chemotherapeutic regimen in patients with advanced soft tissue sarcoma.
Next step The study will continue to assess the objective response rate and duration of response, disease control rate, and overall survival of the enrolled patients. Further clinical development plans will be based on data emerging from this study and scientific advices from competent authorities.
Outlook for the year This announcement does not change the previously announced outlook statement published on August 29, 2012.
Topotarget A/S
For further information, please contact:
Anders Vadsholt, CEO: Direct: +45 39 17 83 45; Cell: +45 28 98 90 55 Axel Mescheder, CMDO: Direct: +45 39 17 83 14; Cell: +45 51 55 71 66
Background information
About Topotarget Topotarget (NASDAQ OMX: TOPO) is an international biopharmaceutical company headquartered in Copenhagen, Denmark, dedicated to clinical development and registration of oncology products. In collaboration with Spectrum Pharmaceuticals, Inc., Topotarget focuses on the development of its lead drug candidate, belinostat, which has shown positive results in the treatment of hematological malignancies and solid tumors, obtained by both mono- and combination therapy. For more information, please refer to www.topotarget.com.
About belinostat Belinostat is a novel pan-HDAC inhibitor in late-stage clinical development with more than 1,000 patients treated. Belinostat has a promising safety profile, which allows combination with traditional chemotherapy. Preclinical experiments demonstrated belinostat to be effective against multiple cancers by inhibiting cell proliferation and inducing programed cell death (apoptosis) in tumor cells. Belinostat has been tested in a number of phase I/II clinical trials in hematological cancers and solid tumors both in mono- and combination therapy. Data from these trials have provided evidence of the anti-tumor effect of belinostat, including as monotherapy in PTCL and cutaneous T-cell lymphoma (CTCL), liver cancer, and thymoma.
Topotarget Safe Harbor Statement This announcement may contain forward-looking statements, including statements about our expectations of the progression of our preclinical and clinical pipeline including the timing for commencement and completion of clinical trials and with respect to cash burn guidance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Topotarget cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: The risk that any one or more of the drug development programs of Topotarget will not proceed as planned for technical, scientific, or commercial reasons or due to patient enrollment issues or based on new information from non-clinical or clinical studies or from other sources; the success of competing products and technologies; technological uncertainty and product development risks; uncertainty of additional funding; Topotarget's history of incurring losses and the uncertainty of achieving profitability; Topotarget's stage of development as a biopharmaceutical company; government regulation; patent infringement claims against Topotarget's products, processes, and technologies; the ability to protect Topotarget's patents and proprietary rights; uncertainties relating to commercialization rights; and product liability exposure. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.
© Topotarget A/S. All Rights Reserved.
Attachment:
https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=405316
Initial results from the first stage of the phase II part of the phase I/II clinical trial of belinostat in combination with doxorubicin in patients with soft tissue sarcomas (PXD101-CLN-14) met predefined protocol criteria to continue into the further clinical development.
Study design This study, conducted by Topotarget, is an open-label, multicenter, dose-escalation phase I/II study to evaluate safety and efficacy of the combination of belinostat with doxorubicin in patients with advanced solid tumors (phase I part) and soft tissue sarcomas (phase II part). The phase I dose escalation part of this study showed that belinostat at a recommended dose of 1000 mg/m2 days 1-5 in combination with 75 mg/m2 doxorubicin on day 5 in a three-week schedule is well-tolerated. Therefore, this dose was used for 20 patients with soft tissue sarcoma in the phase II part of the study. The protocol states that if three or more responders (complete response or partial response) are observed the trial can continue to accrue 40 soft tissue sarcoma patients in total.
Trial results Fifteen out of 20 patients (75%) achieved disease control and all 15 patients remained in disease control at the three-month time point. The objective response rate was 15% (three objective responses) including one complete response and additionally 12 patients achieved disease stabilization. The preliminary results show a median duration of disease control of 7.9 months in the group of responders and 5.9 months in the patient group obtaining stable disease. These are encouraging data since patients suffering from sarcomas have a very dismal prognosis and a paucity of treatment options.
About soft tissue sarcoma Sarcomas are a group of solid tumors in the connective tissue of the body that are treated with surgery, chemotherapy, and/or radiation. Reported objective response rates are very low with complete responses being rare or absent in the trials that have led to registration of anticancer treatments in this indication over the past five years. Doxorubicin as a single agent or in combination with ifosfamide is the most commonly used chemotherapeutic regimen in patients with advanced soft tissue sarcoma.
Next step The study will continue to assess the objective response rate and duration of response, disease control rate, and overall survival of the enrolled patients. Further clinical development plans will be based on data emerging from this study and scientific advices from competent authorities.
Outlook for the year This announcement does not change the previously announced outlook statement published on August 29, 2012.
Topotarget A/S
For further information, please contact:
Anders Vadsholt, CEO: Direct: +45 39 17 83 45; Cell: +45 28 98 90 55 Axel Mescheder, CMDO: Direct: +45 39 17 83 14; Cell: +45 51 55 71 66
Background information
About Topotarget Topotarget (NASDAQ OMX: TOPO) is an international biopharmaceutical company headquartered in Copenhagen, Denmark, dedicated to clinical development and registration of oncology products. In collaboration with Spectrum Pharmaceuticals, Inc., Topotarget focuses on the development of its lead drug candidate, belinostat, which has shown positive results in the treatment of hematological malignancies and solid tumors, obtained by both mono- and combination therapy. For more information, please refer to www.topotarget.com.
About belinostat Belinostat is a novel pan-HDAC inhibitor in late-stage clinical development with more than 1,000 patients treated. Belinostat has a promising safety profile, which allows combination with traditional chemotherapy. Preclinical experiments demonstrated belinostat to be effective against multiple cancers by inhibiting cell proliferation and inducing programed cell death (apoptosis) in tumor cells. Belinostat has been tested in a number of phase I/II clinical trials in hematological cancers and solid tumors both in mono- and combination therapy. Data from these trials have provided evidence of the anti-tumor effect of belinostat, including as monotherapy in PTCL and cutaneous T-cell lymphoma (CTCL), liver cancer, and thymoma.
Topotarget Safe Harbor Statement This announcement may contain forward-looking statements, including statements about our expectations of the progression of our preclinical and clinical pipeline including the timing for commencement and completion of clinical trials and with respect to cash burn guidance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Topotarget cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: The risk that any one or more of the drug development programs of Topotarget will not proceed as planned for technical, scientific, or commercial reasons or due to patient enrollment issues or based on new information from non-clinical or clinical studies or from other sources; the success of competing products and technologies; technological uncertainty and product development risks; uncertainty of additional funding; Topotarget's history of incurring losses and the uncertainty of achieving profitability; Topotarget's stage of development as a biopharmaceutical company; government regulation; patent infringement claims against Topotarget's products, processes, and technologies; the ability to protect Topotarget's patents and proprietary rights; uncertainties relating to commercialization rights; and product liability exposure. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.
© Topotarget A/S. All Rights Reserved.
Attachment:
https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=405316