Mersana Therapeutics announced the initiation of a phase 1B extension study with cancer leading product, XMT-1001, be a novel DNA topoisomerase I inhibitor based on the company's Fleximer ® polymer conjugate platform, in second-line stomach cancer and second / third line non-small cell lung cancer. The study will be carried out in 10 clinical centers in the United States. The phase 1 (b) following the successful completion of a 74-patient phase 1 clinical trial that showed high and long lasting levels XMT-1001 active release products and a security profile free of the toxicities usually with topoisomerase 1 inhibitor associated, such as haemorrhagic cystitis and diarrhea. In addition showed XMT-1001 promising evidence of clinical activities, shrink tumor and stable disease in a heavily pretreated longer.
"Our recently completed phase 1 study confirmed the potential efficacy and safety advantages of the unique design of our lead Fleximer conjugate, XMT-1001," Nick Bacopoulos, PhD., said Chief Executive Officer of Mersana. "We believe we are now able to fully explore the wide tumor potential of the XMT-1001 and look forward to recruitment in our phase 1B program initiate."
"Our clinical experience with XMT-1001 to date suggests that it can safely receive limited to doses by a mechanism, and so may be useful in maximizing the therapeutic potential of its class." The potential benefit of this agent in second-line stomach cancer and in zweiten-/ third-line non-small cell lung cancer, areas of great need for medical, research, good value is ", said Edward A. Paul, m.d., Ph.d., Professor of medicine and Associate Director for clinical ForschungGreenebaum Cancer Center University of Maryland and a principal investigator in the phase 1 (b) study."
Than XMT-1001
XMT-1001 Mersana based product candidate is the most advanced Fleximer ®. It used to free a proprietary, dual-release mechanism, an analog, novel, active Camptothecin that can be converted to Camptothecin, a DNA topoisomerase I inhibitor. In preclinical studies, XMT-1001 was significantly more effective and better tolerated than Camptothecin or irinotecan in models of human cancer, with extended half-life and longer-lasting, high levels in tumor tissue plasma.
On the phase 1 study XMT-1001
The phase 1 trial was an open-label, dose escalation study of XMT-1001 as once every three weeks in patients with advanced solid tumors administered an IV infusion. The study found, the maximum dose (MTD) 113 mg / m2 Camptothecin are tolerated equivalents and evaluates the safety and pharmacokinetics of XMT-1001.
Source: Mersana Therapeutics
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