Millennium and Xenova Initiate Phase I Clinical Trial Of MLN944
Thursday July 3, 2:00 am ET
CAMBRIDGE, Mass., and SLOUGH, U.K., July 3 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) and Xenova Group, plc (Nasdaq: XNVA - News; London Stock Exchange: XEN - News), today announced the initiation of a phase I clinical trial of MLN944 (also known as XR5944). MLN944 is a novel DNA targeting agent under investigation for the treatment of advanced cancers. The phase I clinical trial is an open label, dose-escalation study in adult patients with advanced solid tumors to evaluate the safety and tolerability, as well as pharmacokinetic properties of MLN944. The study will be conducted at three centers in the United Kingdom and will include approximately 40 patients.
MLN944 is a novel DNA targeting agent that in preclinical studies has demonstrated a high level of anti-tumor activity, both in vitro and in vivo, against a number of human tumor models. In human tumor xenograft models, treatment with MLN944 caused both partial and complete regression of large established tumors. Recent data published in the Proceedings for the 2003 Annual Meeting of the American Association for Cancer Research, suggests that MLN944 acts through a novel mechanism of action distinct from other current cytotoxic agents. Further exploration into the mechanism of action is ongoing.
"MLN944 is an important compound in our oncology portfolio that we believe holds great potential and is based on the Millennium commitment to breakthrough science and breakthrough medicine," said Barry Greene, general manager of oncology at Millennium. "With both the preclinical activity data and our growing understanding of the novel mechanism of action, we are optimistic that MLN944 may provide patients with an important new therapeutic option."
"MLN944 has one of the best preclinical profiles we have seen both in vitro and in vivo," said David Oxlade, Xenova's Chief Executive Officer. "We are hopeful that the exciting MLN944 preclinical activity will translate into a clinical compound that helps address the clear and growing need in the marketplace for better, more efficacious cancer treatments."
Millennium licensed MLN944 from Xenova Group plc in December 2001 as part of a larger collaboration including two other compounds MLN576 (XR11576) and MLN612 (XR11612). Millennium is currently funding Xenova to implement development activities associated with the program to the completion of phase II clinical trials, at which time Millennium has the right to assume development responsibility in North America. Xenova retains commercialization and development responsibility for the rest of the world. Enrollment for MLN576 is currently completing in its UK-based Phase I trials and the study data will then be reviewed to assess further development plans.
For more information about MLN944 clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at (800) 589-9005, or for European calls, 1-510-740-1273.
The Millennium Oncology Franchise
Millennium is committed to pursuing oncology as a core franchise area, dedicating significant resources and capabilities in the areas of technology, scientific expertise, clinical development, and strategic business development. To this end, Millennium is focused on leveraging its expertise in kinases, the proteasome pathway, and targeting monoclonal antibodies, and has already produced a deep pipeline that ranges from multiple novel targets to commercialized therapeutic products including VELCADE(TM) (bortezomib) for Injection, an oncology product recently approved by the U.S. Food and Drug Administration. Among the Company's most advanced clinical compounds are MLN518, MLN591RL, MLN2704 and MLN576 (XR11576)... |
