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It had news today:
ROCKVILLE, Md., Jan. 5 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD - News), a clinical-stage pharmaceutical company developing novel therapeutics for the treatment of cancer and inflammation, announced today that it has commenced Phase 1b clinical trials to evaluate the pharmacokinetic properties and safety of Panzem® NCD, its next generation formulation of its lead product candidate, Panzem® (2-methoxyestradiol or 2ME2). Advanced cancer patients whose disease has failed to respond to existing therapies or where no approved therapy is available are expected to be enrolled in the studies. The purpose of the dose escalation studies will be to evaluate the pharmacokinetics and safety of Panzem® NCD. George Wilding, M.D., Director, University of Wisconsin Comprehensive Cancer Center, and Christopher J. Sweeney, M.D., Co-Director, Experimental and Developmental Therapeutics Program, Indiana University Cancer Center, are the Principal Investigators of the studies.
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2ME2 is an orally active small molecule that attacks tumor cells through multiple mechanisms of action and blocks the development of new blood vessels that feed tumor cells. Panzem® Nanocrystal Colloidal Dispersion (Panzem® NCD), an oral liquid formulation, has been shown in pre-clinical studies to significantly increase the drug's bioavailability, which is expected to result in enhanced drug levels of 2ME2 in patients.
"Given the results from previous clinical studies with Panzem®, we are excited to begin studies with Panzem® NCD," stated Dr. Wilding. Dr. Wilding continued, "We believe that the reformulated drug candidate should yield greater bioavailability, as demonstrated in pre-clinical models, which will hopefully improve the clinical outcome for patients."
Dr. Sweeney also commented on the study, "We are looking forward to participating again in the Panzem® clinical program and resuming trials in our patients along with Dr. Wilding at the University of Wisconsin. The goals of these trials are to evaluate pharmacokinetics and safety in cancer patients and, with these results, move into more focused efficacy trials."
"EntreMed is fortunate to be working with exceptional investigators and cancer centers that have previously conducted clinical studies with 2ME2 and recognize its potential," said Carolyn F. Sidor, M.D., EntreMed's Vice President and Chief Medical Officer. "Valuable safety, pharmacokinetic and dosing information will be obtained from this study, which will enable us to move aggressively into the next stages of clinical testing focusing on specific tumor types and combinations with approved treatments. One of the key attributes of next generation cancer treatments will be drug candidates like Panzem® that affect multiple cellular pathways thereby limiting drug resistance. Panzem® is known to have direct anti-tumor activity in addition to anti-angiogenic activity while maintaining a strong safety profile," Dr. Sidor concluded.
In previous Phase II studies in more than 165 cancer patients, Panzem® capsules showed evidence of clinical efficacy, including one partial response and several patients with stable disease. The drug was well tolerated with few side effects. Panzem® capsules were also tested clinically in combination with Taxotere in advanced breast cancer patients resulting in an objective response rate of 20 percent with no added toxicities.
For more information on this study, visit the Clinical Trials section of EntreMed's web site at entremed.com.
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