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news.Xanthus Life Sciences has begun dosing patients in a phase II clinical trial with its investigational drug Symadex in patients with metastatic colorectal cancer who relapsed following prior treatment.
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The primary objective of the study is overall response rate, including patients with complete responses and partial responses. Secondary objectives of the study include, time-to-progression, duration-of-response and overall survival, as well as determination of toxicity and pharmacokinetic characteristics for Symadex.
The trial is being conducted in Europe and is expected to enroll approximately 49 patients with metastatic colorectal cancer following previous failure of treatment with Oxaliplatin and/or Irinotecan.
Patients will receive weekly intravenous infusions of Symadex for three weeks, followed by a week of rest for a total of four cycles. Responding patients will continue for additional cycles with regular tumor assessments.
“We believe that Symadex has particularly strong potential in this cancer type given that the drug has demonstrated superior anti-tumor activity in vitro when compared to three approved agents that are widely used for treating human colorectal cancer,” stated Dr Robert Capizzi, chief medical officer at Xanthus.