Delcath Systems, Inc (DCTH) announced that the U.S. Food and Drug Administration has informed the company that patient enrollment can now resume in the company’s Phase II and Phase III clinical trials of the Delcath System. Through Delcath’s various meetings with both the FDA and the Principal Investigator of the National Cancer Institute, all parties have approved such an action. Current clinical trial sites, already informed that the study can resume immediately, will began testing patients immediately.
Previously, adverse events were observed in four patients enrolled in the Delcath System on October 23, 2007. As a result, the FDA launched a formal inquiry and suspended all clinical trials of the drug after such an inquiry had been completed. However, since the initial suspension of the drug’s trials had been announced, Delcath has since changed protocol procedures for all clinical trials. During the most recent meeting with the FDA, Delcath outlined such changes and proved, without a reasonable doubt, how each change could prevent a recurrence of toxicities in patients. These changes, immediately approved by the FDA, led to the FDA retracing such a suspension.
Richard L. Taney, president and CEO of Delcath systems, stated, “We are pleased with the Agency’s prompt response to and resolution of this issue. We are very appreciative of the timely assistance of the NCI which allowed us to respond to the Agency less than a week after receiving the letter and their presentation of the data contributed greatly to the unusually quick resolution of this matter. A thorough analysis of the clinical facts surrounding these episodes combined with the clinical benefits demonstrated by the Delcath System for these extremely ill patients allowed for a balanced evaluation of FDA safety concerns.”
He concluded by stating, “We look forward to recruiting additional oncology centers for the expansion of our clinical trials as we believe that use of the Delcath System for the targeted, region-specific delivery of high-dose chemotherapeutic agents can bring significant clinical benefit to late-stage cancer patients with very limited treatment options, and consequently, poor prognoses”.
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