Neoprobe, a biomedical company, has announced that the European Medicines Agency has provided positive formal responses to the company’s scientific advice submission regarding RIGScan CR and the pathway to receive a marketing authorization for the drug.
The company asked the European Medicines Agency (EMEA) to review its manufacturing and clinical development plan for RIGScan CR. The EMEA concurred that Neoprobe could use updated and improved manufacturing processes to produce the antibody that is used in RIGScan CR and would be able to use all previously produced drug safety data derived from prior clinical studies to support a marketing authorization.
The EMEA reviewed and agreed to the design and adequacy of a Phase III clinical study to be conducted in 380 patients with diagnosed primary or metastatic/recurrent colorectal cancer. The Phase III study would be a randomized trial with equal control and RIGScan CR treatment cohorts. The primary endpoint of the study would be improved survival for the RIGScan CR treated patients as compared to the control arm.
In addition, the EMEA agreed to the clinical need for a product like RIGScan CR to improve the treatment of patients with colorectal cancer. Finally, the EMEA provided Neoprobe the opportunity to request a conditional marketing authorization after completion of the initial antibody production or prospective clinical activities.
David Bupp, Neoprobe’s president and CEO, said: “The scientific advice response provides a clear, achievable development pathway for RIGScan CR. The response acknowledges that the technology meets a currently unmet medical need and has the potential for improving the long-term prognosis for both primary and recurrent colorectal patients.
“The EMEA has suggested a mechanism for an early termination of the study if, as anticipated, early improved outcomes are observed in the RIGScan treatment arm versus the control arm patients.”
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