The company reached the agreement under the special protocol assessment process (SPA). The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a new drug application, and provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA.
“We’re pleased to have reached agreement with the FDA on the design of this important clinical trial as it provides a well defined pathway for pursuit of marketing approval of PDX,” said Paul Berns, president and CEO of Allos. “We expect to move forward as planned with the initiation of enrollment in this trial by the end of the third quarter.”
As reported at the 2005 American Society of Hematology Annual Meeting, four of seven evaluable patients with T-cell lymphoma achieved a complete response following treatment with PDX, despite having failed multiple prior therapies. The addition of vitamins to the treatment regimen appeared to successfully mitigate the previously established dose limiting toxicity of stomatitis.