TransMolecular reaches agreement with FDA for Phase III brain tumor study

8 December 2008

TransMolecular, a biotechnology company, has reached an agreement with the FDA under the special protocol assessment process for a Phase III trial of 131I-TM601 in patients with newly diagnosed glioblastoma multiforme.

Through the special protocol assessment (SPA), the FDA has agreed that if the 131I-TM601 Phase III study successfully meets its stated endpoints, the design and planned analysis of the trial adequately addresses the objectives necessary to support an efficacy claim in a future NDA submission for regulatory approval.

The randomized Phase III study is designed to evaluate the efficacy of 131I-TM601 in combination with the standard of care (SOC) treatment (external beam radiation therapy and temozolomide) compared to SOC treatment alone in adult patients with glioblastoma multiforme (GBM) undergoing surgical resection. The SPA process provides for a written agreement between the trial's sponsor and the FDA that the design and planned analyses of the clinical trial can be used in support of regulatory approval.

Susan Stewart, vice president of regulatory affairs at TransMolecular, said: "This SPA is a validation of the regulatory strategy that has guided the clinical development of TM601, and we are particularly pleased with elements of our Phase III protocol that, if we are successful, should uniquely position 131I-TM601 as a very promising therapeutic option for patients with GBM.

"The trial will be conducted in patients with newly diagnosed GBM, an area of high unmet medical need. This will enable us to treat patients at initial diagnosis who may derive greater benefit from this targeted therapy than can be obtained by current therapies."

Source Business Review