Under the terms of the binding letter of intent, NeoPharm and Siro have agreed to negotiate in good faith the terms of a clinical research agreement pursuant to which Siro would provide clinical research oversight of the Phase III confirmatory trial in India.
This Phase III trial is projected to enroll a total of 45 patients beginning by the fourth quarter of calendar 2008. NeoPharm anticipates that this Phase III trial will generate substantial data by the end of calendar year 2009. The company will evaluate the results from such a confirmatory trial to decide whether to expand the Phase III trial into a multinational, multicenter trial to increase the patients’s database to satisfy the FDA’s requirements for a Cintredekin Besudotox BLA submission.
Mark Bradshaw, president of Siro ClinPharm USA, said: “We welcome the opportunity to help NeoPharm conduct this complex oncology trial in India, where we believe IL-13 will be most likely to demonstrate significant benefits for patients with glioblastoma multiforme.”