>>WASHINGTON and SYDNEY, Australia, May 16 /PRNewswire/ -- Biotechnology company, Marshall Edwards, Inc., announced today that under the Special Protocol Assessment (SPA) process, it has reached agreement with the United States Food and Drug Administration (FDA) on the design of a pivotal study protocol for its investigational anti-cancer drug, phenoxodiol. The trial, known as the OVATURE study, is designed to test the ability of phenoxodiol to restore sensitivity of late-stage ovarian cancers to carboplatin, a standard form of therapy for ovarian cancer.
The SPA process allows for FDA evaluation of a clinical trial protocol that will form the basis of an efficacy claim for a marketing application, and provides a binding agreement that the study design, including patient numbers, clinical endpoints, and analyses are acceptable to the FDA.
Phenoxodiol received fast track designation for platinum-resistant or refractory ovarian cancer from the FDA in 2004 based on Phase II data, and is eligible for FDA's programs that are designed to facilitate drug development and expedite marketing approval of drugs intended to treat serious or life- threatening disease and to address unmet medical need. As a fast track product, phenoxodiol will be eligible for accelerated approval and priority review of the marketing application.
"We are pleased that the FDA has completed the SPA review process and that we have a mutually-agreed design that provides us with a clearly defined regulatory pathway for pursuing marketing approval of phenoxodiol," said Professor Graham Kelly, Chairman, Marshall Edwards, Inc.
About Ovarian Cancer Treatment
Platinum-based drugs such as cisplatin and carboplatin are a standard form of chemotherapy in ovarian cancer, with a high initial response rate. However, at least 85-90% of these patients will experience disease recurrence, subsequently showing a lower level of response to both platinums and other chemotherapies. Most of these tumors ultimately become resistant to platinums, and platinum-resistant tumors invariably are resistant to other forms of chemotherapy.
About OVATURE
Four hundred and seventy (470) patients are to be enrolled and randomized to two treatment arms -- (i) carboplatin + phenoxodiol, and (ii) carboplatin + placebo. The carboplatin will be administered weekly intravenously, and the phenoxodiol or placebo will be capsules administered 8-hourly on a continuous daily basis.
The trial will involve up to 60 sites in the United States, the United Kingdom, Europe, and Australia.
The primary endpoint of the trial is progression-free survival, representing death or disease progression, whichever comes first. Overall survival is a secondary endpoint.
Enrollment is not expected to open for at least a month. More information about the study will be available in due course at phenoxodiol.com or clinicaltrials.gov. These sites will contain information on when and where the trial is open for enrollment.<<
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So there can't be much news left, unless something they've something to say at ASCO that hasn't been said, which I doubt. Still smelling a financing in the offing . . .
Cheers, Tuck |
