Marshall Edwards Inc., announced that the US FDA has granted the investigational anti-cancer drug, phenoxodiol, fast track status for its intended use in patients with recurrent ovarian cancer.
FDA granted fast track status for the reasons: Recurrent ovarian cancer that is resistant or refractory to platins and taxanes is a life-threatening condition; Phenoxodiol intravenous demonstrates potential to address an unmet medical need by restoring chemo-sensitivity in resistant/refractory ovarian cancer," the company release said.
The Fast Track application submitted to the FDA contained clinical data including tumour measurements based on radiographic examination. The data are from the current phase Ib/IIa study where patients with recurrent ovarian and primary peritoneal cancers are receiving phenoxodiol (intravenous dosage form) in combination with paclitaxel in those patients where the cancer is refractory or resistant to taxanes, or in combination with cisplatin where the cancer is refractory or resistant to platinum-based drugs.
"We are developing phenoxodiol for the treatment of a wide range of cancers, but for the purpose of this fast track programme, we are focusing on its use as a chemo-sensitizing agent in recurrent, late-stage ovarian cancer," said Dr. Graham Kelly, executive chairman of Marshall Edwards, Inc.
"Ovarian cancer is one of the most devastating forms of cancer, with half of the women diagnosed with it dying within five years," Dr. Kelly said adding, "The FDA's decision to accept phenoxodiol into its fast track programme reflects the dire need to provide help for women with this deadly disease once they become resistant to standard anti-cancer drugs."
Phenoxodiol is an investigational product that regulates signal transduction pathways in cancer cells resulting in the break down of the intra-cellular proteins - XIAP (X-linked Inhibitor of Apoptosis Protein) and FLIP (Fas Ligand Inhibitory Protein) - which block the ability of the cancer cell to undergo apoptosis via the death receptor mechanism.
Phenoxodiol works selectively on tumour cells because of its interaction with the tumour-specific NADH oxidase, which is restricted to cancer cells. Clinical trials to date have revealed no significant drug related adverse side effects. Phenoxodiol is an investigational drug and, as such, is not approved for marketing in the United States.
Under the FDA Modernization Act of 1997, designation as a Fast Track product means that the drug for the designated indication is eligible for accelerated marketing approval programmes.