The clinical research organization (CRO) will project manage a new trial that seeks to produce data suitable for an application seeking marketing approval in the US and elsewhere for phenoxodiol for the treatment of recurrent, chemo-refractory ovarian cancer.
This pivotal trial will be known as the OVATURE trial and will represent the third and final stage in the development of phenoxodiol in this indication.
“This pivotal study has been expedited in a departure from the normal progression of clinical development, as a result of the findings from the current phase Ib/IIa trial,” said Dr Graham Kelly, executive chairman of Marshall Edwards. “Although the phase IIa study is not fully enrolled, the positive tumor responses in that study have convinced the company to move forward without delay into a pivotal trial.”
Phenoxodiol is being developed as a drug that has anticancer activity in its own right, but also a particular clinical benefit in being able to restore sensitivity to standard drugs in patients with cancer that has become unresponsive to such drugs. Ovarian, prostate and renal cancers are three cancer types where phenoxodiol is being developed as a chemo-sensitizer.
In the case of patients with late-stage ovarian cancer, the development of resistance to standard drugs is a major barrier to the successful management of these cancers. Being able to restore sensitivity to platinum drugs in particular would represent a major breakthrough in the management of such cancers.