PR coming! Oncolix has an FDA-cleared IND to commence the Phase I study of Prolanta to treat ovarian cancer. Furthermore, Prolanta was granted orphan designation by the FDA for the treatment of ovarian cancer. Because of the unmet medical needs in ovarian cancer, Oncolix will seek accelerated approval after the Phase IIb study, or will roll the Phase IIb results into a Phase III study. Studies in other indications (breast, endometrial cancer and others) are deferred until later in the clinical development process unless the Company receives additional funding (which they did) to commence these trials or the Company enters into a strategic partnership with a large pharmaceutical company.
That large pharmaceutical partnership is Mallinckrodt & BioVectra, they have everything Oncolix needs for the Phase 2B and/or rolling 3, that is the reason for the 8.8% stake.
Targeted therapies are expensive treatments. In the US, Herceptin sells for $64,000 per year (Source: Genentech) and the annual cost of Avastin is $55,000 to more than $80,000 per year, depending on income.If Prolanta could achieve a 5% market share of the US and European prevalence of ovarian cancer, at least $35,000 per patient per year, revenues would surpass $1 billion per year.
The exact reason Mallinckrodt has taken a stake. Clinical trials about to hit the wires.
Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019
GLTA
