Management Team and Scientific Collaborations: Oncolix has assembled an experienced management team in the areas of drug development, clinical trial management and manufacturing. Michael Redman, MBA is the CEO with over 20 years of pharmaceutical and biotech experience. He has extensive licensing experience and has consummated deals with several large pharmaceutical companies. Donald Payne, MBA, has extensive management, financial and drug development experience.
Intellectual Property: Oncolix holds in its name eight issued US patents and additional foreign patents with additional pending applications. Oncolix pays no milestones or royalties on these patents. Prolanta has been granted Orphan Drug designation in the US, which provides seven years of marketing exclusivity. In addition, the Healthcare Reform Bill provides 12 years of data exclusivity for biological products. Orphan status in Europe and Japan would provide 10 years of market exclusivity.
Regulatory Path: Oncolix intends to develop Prolanta primarily as a combination with chemotherapy in ovarian and other cancers. The next indication targeted for Prolanta will be UC/uterine sarcoma. Oncolix intends to commence a Phase IIa trial with a combination of Prolanta with chemotherapy in 2017. Oncolix has the potential to file for Breakthrough Status with the FDA. Oncolix will also evaluate Prolanta in preclinical efficacy studies for the treatment of UC with MD Anderson Cancer Center in 2017.
Business Model: Oncolix intends to add value from Prolanta clinical trials until a desirable exit strategy is achieved. The Company also intends to be a public company in 2017.
Financing: Oncolix has raised $16 million to date. The current investors include the Greenville Hospital System, the Texas Emerging Technology Fund, PoC Capital, BioVectra (now Mallinckrodt), Ernest Mario Family Fund (former CEO of Glaxo) and company management. Oncolix intends to raise additional capital necessary to complete its upcoming Phase IIa trial in ovarian cancer.
