CLINICAL DEVELOPMENT STRATEGY

The first clinical trial of Prolanta in metastatic breast cancer is anticipated to begin in Q4 2010.  This phase I/II clinical research study will consist of three sequential parts: phase Ia is a dose escalation study of Prolanta monotherapy, phase Ib is a dose escalation study of Prolanta in combination with chemotherapy and phase IIa is a study of the optimal dose of Prolanta combined with chemotherapy. The study will assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of Prolanta. In the phase IIa portion of the trial, phosphorylation of tumor oncogenes and expression of markers of proliferation and apoptosis will be evaluated before and after treatment with Prolanta to determine the optimal biologically effective dose. A total of 40 to 50 patients will be evaluated in this trial. The trial will be an open-label study conducted at three sites. Women with breast cancer that is resistant to standard therapies or for which there is no effective treatment will be enrolled.

A Phase IIa trial evaluating the effect of Prolanta in combination with chemotherapy in women with metastatic ovarian cancer will be planned to begin shortly after the start of the Phase IIa breast cancer trial.

Currently, Oncolix is collaborating with researchers at MD Anderson Cancer Center to conduct in vitro and in vivo studies designed to aid in the development of clinical trial strategy for ovarian cancer. Preclinical studies in breast cancer models have shown that treatment with Prolanta in combination with current breast cancer therapies has the potential to improve the clinical outcome and may also demonstrate efficacy in the treatment of patients whose tumors lack the HER2, estrogen and progesterone receptors (triple negative). Therefore, the clinical development path for Prolanta has many options. Oncolix is determining the best strategy to employ while preclinical toxicity studies are underway. These studies are expected to be completed by end of the Q2 2010.

CLINICAL TIMELINES