OVARIAN CANCER                                                                

In the United States, 22,000 new patients are diagnosed each year with ovarian cancer and 14,000 women die of this deadly disease. While the five-year survival rate is 75% when diagnosed in an early stage, once the disease has spread, five year survival is reduced to 20%.  Most women are diagnosed after the disease has spread.  The incidence of ovarian cancer in Europe is 45,000 and worldwide is 225,000. The prevalence in the United States is 177,162. The prevalence in Europe is about twice that of the United States.
The current standard of treatment is surgical debulking of the tumors and aggressive chemotherapy. The current gold standard for treatment consists of carboplatin and paclitaxel.  Renal toxicity, nausea, neuropathy, cardiovascular events, neutropenia, thromobocytopenia and anemia occur in 30% to 90% of patients using this gold standard of treatment.

Approximately 80% of ovarian cancers express prolactin receptors and these tumors are stimulated by prolactin.  More importantly, prolactin can cross-activate many of the same pathways activated by HER2/neu and the ER.  In HER2 positive cancers, prolactin can cross-activate the same intracellular signaling pathways activated by HER2, an oncogene found in 20% of ovarian cancers that is correlated with a more aggressive type of cancer. Therefore, Prolanta serves as novel candidate for ovarian cancer therapy, either as a stand-alone agent or as part of a combinational approach for a larger proportion of patients.

Preclinical data in a mouse model of ovarian cancer indicates that monotherapy with Prolanta may be highly effective in reducing metastatic tumor burden. 
Prolanta could also be added to existing chemotherapeutic regimens for ovarian cancer (combination therapy). Because Prolanta blocks the action of endogenous prolactin with no intrinsic activity of its own, it would be expected to have a minimal side effect profile, particularly as compared to chemotherapies. 

Oncolix intends to file for Orphan Drug Status (US Orphan Drug Act of 1983) for Prolanta. Oncolix will also ask the FDA for Fast Track designation under the FDA Modernization Act of 1997. Fast Track designation must concern a serious life-threatening condition and has to have the potential to address an unmet medical need.
Oncolix will demonstrate that Prolanta addresses a life-threatening disease (ovarian cancer) and the drug has the potential to increase survival by its use in combination with chemotherapy or with patients who become resistant or are intolerant of the harsh toxicities associated with current chemotherapy. Fast Track product sponsors are eligible to engage in increased "early interaction" with the FDA over clinical trial design and other development issues and may submit license applications on a "rolling" basis.
Under the Priority Review requirements (Modernization Act of 1997), the FDA is authorized to designate marketing applications as Priority or Standard. Priority applications are those that represent a drug with a major advance in treatment or provide a treatment where no adequate therapy exists.
Currently, there are no FDA approved therapies for ovarian cancer accessible to patients outside of clinical trial participation, other than chemotherapy, so Prolanta may meet both criteria. With priority status, the FDA intends to complete the review process in less than six months rather than the standard review time of 10 to 18 months.

Prolanta is a variant of normal human prolactin.
The single glycine amino acid at position 129 has been substituted with arginine (red).