Take a look at the wording in Bold Below, the scientist that created Prolanta is the same scientist that created a similar Drug that is used by Pfizer. Sales of that Drug were 160Mil in 2010. GLTY
Sachs Associates
Cancer Bio Partnering Forum
Cancer Bio
Partnering Forum
ADDRESS
14405 Walters Road, Suite 780
Houston, Texas 77014
TELEPHONE
(281) 402-3167
FAX
(281) 698-2070
EMAIL
info@oncolixbio.com
FINANCIAL SUMMARY
Oncolix requires $20 million over the next three years to achieve the following milestones:
• Phase I trial in platinum-resistant ovarian cancer as a monotherapy
• Obtain orphan status in the US, Europe and Japan
• Complete preclinical development for endometrial cancer with MD Anderson
• Phase IIa trial in platinum-resistant ovarian cancer as a monotherapy
• Optimize manufacturing and prepare CMC documentation
• Phase IIb trial in platinum-resistant ovarian cancer as a monotherapy
• Phase I/IIa trial in combination with chemotherapy
COMPANY PROFILE
Oncolix is a clinical-stage biotechnology company focused on cancer. The Company’s primary focus is
developing ProlantaTM for Ovarian Cancer (OC).
Unmet Medical Needs: In the United States, 22,000 new OC patients are diagnosed each year 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 current standard for treatment consists of carboplatin and paclitaxel. Renal toxicity, nausea,
neuromotor toxicity, cardiovascular events, neutropenia, thrombocytopenia and anemia occur in up to 90% of
patients using carboplatin and paclitaxel. There are no targeted therapies approved for OC in the United States.
Solution: Oncolix is developing a novel therapeutic protein (Prolanta). Prolanta targets prolactin receptors, which
are found in gynecological cancers, including OC, endometrial cancer and breast cancer (BC). According to
research performed at MD Anderson Cancer Center (MDACC), monotherapy with Prolanta shows strong activity
in a xenograft mouse model of human OC, substantially reducing both tumor volume and the number of tumors
in a dose-dependent manner with no apparent toxicity noted. Prolanta preclinical data support the potential to
be used in combination with chemotherapy or as a monotherapy for patients resistant to or those who cannot
tolerate chemotherapy.
Novel Mechanism of Action: MDACC discovered that the primary mechanism of action of Prolanta is
autophagocytosis or autophagy. Prolanta also has an anti-angiogenic effect. Furthermore, Prolanta competitively
binds to prolactin receptors. When human prolactin binds to a receptor, it causes glutathione conjugation to
chemotherapy, which transports the drug out of the cancerous cell.
Investment Opportunity: The FDA approved the IND in 2012. Oncolix expects to commence its first human
trial in 2013. A Phase I, open label, dose escalation, 99-day study will evaluate safety, tolerability, efficacy trends
and the optimal dose of Prolanta monotherapy in metastatic OC. Phase IIA trials are planned to further evaluate
efficacy trends with Prolanta used alone or in combination with chemotherapy. Oncolix requires $3.5 million to
complete the Phase I study and approximately $20 million to advance Prolanta through Phase IIb, which could be
a pivotal trial for this orphan designation.
Science: Prolanta is an analog to human prolactin, identical except for a single amino acid substitution at the
129th position of this 199 amino acid protein. Somavert®, developed by the same scientist using a similar
amino acid substitution in human growth hormone, is now sold by Pfizer for the treatment of acromegaly, or
gigantism (2010 sales were $165 million for this orphan indication).
Patents: Oncolix holds in its name five issued US patents and additional foreign patents. Oncolix pays no
milestones or royalties on these patents. In addition, the Healthcare Reform Bill provides 12 years of data
exclusivity for biological products. Orphan status in Europe and Japan would provide ten ye
