According to Florida Hospital, approximately 80,000 women receive a gynecological cancer diagnosis in the United States each year. About half of all gynecological cancer diagnoses are uterine cancer, which contributes to 8,000 deaths each year while ovarian cancer causes 16,000 deaths annually. Oncolix saw a need for an improvement in the current treatment protocol, thus arose Prolanta (G129R).
Background Regarding Oncolix
Oncolix (Pink Sheets: AEPP) is a Houston-based biotechnology company dedicated to the improvement of cancer treatment. Oncolix’s management team has experience in various aspects of innovative pharmaceutical solutions including clinical development, trial management, manufacturing and licensure. Oncolix’s CEO, Michael Redman, has more than 25 years of experience in biotechnology and pharmaceuticals. He has consummated licensing deals with several revered pharmaceutical companies. The company’s main focus is centered around the drug Prolanta™, which has shown promising results as a breakthrough drug for gynecological cancer treatment. The company commenced operations in 2007 and has since been diligently working on solutions for effective and revolutionary treatments for cancer.
What is Prolanta
Prolanta is laboratory-derived protein administered subcutaneously to patients that blocks human prolactin, a hormone responsible for the production of milk in mammals, from prolactin receptors on cancer cells. Prolactin receptors are over-expressed in individuals who have gynecological cancers including ovarian, uterine and cervical cancer as well as breast cancer. Prolanta induces a signaling pathway (PEA-15) that causes the cancer cells to self-destruct (autophagocytosis or autophagy). Prolanta may be the first drug approved for cancer treatment to have the autophagy mechanism of action.
Not only does Prolanta have an anti-prolactin effect (as a prolactin receptor antagonist) that prevents the prolactin from binding with receptors, it also may have the ability to prevent chemoresistance . When human prolactin binds to prolactin receptors on cancer cells, upregulation of glutathione-s-transferace (GST) causes glutathione to bind to taxanes and platins (the major classes of chemotherapy). This binding causes the chemotherapy to be actively transported outside the cancer cell, leading to chemoresistance. Prolanta competitively binds to these prolactin receptors and may prevent the cascade of events that lead to chemoresistance. At MD Anderson Cancer Center, Prolanta significantly decreased both the number and volume of tumors either used alone or in combination with chemotherapy.
Prolanta has potentially two potent mechanisms of action – autophagy and prevention of chemotherapy resistance. Furthermore, Prolanta has shown to be synergistic to other cancer treatments, including Herceptin, Tykerb, tamoxifen and chemotherapy.
Prolanta does not have the side effects associated with chemotherapy, which are substantial. Because Prolanta is identical to human prolactin with the exception of one single amino acid change (glycine to arginine at the 129th position of human prolactin), Prolanta has to date shown the side effects are minimal. To date in clinical trials, the only side effects associated with the drug have been itchiness and redness at the injection site. Prolanta could be the first drug approved for cancer treatment to have an autophagy mechanism of action. Autophagy describes the body’s natural process of destroying cells in the body.
When Prolanta enters the market, it could be used in conjunction with chemotherapy or alone. Patients who can’t tolerate chemotherapy or are resistant to the drugs could use Prolanta as a monotherapy while patients who are able to tolerate chemo will be able to use both to combat cancer more effectively.
The traditional treatment for ovarian cancer includes a combination of carboplatin and paclitaxel. These two chemotherapy drugs cause harmful side effects such as nausea, neuromotor toxicity, neutropenia, thrombocytopenia, cardiovascular events, anemia and nausea in up to 90 percent of patients. In preclinical studies conducted by the MD Anderson Center, no toxicity was reported with the use of Prolanta. More will be known about potential side effects as the clinical trials progress.
Prolanta’s Clinical Trial Status
As of mid-September, of 2017, Prolanta is in the first phase of clinical trials as a sole treatment (monotherapy) for ovarian cancer. Oncolix plans to initiate a Phase IIa trial in 2018. In regard to the use of Prolanta as a treatment for ovarian cancer along with chemotherapy, the clinical trials will begin in 2018. Oncolix is working with MD Anderson to evaluate additional gynecological cancers.
Prolanta Marketing Information
Prolanta received Orphan Designation from the U.S. Food and Drug Administration (FDA). An Orphan Designation refers to the approval of a drug as a treatment specifically for a rare condition. Orphan status of a drug allows Oncolix to remain as the only company to market the drug for seven years after regulatory approval. If it would earn Orphan Designation in Europe or Japan, Oncolix would be able to be the sole manufacturer of Prolanta for 10 years. Oncolix owns eight U.S. patents, which Oncolix doesn’t pay any royalties. Furthermore, as a biological drug, Prolanta also has 12 years of market exclusivity in the USA under current legislation.
Ovarian cancer is the second most common gynecological cancer. It’s the eighth most common type of cancer when compared to all other types of cancer. Presently, ovarian cancer only has a 28 percent five-year survival rate in its later stages. Unfortunately, most cases of gynecological cancers aren’t diagnosed until after the disease has progressed. Realities like these have led to several revered medical centers and associations helping to fund Prolanta’s development. To date, Oncolix has raised $16 million dollars. The Texas Emerging Technology Fund, PoC Capital, Ernest Mario Family Fund and Greenville Hospital System are among the current investors. Oncolix will require additional funding to complete the Phase IIa trial for ovarian cancer, so the company intends to raise more capital from investors.
About the Author
Stuart Smith is the CEO and Founder of SmallCapVoice.com. SmallCapVoice.com. is a recognized corporate investor relations firm, with clients nationwide, known for its ability to help emerging growth companies build a following among retail and institutional investors. SmallCapVoice.com utilizes its stock newsletter to feature its daily stock picks, audio interviews, as well as its clients’ financial news releases. SmallCapVoice.com also offers individual investors all the tools they need to make informed decisions about the stocks they are interested in. Tools like stock charts, stock alerts, and Company Information Sheets can assist with investing in stocks that are traded on the OTC BB and Pink Sheets. To learn more about SmallCapVoice.com and their services, please visit http://smallcapvoice.com/blog/the-small-cap-daily-small-cap-newsletter/