Oncolix, Inc. (Privately Held)

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February 24, 2012 Issue

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With their Therapeutic Protein Drug Prolanta Having a Unique Mechanism of Action Called Autophagy that Causes the Death of Cancerous Cells, Oncolix, Inc. is Well Positioned for a Major Breakthrough in Both Medical and Clinical Science – With their First Target being Ovarian Cancer

Company Profile:
www.oncolixbio.com

Oncolix, Inc.(Oncolix) is a bio-pharmaceutical company based in Houston, Texas. The company is in late pre-clinical development of Prolanta™, a targeted therapeutic protein for the treatment of ovarian and breast cancer. The aim of Oncolix's product development is to bring to market agents with increased efficacy and decreased toxicity in ovarian and breast cancer therapy through targeted therapies. Prolanta™ is anticipated to be effective in the majority these cancer patients as this therapy targets tumors that express the prolactin receptor which occurs in the majority of ovarian and breast tumors.

Michael T. Redman, CEO & Board Member

Mr. Redman is the chief executive officer of Oncolix, Inc. and has served in this position since formation of the company in November of 2006.

Prior to Oncolix, Mr. Redman was the CEO of Bone Medical, a public company focused in the area of oral peptide delivery of products related to musculoskeletal disorders. Immediately prior to Bone Medical, Mr. Redman was the CEO and co-founder of Opexa Pharmaceuticals, which commenced operations in February of 2001 and was successfully sold to PharmaFrontiers Corporation in November of 2004. PharmaFrontiers later reorganized the company, which is now named Opexa Therapeutics, a NASDAQ-listed company.

His career spans over 25 years in the pharmaceuticals and biotechnology industry and encompasses leadership in sales, marketing, business and commercial development. In addition to the three companies in which he served as CEO, Mr. Redman also held key management positions with Zonagen, Aronex Pharmaceuticals, Biovail, and American Home Products.

Mr. Redman has been instrumental in closing multiple pharmaceutical licensing deals, both domestic and international. These deals include in-licensing of university and NIH intellectual property, acquisitions and divestitures. He is an active member of the Licensing Executives Society and formerly served on its Executive Committee. Mr. Redman earned a BA in Biology from the University of Missouri and a Masters in Business Administration from the University of Phoenix.

Healthcare
Bio-Pharmaceutical
(Privately Held)

Oncolix, Inc.
14405 Walters Road, Suite 780
Houston, TX 77014
Phone: 281-402-3168
www.oncolixbio.com

 

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – February 24, 2012

CEOCFO: Mr. Redman, you have a fairly extensive experience in the industry, what attracted you to Oncolix?

Mr. Redman: I think what first attracted me to the company is that the Greenville Hospital system had a translational research program with more than twenty different technologies. Originally they asked me to commercialize all of them, but then when I looked at the opportunities I saw that there was one gem and that was the drug that is now called Prolanta. Therefore, the rest of these technologies returned back over to the Greenville Hospital system and we put all of our efforts into a drug that is now ready for human clinical trials.

CEOCFO: Would you tell us a little about Prolanta?

Mr. Redman: Prolanta is a drug that is a therapeutic protein. It is identical to human prolactin with the exception of a single amino acid change. Human prolactin has 199 amino acids. We substitute a very small glycine with a very large arginine at the 129^th amino acid position of this protein, which changes our drug in a way that is now serving as an antagonist and therefore it blocks prolactin receptors that are found on the surfaces of gynecological cancers and breast cancers. By disrupting this signaling pathway, it causes death of the cancerous cells by a unique mechanism of action, which is called autophagocytosis or autophagy.

CEOCFO: Where is Oncolix in the development process?

Mr. Redman: On January 19^th of this year we received clearance from the FDA to commence our first clinical trial in humans.

CEOCFO: What does Oncolix need to get the trials started?

Mr. Redman: Right now we are manufacturing a drug and putting it on stability. In addition, we are trying to raise some additional capital so we can fund the company through the end of our Phase I trial. We have closed about one-third of the money that is required over the next twelve months last week.

CEOCFO: What is the potential market for Prolanta? Will it be used alone in combination with other drugs? What phase of the cancer is being targeted?

Mr. Redman: Currently, the market for ovarian cancer is relatively small compared to other cancer markets and that is only because the current therapies being used are old chemotherapy drugs. If we had some targeted therapies approved for ovarian cancer like we do in breast cancer, for example with Herceptin, then the market would grow exponentially in my opinion. To give you an example, the therapies in ovarian cancer are very inexpensive as compared to Herceptin in breast cancer, which can cost more than $40 thousand per patient per year. There are some other products in the pipeline for ovarian cancer, but today there are no approved targeted drugs in ovarian cancer in the United States. Getting back to the second question, which is will this drug work as a model therapy or a combinational therapy? The answer is we believe that it could work both ways. In ovarian cancer, patients very quickly become resistant to chemotherapy and our preclinical research shows that our drug will work effectively alone or in combination with chemotherapy. In ovarian cancer and in breast cancer animal models, the data shows that we will work either as a monotherapy or in  combination with chemotherapy or targeted drugs like Herceptin, Tykerb or tamoxifen.

CEOCFO: What have you learned from prior experience in the commercialization process about how to actually get people to sit up and pay attention once you got all the data?

Mr. Redman: I wish I could tell you that there was a magic formula, but the science always speaks for itself. Very intelligent people such as scientists and clinicians look at the data, so trying to paint a nice story behind a bad drug normally does not work very long. However, compelling data makes the management team look much better.

CEOCFO: Targeted drugs seem to be a big focus in cancer these days!

Mr. Redman: There are targeted drugs being developed for all different types of cancer. Now, there is a segment of the industry that is only looking at trying to make a better mouse trap with the chemotherapy drugs to make them safer and better tolerated. However, the majority of the emphasis is in targeted therapies for ovarian cancer as well as all the other gynecological cancers and in cancer in general. These targeted therapies usually have a more robust mechanism of action and they generally have a much safer profile than chemotherapy drugs.

CEOCFO: Why did Oncolix choose to start with breast cancer and ovarian cancer; is there a link between the two?
Mr. Redman: We first developed this drug with the Greenville Hospital system, and Wen Chen, who is the inventor of Prolanta, focused his attention on breast cancer. The reason that we are starting with ovarian cancer has nothing to do with the market potential for ovarian cancer. It is just that it is less expensive, the trials are shorter and there is less competition in ovarian cancer. We were fortunate enough to meet Anil Sood at MD Anderson and he convinced us that ovarian cancer should be our first target. Ovarian cancer is also an Orphan Drug potential submission, so the registration cost would be less expensive. We can possibly get a registration on a well controlled Phase IIb trial and be either primary therapy or neo-adjuvant therapy with chemotherapy. In breast cancer we would start off as a fourth or fifth line therapy, so there are many advantages of targeting ovarian cancer prior to focusing on breast cancer. It would probably take 2,000 to 3,000 patients to get a registration in breast cancer, but the number of ovarian cancer patients would be substantially less.

CEOCFO: Is Oncolix looking to work with partners, and if so, at what point might you want to reach out to others to join with you?

Mr. Redman: We are always willing to work with partners, but it is a matter of wine before its time. We believe that with limited resources we could advance this product to a stage that it would be far more valuable to our current shareholders as compared to licensing out the product before we have any human data.

CEOCFO: Why should investors pay attention now to Oncolix?

Mr. Redman: Our drug may be a major breakthrough in both medical and clinical science. First of all, it is the novel mechanism of action. Second, there have been a number of companies that have tried to find a drug that will be effective in ovarian cancer and there has been very little advancement in this disease in the last twenty to twenty-five years. Therefore, it is a market that would be lucrative if someone could come up with a product that demonstrates efficacy and we think we have that with Prolanta.

CEOCFO: Final thoughts, what should people remember most about Oncolix?

Mr. Redman: I would like to say that we all know it is a tough market to raise money in the current environment, but good companies with good drugs do get funded and we are very optimistic that we will continue to receive funding. We have raised $10.8 million so far and we have every reason to believe that if we continue showing good results we will always be financed, so we can advance our drug into advanced clinical trials.

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Prolanta is a drug that is a therapeutic protein. It is identical to human prolactin with the exception of a single amino acid change. Human prolactin has 199 amino acids. We substitute a very small glycine with a very large arginine at the 129^th amino acid position of this protein, which changes our drug in a way that is now serving as an antagonist and therefore it blocks prolactin receptors that are found on the surfaces of gynecological cancers and breast cancers. By disrupting this signaling pathway, it causes death of the cancerous cells by a unique mechanism of action, which is called autophagocytosis or autophagy. - Michael T. Redman