Q: Investorideas.com
Dr. Slilaty can you explain to investors the significance of the recent move to Canada corporately and what direct benefits are realized?
A: Dr. Steve N. Slilaty Ph.D., Chairman, CEO
There are several advantages relating to the fiscal environment in Canada which are conducive to companies planning to expand through acquisitions. For example, there are provisions in the Canadian Tax Act which allow Canadian companies to acquire other Canadian companies in a share exchange transaction on a tax exempt basis. In addition, there are significant tax credits available to Canadian companies conducting R&D in Canada and Sunshine’s drug development program would benefit a great deal such tax provisions.
Q: Investorideas.com
For investors unfamiliar with your company, can you give a brief history of some of the data and testing on your lead compound Adva-27a and the basic principle of how it works?
A: Dr. Steve N. Slilaty Ph.D., Chairman, CEO
Adva-27a is Topoisomerase 2 inhibitor. Suppression of Topoisomerase 2 enzyme activity is a well-established anticancer target. Unlike all existing Topoisomerase 2 inhibitors, Adva-27a continues to work even when cells become multidrug resistant. This remarkable property is unique to Adva-27a! Our preclinical studies to date have shown that:
- Adva-27a is effective at killing different types of multidrug resistant cancer cells, including:
- Breast Cancer Cells (MCF-7/MDR)
- Small-Cell Lung Cancer Cells (H69AR)
- Uterine Cancer (MES-SA/Dx5)
- Pancreatic Cancer (Panc-1)
- Adva-27a is unaffected by P-Glycoprotein, the enzyme responsible for making cancer cells resistant to anti-tumor drugs
- Adva-27a has excellent clearance time (half-life = 54 minutes) as indicated by human microsomes stability studies and pharmacokinetics data in rats
- Adva-27a clearance is independent of Cytochrome P450, a mechanism that is less likely to produce toxic intermediates
- Adva-27a is an excellent inhibitor of Topoisomerase II with an IC50 of only 13.7 micromolar
- Adva-27a has shown excellent pharmacokinetics profile as indicated by studies done in rats
- Adva-27a does not inhibit tubulin assembly
- Adva-27a exhibits low toxicity levels as indicated by measurements using the non-cancerous cell line, HMEC
With data on multiple cancers, is there one area the company will focus on specifically?
A: Dr. Steve N. Slilaty Ph.D., Chairman, CEO
Yes, we are initially focused on treating breast cancer patients whose disease has become multidrug resistant. These patients currently have no treatment options available to them as all existing anticancer drugs cease to work. We are anxious to make our Adva-27a available to them soon. To this end, we have signed an agreement with McGill University’s Jewish General Hospital here in Montreal ( Canada) to conduct Phase I clinical trials on such patients. This is the first step in our clinical development program of Adva-27a.
Q: Investorideas.com
For investors unfamiliar with the difference between getting approval in Canada vs. US FDA approval, can you explain the process in Canada, the timelines, cost and what is next for Sunshine Biopharma?
A: Dr. Steve N. Slilaty Ph.D., Chairman, CEO
The approval process in Canada is very similar to that of the United States. Health Canada has very similar guidelines to those established by the FDA in the U.S. In fact, our Phase I clinical trials protocols are compliant with the requirements on both sides of the boarder and we will be able to file our results both in Canada and the US pretty much simultaneously. In terms of timelines, like the U.S., Canada has a so-called “fast-track” process for which is available for drugs that treat terminally ill patients as is the case with Adva-27a. Next, we anticipate initiating the human trials following completion of our next round of financing.
About Adva-27a
Adva-27a is Sunshine Biopharma's lead anticancer compound, a small molecule that has recently been shown to be effective at killing multidrug resistant breast cancer cells, small-cell lung cancer cells, uterine sarcoma cells and pancreatic cancer cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). Adva-27a is currently in the IND-Enabling stage of development. The original U.S. patent covering Adva-27a was issued on August 7, 2012 under US patent number 8,236,935.
About Sunshine Biopharma Inc. (OTCQB: SBFM):
Sunshine Biopharma is a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer. The Company's lead compound, Adva-27a targets aggressive forms of cancer www.sunshinebiopharma.com
Recent news: http://finance.yahoo.com/news/sunshine-biopharma-domicile-canada-expansion-130000999.html
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