MONTREAL--(Marketwire - September 13, 2012) - Sunshine Biopharma Inc. (OTCBB: SBFM), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, reports recent progress which has enabled the Company to advance to the next phase of drug development, namely GMP manufacturing, IND-enabling studies and Phase I clinical trials in humans.
"We have made significant recent strides in terms of research results showing the effectiveness of our lead compound against cancer cells as well as in our manufacturing, and recent fund raising efforts," said Dr. Steve N. Slilaty, President and CEO of Sunshine Biopharma.
While Adva-27a has proven very effective in its ability to kill various types of cancer cells, the compound's most remarkable activity is against multidrug resistant cancer cells. The Company has previously reported that Adva-27a is particularly effective against Multidrug Resistant Breast Cancer cells (MCF-7/MDR) and Small-Cell Lung Cancer cells (H69AR).
The Company has also previously reported that Adva-27a has performed extremely well in a battery of preclinical tests. These tests have shown that:
- 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.
- 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.
The initial indication for Adva-27a's Phase I human trials will be multidrug resistant breast cancer for which there are little or no treatment options.
The Company has recently taken delivery of a new batch of Adva-27a from the Contract Manufacturing Organization (CMO) and now is proceeding to conduct a series of requisite biological tests to ensure that the newly manufactured batch is identical to the original, not only in terms of chemical structure but also in terms of biological activity.
The Company has recently raised $460,000 through a private offering of its Common Stock, with proceeds being used for manufacturing and other activities in preparation for Phase I clinical trials.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.