It’s been almost three years since we wrote about the promising pre-clinical research being conducted on multiple types of cancer by Montreal-based and U.S.-listed Sunshine Biopharma (OTCQB:SBFM) with its flagship drug Adva-27a, a topoisomerase-2 (Top-2) inhibitor. Our biotech team at AllPennyStocks.com liked what they saw in the small molecule compound back then and still do today, but the drug has still as of yet to enter the clinic.
Lab studies have demonstrated a strong pharmacokinetic profile and data published respected peer-reviewed journals have shown Adva-27a to be effective at destroying multi-drug resistant breast cancer cells, small-cell lung cancer cells, uterine sarcoma cells and pancreatic cancer cells.
The day that humans are finally infused with the experimental drug seems to be drawing closer with Sunshine agreeing in November with global pharmaceutical supplier Lonza to manufacture Adva-27a. Lonza is in the process of manufacturing two kilograms of Adva-27a for clinical studies. Sunshine says it plans to run a tandem of Phase 1 clinical trials on Adva-27a, one for pancreatic cancer and another at McGill University’s Jewish General Hospital in Montreal, for multi-drug resistant breast cancer patients.
Adva-27a is protected under patents in the United States, Canada and Europe. As announced on Tuesday, India can be added to the list with the issuance of a "Notice of Allowance" for the company’s patent application issued for the country.
"In addition to a market comprised of a population of over 1.2 billion people, India is a major participant in the manufacturing and exportation of pharmaceutical products and raw materials around the world," said Dr. Steve N. Slilaty, Chief Executive Officer of Sunshine Biopharma, in the press release today.
Effectively destroying multi-drug resistant tumors is a reason for a great deal of optimism for any drug in development. In the simplest sense, any cancer that kills a person has become drug resistant, as the cancerous cells become impervious to the drug. Top-2 inhibitors are popular targets as chemotherapeutic agents as they induce apoptosis (programmed cell death) by interrupting the ligation step in the cell cycle, amongst other things.
Top-2 inhibitors also are believed to be able to improve clinical outcomes for bacterial infections, such as the Phase 2 trial being conducted by GlaxoSmithKline (NYSE:GSK) of GSK2140944 for treating Gram-positive acute bacterial skin and skin structure infections (ABSSSI). Sunshine sees possibilities in the bacterial space also, including a possible treatment for Ebola.
The patent is good news for Sunshine and the possibilities to treat bacterial infections certainly is a tremendous market, but right now investors seem to want to see the Adva-27a being evaluated for safety and potential efficacy in humans.
Despite encouraging preclinical studies, the stock has been in a perpetual downtrend, trading as high as $1.45 in 2011, $0.79 in 2012, $0.46 in 2013 and $0.27 last year. Shares have now sunk in the area of a penny with a market capitalization around $1 million. Volume has significantly increased in the past two weeks and the stock looks to have found a support just above one cent per share, including trading ahead by 13.8% on Tuesday to close at $0.0165. Biotechs can go through some wild swings and odd valuations, but if Sunshine can initiate one clinical trial underway – and certainly if it can get both going – the $1 million market cap should be a thing of
the past as the preclinical data is too compelling to simply ignore. Proper due diligence is, as always, encouraged.
