Full Press Release Details
MONTREAL, Aug. 10, 2011 (GLOBE NEWSWIRE) -- Sunshine Biopharma Inc. (OTCBB:SBFM) - Aggressive breast cancer has been traced to two key genetic culprits: the HER2 and TOP2 genes. Roche's Herceptin drug is the standard of care for HER2 positive patients, but there is currently no therapy that targets TOP2.
Enter Sunshine Biopharma (OTCBB:SBFM) of Montreal.
Its flagship compound, Adva-27a, has shown "phenomenal results" in early testing to target and inhibit the Topoisomerase 2 (Top2) enzyme, one of the most important targets for treating aggressive cancer, CFO Camille Sebaaly says in an exclusive interview with BioTuesdays.com.
"Our technology is unique," he says, adding that Sunshine is the "only company that has a Top2 inhibitor" and that "we have two patents covering our technology and lead compound."
Investor interest in Sunshine exploded last month after the company disclosed that it had completed a detailed cytotoxicity study (a measure of a drug's ability to destroy cancer cells in vitro) of Adva-27a in a multidrug resistant breast cancer cell line.
The study's results showed that Adva-27a is 16 times more effective at killing multidrug resistant breast cancer cells than Etoposide, the current chemotherapy of choice.
In addition, data generated by the study revealed that Adva-27a is unaffected by the molecular machinery which makes cancer cells resistant to drugs, a major reason for the failure of many chemotherapies.
Mr. Sebaaly says that when aggressive cancer cells make too much of the Top2 enzyme, cells proliferate and metastasize. He states, "So, if you can inhibit or destroy the activity of Top2, you would then be able to prevent cancer cells from spreading." Moreover, the more Top2 the cell makes, the more effective Adva-27a is at killing that cell, he adds.
Shares of Sunshine, after closing out the month of June at 55 cents, jumped 73% to finish at 95 cents on Friday, giving the company a market cap of $29 million. The stock touched a 52-week high of $1.45 last week.
According to the American Cancer Society, some 1.5 million new cases of cancer are diagnosed each year in the U.S., of which 230,000 are breast cancer cases. More than 11 million Americans are living with cancer, including 2.5 million with breast cancer.
Sunshine developed its proprietary Difluoro chemistry to synthesize Adva-27a in collaboration with l'Institut National des Sciences Appliquees of France. Specifically, the technology results in the replacement of an unstable "diester bond" found in many therapeutically important compounds, which links different parts of a molecule together, with a completely stable mimic, known as a "Difluoro bond". The technology has allowed the company to create a variety of therapeutic compounds that are stable and often more active than the original drugs.
Mr. Sebaaly says that in addition to its initial indication of multidrug resistant breast cancer, Adva-27a can be used to treat other Top2 positive cancer types, including, prostrate, colon, lung, ovarian and stomach, and notes that prostate cancer will likely be the second indication for the drug, which can be taken orally.
Mr. Sebaaly says the protocol for a Phase 1 clinical trial of Adva-27a, involving 20 to 25 cancer patients, is in the process of being completed. "Our multidrug resistant breast cancer clinical trial qualifies for "fast track" regulatory review process both in the U.S. and Canada," he adds.
The trial will be conducted at McGill University's Jewish General Hospital in Montreal. If the trial is successful, Sunshine hopes to receive regulatory approval for "compassionate use" sales of Adva-27a, Mr. Sebaaly adds.
Mr. Sebaaly says Sunshine doesn't have a partnering strategy now, adding, "We will consider a possible partnering deal after Phase 1. If the drug proves to do in humans what we expect, it will be a blockbuster."
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