Sunshine Biopharma Inc. (OTCQB: SBFM) reported on Thursday that it is in negotiations with Contract Manufacturing Organizations, or CMOs, as the next progression towards the anticipated clinical trials of its flagship cancer drug, Adva-27a, against multi-drug resistant forms of breast cancer.

The trials are scheduled to be hosted by the leading cancer center Jewish General Hospital in Montreal, Canada, one of McGill University’s hospital centers. Filings with the SEC for Sunshine show the trials are targeted to begin in late 2013 or early in 2014.

The company filed a patent in January for Adva-27a, clearing the path for discussions with manufacturers to produce one kilogram of material, enough to complete the remaining pre-clinical research – including toxicology studies – and the first planned clinical trial, according to the company.

Sunshine also said that it intends to offer any leftover Adva-27a from the one kilo batch for “compassionate use,” programs where seriously-ill cancer patients that are not part of a clinical trial can request access the investigational drug.

Some readers may remember the social media efforts early in 2012 by Darlene Gant, a HER2-positive breast cancer patient that used YouTube to post a self-made video plea for Roche’s (OTCQX: RHHBY) Genentech to give her some pertuzumab for compassionate use before it was approved. Genetech initially had refused, even though the FDA had given the green light, but eventually provided the drug candidate. Pertuzumab, also called Perjeta, gained FDA approval in June 2012 as a treatment in combinations with Herceptin and docetaxel for HER2-positive breast cancer patients.

Roche, the biggest cancer drug maker in the world, has control of the HER2 breast cancer market with its franchise. Herceptin, which is also used for stomach cancer, generated about $6.2 billion in global sales in 2012.

Even as robust as the sales figure is for Roche, the HER2-positive cancer population is actually the minority; representing about 25 – 30 percent of all breast cancer patients. The remaining patients fall into the category of being Top2-positive, for which there are no approved drugs targeting this biomarker that have remotely come close to Roche’s success with Herceptin.

Sunshine has its focus on the Top2-positive market with Adva-27a. According to recent press, Adva-27a has shown potent anti-tumor activity across every cell line tested, including multidrug resistant breast cancer, multidrug resistant uterine cancer and small-cell lung cancer.

“The excitement is growing stronger at Sunshine Biopharma as we move towards completion of the IND-Enabling studies and the filing of our IND application. We have systematically collected years’ worth of data demonstrating the potential of Adva-27a and feel that we are well positioned to deliver on our commitment to build shareholder value with our novel breast cancer compound,” said Dr. Steve N. Slilaty, President and Chief Executive Officer of Sunshine Biopharma, in today’s statement.

Shares of SBFM are ahead by 30 percent over the past 52 weeks, trading at 26 cents on Thursday. In the typical cycle of a biotech nearing trials, it could be expected that activity around this stock will be increasing in coming months as the human trials approach.

Sunshine Biopharma (SBFM) Stock Quote and News:

Roche Holdings (RHHBY) Stock Quote and News:

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