SBFM Rocka's New Stock Profile Sunshine Biopharma,

SBFM
Rocka's New Stock Profile
Sunshine Biopharma, Inc. SBFM

Sunshine Biopharma, Inc. is a Montreal, Canadian based biotech company that is focused on the research, development and commercialization of drugs for the treatment of various forms of cancer.

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

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.

Proprietary Technology

Many therapeutically important compounds contain diester bonds that link different parts of the molecule together. Diester bonds are naturally unstable often leading to suboptimal performance when the molecule is administered to patients. Diester bonds have specific electrostatic properties and three-dimensional structure that cannot be easily mimicked by other bonds. Chemical structures that do not mimic the diester bond correctly invariably render the compound biologically inactive. In collaboration with Institut National des Sciences Appliquées de Rouen in France (“INSA”), our licensor, Advanomics Corporation, has developed a way to replace the diester bond with a Carbon-Difluoride bond which acts as a perfect diester isostere. An isostere is a different chemical structure that mimics the properties of the original. In the body, Carbon-Difluoride compounds are resistant to metabolic degradation but are recognized similarly to the diester containing compounds (see Figure below). This technology allows us to create a large variety of therapeutic compounds that are completely stable and often more active than the original drugs.

This unique capability allowed us to create our Lead Compound, Adva-27a, an effective and highly specific Topoisomerase II (Top2) Inhibitor. Our in vitro studies have shown that Adva-27a is very effective at killing a variety of cancer types including Multi-Drug Resistant Breast Cancer.


Our Carbon-Difluoride Technology is covered by issued and pending patents filed under PCT/FR2003/002330 and PCT/FR2007/000697.

According to the American Cancer Society:

•Approximately 1.5 million new cases of cancer are diagnosed each year in the U.S.
•Over 11 million Americans are living with cancer.
•Virtually all cancers are either aggressive at the onset or become aggressive over time.
•The overall cost of disease treatment is over $126 billion annually.

Aggressive Cancers

•There are two genes which are associated with aggressive forms of cancer: Her2 and Top2
•Herceptin (R)* is an effective treatment for Her2 positive patients.
•There are currently no effective therapies that target Top 2.
•*Herceptin (R)* sales are $1.8 Billion per year.


The Her2 and Top2 Genes

•Her2 gene encodes Human Epidermal Growth Factor Receptor 2
•Top 2 gene encodes Topoisomerase II, an enzyme that unwinds DNA and is required for cell proliferation.
•Her2 and Top2 are located on Chromosome 17 near the BRCA1 gene at 17q21-q22.
•Top2 is often co-amplified in aggressive cancers.
•As many as 10 copies of the Top2 gene have been found in Multi-Drug Resistant Breast Cancer cells.

Inhibition of the Top2 Enzyme

•Inhibition of Topoisomerase II activity (Top2) is essential in the fight against aggressive types of cancer, including multi-resistant breast cancer.

RECENT DEVELOPMENTS

On November 15, 2011 the company announced that it had successfully completed the preclinical studies for Adva-27a, the Company’s lead oncology drug candidate. Adva-27a was found to have unique pharmaceutical properties of substantial clinical interest. In summary, the results to date have shown that:

• Adva-27a is 16-times more effective at killing multidrug resistant breast cancer cells than Etoposide, the drug currently in use.
• 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.
• Adva-27a’s initial indication will be multidrug resistant breast cancer for which there are little or no treatment options.
At that time, the company said, “We are now ready to move to the next stage in our Adva-27a drug development program,” said Dr. Steve N. Slilaty, President and CEO of Sunshine Biopharma. “In this stage we will conduct GMP manufacturing of Adva-27a and then use the material to perform the so-called IND-enabling studies, following which we will file our IND Application and proceed to doing Phase I clinical trials,” he added. Dr. Slilaty also stated, “We are delighted to have completed this milestone and are looking forward to the challenges ahead leading to our ultimate goal of improving the quality of life for cancer sufferers.”
The company anticipated that this stage would take 3-4 months to complete from the start date of mid-November.

Partnerships

In June 2011, Sunshine Biopharma entered into a Clinical Trials Agreement with The Jewish General Hospital, one of McGill University’s Hospital Centers, to conduct the necessary research and development to advance Sunshine’s lead compound, Adva-27a, through the various stages of preclinical studies and Phase I clinical trials for Top2 Positive Cancers including small-cell lung cancer.

In January 2011, Sunshine Biopharma entered into a collaboration agreement with Binghamton University (Binghamton, NY) to begin conducting the necessary research and development to advance Sunshine’s lead compound, Adva-27a through various stages of preclinical development and Phase I clinical trials for breast cancer and prostate cancer.

The Company is planning to expand its product line through acquisitions and/or in-licensing as well as in-house research & development.

Financials

10-Q http://www.otcmarkets.com/edgar/GetFilingHtml...ID=8228843

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