Whitefish, MT / August 18, 2014 / Many forms of cancer are characterized by a lack of cellular apoptosis (e.g. cell death) and down-regulation of the immune system. In the case of the latter, cytotoxic T lymphocytes ("CTLs") are largely responsible for recognizing and killing cancer cells, but there are some inhibitory mechanisms that interrupt the destruction and prevents cancer cells from being targeted and destroyed.
Cytotoxic T-lymphocyte associated protein 4, better known as CTLA-4, is a key protein receptor found on the surface of T-cells that down-regulates the immune system and leads to cellular immune attack on antigens. Blocking CTLA-4 inhibits the immune system's tolerance for tumors and has become a useful strategy for cancer patients as the first approved immune checkpoint blockade therapy.
Bristol-Myers Squibb (NYSE: BMY) developed the first monoclonal antibody that works to activate the immune system by targeting CTLA-4 under the brand name Yervoy. In March 2011, the FDA approved the treatment for patients with late-stage melanoma that has spread or cannot be removed by surgery, while similar approvals were granted by Health Canada and the European Union.
Targeting Breast Cancer
Premier Biomedical Inc. (OTC: BIEI), a biopharmaceutical company focused on developing and commercializing innovative immune system manipulation therapies for breast cancer and potential novel therapies for other conditions, has been evaluating strategies to take its own Anti-CTLA4 breast cancer treatment through the FDA approval process over the past few quarters.
Premier Biomedical's experimentation on the efficacy of their unique, patent-pending formulation of an anti-CTLA-4 breast cancer drug on mice was presented at the peer-reviewed April 5-9, 2014 American Association for Cancer Research Symposium in San Diego, California. In June, the company released a market study conducted by Penn Biotech Group Healthcare Consulting ("PBG") to evaluate the process. The group projected potential annual revenue of up to $1.9 billion after an exhaustive analysis that included 450 hours of pro-bono work interviewing oncologists and reviewing medical literature to derive an accurate estimate.
The indication joins many other ongoing studies of CTLA-4's role in other cancers, including prostate and lung cancers. In a June 2009 prostate cancer study, two patients involved in a Phase II trial who had been told their condition was inoperable saw their tumors shrink such that the operation was possible and they are now cancer free, although the results are a bit premature.
Diversified Pipeline
Premier Biomedical has a number of other ongoing projects in addition to its Anti-CTLA-4-based breast cancer drug. In two upcoming clinical trials, the company plans on testing its Feldetrex(tm) pain medication, followed by a separate clinical trial of its core technology designed to remove the pathophysiological basis of the disease in what could be a breakthrough moment for the company.
With over $4.5 billion in annual sales for Pfizer Inc.'s (NYSE: PFE) Lyrica(r), a leading drug designed to treat nerve and muscle pain, the company's Feldetrex(tm) could generate significant revenue if successful in capturing a portion of the market. The second clinical trial could have further reaching implications with the potential to treat roughly 19 diseases that are difficult to cure or incurable.
Both of the company's clinical trials will be conducted with the support of the U.S. Department of Defense's William Beaumont Army Medical Center ("WBAMC") and the University of Texas El Paso ("UTEP"). These partners have been instrumental in helping the company progress through its clinical trials and provide credibility for its efforts given that it remains a micro-cap stock with a $3.2 million market cap.
Looking Ahead
Premier Biomedical has numerous upcoming catalysts through both Anti-CTLA-4 breast cancer program and its two upcoming clinical trials. While the two clinical trials provide near-term potential, the breast cancer therapeutic could have blockbuster potential if it reaches PBG's estimates over the long-term. Investors may want to keep an eye on the stock as a result moving forward.
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Source: Emerging Growth LLC