A Biotech Triple Play

by John Persinos
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Submitted by John Persinos as part of our contributors program.

Here’s a startling fact: The odds around the world of getting stricken with cancer are approximately 44 percent for men and 38 percent for women. Clearly, there’s still a dire need to combat the global scourge of cancer with more effective treatments.

Oncologists, the physicians who study, diagnose, and treat cancerous tumors, increasingly believe that the most powerful weapon in the War on Cancer would be a gene therapy that stimulates certain existing functions within human cells. For many researchers, the Holy Grail of cancer treatment is to leverage inherent aspects of the body to defend itself.

Most cancer treatments don’t take this approach, but that’s precisely the path pursued by Senesco Technologies(OTC QB:SNTI).

Senesco, a biotechnology firm based in Bridgewater, NJ, is developing a promising therapy, dubbed SNS01-T, for multiple myeloma.

Multiple myeloma is an incurable cancer of plasma cells, whereby abnormal cells accumulate in the bone marrow, leading to bone lesions and undermining the generation of healthy blood cells. SNS01-T targets the cancers of B-cells, which are the immune system’s white blood cells.

Senesco’s cancer treatment selectively induces apoptosis (i.e., cell death) via eukaryotic translation initiation factor 5A (eIF5A), a protein in humans that is believed to be an important regulator of cell growth and cell death.

Senesco’s researchers have discovered that accelerating apoptosis has applications in treating cancer, while delaying apoptosis may be useful in treating certain inflammatory diseases, notably diabetes. The incidence of diabetes is accelerating around the world, especially in increasingly affluent emerging nations that are adopting western lifestyles.

The opportunities for this type of treatment in the “life sciences” sector are massive. The market for cancer vaccines grew from $48 billion a year in 2010 to $75 billion in 2012.

Drugs that target “signaling pathways,” of which Senesco’s treatment is a leading example, represent the hottest area of cancer research today.

A signaling pathway encompasses a group of molecules within a cell that work in concert to control one or more cell functions, such as cell death. After the first molecule in a pathway receives a signal, it activates another molecule.

This process is repeated until the last molecule is activated and the cell function involved is performed. The presence of abnormal activation within signaling pathways—when triggers go “haywire,” so to speak—can generate cancerous tumors. Senesco’s treatment blocks or manipulates these pathways, consequently blocking cancer cell growth and killing cancer cells.

The US government has granted Senesco “orphan drug” status for SNS01-T, the company’s lead drug candidate for treatment of multiple myeloma. The federal Orphan Drug Act grants special status to a product to treat a rare disease or condition upon request of a sponsor. The product to treat the rare disease or condition must adhere to certain federal criteria, which Senesco has met.

This orphan designation is much coveted by biotech firms, because it streamlines and hastens the US Food and Drug Administration (FDA) approval process, removes copious amounts of red tape, and gives the drug enhanced patent protection.

The rationale for the law is to encourage the launch of valuable drugs that might not make it to market because they’re too expensive to develop.

Smaller firms, in particular, find the law useful because it allows them to devote time and money to the development of drugs without fearing that a larger competitor with deeper pockets will swoop in and compete against them.

Orphan designation also qualifies the sponsor of the product for tax credits and marketing incentives. For example, an orphan drug is not subject to a prescription drug user fee.

Senesco’s therapy has already successfully completed Phase 1b/2a of the FDA’s clinical trials, with promising results. The trials found that SNS01-T was well tolerated, with two out of three patients achieving “stability” of their disease. Phase 2b of the study is slated to begin sometime this year.

Three Goals, Same Technology

It may seem hard to fathom, but Senesco’s initial focus was on genetically modified seeds, using the same technology to help farmers enhance the yields and disease resistance of their crops.

Senesco develops and licenses the same cancer-fighting gene technologies to boost the quality and productivity of fruits, flowers, vegetables, forestry species, agronomic crops, and biofuel feedstock crops. It’s all accomplished by the very same control of cell death and growth in plants.

In the agricultural sector, Senesco enjoys a marketing partnership with ag giant Monsanto (NYSE: MON), the world leader in the production and development of genetically modified seeds.

The US is a huge and estab­lished market for Senesco’s genetically modified seeds. However, there also are major opportunities for growth in emerging markets that are increasingly looking to boost grain crops, to meet the booming consumption of meat by their rising middle classes.

Drought-resistance plays a major role as well. During last year’s growing season in the US, drought plagued roughly 56 percent of the contiguous US, one of the most extensive water shortages in US history.

Worldwide drought created by climate change, combined with the adoption of America-type diets in countries such as China, add up to exploding demand for the sort of seeds that Senesco is pioneering.

Senesco is still involved in agriculture and is expanding its footprint in biofuels, but its main focus this year and beyond is life sciences, where it expects the greatest opportunities.

Nonetheless, the company is attempting a unique triple play: to feed the world, cure cancer and create alternative fuels, all with the same gene technologies.

Senesco has yet to realize any revenue or profits, but it sports a market cap of $30 million and boasts a board of stellar names in the biotech field, including Harlan Waksal, MD (co-founder of ImClone Systems), who are privately funding the company’s research and development.

A start-up biotechnology company such as Senesco is a riskier play that’s only appropriate for aggressive investors.

Biotech companies are notorious for showing great promise and then crashing and burning, either because they couldn’t get their drugs through the FDA gauntlet or they ran out of cash.

To be sure, Senesco faces risks that are typical of the biotech sector. The company’s success is contingent on its ability to recruit patients for its clinical trials; to consummate additional financings; obtain approval of patent applications; and the timing and success of its preclinical research and clinical trials.

However, if Senesco’s financing lasts and its drugs get approved, the returns for investors could be huge.

John Persinos is managing director of Investing Daily.

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