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Jan 182013

The Hygiology Post is presenting information about a company that seems to have much potential to help many people. Both 2012 and 2013 appear to be pivotal years in determining how helpful the patented technologies may actually be for people.

Senesco Technologies has continued to update information on its web site (https://www.senesco.com/; obtained on 01-18-13). As a matter of disclosure : The author continues to be a current shareholder in the company.

An article published within the past hour in “Seeking Alpha” titled “4 Promising Growth Stories in Therapeutics” (https://seekingalpha.com/article/1120801-4-promising-growth-stories-in-therapeutics?source=yahoo; obtained on 1-18-13) and reportedly written by Cris Frangold was not on Senesco Technologies web site. The article does seem to present an interesting perspective on several companies including Senesco Technologies. Here is an excerpt :

“Senesco Technologies, which is focusing on its eIF5A technology, is sponsoring a clinical study in multiple myeloma with its lead therapeutic candidate SNS01-T, which targets B-cell cancers by selectively inducing apoptosis via eIF5A. eIF5A is believed to be an important regulator of cell growth and cell death. Accelerating apoptosis may have applications in treating cancer, while delaying apoptosis may be useful in treating certain inflammatory and ischemic diseases, including diabetes. Cell death or apoptosis may be the answer to treating cancer. Senesco is exploring ways in which apoptosis can be used to control and stop cancer.

The eIF5a pathway is thought to function as a ‘master switch’ for a natural growth control that functions in most if not all cancers. It regulates the main pathways that trigger cell death, apoptosis, and make it more difficult for malignant cells to avoid responding to the programmed cell death signal that normally protects the body from cancer. eIF5A is a key regulator of tumor biology and SNS01-T is the first-in-class agent to target eIF5A. It selectively triggers apoptosis in B-cell cancers and single agent activity and synergy with lenalidomide or bortezomib in mouse models.SNS01-T has three components-siRNA suppresses pro-survival hypusine form resulting in inhibition of NF-kB activation, Plasmid expressing stable eIF5A under control of B-cell specific promoter induces apoptosis selectively . Polyethylenimine (PEI) forms a nanoparticle that protects the RNA and DNA from destruction in the blood and aids uptake into the cancer cells.

NS01-T results from Phase 1b/2a in multiple myeloma show good safety and an effect at the lowest dose. SNS01-T selectively triggers apoptosis, programmed cell death, in B-cell cancers like MM, MCL and DLBCL. The combination of lenalidomide and SNS01-T performs better than either treatment alone in mouse xenograft models of MM and MCL. SNS01-T showed good tolerability and stable disease in first cohort of Phase 1b/2a multiple myeloma trial. It can be extended in current form without further non-clinical investment to treat non-Hodgkin lymphoma and can be easily modified to target any other cancer including solid tumors. There are plenty of opportunities in a wide range of cancers with multiple therapeutic candidates from eIF5A platform and there is a billion dollar market opportunity for B-cell cancers alone. eIF5A modulation leads to death in all human cancer cell lines that have been tested to date and the company believes that the technology may be applied to any tumor type. Potential therapeutic applications include other diseases associated with suppressed or premature apoptosis, including inflammation, diabetes and ischemia.

Senesco has reported that interim results from the ongoing Phase 1b/2a study were presented by Dr. John Lust, the PI at Mayo Clinic, Rochester, Minnesota at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta, Georgia. Cohort 1 was completed in August 2012 and currently two of the planned three patients in cohort 2 have completed dosing. No drug-related serious adverse events or disease limiting toxicities have been recorded to date. In multiple myeloma, normal plasma cells have transformed into malignant myeloma cells that accumulate in the bone marrow and produce large quantities of a protein called monoclonal (M) protein which is released into the blood stream.

Multiple myeloma is an incurable cancer of plasma cells, a type of white blood cell derived from B-lymphocytes, normally responsible for the production of antibodies, in which abnormal cells accumulate in the bone marrow leading to bone lesions and interfering with the production of normal blood cells. Senesco was previously granted orphan drug status for SNS01-T, the Company’s lead drug candidate for treatment of multiple myeloma. Mantle cell lymphoma (MCL) is a form of non-Hodgkin’s lymphoma (NHL), constituting roughly 6 percent of all NHL cases in the United States with a prevalence of approximately 30,000 cases. It is considered an aggressive form of B-cell lymphoma and SNS01-T was granted orphan drug status for treatment. Diffuse large B-cell lymphoma is a fast growing form that is the commonest of non-Hodgkin’s lymphoma (NHL) accounting for 30 percent of new cases every year and there are approximately 120,000 cases in the U.S. SNS01-T was granted orphan drug status for treatment of this condition.

…Investors should be aware of the risks of investing in a microcap like Senesco Technologies. Microcap stocks are attractive due to their potential to generate high profits, but those profits come at the cost of higher risk. Senesco Technologies is a development stage biotech with a limited operating history. The company was started in 2009 and has limited assets and capital.

It is possible that SNS01-T won’t obtain FDA approval. SNS01-T is much different from other drugs in this space like Kyprolis, Revlimid and Velcade because it specifically targets B-cell cancers and selectively induces apoptosis via eIF5A. Conversely, Kyprolis and Velcade belong to a class of drugs known as proteasome inhibitors. They work by preventing the breakdown of protein in cancer cells, triggering their death. Revlimid contains lenalidomide, which is an immunomodulating agent. Lenalidomide stops cancerous plasma cells from multiplying. It also enhances the action of cells in the immune system called natural killer cells. These naturally attack abnormal cells, including cancerous cells. In order to grow, cancerous cells need a blood supply that provides them with nutri lenalidomide also stops the development of new blood vessels, which helps cut off the blood supply (nutrients) to cancerous cells.

…Even if Senesco can get approval, it is possible that Senesco won’t have enough money to get SNS01-T to the commericial drug phase. I estimate that Senesco will need at a minimum $2 million to commercialize SNS01-T. As of September 30th, 2012, Senesco had cash and cash equivalents of $1,312,056. Senesco believes that its current cash resources and ability to utilize its unused line of credit and delay certain costs are sufficient to fund operations through March 31st, 2013. The problem with this is that Senesco’s short-term goals and objectives for 2013 include staying on track to complete its Phase 1b/2a multiple myeloma trial with SNS01-T in 2013 and start a Phase 2b study toward the end of 2013. Both activities will burn significant capital, compounded by the company’s total contractual cash obligations listed above.

Senesco expects that patient recruitment for its SNS01-T trial will be opened soon at the John Theurer Cancer Center at Hackensack University Medical Center where David S. Siegel, M.D., Ph.D., chief of the Division of Multiple Myeloma, is one of the nation’s leading experts on multiple myeloma. Dr. Siegel served as lead investigator of the multi-center, Phase 2b study involving 30 cancer centers in North America that led to the FDA’s fast-track approval of Kyprolis for relapsed multiple myeloma patients.

Senesco has adopted a novel and innovative approach to cancer treatment, and results so far have been impressive…”

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Louis DeCola, Jr.                                    © 2013 The Hygiology Post ®