Senesco Technologies is advancing an exceptional IP portfolio of therapeutic capabilities for cancer and even certain inflammatory or ischemic (lack of blood supply) diseases, based on a technology platform developed around the identified function of eIF5A as a master switch regulator of cell growth and/or death (apoptosis). The company's technology is derived from the breakthrough research of Director (since 2001) and Executive VP of R&D for SNTI, John E. Thompson, Ph.D., whose work in senescence (cellular aging) first turned up the remarkable characteristics of this gene called eukaryotic translation initiation factor 5A, or eIF5A, which acts like a biological switch, telling the cell to either endure or perish.
The capacity of this technology to accelerate (cancer treatment) or retard (inflammatory or ischemic treatments) cell death has profound implications and the most recent summary (Phase 1b/2a Dec 10, 2012) of trialing progress on SNTI's lead therapeutic treatment targeting primarily multiple myeloma, SNS01-T, is a strong indicator of the potential here. SNS01-T is the subject of an open IND and this on-going study focused on multiple myeloma. Senesco's lead therapeutic treatment is comprised of a three-pronged modular approach using a DNA plasmid, a small inhibitory RNA (siRNA), and polyethylenimine to maximize results.
The company is really changing the way cancer is treated with SNS01-T and their IP position covers composition of matter, as well as method of use, already linked through preclinical studies to observed modulation of both intrinsic (via tumor suppressor protein p53) and extrinsic pathways (killing the cell receptor). These pathways are already well established by cancer therapeutics like Revlimid®, Velcade® and Gleevec®, meaning that SNS01-T's recently demonstrated progress in the Phase 1b/2a study (presented by Dr. John Lust of the PI at Mayo Clinic in Rochester, Minnesota, during the 54th American Society of Hematology Annual Meeting and Exposition down in Atlanta), offers real hope to patients suffering from this incurable cancer of the plasma cells. Multiple myeloma is a particularly difficult cancer where malignant plasma cells build up inside the bone marrow, leading to serious bone lesions and disruption of white blood cell production, ultimately causing a host of maladies from bone disease and renal dysfunction, to severe nerve damage.
Positive safety and efficacy data in this most recent open-label, multi-dose study (even at the lowest dose) mirrors prior, successful work done in rodents (human tumors were established in mice and successfully inhibited, especially when paired with Revlimid), where significant tumor growth inhibition and reductions in the primary indicator of malignant myeloma cells, M-protein (monoclonal) build up in the blood, showed strong end points for survival rates in multiple myeloma, mantle cell, and diffuse large B-cell lymphomas. In cohort 2 of this recent study, one patient with diffuse large B-cell lymphoma is being looked at closely (in addition to the multiple myeloma patients) and anticipation is high that the four-fold increase in dosage when group 3 starts up this year will really improve the already good results that show stabilization of multiple myeloma and a decline in plasma cell levels (indicating actual regression). No drug-related adverse events or dose-limiting toxicities spell good news for this 4-cohort, dose-escalation study and the general tolerability seen thus far underscores this key safety factor as pertains to the eventual commercial success of SNS01-T.
Modulation of eIF5A to induce apoptosis via either or both pathways is a compelling IP position and investors will take note that this approach is quite unique within the oncology space, theoretically applicable to most, if not all types of cancer. Take a moment to let that sink in before going too far into the technical details of SNTI's trialing developments, because the forthcoming diffuse large B-cell lymphoma data will give a strong indication of the kind of traction we are talking about here. Previous testing in rodents using an intravenous administration of eIF5A plasmid showed marked inhibition of growth in disseminated melanoma tumors in the lungs, with considerable drop in overall mass (strong measure of tumor burden), a data set which adds yet more reinforcement to the broad-spectrum applicability of this technology in both solid and disseminated tumors.
It is also important to note, to further indicate the broad potential of this tech platform based on eIF5A trigger dynamics, that the original discovery of eIF5A was in plants and that this gene has apparently been highly conserved across the plant and animal kingdoms (as the human/animal sequence is nearly identical in plants). Thus there is a whole range of Agribusiness applications for eIF5A, which is found in all plants and so offers a brilliant implementation pipeline for the company's technology, requiring zero additional foreign genetic material in order to function properly. From extending the shelf-life of perishable produce by delaying the onset of senescence (which also circumvents the poor taste quality problems introduced by competing technologies), to improving seed yield in grain and cereal crops and there is a whole slew of secondary upsides that help set SNTI's technology apart from any potential competitors. Additional applications like increasing biomass yield and growth rates, as well as improving the heartiness of crops to make them more resistant to environmental stresses (thus opening up wider growing seasons or regions), help to further map out a second huge territory for SNTI's IP portfolio beyond the oncology space.
One look at the growing statistical data is all it takes to understand where SNTI is going as a company. Multiple myeloma is now just behind non-Hodgkin's lymphoma for blood cancers and represents roughly 1% of all cancers (2% of all cancer deaths). Diffuse large B-cell lymphoma alone represents a billion dollar market and is the fastest-growing, most common form of non-Hodgkin's lymphoma, with around 120k cases in the U.S. alone. Mantle cell lymphoma is another major target, at around 6% of non-Hodgkin's lymphoma (30k U.S. cases).
Given the nature of the ongoing study of SNS01-T, investors can look forward to periodic news bursts as the company rockets into Phase 2b during the second half of this year and confidence is high at SNTI that they will have meaningful top line results to look at by mid-2013.
For more information on Senesco Technologies, visit www.Senesco.com
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