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Jan 122014
 

“Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

(Editors’ Note: This article covers a micro-cap stock. Please be aware of the risks associated with these stocks.)

Progress in the treatments of most cancers is a gradual and incremental process in which very few therapies can come close to creating a cure on their own. Cancer cells have evolved numerous biological mechanisms that allow them to overcome the effect of most drugs when used as a single agent. This has led to the near universal practice of combining drugs with different modes of action, most commonly chemotherapies, monoclonal antibodies and targeted therapies. Used in combination, they can produce synergistic results.My interest in Senesco (OTCQB:SNTI) initially was based on their lead drug SNS01-T, which has a very unique and differentiated mechanism of action. This gives rise to the promise that it could offer a unique approach to treating cancer that could result in its being added to existing therapies. It is this differentiated mechanism of action that makes SNS01-T so conceptually interesting to me. The recent announcement of the potential merger with Fabrus and with this the involvement of the famed biotechnology investor Dr. Phillip Frost has added to my interest. I will go into this shortly.

SNS01-T stems from Senesco’s unique understanding of the gene called eukaryotic translation initiation factor or eIF5A which plays an integral role in regulating the life and death (apoptosis) of cells. Cells are programmed to have a finite lifespan and once this has been reached, nature has evolved mechanisms to cause cells to die and be eliminated from the body, a process known as apoptosis. Most forms of cancers are the result of cells that have developed mutations that allow them to evade apoptosis. Senesco’s objective is to alter cancer cells so that they are once again subject to the programmed death cycle.

SNS01-T has the promise that because of its highly proprietary and unique biological approach, it can be added to existing therapies to improve overall outcomes. The initial therapeutic target of SNS01-T is B cell cancers, principally multiple myeloma (MM) and non-Hodgkin’s lymphomas such as diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). Animal studies have suggested that it is highly synergistic with Revlimid and Velcade, the two current mainstay drugs for treating multiple myeloma. This suggests a promising pathway to clinical development

The company is now in a Phase Ib/IIa trial that is primarily evaluating SNS01-T in multiple myeloma and to a lesser extent in diffuse large B cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). The primary purpose of the trial is to establish that the drug is safe. The trial started with a low dosage of SNS01-T in cohort 1 and then progressed to higher doses in cohorts 2 and 3. These doses have each demonstrated that the drug is safe. In addition in nine evaluable patients, the drug has stabilized the cancer for a period of time in five MM patients and one DLBCL patient.

The Phase Ib/IIa trial is entering a critical phase as the fourth cohort of six patients (possibly more) is now being recruited. The dosing in cohort 4 on an mg/kg dosing basis is nearly double that of cohort 3 and thirty times greater than cohort 1. Preclinical data in both MM and DLBCL demonstrated pronounced tumor shrinkage at this dose level.

I think that in order for the company to move to a Phase IIb trial, SNS01-T will have to show at least one objective response in which the tumor shrinks for a meaningful period of time. Stable disease will not be enough to warrant moving forward. In the event that this is not achieved, the options would be to add more patients, increase the dose, and increase the number of cycles or some combination of the three. Results of cohort 4 could be known by 3Q or 4Q, 2014.

Senesco’s stock has asymmetric upside potential if results in cohort 4 are promising and allow the company to move into a Phase IIb trial that could be potentially the basis for approval. This trial could start in 1H, 2015 and potentially complete in late 2016 in a positive scenario. This could lead to an NDA filing in 2017 and approval in 2018 if everything goes right.”

 

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Louis DeCola, Jr.  © 2014                                   The Hygiology Post ®