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Apr 222013
 
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 04-22-13). As a matter of disclosure : The author continues to be a current shareholder in the company.
 
The following article titled “Senesco Announces Completion of Cohort 2 of its Phase 1a/2b Trial” (https://finance.yahoo.com/news/senesco-announces-completion-cohort-2-123000224.html; retrived on 4-22-13) was apparently released within the past hour by “Business Wire” and began in the following way:
 
“…Senesco Technologies, Inc. (“Senesco” or the “Company”) (OTC QB: SNTI) reported today that it has completed cohort 2 in its Phase 1b/2a clinical study of SNS01-T.

In cohort 2, two multiple myeloma patients and one diffuse large B-cell lymphoma patient have completed the study. The safety data for the group will be provided to the Data Review Committee (DRC), who will meet and advise Senesco whether it is appropriate to proceed with cohort 3 and escalate the dose level to 0.2 mg/kg, a four-fold increase.

“We are pleased to have completed the second cohort in our Phase 1b/2a study,” stated Leslie J. Browne, Ph.D., President and Chief Executive Officer of Senesco. “As soon as the DRC gives the go ahead, we expect to initiate cohort 3 and increase the dose level to 0.2 mg/kg.”

The study is an open-label, multiple-dose, dose-escalation study, which will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell (MCL) or diffuse large B-cell lymphoma (DLBCL) patients. While the primary objective of this study is to evaluate safety and tolerability, the effect of SNS01-T on tumor response and time to relapse or progression will be assessed using multiple well-established metrics including measurement of monoclonal protein in multiple myeloma and CT imaging in MCL and DLBCL.

In the study, patients are dosed twice-weekly for 6 weeks followed by an observation period. The first group of patients received 0.0125 mg/kg per dose by intravenous infusion. The second group received 0.05 mg/kg and the planned dose levels for the third and fourth groups are 0.2 and 0.375 mg/kg, respectively. The top dose planned is 30 fold higher than the starting dose in cohort 1.”

 
An article published over two months ago on 2-07-13 in “Seeking Alpha” titled “Is Senesco Technologies The Next Cellceutix?” (https://seekingalpha.com/article/1164721-is-senesco-technologies-the-next-cellceutix; obtained on 2-24-03) by contributor “Markus Aarnio” was not on the Senesco Technologies web site. The contributor wrote the following preceding the article :
 
“Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in SNTI.OB over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.”
 
Here is an excerpt : 
 
Senesco Technologies (SNT) is the smallest company that I wish to present and add to my current long position in the upcoming week. The $17.55 million market capitalization company is trading strongly over the last week after hitting its 52-week lows of $0.1139 just a couple of weeks ago. Friday’s close at $0.15 was flat for the day but with above average volume, as was most of the week. The small pharmaceutical is developing SNS01-T, a cancer therapy intended to selectively trigger apoptosis (cell death, often minimized in cancer cells) in B-cell cancers such as multiple myeloma (MM), mantle cell lymphomas and diffuse large B-cell lymphomas. On December 10th the company reported preliminary findings in its ongoing small phase 1b/2a trial evaluating the drug for multiple myeloma. The company is evaluating the therapy’s effect on M-protein levels, a protein produced by malignant cells as they accumulate in bone marrow and subsequently released into the blood stream. As MM patients’ condition progresses, M-protein levels also increase. Therefore, the company is using M-protein levels as an indicator of possible drug efficacy. Stable or decreasing levels of M-protein could be construed a positive in the early stage trials.
 
 
In a two cohort trial, two patients in cohort 1 were evaluable at the time of data release. Both patients had stable M-protein levels within 25% of baseline levels at weeks 3 and 6, considered to be ‘stable disease’. Patient number 2 responded particularly well. 4 weeks after the treatment stopped (last dosage given at week 6), at week 10, he remained within 25% of the baseline level. Meanwhile patient number 1, although not a startling progression, did have M-protein levels trend up slightly after the 6 week regimen was discontinued with 26% increase above baseline by week 9 (3 weeks after dosing stopped) and 30% increase by week 12 (6 weeks after dosing stopped). These results are early stage and of a small sample set, but definitely are showing some promise at this stage with subsequent data evaluations coming likely soon. A third patient of this cohort will complete dosing in ‘early 2013’ and will give additional data soon. This cohort is a low-dosage cohort, and higher dosage trials will come soon if efficacy and safety profiles are maintained. With some efficacy already proving evident, increasing efficacy with a maintained safety profile could prove to be very promising and will begin garnering investor interest in the coming weeks.In cohort number 2, two patients are being evaluated. One has MM and the second has B-cell lymphoma. The MM patient had baseline levels still within 25% of the baseline values at weeks 3 and 6 weeks. The B-cell lymphoma patient will be analyzed by tumor response, with tumor imaging information was not completed as of that press release. The 2 cohort trial is a dose escalation trial with additional dosages being increased from the first levels (0.0125mg/kg, as reported above) to 0.05mg/kg, 0.20mg/kg and then 0.375mg/kg, if the Data Review Committee gives the go-ahead from each dosage level to the next with efficacy and safety data being the determining factors. With tradeoffs made in cancer treatment of higher dosages often giving better efficacy but conversely less safe profiles, the gradual increase of dosage allowed will likely each bring more investor interest to the drug’s possibilities.
 
 
Senesco is a high risk investment moving forward. However, its current low valuation, low share price (just recently bouncing off a 52-week low) and increasing volume is showing that some investors are just beginning to take note of the company. If the current share price proves to be at a bottom, entry now could prove to be a wise choice if future data confirms efficacy at least at the lower dosages and more so if higher dosages confirm greater efficacy and still acceptable safety profiles. As pertaining to dilutive financing, the company announced recent $3 million financing on January 4th, which should forego additional financing, at least in the near future. The risk/reward level is now acceptable to me as an investor, but it may not be for everyone with the company being a development-phase company and trading on the less liquid OTCBB markets. Much additional research should be done by interested investors.”
 
 

The Hygiology Post ® welcomes feedback from readers as to whether the articles (individually and/or collectively) help fulfill its vision and mission.

 

Louis DeCola, Jr.                                    © 2013 The Hygiology Post ®