UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_______________________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported):December 10, 2013
Senesco Technologies, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-31326 | 84-1368850 | ||
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 721 Route 202-206, Suite 130, Bridgewater, NJ | 08807 | |
| (Address of Principal Executive Offices) | (Zip Code) |
| (908) 864-4444 |
(Registrant's telephone number, including area code) |
___________________Not applicable_____________________ (Former Name or Former Address, if Changed Since Last Report) |
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
Item 8.01 Other Events.
On December 10, 2013, Senesco Technologies, Inc. (“Senesco” or the “Company”) issued a press release announcing the results of preclinical studies with SNS01-T at the 55th American Society of Hematology Annual Meeting in New Orleans.
Senesco’s drug candidate, SNS01-T, which is the subject of an on-going Phase 1b/2a clinical study in B-cell cancers, induces cell death in cancer cells by reducing the levels of a protective protein and replacing it with a protein that induces cell death. The drug candidate was taken up more efficiently by malignant B-cells than normal human B-cells in non-clinical studies. Although 50% of normal B-cells took up SNS01-T, it did not cause cell death in the healthy cells, whereas cell death was readily seen in human myeloma cells.
Laboratory studies have already shown that, due to its design, SNS01-T does not produce significant levels of the message that makes the death-inducing protein in normal tissues including heart and liver. The new discoveries provide evidence suggesting SNS01-T may not affect normal human B-cells, which are an important protective component of the body’s immune system. This is in contrast to existing B-cell cancer therapies like rituximab, which is widely used in mantle cell and diffuse large cell lymphomas.
The study is an open-label, multiple-dose, dose-escalation study to evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma and B-cell lymphoma patients. While the primary objective is to evaluate safety and tolerability, the effect of SNS01-T on tumor response and time to relapse or progression is assessed using multiple well-established metrics including measurement of monoclonal protein in multiple myeloma and CT imaging in B-cell lymphomas.
In the study patients are dosed twice-weekly by intravenous infusion for six weeks followed by an observation period. The first and second cohorts of patients received 0.0125 mg/kg and 0.05 mg/kg per dose, respectively.The third cohort received 0.2 mg/kg and the planned dose level for cohort 4 is 0.375 mg/kg, which is 30 fold higher than the starting dose in group 1. It is expected that the study will enroll six to nine patients to complete cohort 4.
A copy of the press release isfiled as Exhibit 99.1 hereto and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description |
| 99.1 | Press Release of Senesco Technologies, Inc. dated December 10, 2013. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| SENESCO TECHNOLOGIES, INC. | |
| Dated: December 10, 2013 | By: /s/ Leslie J. Browne, Ph.D. |
| Name: Leslie J. Browne, Ph.D. | |
| Title: President and Chief Executive Officer |