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 4, 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 4, 2013, Senesco Technologies, Inc. (“Senesco” or the “Company”) issued a press release announcing the completion of cohort 3 of its Phase 1b/2a clinical trial for its drug, SNS01-T, for the treatment of multiple myeloma and lymphoma. The Company has also received approval from its Data Review Committee to proceed to cohort 4, which is expected to require six evaluable patients. The Data Review Committee’s review of the results of cohort 3 concluded that SNS01-T was safe and well tolerated at a dose of 0.2 mg/Kg. No drug-related serious adverse events or dose limiting toxicities have been observed in the study. The patients in cohort 4 will be receiving 0.375 mg/Kg of SNS01-T.
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, mantle cell (MCL) or diffuse large B-cell lymphoma (DLBCL) 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 will be 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 groups of patients received respectively 0.0125 mg/Kg and 0.05 mg/Kg per dose.The third group received 0.2 mg/Kg and the planned dose level for group 4 is 0.375 mg/Kg, which is 30 fold higher than the starting dose in group 1.
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 4, 2013. |
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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 4, 2013 | By:/s/ Leslie J. Browne, Ph.D. |
| Name: Leslie J. Browne, Ph.D. | |
| Title: President and Chief Executive Officer |
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