0001144204-12-019689.txt : 20120403 0001144204-12-019689.hdr.sgml : 20120403 20120403123230 ACCESSION NUMBER: 0001144204-12-019689 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20120329 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120403 DATE AS OF CHANGE: 20120403 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENSPERA INC CENTRAL INDEX KEY: 0001421204 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 333-153829 FILM NUMBER: 12736283 BUSINESS ADDRESS: STREET 1: 2511 N LOOP 1604 W STREET 2: SUITE 204 CITY: SAN ANTONIO STATE: TX ZIP: 78258 BUSINESS PHONE: (210) 479-8112 MAIL ADDRESS: STREET 1: 2511 N LOOP 1604 W STREET 2: SUITE 204 CITY: SAN ANTONIO STATE: TX ZIP: 78258 8-K 1 v308424_8k.htm CURRENT REPORT

 

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): April 3, 2012 (March 29, 2012)

 

 

 

GENSPERA, INC.

 

(Exact name of registrant as specified in Charter)

 

 

Delaware   0001421204   20-0438951
(State or other jurisdiction of
incorporation or organization)
  (Commission File No.)   (IRS Employee Identification No.)

 

2511 N Loop 1604 W, Suite 204

San Antonio, TX 78258

(Address of Principal Executive Offices)

 

210-479-8112

(Issuer Telephone number)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨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 March 29, 2012, GenSpera, Inc. (the “Company”) announced the completion of the dose-escalation component of its ongoing Phase I trial, the initiation of the Phase 1b component of the trial and that the Company is preparing to commence Phase II clinical studies of its chemotherapeutic agent, G-202. A copy of the press release is attached to this report as Exhibit 99.01.

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Dated: April 3, 2012

  GenSpera, Inc.
   
  By:  /s/ Craig Dionne
    Craig Dionne
Chief Executive Officer

 

 

 
 

 

INDEX OF EXHIBITS

 

            Incorporated by Reference

Exhibit

No.

 

  

Description

 

  Filed

Herewith

 

 

Form

 

Exhibit

No. 

 

 

File No.

 

 

Filing Date

99.01   Press Release dated March 29, 2012   *                
                         

 

  

 
 

EX-99.1 2 v308424_ex99-1.htm PRESS RELEASE

 

 

 

 

CONTACT:

 

Company:Craig Dionne, Ph.D., CEO
GenSpera, Inc. (210) 479-8112
Investors:Steve Chizzik
The Verrazano Group (908) 688-9111
Media:Deanne Eagle
Planet Communications (917) 837-5866

 

 

GENSPERA'S G-202 CLINICAL TRIAL ADVANCES TO PHASE Ib

COMPANY PreparES to launch Phase II

 

SAN ANTONIO, Texas, March 29, 2012 – GenSpera, Inc. (OTCBB:GNSZ) announced the successful completion of the dose-escalation component in the ongoing Phase I trial of its lead chemotherapeutic agent, G-202. The trial will continue as a Phase Ib study evaluating G-202 in up to eighteen additional patients to further refine the dosing regimen and determine a recommended dose for Phase II clinical studies. Additionally, GenSpera expects to initiate its first Phase II study in castrate-resistant, chemotherapy-naïve prostate cancer patients within the next few months, also with G-202.

 

"This is a critical step in the GenSpera clinical program and is a major validation for both the thapsigargin-based prodrug platform and GenSpera," said Craig Dionne, Ph.D., GenSpera’s CEO. He added, “Our lead compound, G-202, has performed as expected in our multi-center safety trial and we are now aggressively pursuing the design and implementation of multiple Phase II trials in different types of cancers."

 

About The Trial

 

The G-202 Phase I study was designed to evaluate G-202's safety and tolerability at escalating doses of the drug. Twenty-eight patients were treated in the Phase I study, at doses ranging from 1.2 mg/m2/dose (~2 mg/dose) up to 88 mg/m2/dose (~150 mg/dose). The drug exposure in patients receiving the higher doses of G-202 falls within the range associated with anti-tumor efficacy in animal models. Although the study was not designed to determine the anti-tumor effects of the drug, signs of potential positive effects were observed.

 

The Phase Ib portion of the study will evaluate G-202 in a maximum of eighteen additional patients to further refine a dosing regimen and determine a recommended dose for Phase II clinical studies. The trial is being conducted at the University of Wisconsin Carbone Cancer Center, Madison, Wisconsin; the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland and the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio in San Antonio, Texas.

 

 
 

About GenSpera

 

GenSpera, Inc. is a development stage oncology company focused on therapeutics that we believe have the potential to deliver a potent, unique and patented drug directly to tumors. GenSpera’s technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a prodrug delivery system that appears to release the drug only within the tumor. Unlike standard cancer drugs, thapsigargin kills cells independently of their division rate, thus making it effective at killing all fast- and slow-growing cancers and cancer stem cells.

 

GenSpera’s prodrug platform is the subject of nine U.S. issued patents, with three additional US patent applications as well as one PCT application (subject to possible U.S. government rights and certain rights for use in research pending). Prodrug chemotherapy is a relatively new approach to cancer treatments. The prodrug cytotoxin is administered in an inactive form. We believe it becomes active only within the tumor. This treatment has the potential to avoid higher levels of toxicity to the rest of the body and the dangerous associated side effects, such as destruction of blood cells.

 

GenSpera is conducting a Phase Ib clinical trial targeting solid tumor cancers with its lead drug, G-202, at Johns Hopkins University, the University of Wisconsin, and the Cancer Therapy and Research Center in San Antonio. GenSpera expects to initiate multiple Phase II trials for G-202 in several different types of cancer.

 

The company’s pipeline of drugs also includes G-115 and G-301, which both directly target prostate cancer.

 

GenSpera, Inc. owns and controls all rights to G-202, G-115, and G-301 and anticipates a strategic partnership to maximize the value of these drugs as they progress through future clinical trials. To date, GenSpera has generated no revenues from the sale of its products and has experienced substantial net operating losses.

 

For more information, please visit the Company’s website: www.genspera.com .

 

Cautionary Statement Regarding Forward Looking Information

 

This news release may contain forward-looking statements. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of GenSpera’s technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties will be detailed from time to time in GenSpera’s periodic reports.

# # #

 
 

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