0001144204-14-060730.txt : 20141015 0001144204-14-060730.hdr.sgml : 20141015 20141010173056 ACCESSION NUMBER: 0001144204-14-060730 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20141009 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20141010 DATE AS OF CHANGE: 20141010 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 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 333-153829 FILM NUMBER: 141153178 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 v391185_8k.htm 8-K

 

 

 

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): October 10, 2014 (October 9, 2014)

 

 

 

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 8.01Other Events.

 

On October 9, 2014, GenSpera, Inc. (the “Company”) announced that patient enrollment has been completed in the Company’s Phase II clinical trial in patients with liver cancer (hepatocellular carcinoma). A copy of the press release is attached to this report as Exhibit 99.01.

 

Item 9.01Financial Statements and Exhibits.

 

Exhibit

No.

 

  

Description

 
99.01   Press Release dated October 9, 2014.    

 

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: October 10, 2014

 

GenSpera, Inc.
     
By:   /s/ Craig Dionne
   

Craig Dionne

Chief Executive Officer


 
 

 

  

INDEX OF EXHIBITS

 

Exhibit

No.

 

  

Description

99.01   Press Release dated October 9, 2014.    

 

 

EX-99.1 2 v391185_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

GENSPERA ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN THE PHASE II CLINICAL TRIAL OF MIPSAGARGIN IN LIVER CANCER PATIENTS

 

SAN ANTONIO, Texas, October 9, 2014 – GenSpera, Inc. (OTCQB: GNSZ), a leader in developing prodrug therapeutics for the treatment of cancer, today announced that patient enrollment has been completed in the company’s Phase II clinical trial in patients with liver cancer (hepatocellular carcinoma). Formal results of the study are expected to be available during the first quarter of 2015.

 

“We are grateful to the trial investigators for their efforts, as well as the patients and their loved ones who are supporting this important trial,” said Craig Dionne, PhD, GenSpera’s CEO. “The completion of the enrollment period for this trial marks another company milestone. The data we have collected to date establish proof of concept for mipsagargin’s destruction of blood vessels within tumors and encouraging signs of potential anti-tumor activity. We anticipate similar results in our ongoing Phase II trials in patients with glioblastoma as well as our planned Phase II trial in patients with prostate cancer.”

 

Interim data from the ongoing Phase II clinical trial in liver cancer patients were recently presented at the Asia Pacific Primary Liver Cancer Expert Meeting in Taipei in July 2014 (APPLE2014) and at the International Liver Cancer Association (ILCA) meeting in Kyoto in September 2014. Impressively, 80% of liver cancer patients in the Phase Ib and Phase II studies experienced disease stabilization at two months and a significant percentage of patients had stable disease for at least nine months after beginning treatment with mipsagargin.

 

The US Food and Drug Administration (FDA) granted Orphan Drug designation in 2013 for the evaluation of mipsagargin in patients with hepatocellular carcinoma.

 

About GenSpera

 

GenSpera’s technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a prodrug delivery system that provides for the targeted release of drug candidates within a tumor. Unlike typical chemotherapeutic agents, thapsigargin results in cell death irrespective of the rate of cell division, which may provide an effective approach to kill both fast- and slow-growing cancers. GenSpera’s lead drug candidate, mipsagargin, is activated by the enzyme PSMA, which is found at high levels in the vasculature of liver and glioblastoma cancers and in the vasculature of almost all other solid tumors. Mipsagargin is expected to have potential efficacy in a wide variety of tumor types.

 

Mipsagargin Phase II clinical trials are underway in both hepatocellular carcinoma (liver cancer) and glioblastoma patients (brain cancer).

 

For more information, please visit the company’s website: www.genspera.com or follow us on Twitter @GenSperaNews.

 

Company presentations are available at: http://www.genspera.com/

 

Watch the Corporate Video:

http://youtu.be/jULjEul-mBk

 

 
 

 

Cautionary Statement Regarding Forward Looking Information

 

This news release may contain forward-looking statements. Investors are cautioned that 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 filed with the Securities and Exchange Commission.

 

CONTACT:

 

Company:

Craig Dionne, PhD, CEO

GenSpera, Inc. (210) 479-8112

 

Investor Relations:

Steve Gersten

Capital Markets Group

Steve@CapMarketsGroup.com

+1-813-926-8920

 

Media:

Dawn Van Zant

(800) 665 0411

 

 

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