0001144204-14-016452.txt : 20140318 0001144204-14-016452.hdr.sgml : 20140318 20140318171027 ACCESSION NUMBER: 0001144204-14-016452 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140318 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140318 DATE AS OF CHANGE: 20140318 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: 14701787 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 v372105_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): March 18, 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 March 18, 2014, GenSpera, Inc. (the “Company”) announced that the first patient was enrolled in the Phase II clinical trial of its lead compound, G-202, in patients who have glioblastoma multiforme. A copy of the press release is attached to this report as Exhibit 99.01.

 

 

Item 9.01.Financial Statements and Exhibits.

 

Exhibit No.

 

Description

99.01   Press Release dated March 18, 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: March 18, 2014

 

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

 

 
 

 

INDEX OF EXHIBITS

 

Exhibit No.

 

Description

99.01   Press Release dated March 18, 2014

 

 
 

 

 

EX-99.01 2 v372105_ex99-01.htm PRESS RELEASE

 

 

 

FIRST PATIENT ENROLLED IN GENSPERA G-202 PHASE II GLIOBLASTOMA TRIAL

 

 

SAN ANTONIO, Texas, March 18, 2014 – GenSpera, Inc. (OTCQB:GNSZ) announced that the first patient was enrolled in the Phase II clinical trial of its lead compound, G-202, in patients who have glioblastoma multiforme (GBM), the most prevalent type of primary brain cancer. The trial is being conducted at UC San Diego Moores Cancer Center. This Phase II G-202 trial will treat up to 34 patients with GBM that has progressed or recurred after at least one other treatment.

 

Researchers at the UC San Diego School of Medicine are focused on creating improved therapies for brain cancer patients. As such, we were one of the first to show robust expression of PSMA in the vasculature of glioblastomas, as well as in other gliomas, which formed the rationale to proceed with G-202 in a GBM clinical trial,” said Santosh Kesari, MD, PhD, co-investigator, neuro-oncologist and director of the Translational Neuro-Oncology Laboratories at UC San Diego Moores Cancer Center.

 

“We are excited to open this clinical trial using a novel tumor-targeting technology in recurrent glioblastoma patients with the goal of improving survival and identifying biomarkers of response," said principal investigator, David Piccioni, MD, PhD.

 

“The GBM trial constitutes another milestone in our plan to develop G-202 in multiple cancer indications,” said Craig Dionne, PhD, GenSpera CEO. “We are particularly pleased to collaborate with Dr. Kesari and his colleagues, who have been so instrumental in developing the rationale for potential utility of G-202 in GBM and other brain tumors.”

 

About Glioblastoma Multiforme

 

Glioblastoma Multiforme (GBM) is the most common type of malignant primary brain tumor and is characterized by a highly-invasive and angiogenic (forming new blood vessels) pattern of growth and a low survival rate. Only 30% of patients survive one year after diagnosis. At five years, the survival rate drops to 3%. Treatment options currently are limited and include surgery, combined with some form of radiation and/or chemotherapy. No established protocol exists for chemotherapy and none of the regimens are curative, according to the American Association of Neurological Surgeons. Efforts to improve second-line therapies have met with only limited success. Two recent late-stage studies with anti-cancer agents led to only marginal improvements. A large unmet medical need still remains for new treatments for patients with GBM.

 

 
 

 

About the Trial

 

This Phase II trial will treat up to 34 patients with recurrent or progressive glioblastoma who have undergone at least one prior treatment regimen that must include surgery and/or radiotherapy. The primary endpoint of the trial is six-month progression-free survival after at least two cycles of treatment.

 

About the Translational Neuro-Oncology Laboratories at UCSD Moores Cancer Center

 

UC San Diego Moores Cancer Center is home to nearly 350 medical and radiation oncologists, cancer surgeons, and researchers. It is one of only 41 National Cancer Institute-designated comprehensive cancer centers in the United States, a rare honor distinguishing exceptionally high achievement in research, clinical care, education and community outreach and partnerships. For more information, visit www.cancer.ucsd.edu. Specific information about Professor Santosh Kesari and his work can be found at www.kesarilab.ucsd.edu.

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, G-202, 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. G-202 is therefore expected to have potential efficacy in a wide variety of tumor types.

 

G-202 Phase II clinical trials are underway in both hepatocellular carcinoma and glioblastoma.

 

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

 

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

 

Media:Deanne Eagle

Planet Communications (917) 837-5866

 

Investors:John Baldissera

BPC Financial Marketing (800) 368-1217

 

 
 

 

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