0001144204-14-038711.txt : 20140626 0001144204-14-038711.hdr.sgml : 20140626 20140620131808 ACCESSION NUMBER: 0001144204-14-038711 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140619 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140620 DATE AS OF CHANGE: 20140620 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIO-PATH HOLDINGS INC CENTRAL INDEX KEY: 0001133818 STANDARD INDUSTRIAL CLASSIFICATION: RETAIL-MISCELLANEOUS SHOPPING GOODS STORES [5940] IRS NUMBER: 870652870 STATE OF INCORPORATION: UT FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36333 FILM NUMBER: 14932272 BUSINESS ADDRESS: STREET 1: 2626 SOUTH LOOP, SUITE 180 CITY: HOUSTON STATE: TX ZIP: 77054 BUSINESS PHONE: 8329716616 MAIL ADDRESS: STREET 1: 2626 SOUTH LOOP, SUITE 180 CITY: HOUSTON STATE: TX ZIP: 77054 FORMER COMPANY: FORMER CONFORMED NAME: OGDEN GOLF CO CORP DATE OF NAME CHANGE: 20010205 8-K 1 v381878_8k.htm 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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):  June 19, 2014

 

BIO-PATH HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

  

Utah 000-53404 87-0652870

(State or other jurisdiction

of incorporation)

 

(Commission File Number) (IRS Employer Identification No.)

  

2626 South Loop, Suite 180, Houston, Texas 77054
(Address of principal executive offices) (Zip Code)

 

(832) 971-6616

(Registrant’s Telephone Number, Including Area Code)

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

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 June 19, 2014, Bio-Path Holdings, Inc. issued a press release titled “Enrollment Continues Into Bio-Path Holdings Phase I Clinical Trial.”

 

A copy of such press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit    
Number   Description
     
99.1   Press Release dated June 19, 2014  
     

 

 
 

SIGNATURES

 

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.

 

  BIO-PATH HOLDINGS, Inc.  
       
Dated:  June 20, 2014 By:   /s/ Peter H. Nielsen  
         Peter H. Nielsen  
         President and Chief Executive Officer  

 

 

 
 

EXHIBIT INDEX

 

Exhibit    
Number   Description
     
99.1   Press Release dated June 19, 2014  
     

 

 

EX-99.1 2 v381878_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Enrollment Continues Into Bio-Path Holdings Phase I Clinical Trial

 

 

HOUSTON, TX, June 19, 2014 – Bio-Path Holdings, Inc., (NASDAQ:BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced enrollment is now resuming into its Phase I clinical trial evaluating its lead compound, Liposomal Grb-2, in blood cancers. Sufficient drug quantities are now in place to complete Cohort 6 of the trial.

 

To date, Bio-Path has successfully completed five cohorts of the Phase I clinical trial and has treated two patients in the sixth cohort. The trial requires three evaluable patients per cohort. The Company intends to evaluate patient results at the end of Cohort 6 to determine if the optimal biological dose has been reached, which would bring a close to the Phase I clinical trial.

 

“We are pleased to once again be in a position to enroll patients into Cohort 6 of our clinical trial and look toward closing this cohort in the third quarter,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path. “Based on results of the six cohorts, we will then finalize our plans for the next phase of development."

 

About Growth Receptor Bound protein-2 (Grb-2)

 

The adaptor protein Growth Receptor Bound protein-2 (Grb-2) is essential to cancer cell signaling because it is utilized by oncogenic tyrosine kinases to induce cancer progression. Suppressing the function or expression of Grb-2 should interrupt its vital signaling function and have a therapeutic application in cancer. BP-100.1.01 is a neutral-charge, liposome-incorporated antisense drug substance designed to inhibit Grb-2 expression.

 

About Bio-Path Holdings, Inc.

 

Bio-Path is a biotechnology company focused on developing therapeutic products utilizing its proprietary liposomal delivery technology designed to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion. Bio-Path’s lead product candidate, Liposomal Grb-2, is in a Phase I study for blood cancers and in preclinical studies for triple negative and inflammatory breast cancers. Bio-Path’s second drug candidate, also a liposomal antisense drug, is ready for the clinic where it will be evaluated in lymphoma and solid tumors.

 

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, and such other risks which are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

 

 
 

 

For more information, please visit the Company's website at http://www.biopathholdings.com.

 

 

 

# # #

Contact Information:

 

Peter Nielsen

President & Chief Executive Officer

Tel 832.971.6616

 

Rhonda Chiger (investors)

Rx Communications Group, LLC

917-322-2569

rchiger@rxir.com

 

 

 

 

 

 

 

 

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