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 | |
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