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): July 25, 2011 (July 20, 2011)
_______________
BIOCANCELL THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
|
Delaware
|
333-156252
|
20-4630076
|
|
(State or other jurisdiction of incorporation)
|
Commission File Number
|
(IRS Employer Identification No.)
|
Beck Science Center, 8 Hartom St, Har Hotzvim, Jerusalem, Israel, 97775
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: 972-2-548-6555
(Former name or former address, if change since last report)
Check the appropriate box below if the Form 8-K filing is to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
o
|
Written communications pursuant to Rule 425 under the Securities Act (17CFR 230.425)
|
|
o
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
o
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
o
|
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 July 20, 2011, BioCancell Therapeutics, Inc. (“BioCancell”) was notified that it had received approval from the Food and Drug Administration (FDA) to commence a Phase IIb pancreatic cancer clinical trial in the U.S.A, using BioCancell’s lead product, BC-819 in sequence with the FDA-approved drug Gemzar (Gemcitabine), in patients with locally advanced unresectable pancreatic cancer who have never received treatment (the “Clinical Trial”).
The Clinical Trial is expected to include approximately 100 participants in 25 to 30 medical centers in locations including the U.S.A., Europe and Israel. One group, comprised of half of the participants, is to be treated with the combination of BC-819 and Gemzar (the current standard chemotherapy for pancreatic cancer), while a second group is to be treated with Gemzar alone. The primary endpoint of the trial is Progression-Free Survival.
An interim analysis to assess the safety of the treatment is planned after the recruitment of the first 18 patients, in order to determine the dose of BC-819 for the remainder of the Clinical Trial.
In advance of the commencement of the Clinical Trial, BioCancell will be required to receive regulatory approvals, including from local government authorities and participating medical centers.
The Clinical Trial comes in addition to two clinical trials currently being run by BioCancell – a Phase IIb clinical trial of BC-819 as a treatment for superficial bladder cancer, and a Phase I/IIa clinical trial of BC-819 as a treatment for ovarian cancer. It follows a Phase I/IIa clinical trial of BC-819 as a treatment for pancreatic cancer, and a pre-clinical hamster study comparing BC-819 used in sequence with Gemzar, to Gemzar alone.
SIGNATURE
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.
|
BIOCANCELL THERAPEUTICS, INC.
|
||
|
Dated: July 25, 2011
|
By:
|
/s/ Avraham Hampel
|
|
Avraham Hampel
|
||
|
Company Secretary
|
||