TEL AVIV, Israel--(BUSINESS WIRE)-- Tikcro Technologies Ltd. (Pink Sheets: TIKRF)(“Tikcro”) announced today that BioCancell, a clinical stage biotechnology company focused on developing targeted cancer therapies for solid cancer tumors, in which Tikcro holds approximately 26% on a fully diluted basis, has commenced enrollment of its Phase IIb pancreatic cancer clinical trial with a first treatment of the first patient.
The trial will examine the effect of BioCancell's BC-819 in sequence with Gemcitabine (the current standard chemotherapy for pancreatic cancer) in patients with locally-advanced, unresectable pancreatic cancer. The clinical trial is expected to include approximately 100 participants in multiple medical centers in Europe, Israel and the U.S. Half of the participants will be treated with the combination of BioCancell's BC-819 and Gemcitabine, and the other half will be treated with Gemcitabine alone. The primary endpoint of the trial is progression-free survival. Secondary objectives include overall survival, response rate and resectability of the target tumor lesion.
An interim analysis is planned for after the recruitment of the first 18 patients in order to determine the appropriate dose of BC-819 to utilize for the remainder of the trial.
The U.S. FDA granted BioCancell a "Fast Track" designation for BC-819, as a treatment for locally-advanced pancreatic carcinoma. Fast Track designation is expected to expedite FDA review of BC-819 and the process of clinical trials.
About Tikcro Technologies:
Tikcro has holdings in BioCancell Therapeutics, Inc., a clinical-stage biopharmaceutical company operating in the area of cancer treatment. BioCancell's leading drug, BC-819, is a double stranded DNA plasmid construct that incorporates the gene for diphtheria toxin (DTA) under the regulation of the promoter sequence for H19 gene. Pursuant to U.S. FDA approved protocols, BioCancell is conducting a phase IIb clinical trial for the treatment of pancreatic cancer, phase IIb clinical trial for the treatment of superficial bladder carcinoma cancer and a Phase I/IIa clinical trial for the treatment of ovarian cancer.
For more information, visit Tikcro website at www.tikcro.com.
Safe Harbor Statement
Certain of the statements contained herein may be considered forward-looking statements that involve risks and uncertainties including, but not limited to, risks related to our ability to raise financing and the business of BioCancell, including, but not limited to, the development, testing, regulatory approval and commercialization of its products, its intellectual property rights, its funding, its competition, its exposure to lawsuits and its dependence on key suppliers and personnel. Such risks and uncertainties are set forth in the Company's SEC reports, including the Company's Form 20-F. Actual results may materially differ. Results of operations in any past period should not be considered indicative of the results to be expected for future periods. We undertake no duty to update any forward-looking information.
KEYWORDS: Middle East Israel
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical FDA General Health