JERUSALEM, Nov. 15, 2017 (GLOBE NEWSWIRE) — BioCanCell Ltd. (TASE:BICL), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapies to treat cancer, announced today additional final clinical trial results for its combination therapy clinical trial of BC-819, BioCanCell’s lead drug, together with BCG, a current therapy for bladder cancer patients (the “Combination Therapy”). BC-819 is an intravesical gene therapy consisting of a recombinant DNA construct which delivers a lethal cellular toxin, engineered from diphtheria, specifically to malignant cells in the bladder. Full data has been submitted to the 2018 Genitourinary Cancers Symposium Annual meeting being held in San Francisco, CA from February 8th through 10th, 2018.
The objective of the trial was to examine the safety and tolerability of the Combination Therapy administered over six or 12 weeks (maintenance BC-819 was not administered), comparing three different modes of administration in intermediate-risk and high-risk NMIBC patients. A total of 38 patients were recruited for the trial. Patients are being followed for up to 2 years, and the median follow-up at the time of the analysis is approximately 18 months. The population was analyzed according to intention to treat (ITT), in which all patients accepted are included, and as the subgroups were not randomized, results are presented for the entire population.
Based on a Kaplan-Meier estimate of all participants, the median time to recurrence for the overall ITT population has not been reached, and the median time to progression also has not been reached. The safety profile of the drug in combination with BCG demonstrated minimal adverse events attributed to BC-819, none of which were serious (SAEs). Overall, the safety profile of the drug was consistent with prior data.
These data demonstrate that administration of BC-819 in combination with BCG is feasible and exhibits clinically meaningful activity. The safety profile suggests that BC-819 is well tolerated and does not add substantial toxicity to intravesical therapy.
“We are encouraged by the updated study results given the limited treatment options currently available for patients with non-muscle invasive bladder cancer (NMIBC), a serious area of unmet medical need,” commented Frank Haluska, M.D, Ph.D., BioCanCell’s President and Chief Executive Officer.
BioCanCell’s lead product candidate, BC-819, is a double-stranded DNA plasmid being developed as an intravesical gene therapy for early stage, non-muscle invasive bladder cancer (NMIBC). The plasmid, when taken up by malignant bladder cancer cells, expresses a lethal toxin engineered from diphtheria specifically in the tumor. BioCanCell has successfully completed phase 1/2 and phase 2 clinical trials of BC-819 in patients with NMIBC, as well as a phase 2 study of combination therapy of BC-819 and Bacillus Calmette-Guérin (BCG).
About Bladder Cancer
Bladder cancer is the fourth most common malignancy in men, and the ninth most common overall, in the United States. Annual incidence for 2016 is estimated to be approximately 77,000 new cases in the United States, and approximately 150,000 new cases in Europe. Because of the prolonged natural history of the disease its US prevalence is high, estimated to comprise about 570,000 cases. Approximately 75% of bladder cancer cases are classified as non-muscle-invasive bladder cancer (NMIBC), defined as tumor that is confined to the bladder epithelium and underlying connective tissue, without penetration to the muscular layer of the bladder or metastasis to local or distant structures. Patients with NMIBC are treated by trans-urethral resection (TUR) of primary tumors, followed by adjuvant therapy administered into the bladder (intravesically). The most frequently utilized therapy is BCG, but toxicity of therapy can be limiting, and as many as 70% of NMIBC patients treated with BCG will suffer from recurrences within five years of treatment. For patients in whom BCG treatment has failed, the standard recommendation for therapy is cystectomy. In the US, bladder cancer has the highest lifetime per-patient treatment cost of all cancers. For these reasons, the need for new treatments for this common and refractory condition is substantial.
BioCanCell is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer. The Company’s most advanced product candidate, BC-819, is in development as a treatment for early stage, non-muscle-invasive bladder cancer (NMIBC). Two registrational clinical trials of BC-819 are planned to be initiated: a single arm trial in patients whose disease is unresponsive to standard therapy, and a randomized trial, under a special protocol assessment (SPA) from the U.S Food and Drug Administration (FDA), in patients who have failed a first course of treatment. For additional information please go to www.biocancell.com.
Forward Looking Statements
This press release contains “forward-looking statements” that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of clinical trials, the anticipated effects of receiving Fast Track designation, the anticipated timeframe for conducting additional clinical trials and making regulatory submissions, and other strategic and business plans and objectives. These forward-looking statements are based on information BioCanCell has when those statements are made or its management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to: the success of the approach to discover and develop prospective therapeutic products, which is new and may never lead to marketable products; a lack of history of commercial sales; a dependence on the success of BC-819, the development of which will require significant additional clinical testing before regulatory approval can be sought and commercial sales launched; a need to raise substantial additional funds to complete R&D activities; an ability to overcome scientific or technological difficulties that may be encountered and that may impede R&D activities; and an ability to obtain and maintain intellectual property protection for product candidates, including pursuant to licensed patents.
Frank Haluska, M.D., Ph.D.
President and Chief Executive Officer
Patricia L. Bank