RAANANA, Israel, Sept. 27, 2016 /PRNewswire/ -- XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus, today reported financial results for the three and six months ended June 30, 2016, as well as a clinical and operational update on the development program for its lead drug candidate hCDR1 in the treatment of Systemic Lupus Erythematosus (SLE).
"In the first half of 2016 we achieved important milestones towards commencing our Phase 2 hCDR1 study, which we believe is designed to reveal strong efficacy results for our drug in the treatment of SLE. The trial design is based on very encouraging feedback from the U.S. FDA regarding BILAG as the efficacy endpoint and 0.5 mg as the weekly dosage of hCDR1. These are parameters that produced successful results in a prior trial," stated Josh Levine, CEO of XTL. "We continue to build our hCDR1 IP portfolio with the filing of two patent applications in the US, as well as working on chemistry, manufacturing and controls for Phase 2, future trials, and future commercial production."
Clinical and Operational Update:
- Prepared to Commence Phase 2 Trial
During the first half of 2016, XTL completed the clinical trial design of its Phase 2 study of hCDR1 in the treatment of SLE. The protocol was designed in consultation with its world renowned Clinical Advisory Board and based on encouraging feedback from a pre-investigational new drug (IND) meeting package submission to the U.S. FDA. The trial design includes a treatment arm dosing weekly at 0.5 mg hCDR1 and BILAG, a measure of lupus disease activity, as the measure for the primary efficacy endpoint. Data from the prior Phase 2 study clearly showed a statistically significant effect of a 0.5 mg dose of hCDR1 on the BILAG index. XTL believes the FDA's guidance will improve the likelihood of a successful trial. The FDA's guidance also included parameters on patient inclusion criteria and patient population for safety requirements for marketing approval.
- Production Batches of hCDR1 Ready for Phase 2 Trial
XTL completed production of representative batches of hCDR1, with BioConnection NV during the first half of 2016. These manufactured batches advance XTL's chemistry, manufacturing and controls (CMC) program for the planned Phase 2 trial of hCDR1.
- Strengthened Intellectual Property Portfolio
hCDR1 was recently granted an important patent in Europe titled "Parenteral Formulations of Peptides for the Treatment of Systemic Lupus Erythematosus," which addresses non-oral drug formulations of hCDR1 in the treatment of SLE. In a move to further broaden hCDR1's intellectual property rights, XTL filed two new patent applications with the U.S. Patent and Trademark Office to protect doses of hCDR1 lower than 0.5 mg weekly in the treatment of SLE.
Financial Overview
XTL reported $2.6 million in cash and cash equivalents as of June 30, 2016. Funds will be used to advance the hCDR1 clinical program for the treatment of SLE.
Research and development expenses for the quarter ended June 30, 2016 were $122,000 compared with $69,000 for the same period in 2015. For the six months ended June 30, 2016 research and development expenses were $355,000 compared with $111,000 for the same period in 2015. The three and six-month period increases reflect the Company's increased investment in the hCDR1 clinical program and preparations for a Phase 2 clinical trial. First and second quarter development activities included the completion of the trial design for the planned Phase 2 trial of hCDR1 for the treatment of SLE and production of the drug product for that trial. The initiation of the clinical trial will require the Company to raise additional capital.
General and administrative expenses for the three months ended June 30, 2016 were $344,000 compared with $412,000 for the same period in 2015. For the six months ended June 30, 2016 general and administrative expenses were $713,000 compared to $746,000 in the first half of 2015.
XTL reported an operating loss for the quarter ended June 30, 2016 of $466,000 compared with $481,000 for the same period in 2015.
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