• BioLineRx Ltd., of Jerusalem, said it received regulatory approval in the U.S. to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML). The open-label study under an investigational new drug application is designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adults with relapsed/refractory AML. The primary endpoints are safety and tolerability, with secondary endpoints including the pharmacokinetic profile of the drug and an efficacy evaluation as assessed by various parameters, such as response rate as measured by bone marrow biopsy. The study also was designed to enable investigators to evaluate the capabilities of BL-8040 in mobilizing cancer cells from the bone marrow to the peripheral blood and in inducing their cell death. The study is expected to enroll up to 50 patients at sites in the U.S. and Israel. The importance of BL-8040 to the BioLineRx pipeline increased last month after the company halted a Phase II/III trial of its lead compound, orally available GABA-enhanced antipsychotic BL-1020, in schizophrenia. On Wednesday, the company's shares (NASDAQ:BLRX) gained 9 cents, closing at $1.86. (See BioWorld Today, March 27, 2013.)

• Laboratorios Salvat SA, of Barcelona, Spain, and Kwang Dong Pharmaceutical Co. Ltd., of Seoul, South Korea, said they completed the Phase IIb trial of Tarafenacin, in development for treating overactive bladder syndrome. Data showed the drug, at doses of 0.2 mg and 0.4 mg, proved superior to placebo after four weeks in reducing the number of micturitions per day, the main endpoint of the study. Tarafenacin also showed the expected dose-efficacy response and confirmed a safety profile seen in earlier studies. The companies said data are sufficient to warrant moving into Phase III development.

• Photocure ASA, of Oslo, Norway, reported final results from its Phase IIb study of Cevira in patients with human papillomavirus (HPV)-related disease of the cervix, showing that the drug-delivery device demonstrated significant and sustained efficacy in the eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients. The optimal dose of Cevira 5 percent demonstrated a statistically significant and sustained lesion response compared to placebo (95 percent vs. 62 percent) at six months (p < 0.02). Data were further supported by high clearance of HPV subtypes 16 and 18, which carry high oncogenic risk, in the CIN2 cohort of 83 percent vs. 33 percent at six months.

• Regentis Biomaterials Ltd., of Or-Akiva, Israel, expanded the study of its GelrinC implant to 12 additional sites in Germany, Belgium, Poland, the Netherlands and Israel. The study will enroll another 30 patients, bringing the number of treated patients to 53. The biodegradable GelrinC implant helps grow hyaline-like cartilage in damaged knees by filling cartilage lesions with acellular material. The regenerated cartilage takes the exact form of the defect, with the goal of allowing a patient's knees to function normally and without pain. Regentis raised $10 million last year in a Series C financing to support clinical studies and commercial launch of GelrinC in Europe. (See BioWorld Today, May 15, 2012.)

• XOMA Corp., of Berkeley, Calif., said the National Eye Institute opened its noninfectious, active, anterior scleritis trial for patient enrollment. The open-label Phase I/II study is designed to assess the safety and potential efficacy of gevokizumab, a monoclonal antibody designed to bind to interleukin-1 beta. The study is expected to enroll 10 patients with scleral inflammatory grades of greater than or equal to 1-plus in at least one eye using a standardized photographic scleritis grading system. Patients who respond during the 16-week trial will have the option to continue treatment for an additional 20 weeks.

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