• La Jolla Pharmaceutical Co., of San Diego, released data detailing the ability of lead product candidate GCS-100 to improve renal function. The retrospective analysis details the positive effect that GCS-100 treatment had on the estimated glomerular filtration rate in patients with poorly functioning kidneys. GCS-100 is being developed as a treatment for chronic kidney disease, with a Phase IIa trial expected to begin soon.

• Lpath Inc., of San Diego, began dosing in a Phase IIa trial of Asonep for renal cell carcinoma in patients that have failed standard VEGF- or mTOR-targeted treatments. Asonep is a humanized antibody designed to neutralize sphingosine-1-phosphate, a target of significance in multiple sclerosis and may contribute to progression of some cancers. Lpath also is studying Asonep in a four-arm, double-blind, Phase II study in patients with wet age-related macular degeneration.

• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., enrolled its last patient in a Phase II trial of MM-121 in combination with exemestane in postmenopausal women with locally advanced or metastatic estrogen receptor-positive or HER2-negative breast cancer. The study will assess effectiveness of the combination compared to exemestane alone. It enrolled 118 patients and is being carried out in the U.S., Canada, Russia and Europe. Top-line results are due in the second half of 2013.

• Omeros Corp., of Seattle, said the FDA cleared its investigational new drug application to evaluate OMS824, a selective phosphodiesterase 10 inhibitor, in Huntington's disease. The company plans to advance the drug into Phase II trials next quarter in Huntington's disease and later this year in schizophrenia. Omeros also said it has requested orphan drug designation for OMS824 in Huntington's.

• OncoGenex Pharmaceuticals Inc., of Bothell, Wash., began a Phase II (Cedar) trial of heat-shock protein 27 (Hsp27) inhibitor OGX-427 for advanced squamous cell lung cancer. The randomized, open-label study will assess progression-free survival in about 140 patients given OGX-427 plus gemcitabine and carboplatin vs. gemcitabine and carboplatin alone. Secondary objectives of the trial are tumor response rates, overall survival, safety, tolerability and quality of life. An additional analysis will evaluate Hsp27 levels and identify potential biomarkers for predicting response to treatment.

• Repros Therapeutics Inc., of The Woodlands, Texas, said the FDA recommended a Phase IIb study of Proellex-V, a product in development by for uterine fibroids, before proceeding to Phase III. In a meeting between the agency and the company, it was agreed that the primary indication and label for Proellex-V should be for treatment of severe menstrual bleeding associated with fibroids, using the Pictorial Blood Loss Assessment as primary endpoint, and that if the company proposes a label based on patient-reported outcome, that must be validated prior to the start of Phase III. Lastly, the FDA will review the protocol prior to study initiation.

• Sorcimed Biopharma Inc., of Toronto, treated its first patient in a Phase I trial of SOR-C13 for advanced cancer tumors, particularly ovarian cancers. The open-label study will be carried out in the U.S. and Canada, and will assess pharmacokinetics and biomarkers, and look for initial evidence of efficacy. SOR-C13 is derived from the venom of the northern short-tailed shrew. Preclinical studies have shown that it induces apoptosis, inhibits cell proliferation and reduces tumor volume.

• Spring Bank Pharmaceuticals Inc., of Milford, Mass., initiated dosing in a Phase I study of SB 9200, its investigational, once-daily, oral therapy for the treatment of hepatitis C virus (HCV) infection. The study will be conducted in healthy, HCV-infected patients and is designed to assess both the safety and antiviral efficacy of SB 9200. SB 9200 is based on the company's Small Molecule Nucleic Acid Hybrid (SMNH) technology platform. While the primary endpoint is safety, secondary objectives include an analysis of dose vs. viral load reduction, liver function, safety labs and host immune expression, as well as characterization of plasma and urine pharmacokinetics and assessment of pharmacodynamic activity.

• Umecrine Mood AB, of Solna, Sweden, began dosing in a Phase I/II trial of UC1010 for premenstrual dysphoric disorder (PMDD). The double-blind, multicenter study will assess safety and efficacy of the drug in 120 patients. PMDD is currently treated with antidepressants, but those treatments often are not effective or carry side effects.

• Virobay Inc., of Menlo Park, Calif., started a Phase I trial for an oral pain treatment dubbed VBY-036, a selective cathepsin S inhibitor. The double-blind, randomized, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of VBY-036 in healthy adults.

• Zensun Sci and Tech Ltd., of Shanghai, China, reported results from four completed Phase II trials of its heart failure drug, Neucardin. The studies included three double-blind, placebo-controlled Phase II trials, and showed that Neucardin reduced all-cause mortality, improved heart function, reduced heart volumes and improved exercise capacity and quality of life on top of the current standard of care in patients with chronic heart failure. Zensun has filed a new drug application for accelerated market approval in China based on those data, and is planning a Phase III trial in the U.S.