Actinium Pharmaceuticals Inc., of New York, reported phase I results showing that Actimab-A produced a 50 percent complete response at the selected phase II dose in patients with newly diagnosed acute myeloid leukemia with low peripheral blast burden. The trial enrolled 18 patients, with complete responses seen in 28 percent of patients at all dose levels. Actinium plans to begin enrolling patients in a phase II study, testing Actimab-A at the 2 µCi/kg/fractionated dose, in the second half of this year. Actimab-A emerged from the firm's alpha particle immunotherapy program and consists of monoclonal antibodyHuM195 and radioisotope actinium-225.

Antares Pharma Inc., of Ewing, N.J., said the last patient completed treatment in a dose-blinded, multiple-dose, concentration-controlled, 26-week phase III trial testing its Quickshot Testosterone, administered subcutaneously once weekly to adult males with hypogonadism. The company plans to combine data from that study with previously reported pharmacokinetic and safety data from an earlier study, QST-13-003, for a new drug application filings, expected later this year or in early 2017.

Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said it reached agreement with the EMA on the final design for a pivotal phase III trial testing piclidenoson (CF101), its A3 adenosine receptor agonist (A3AR), in rheumatoid arthritis (RA). The company plans to compare piclidenoson to methotrexate in the treatment of 500 early RA patients. The primary endpoint will be low disease activity as measured by Disease Activity Scores at week 12. Secondary endpoints include American College of Rheumatology score 20, 50 and 70 and the correlation between A3AR expression at baseline and patients' response to piclidenoson. The study is set to start in the second or third quarter.

Contravir Pharmaceuticals Inc., of Edison, N.J., said it began screening patients with chronic hepatitis B virus for a head-to-head phase IIa study comparing its CMX157 to tenofovir DF (TDF, Gilead Sciences Inc.), following a positive recommendation from an independent data safety monitoring board. The study will compare sequentially escalating doses of CMX157, beginning at a 5 mg daily CMX157 dose compared to 300 mg daily dose of TDF. The study is expected to conclude in the fourth quarter of 2016. CMX is an analogue of tenofovir.

Curis Inc., of Lexington, Mass., said the FDA accepted its investigational new drug application for CA-170, an oral, small molecule designed to inhibit immune checkpoints PD-L1 and VISTA (V-domain immunoglobulin suppressor of T-cell activation). Preclinical data demonstrated that CA-170 can induce effective proliferation and cytokine production by T cells in culture that are specifically suppressed by PD-L1 or VISTA. It also demonstrated in vivo antitumor activity similar to anti-PD-1 or anti-VISTA antibodies in multiple mouse tumor models and appeared safe to administer based on toxicology studies.

Evoke Pharma Inc., of Solana Beach, Calif., said the last subject completed treatment in its pivotal phase III study for EVK-001, a nasal delivery formulation of metoclopramide designed to relieve symptoms associated with acute and recurrent diabetic gastroparesis in women. The primary endpoint in the four-week, U.S., randomized, double-blind, placebo-controlled trial is the change in gastroparesis symptoms at week four utilizing a Patient Report Outcome symptom assessment instrument. Top-line data are expected early in the third quarter.

Eyegate Pharmaceuticals Inc., of Waltham, Mass., said interim data from its phase Ib/IIa trial testing lead candidate iontophoretic EGP-437 in ocular inflammation and pain in cataract surgery patients showed that a majority had a positive response, with some patients in the 9 mA-min and 14 mA-min dose cohorts presenting with clinically relevant reductions in anterior chamber cell count (ACC) – zero or trace ACC levels at day 14. All subjects experienced low pain throughout the duration of the trial. Enrollment will continue for the remaining cohorts. The primary endpoint for all cohorts is ACC at day 14, with secondary endpoints measuring pain score and intra-ocular pressure.

Galmed Pharmaceuticals Ltd., of Tel-Aviv, Israel, randomized half of the patients, or 120, in the phase IIb ARREST (ARamchol for the REsolution of STeatohepatitis) study testing the SCD1 enzyme inhibitor aramchol in patients with non-alcoholic steatohepatitis who also suffer from obesity and insulin resistance.

Genticel SA, of Toulouse, France, said phase I results published in Clinical Cancer Research showed that GTL001, a bivalent vaccine candidate, was generally safe and well-tolerated and induced a specific immune response in women with normal cytology infected with human papillomavirus (HPV) 16 or 18. The study also provided initial evidence that GTL001 could promote clearance of HPV16/18 in that population.

Hepatera LLC, of Moscow, and its development partner Myr GmbH, of Burgwedel, Germany, said favorable results of the first-in-human phase I study in healthy volunteers, and the proof-of-concept phase IIa study in hepatitis B virus(HBV)/hepatitis D virus co-infected patients were published as two separate "back-to-back" articles in the Journal of Hepatology. The drug involved, Myrcludex B, is described as a first-in-class entry inhibitor for treatment of such chronic infections. The drug inhibits the recently identified HBV receptor on the hepatocyte surface and prevents the infection of the healthy cells and viral spreading within the liver.

Lipidor AB, of Stockholm, and Cadila Pharmaceuticals Ltd., of Gujarat, India, entered a collaboration on the commercialization of a sprayable anti-psoriatic product consisting of the generic vitamin D analogue, calcipotriol, formulated with Lipidor´s patented lipid-based drug delivery technology, Akvano. The product targets patients with mild to moderate psoriasis. Under the agreement, Cadila Pharmaceuticals will conduct a phase III program in India starting in 2016.

Pharmaengine Inc., of Taipei, Taiwan, said the first patient has been dosed in a global pivotal phase II/III trial of PEP503 (NBTXR3) in soft tissue sarcoma at Perpetual Succor Hospital in Cebu, the Philippines. The multinational, randomized, open-label, two-arm study, referred to as Study 301, is being conducted in partnership with Pharmaengine's partner, Nanobiotix SA, of Paris. The primary objective of Study 301 is to enhance the pathological complete response rate by dosing PEP503 through intra-tumor injection and then activated by external beam radiation therapy. The efficacy of PEP503 combined with radiotherapy in the experiment will be compared with that of radiotherapy alone. PEP503 is a nanoparticle formulation of hafnium oxide crystals for the local treatment of tumors to enhance the efficacy of radiotherapy.

Portola Pharmaceuticals Inc., of South San Francisco, dosed the first patient in a phase IIa study that is evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell and T-cell malignancies who have failed multiple therapies. Cerdulatinib is an oral, dual Syk/JAK kinase inhibitor in development to treat patients with resistant or relapsed hematologic cancer. The drug inhibits two key cell signaling pathways that promote cancer cell growth in certain hematologic malignancies, Portola said.

Regulus Therapeutics Inc., of La Jolla, Calif., expanded its clinical trial collaboration agreement with Glaxosmithkline plc (GSK), of London, for the development of RG-101, Regulus' wholly owned, GalNAc-conjugated anti-miR that targets miR-122. In the expanded collaboration, the companies plan to conduct a multi-centered, randomized, dose-ranging phase II study evaluating the combination of RG-101 and GSK's long-acting parenteral formulation of GSK2878175 as a potential single-visit cure in patients chronically infected with hepatitis C virus. The study will be conducted outside the U.S. and is planned to begin in the fourth quarter of 2016.

Stealth Biotherapeutics Inc., of Boston, started Resight, a phase II study evaluating the topical eye drop delivery of elamipretide (formerly known as Ocuvia) for the treatment of patients with Leber's hereditary optic neuropathy, an inherited mitochondrial disease that causes central vision loss stemming from the damage to retinal ganglion cells due to dysfunction of energy-producing complexes in the mitochondria. The disease, which can lead to legal blindness, affects more men than women and often strikes patients in their late teens and early 20s. Elamipretide is described as having the potential to modify disease by preserving energetics and restoring normal energy production in mitochondria while decreasing oxidative stress.

Theravance Biopharma Inc., of Dublin, said enrollment has been completed in each of the three ongoing trials comprising the company’s phase III program for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist in development for the treatment of chronic obstructive pulmonary disease. More than 2,300 patients have been enrolled in the phase III program, which includes two replicate efficacy studies and a single 12-month safety stud and is designed to support a new drug application. Top-line data from two efficacy studies are in the late third quarter or early fourth quarter, with the data from safety trial following in 2017. Revefenacin is partnered with Mylan NV, of Canonsburg, Pa.