Aduro Biotech Inc., of Berkeley, Calif., said it enrolled the first patients in a phase I trial of immunotherapy ADU-623, from its live-attenuated, double-deleted Listeria monocytogenes platform, in high-grade glioma. The study will enroll up to 38 patients who previously have been treated with standard of care and will evaluate three dose levels, with the primary goal of establishing safety and finding the optimal dose. Patients' tumor responses and immune responses also will be evaluated. The project has been funded by grants from the Kuni Foundation and Providence Portland Medical Foundation and is being conducted at the Earle A. Chiles Research Institute at Providence Cancer Center in Portland, Ore.

Advaxis Inc., of Princeton, N.J, said it plans to start a clinical development program with ADXS-cHER2, an immunotherapy candidate designed to target the HER2 oncogene, for the treatment of pediatric osteosarcoma. The drug demonstrated a statistically significant prolonged overall survival benefit compared to standard of care in a veterinarian clinical study with pet dogs with naturally occurring osteosarcoma. Advaxis is conducting the required investigational new drug application-enabling studies.

Aerpio Therapeutics Inc., of Cincinnati, presented full results from its phase Ib/IIa study of Tie2 activator AKB-9778 for the treatment of diabetic macular edema ad the Association for Research in Vision and Ophthalmology meeting in Orlando, Fla. In the study, one month of daily ABK-9778 treatment was well tolerated, produced clinically meaningful reduction in retinal thickness, with concomitant improvement in visual acuity, in some patients. The 28-day study enrolled 24 patients in six-patient cohorts. After one month of treatment at doses of 15 mg or higher, seven of 18 patients demonstrated a reduction in central retinal subfield thickness of greater than 50 mcg, while 13 of 18 patients gained five or more letters of visual acuity.

Alcobra Ltd., of Tel Aviv, Israel, presented phase IIb data at the American Psychiatric Association meeting in New York, showing that its MDX (metadoxine extended release) candidate in adults with predominantly inattentive attention deficit hyperactivity disorder (PI-ADHD) provided significant benefit after one dose and was as well tolerated vs. placebo. The study enrolled 36 adults diagnosed with PI-ADHD, with the primary endpoint defined as the mean change from baseline of the Test of Variable of Attention (TOVA) ADHD Score. The company previously reported that the intent-to-treat analysis demonstrated a statistically significant change from baseline for a single dose of MDX 1,400 mg vs. placebo on the TOVA ADHD Score (p = 0.009). Data also demonstrated a statistically significant change from baseline for MDX 1,400 mg compared to placebo on the TOVA subscore of response time variability, a subscore correlated with attention and cognition (p = 0.022). There were no significant differences observed between the MDX 700-mg dose and placebo in the primary or secondary efficacy endpoints.

Angstrom Pharmaceuticals Inc., of San Diego, said it activated a phase II trial to determine the safety, tolerability and efficacy of A6, its CD44-binding peptide, in chronic lymphocytic leukemia. The open-label study will enroll 20 patients.

Covagen AG, of Zurich, Switzerland, said it started a phase Ib/IIa study of Fynomab candidate COVA322, a bispecific TNF/IL-17A inhibitor, in development for rheumatoid arthritis, psoriatic arthritis and other inflammatory diseases. The study will enroll 39 patients with psoriasis and will evaluate safety, as well as biological activity, of a single ascending dose of COVA322. Secondary endpoints include readouts on psoriatic skin lesions and biological responses measured via skin biopsies.

Cytrx Corp., of Los Angeles, presented updated progression-free survival (PFS) and overall survival (OS) data from its phase Ib/II study of aldoxorubicin at its R&D day Friday, showing that aldoxorubicin administered at its maximum-tolerated dose of 350/mg/m2 showed a substantial increase in PFS in patients with advanced soft-tissue sarcoma. Partial responses were observed in five of 13 patients (38 percent), and stable disease was observed in six of 13 patients (46 percent). The final reported data showed observed median PFS of 11 months and median OS of 17 months. Aldoxorubicin is in phase III testing as a second-line treatment in soft-tissue sarcoma. (See BioWorld Today, Dec. 12, 2013.)

Immune Pharmaceuticals Inc., of New York, said it is ready to move to phase III testing with Amiket, a topical drug for the treatment of neuropathic pain, and said it will prioritize postherpetic neuralgia (PHN) as the first indication for development and commercialization. Amiket previously received orphan drug designation in PHN and has completed three phase II trials, including one study in which Amiket demonstrated statistically significant efficacy in reducing pain in PHN patients, at both low and high doses, compared to placebo.

MEI Pharma Inc., of San Diego, said the first patient was dosed in a phase Ib study testing mitochondrial inhibitor ME-344 in combination with Hycamtin (topotecan) in patients with solid tumors, including small-cell lung and ovarian cancers. The open-label trial is expected to enroll up to 64 patients, with preliminary data anticipated by the first quarter of 2015.

Melinta Therapeutics Inc., of New Haven, Conn., said it started patient enrollment in a phase III trial testing oral and intravenous (I.V.) delafloxacin, a fluoroquinolone, in adults with acute bacterial skin and skin structure infections (ABSSSIs). The study is designed to compare the efficacy and safety of both formulations of delafloxacin to a control regimen of I.V. vancomycin plus aztreonam. About 600 patients will be enrolled, and patients in the delafloxacin arm will receive the I.V. formulation twice daily for three days before switching to oral delafloxacin twice daily. All patients will receive a minimum of five days of dosing, with a maximum of 14 days of treatment at the investigators' discretion. Results from this trial, and those from a second, ongoing phase III study testing I.V. delafloxacin, are expected to support regulatory filings in the U.S. and in other regions. Delafloxacin previously gained designation as a qualified infectious disease product for the treatment of ABSSSI.

Pulmatrix Inc., of Lexington, Mass., said it completed the second part of a two-part phase Ib trial testing PUR0200, a bronchodilator therapy based on the firm's Isperse inhaled dry powder technology, in chronic obstructive pulmonary disease. Data presented at the Respiratory Drug Delivery conference in Fajardo, Puerto Rico, demonstrated that all doses of PUR0200 resulted in statistically significant increases in lung function compared to placebo, as measured by peak and trough FEV1 increases from baseline, and that lung function improvement following all PUR0200 doses was similar or numerically greater than the active compactor arm. Because of Isperse's delivery capabilities, nominal doses of PUR0200 were 50 percent to 80 percent lower than the nominal dose of the active comparator lactose blend formulation, the company said. Additional testing is slated for the second half of this year. Pulmatrix also presented preclinical data for fluoroquinilone Levofloxacin candidate PUR0400, also formulated with Isperse, showing that it exhibits desirable physical and aerosol properties, while exhibiting stability across storage conditions. PUR0400 is in development as an antibiotic for treating respiratory diseases such as cystic fibrosis (CF) and non-CF bronchiectasis.

Questcor Pharmaceuticals Inc., of Anaheim, Calif., said results from a study testing H.P. Acthar gel (repository corticotropin injection) in systemic lupus erythematosus were published in LUPUS, with data from the 10-patient study showing that Acthar treatment resulted in significant improvements in certain clinical outcome measures that indicate a reduction of lupus disease activity.