• Alder BioPharmaceuticals Inc., of Bothell, Wash., said it started a Phase I study of antibody therapeutic candidate ALD403, designed to target the calcitonin gene-related peptide for treating migraine. The study will evaluate the safety and tolerability of the drug, administered via both intravenous infusion and subcutaneous injection, in healthy volunteers followed for 12 weeks after treatment. The trial also will evaluate the pharmacokinetic and pharmacodynamics profiles of the drug in healthy subjects.

• Kythera Biopharmaceuticals Inc., of Los Angeles, presented initial results from the first of two European Phase III trials showing that ATX-101, a facial injectable for reducing submental fat, resulted in a statistically significant reduction in submental fat relative to placebo, as measured using a five-point Clinical-Reported Submental Fat Rating Scale (mean of 0.90 vs. 0.22; p < 0.001, week 24). Similarly, the drug resulted in a statistically significant percentage of subjects, relative to placebo, achieving a predefined categorical change using a seven-point Subject Self Rating Scale (66. 1 vs. 28.7; p < 0.001, week 24). Data were presented at the American Society for Aesthetic Plastic Surgery meeting in Vancouver, British Columbia. Top-line data were released last month. (See BioWorld Today, April 26, 2012.)

• Millennium, of Cambridge, Mass., a unit of Takeda Pharmaceutical Co. Ltd., and Seattle Genetics Inc., of Bothell, Wash., said they started a pivotal Phase III trial of Adcetris (brentuximab vedotin) in patients with CD30-expressing cutaneous T-cell lymphoma (CTLC) who received at least one prior systemic therapy. The study, which is being conducted under a special protocol assessment, will test the antibody-drug conjugate vs. investigator's choice of methotrexate or bexarotene in CTCL patients, including those with primary cutaneous anaplastic large-cell lymphoma or mycosis fungoides. The primary endpoint is overall response rate, lasting at least four months. Secondary endpoints include complete response, progression-free survival and burden of symptoms. About 124 patients will be enrolled in the trial.

• NovaDigm Therapeutics Inc., of Grand Forks, N.D., reported Phase I data showing a single dose of NDV-3, a prophylactic vaccine containing recombinant Als3, a surface adhesion/invasion from Candida albicans, was safe and well tolerated, with or without alum adjuvant, and induced strong antibody and T-cell immune responses. The study enrolled 160 healthy adults and tested three different formulations and two routes of administration. All three vaccinated groups showed rapid increases in serum and vaginal immunoglobulin G and immunoglobulin A1 antibodies by day seven following vaccination, which peaked at day 14. Data were presented at the Conference on Vaccine Research in Baltimore.

• Prolor Biotech Inc., of Nes-Ziona, Israel, reported top-line results from a 42-patient Phase II four-month treatment extension study of hGH-CTP, its long-acting version of human growth hormone, in growth hormone-deficient adults. Data reaffirmed the company's prior Phase II findings, showing that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of marketed human growth hormone and further validated the dosing regimen for the firm's planned Phase III trial.