DBV Technologies announces results from Phase II study of Viaskin Milk in milk-allergic patients. Positive preliminary results support Viaskin Milk’s potential as the first treatment for patients suffering from IgE-mediated cow’s milk protein allergy (CMPA), an unmet medical need for which there are no approved therapies. A statistically significant desensitization to milk was observed in children ages two to 11 treated with Viaskin Milk 300 µg for 12 months. The Viaskin Milk Efficacy and Safety (MILES) trial is a multi-center, double-blind, placebo-controlled, randomized Phase I/II trial to study the safety and efficacy of Viaskin Milk conducted at 17 sites in North America where 198 patients were randomized 1:1:1:1 into four treatment arms to evaluate three doses of Viaskin Milk, 150 mcg, 300 mcg and 500 mcg, compared to placebo. Patients received a daily application of the Viaskin Milk patch over 12 months. Following analyses of the data, the 300 µg dose was identified as the most effective tested dose for children.
Geneva reported positive top line results of the IMPLANT2 Phase III clinical trial of its oral oxytocin receptor antagonist, nolasiban, which is being developed for improving pregnancy rates following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures. IMPLANT2 is a Phase III, randomized, double blind, clinical trial assessing nolasiban compared to placebo for improving the rate of pregnancy in patients undergoing IVF or ICSI due to low fertility. The Phase III trial included 778 patients from across nine countries. Following ovarian stimulation, egg retrieval and fertilization, eligible women were randomized to receive either a single, oral dose of 900 mg nolasiban or placebo four hours before D3 or D5 fresh, single ET. Patients received either a single 900 mg dose of nolasiban or placebo (1:1) orally on the day of embryo transfer (ET). The primary endpoint of the clinical trial was met, with an absolute increase in ongoing pregnancy rate at 10 weeks of 7.1 percent (placebo 28.5 percent and nolasiban 35.6 percent, p = 0.031). This represents a relative increase of 25 percent in the ongoing pregnancy rate after administration of nolasiban compared to placebo.
Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for XGEVA(denosumab) to cover skeletal-related events in patients with multiple myeloma. The study was an international, Phase III, randomized, double-blind, multicenter trial of XGEVA compared with zoledronic acid in the prevention of skeletal-related events in adult patients with newly diagnosed multiple myeloma and bone disease. In the study, a total of 1,718 patients were randomized to receive either subcutaneous XGEVA 120 mg and intravenous placebo every four weeks, or intravenous zoledronic acid 4 mg and subcutaneous placebo every four weeks, plus investigators’ choice first-line antimyeloma therapy. XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95 percent CI: 0.85-1.14). The median time to first on-study skeletal-related event was 22.83 months for XGEVA and 23.98 months for zoledronic acid.
Intensity Therapeutics announced completion of the first safety cohort (A) of the Company’s Phase 1/2 international clinical study evaluating lead product, INT230-6. Following intratumoral drug injections into superficial lesions in six patients with either ovarian, thyroid, head and neck or skin cancers, there were no dose limiting toxicities. INT230-6 is a novel, anti-cancer drug for direct intratumoral injection. The product contains potent anti-cancer agents that disperse throughout tumors and diffuse into cancer cells. INT230-6 was identified from Intensity’s DfuseRx platform and is being evaluated in a clinical trial; IT-01. In preclinical studies INT230-6 administration eradicated tumors by a combination of direct tumor kill coupled with recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. The study will characterize the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response.