Actinium Pharmaceuticals Inc., of New York, submitted an investigational new drug application to FDA for Iomab-B, a radioimmunotherapeutic that conditions acute myeloid leukemia patients for a hematopoietic stem cell transplant. If the FDA approves it, the firm plans a single, pivotal phase III study in refractor and relapsed patients over age 55.

Anavex Life Sciences Corp., of New York, is moving forward with the development program for ANAVEX 2-73, based on guidance received from the FDA regarding the prospective Alzheimer's disease treatment. The company plans a larger double-blinded, randomized, placebo-controlled phase II/III trial, after collecting data from a phase IIa study with the compound.

Bind Therapeutics Inc., of Cambridge, Mass., started patient dosing in a phase I trial with Accurin AZD281 in solid tumors. AZD2811, a selective inhibitor of Aurora B kinase that has been shown to be active in both solid and hematological tumors in preclinical models, is the second Accurin candidate to enter clinical development. The phase I trial is enrolling patients with advanced solid tumors, including patients with small cell lung cancer, and is being conducted by Astrazeneca plc, of London, under the companies' 2013 collaboration agreement. Bind earned a $4 million milestone payment with the dosing of the first patient. (See BioWorld Today, April 23, 2013.)

Bristol-Myers Squibb Co., of Princeton, N.J., announced new long-term data of Opdivo (nivolumab) in treatment-naïve BRAF wild-type advanced melanoma from Checkmate-066. In the trial, Opdivo continued to demonstrate superior overall survival versus dacarbazine with 57.7 percent of patients alive at two years compared to 26.7 percent of patients treated with dacarbazine. The safety profile of Opdivo was consistent with prior studies. The two-year survival and safety data from Checkmate-066 represent the longest follow-up from a randomized study of any PD-1 immune checkpoint inhibitor in the first-line setting of advanced melanoma. These data will be presented as a late-breaking presentation at the Society for Melanoma Research 2015 International Congress.

Immuron Ltd., of Melbourne, Australia, said its phase IIb IMM-124E clinical trial for the treatment of non-alcoholic steatohepatitis (NASH), has successfully passed a 25 percent recruitment milestone with 35 patients randomized into either arms. No significant treatment adverse events have been reported. The primary endpoint of the NASH study is to prove safety and efficacy of IMM-124 in the reduction of fatty liver as confirmed by MRI, and in the reduction of liver enzymes over a six month treatment period.

Morphotek Inc., a subsidiary of Eisai Inc., of Woodcliff Lake, N.J., enrolled the first patient in the randomized, double-blind ARTEMIS (Amatuximab Research in Treatment-naïve Epithelial Mesothelioma: Impact on Survival) trial evaluating the efficacy and safety of amatuximab (MORAb-009), its monoclonal antibody targeting mesothelin, when combined with the standard chemotherapy regimen of pemetrexed plus cisplatin to treat malignant pleural mesothelioma (MPM). Design of the randomized, double-blind, placebo-controlled MORAb-009-201 study is based on exposure response results from the completed 89-patient MORAb-009-003 phase II study, with the goal of evaluating whether amatuximab improves overall survival in MPM patients. Patients will receive standard-of-care chemotherapy for four to six cycles combined with either amatuximab or placebo, followed by maintenance therapy with amatuximab or placebo. Secondary objectives include evaluation of progression-free survival, objective response rate, duration of response, disease control and performance status maintenance, disease control rate, health-related quality of life and safety. Morphotek expects to enroll 560 patients in the study, which will be conducted in Australia, Europe and the U.S.

Oncolytics Biotech Inc., of Calgary, Alberta, initiated a phase Ib study of its reovirus variant, Reolysin, in combination with standard doses of bortezomib (Velcade, Millennium: The Takeda Oncology Co.) and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM). The first stage of the open-label, phase Ib trial will enroll three to six adult patients with RRMM in each of two cohorts, and the second stage will enroll up to 12 patients at the maximum tolerated dose from the first stage. In addition to determining the MTD, the study will examine the safety profile of Reolysin in combination with the other agents, explore the toxicities and pharmacodynamics of the combination and determine the preliminary response rate in patients with RRMM.

Orthocell Ltd., of Perth, Australia, said its regenerative cell therapy Ortho-Aci has been applied to its first patient in Singapore, the latest international market into which Orthocell has expanded Ortho-Aci, following its successful entry to Hong Kong earlier this year where the therapy was used on patients with articular cartilage damage within the knee joint. The approach involves taking cartilage cells from a patient via a biopsy, expanding the cell volume in a laboratory, and then implanting these cells surgically back into the area of cartilage damage to regenerate the lost tissue.

Otonomy Inc., of San Diego, enrolled the first patients in the U.S. phase III trial of OTO-104, a sustained-exposure form of dexamethasone, in Ménière's disease. A second phase III trial is expected to start in the European Union in the first quarter of 2016.

Pfizer Inc., of News York, said PROFILE 1029, its phase III study of Xalkori (crizotinib), met its primary objective of prolonging progression-free survival in previously untreated East Asian patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) compared to standard chemotherapy. PROFILE 1029 was the second positive phase III for Xalkori in the first-line setting and the third in ALK-positive NSCLC. Pfizer said adverse events observed with Xalkori in PROFILE 1029 were generally consistent with findings from previous trials. The company plans to submit efficacy and safety data for presentation at an undisclosed medical meeting.

Prima Biomed Ltd., of Sydney, Australia, said it plans to launch a phase I safety and dose-finding trial of IMP321, its antigen-presenting cell activator, in combination with an approved checkpoint inhibitor in patients with metastatic melanoma. TACTI-mel (Two ACTive Immunotherapeutics in melanoma) will recruit 24 patients with stage III/IV metastatic melanoma who will receive ascending subcutaneous doses of IMP321 up to 30 mg per injection fortnightly for 13 injections. The study will mainly evaluate the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of IMP321 at various doses and the nature of the immune response in the combination. The Human Research Ethics Committee at the Greenslopes (Queensland) Private Hospital approved the trial protocol, and dosing of the first patient is expected in the first half of 2016.

Rebiotix Inc., of Roseville, Minn., completed enrollment in the phase IIb PUNCH CD 2 study, designed to evaluate RBX2660 to treat multi-recurrent Clostridium difficile infection. The study enrolled 117 patients recruited across more than 20 sites in the U.S. and Canada, who were randomized into three groups to assess the safety and efficacy of RBX2660 compared to placebo. (See BioWorld Today, Sept. 30, 2013.)

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