Actinium Pharmaceuticals Inc., of New York, said the first patient was treated with Actimab-A in the fourth and final cohort of the ongoing phase I/II trial of the drug candidate, which is in development for newly diagnosed acute myeloid leukemia patients older than 60 who are ineligible for standard induction chemotherapy. Patients in the last cohort are being treated at 2.0 μCi/kg per dose of Actimab-A. The three previous cohorts were treated at dose levels of 0.5, 1.0 and 1.5 μCi/kg per fractionated dose, respectively. The company said maximum tolerated dose (MTD) was not yet reached and no peri-induction mortality occurred among patients, although dose dependent responses were observed. The MTD from the current trial will be used in the phase II portion of the study.
Biothera Inc., of Eagan, Minn., said the combination of its investigational cancer immunotherapy, Imprime PGG, with bevacizumab (Avastin, Genentech Inc./Roche AG) showed additional reductions in tumor burden during the maintenance phase of its phase II trial in non-small-cell lung cancer (NSCLC). In the randomized study in non-squamous NSCLC, Imprime PGG was administered in combination with bevacizumab and platinum-based doublet chemotherapy. After four to six cycles of treatment, patients received maintenance therapy of bevacizumab with or without Imprime PGG. Additional reductions in tumor burden (>10mm) were observed in 20 percent (n = 6) of patients in the Imprime PGG group but not in the control group. Biothera also said the objective response rate between the treatment and control groups was 60.4 percent vs. 43.5 percent, respectively. Duration of response was 10.3 months vs. 5.6 months, respectively, and median overall survival was 16.1 months vs. 11.6 months. The data were reported at the European Lung Cancer Conference in Geneva.
Cellectar Biosciences Inc., of Madison, Wis., has initiated patient dosing in a phase I proof-of-concept study of its FDA orphan-designated radiopharmaceutical I-131-CLR1404 in patients with relapsed or refractory multiple myeloma. The multicenter, open-label, sequential group, dose escalation study will evaluate the safety and tolerability experimental therapy with and without concurrent weekly dexamethasone in multiple myeloma patients who have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor. Secondary objectives of the study are to identify a recommended phase II dose and assess therapeutic activity, which will be assessed by overall response rate, time to progression and duration of response. The agent is also being evaluated in a phase II glioblastoma imaging trial.
Celsion Corp. shares (NASDAQ:CLSN) rose 49 cents, or 18.4 percent, to $3.15 on Wednesday after the Lawrenceville, N.J.-based company announced positive interim data from its ongoing open-label phase II DIGNITY trial of Thermodox in recurrent chest wall breast cancer. The trial is evaluating Thermodox in combination with mild hyperthermia. Of the 16 patients enrolled and treated, 12 were eligible for evaluation of efficacy. Based on data available to date, 67 percent of patients experienced a clinical benefit, with a local response rate of 58 percent. There were five complete responses, two partial responses and one patient with stable disease. The company said that it remains on track to complete enrollment in the study in the third quarter. (See BioWorld Today, Feb. 23, 2015.)
Cytotools AG, of Darmstadt, Germany, has completed enrollment for European studies on the treatment of diabetic foot ulcer and ulcus cruris, also known as venous leg ulcer, with Dermapro, its wound healing drug that is derived from dichloric acid. The company is beginning treatment of the last-in patients now for three and four month periods. The patients are part of a phase III study of Dermapro and will also be included in a phase II/III study of Dermapro for ulcus cruris. Results of the diabetic foot study are expected in the second half of this year, while an interim analysis of the ulcus cruris study and an evaluation by the study's data safety and monitoring board is anticipated in July 2015.
Heart Metabolics Ltd., of Dublin, received an agreement letter from the FDA related to the company's proposed phase III trial special protocol assessment, agreeing to a single, randomized, pivotal trial of 350 patients evaluating perhexiline for the treatment of moderate-to-severe hypertrophic cardiomyopathy. In conjunction with this achievement, William Daly has joined firm as president and CEO, and Gregory Ayers joined as chief medical officer, the company said. Perhexiline works by reducing fatty acid metabolism through the inhibition of carnitine palmitoyltransferase, the enzyme responsible for mitochondrial uptake of long-chain fatty acids.
Oncobiologics Inc., of Cranbury, N.J., said clinical development for ONS-1045, an Avastin (bevacizumab, Roche AG) biosimilar candidate, is under way with dosing completed in its pivotal pharmacokinetic (PK) study currently being conducted at the Center for Human Drug Research (CHDR) in Leiden, the Netherlands. ONS-1045 is being studied in a 3-arm single-dose PK study in healthy male volunteers to compare it against both the US- and EU-sourced Avastin reference products, and the two reference products to each other.
Oncolytics Biotech Inc., of Calgary, Alberta, made a presentation at the Royal Society of Medicine's titled "Immuno-oncology: Using the Body's Own Weapons" conference in London. The presentation included data from a single arm clinical study examining the use of Reolysin reovirus variant in combination with gemcitabine in patients with advanced pancreatic cancer, PD-1 and PD-L1 up regulation data from a single arm clinical study examining the use of Reolysin in patients with primary glioblastomas or brain metastases, as well as preclinical data. The company offered clinical evidence that Reolysin treatment results in immunological changes to both the tumor cells and the tumor microenvironment that is conducive to novel immune targeting interventions. Updated results from the REO 017 study, in which pancreatic cancer patients received combination therapy with Reolysin and gemcitabine, demonstrated a median overall survival of 10.2 months, and one- and two-year survival rates of 45 percent and 24 percent, respectively.
OWC Pharmaceutical Research Corp., of Petach Tikva, Israel, said its wholly owned subsidiary, One World Cannabis Ltd. – after receiving preliminary results on the effect of several combinations of cannabinol and tetrahydrocannabinol on multiple myeloma cells – will continue its basic science study with multiple myeloma human cells with results of this stage of the study expected within two months.
Replicel Life Sciences Inc., of Vancouver, British Columbia, said it has received approval from the University of British Columbia (UBC) Clinical Research Ethics Board (CREB) to conduct a phase I/II trial at the UBC Hospital. The double-blind, placebo-controlled, single-center study will evaluate the efficacy and safety of RCT-01 in men and women with unilateral, chronic Achilles tendinosis to determine the potential of its tendon repair product, RCT-01, to treat chronic tendon injury. It will include 28 participants who will receive ultrasound-guided injections of either RCT-01 or placebo (on a 3:1 treatment-to-placebo ratio) directly into areas of injury within the Achilles tendon. Participants' overall health and tendinosis will be monitored over a six month period while they undergo post-treatment physiotherapy to help facilitate recovery.