Data from an ongoing Phase I/II study confirmed clinical evidence of the antitumor activity at multiple dose levels in patients with anaplastic lymphoma kinase-positive NSCLC, including brain metastases, and initial clinical evidence of antitumor activity in patients with EGFR receptor mutation NSCLC. (See BioWorld Today, Dec. 17, 2012...and the clinical benefit response rate was 82 percent

The drug is being evaluated in non-small-cell lung cancer...PharmAthene Inc., of Annapolis, Md., said the FDA lifted the clinical hold placed on a proposed Phase II study of SparVax, a next-generation recombinant anthrax vaccine

In the trial, aldoxorubicin showed prolonged clinical activity, including partial tumor response, in two subjects with small-cell lung cancer who had failed other therapies

Clinical improvements were seen in all patients with reductions in median stool frequency from 23 to 14 per week (p = 0.03) and an improvement in the median Bristol Stool Form Scale assessing stool type from 5.515 to 4.34 (p = 0.05...Peregrine Pharmaceuticals Inc., of Tustin, Calif., said it reached agreement with the FDA on a Phase III registration trial of lead immunotherapeutic candidate bavituximab in second-line non-small-cell lung cancer (NSCLC...Interim data from that study were reported

The analyses included the description of new predictive biomarkers of clinical response to Vectibix, activating mutations in KRAS (beyond exon 2) and in NRAS, collectively referred to as RAS...Additional edata will be presented at the annual meeting of the American Society of Clinical Oncology in Chicago...ACT is currently enrolling patients in three clinical trials in the U.S

The trial (PINNACLE) will evaluate OMP-59R5 in combination with cisplatin and etoposide in first-line, extensive-stage small-cell lung cancer...Sangamo BioSciences Inc., of Richmond, Calif., said it presented new clinical data, which demonstrated that SB-728-T treatment resulted in a reduction in the HIV reservoir in HIV-infected subjects, at the 16th Annual Meeting of the American Society of Gene and Cell Therapy in Salt Lake City...HIV-infected subjects enrolled in an ongoing SB-728-902 clinical

The company is planning a potential pivotal trial in small-cell lung cancer and a confirmatory activity trial in endometrial cancer...The PROCEED (PROve Clinical Efficacy and Effect of Delafloxacin) study is designed to test delafloxacin 300 mg, given intravenously every 12 hours, compared to vancomycin 15 mg/kg plus aztreonam 2 g I.V., also given every 12 hours...The study includes clinical and microbiological endpoints to assess the efficacy

Chimerix Inc., of Durham, N.C., presented the first clinical outcomes data on lead candidate CMX001 in life-threatening infection with adenovirus (AdV), a disease with no approved therapy...Merrimack Pharmaceuticals Inc., of Cambridge, Mass., reported that the last patient has been enrolled in the first cohort of a randomized Phase II trial of MM-121 in combination with erlotinib for the treatment of non-small-cell lung cancer (NSCLC

Ariad Pharmaceuticals Inc., of Cambridge, Mass., presented data for AP26113 showing that the drug inhibits clinically identified crizotinib-resistant ALK mutations and oncogenic ROS1 fusions in patients with non-small-cell lung cancer (NSCLC...The study was carried out to explore previous clinical findings with cabozantinib in castration-resistant prostate cancer patients with bone metastases showing a 67 percent rate of bone scan response and other clinical signs of effect

RP5063 also showed efficacy in the Clinical Global Impression Severity Scale and was well tolerated...Viralytics Ltd., of Sydney, Australia, said it finalized the clinical study report on the Phase I evaluation of Cavatak, administered intravenously to late-stage melanoma, prostate, breast or colorectal cancer patients, with results showing that the oncolytic virus-based drug candidate was well tolerated, with some evidence of stable disease despite most patients only receiving a single dose...The

Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...Merrimack Pharmaceuticals Inc., of Cambridge, Mass., said one cohort of a Phase II non-small-cell lung cancer (NSCLC) study did not meet its

Biothera Inc., of Eagen, Minn., said it completed enrollment of its 90-patient Phase IIb study testing Imprime PGG, Avastin (bevacizumab, Roche AG) and two chemotherapeutic drugs in non-small-cell lung cancer...Cytos Biotechnology Ltd., of Zurich, Switzerland, said results from a Phase IIa trial showed that CYT003, an immune modulator for the potential treatment of asthma, met all clinical endpoints, with patients treated with CYT003 having their asthma control improved despite the withdrawal of

The study enrolled 87 patients with Stage III or Stage IV lung cancer or colorectal cancer who also are suffering severe weight loss and fatigue...Also, 93 percent of people in that dose group showed no clinical symptoms of influenza after three days of treatment, compared to 41 percent of people in the placebo group

RBC Capital Markets analyst Douglas Miehm wrote in a research report that the latest news in lung cancer "is less clouded by the September...NCIC Clinical Trials Group at Queen's University in Kingston, Ontario, is conducting four studies in various tumor types, which will "go a long way to helping us figure out" where to put the most resources, Look said...The multitude of clinical trials adds up to a program that "sounds like a heck of a burn requirement

The primary objectives include the evaluation of adverse events and the evaluation of six-month clinical response...Edison Pharmaceuticals Inc., of Mountain View, Calif., said it started a Phase II study, titled "Double-Blind, Placebo-Controlled Clinical Trial of EPI-743 in Patients with Cobalamin C Defect...Peregrine Pharmaceuticals Inc., of Tustin, Calif., said updated data from its Phase II study testing bavituximab in patients with second-line non-small-cell lung cancer showed a meaningful

Critical Pharmaceuticals Ltd., of Nottingham, UK, completed a second clinical study of CP024, a growth hormone nasal spray in development for growth disorders in children and adults...ImmunoGen Inc., of Waltham, Mass., completed patient enrollment in the first stage of its NORTH Phase II trial assessing clinically meaningful benefit of IMGN901 in small-cell lung cancer

Nektar Therapeutics Inc., of San Francisco, said it started a Phase II study of etirinotecan pegol in patients with metastatic and recurrent non-small-cell lung cancer...Portola Pharmaceuticals Inc., of South San Francisco, inked a clinical collaboration with Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, and Bayer AG, of Leverkusen, Germany, to evaluate the safety of PRT4445, an antidote for Factor Xa inhibitors, in healthy volunteers to have been administered

CytRx Corp., of Los Angeles, said a data safety monitoring committee recommended continuing a Phase IIb trial of tamibarotene with chemotherapy in non-small-cell lung cancer...The goal of the trial will be first to find optimum dosing of the drug, and second to assess safety, pharmacokinetics, pharmacodynamics and clinical activity in disease-specific cohorts of at least 12 patients each

The company has an extensive pipeline of products in clinical development, including HyperAcute Pancreas (algenpantucel-L), HyperAcute Lung (tergenpumatucel-L), HyperAcute Melanoma, HyperAcute Renal and others...HyperAcute Lung (tergenpumatucel-L) is in a Phase IIb/III study in advanced non-small-cell lung cancer, and HyperAcute Melanoma is in Phase II, with a Phase IIb launch anticipated in the second half of 2013