Bioheart Inc., of Sunrise, Fla., said it is expanding its U.S. and European trials of MyoCell adult myogenic stem cell composition and MyoCath needle-injection catheter product candidates. In October, the company finalized its proposed protocol for a U.S. Phase II trial, which is designed to enroll up to 450 patients to confirm the safety and efficacy of adult myogenic stem cell transplantation in treating heart failure. In Europe, Bioheart expanded its Phase IIa trial from five testing centers
Aegerion Pharmaceuticals Inc., of Bridgewater, N.J., said interim results from an ongoing Phase II trial of its cholesterol management compound, AEGR-733, in combination with Zetia (ezetimibe, Schering-Plough Corp.), show that patients receiving both achieved an LDL reduction of 35 percent after four weeks. Patients treated with Zetia alone achieved a 20 percent reduction. As a monotherapy, AEGR 733 was found to reduce mean LDL-C 19 percent and 28 percent in patients who received the 5-mg dose
Advanced Viral Research Corp., of Yonkers, N.Y., filed an amendment with the FDA to its existing investigational new drug application to expand the use of its product, AVR118, to include topical and intralesional therapy, which could be used in treating dermatologic conditions. AVR118 is a cytoprotective agent in development for cachexia-related disorders and has shown topical wound healing properties in animal models. Dyax Corp., of Cambridge, Mass., said findings from its 77-patient EDEMA2
Allos Therapeutics Inc., of Westminster, Colo., said Phase II data reported at the American Society for Therapeutic Radiology and Oncology meeting in Philadelphia showed that Efaproxyn (efaproxiral) produced superior survival in patients with unresectable non-small-cell lung cancer receiving sequential chemoradiotherapy compared to those with similar characteristics in another trial, the Radiation Therapy Oncology Group (RTOG) 94-10 study. Specifically, median survival of Efaproxyn patients was
Anacor Pharmaceuticals Inc., of Palo Alto, Calif., started dosing patients in a Phase IIb study of ANO128, a topical anti-inflammatory candidate for atopic dermatitis. The trial is expected to enroll 200 patients between the ages of 2 and 17 with moderate forms of the disease who will receive ANO128 or a placebo cream twice a day for six weeks. Researchers plan to assess efficacy using a 6-point static global assessment scale. Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia
Adherex Technologies Inc., of Research Triangle Park, N.C., said data from its proof-of-mechanism trial of eniluracil showed that three patients who received a single, oral dose of the drug 12 to 14 hours prior to surgery for colorectal cancer resulted in inhibition of dihydropyrimidine dehydrogenase (DPD) activity. The company also reported results from 16 patients enrolled to date in its Phase I trial of eniluracil plus 5-fluorouracil in solid tumors. In the 13 patients for whom DPD results
Advaxis Inc., of North Brunswick, N.J., completed enrolling and dosing the first cohort of patients diagnosed with advanced, recurrent or progressive cervical cancer in its Phase I/II trial of Lovaxin C. Review by an independent safety panel found that this first assessment of a modified Listeria-based live vaccine was safe. Dose escalation is ongoing, and the primary endpoint is to establish a maximum safe dose. Biopure Corp., of Cambridge, Mass., said an independent data and safety
Inspire Pharmaceuticals Inc., of Durham, N.C., reported results of a 28-day Phase II study of denufosol inhalation solution in cystic fibrosis patients, ages 5 to 7, showing that both the 20-mg and 60-mg doses of the drug given three times daily were well tolerated, with a safety profile similar to placebo. Data were presented at the 2006 North American Cystic Fibrosis Conference in Denver. Inspire has initiated the first of two planned Phase III trials to evaluate 60 mg of denufosol vs
Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported additional positive efficacy data on AP23573, an mTOR inhibitor, from further analysis of its ongoing Phase II trial in metastatic and/or unresectable bone and soft-tissue sarcomas. Sixty-one patients in the 212-patient trial who had clinical-benefit response with AP23573 - defined as tumor regression or disease stabilization - had a progression-free survival rate at six months of 70 percent, which nearly tripled that of the overall
Cellgate Inc., of Redwood City, Calif., began a Phase II trial of its lead compound, CGC-11047, in metastatic hormone refractory prostate cancer. It will enroll 40 patients who have not yet received prior chemotherapy, and its primary endpoint is efficacy based on prostate specific antigen response. Safety, tolerability and time to progression also will be evaluated. CGC-11047, a polyamine analogue designed to halt cell growth and induce apoptosis, will be administered as a single-agent in once
Array BioPharma Inc., of Boulder, Colo., filed an investigational new drug application for ARRY-797, a selective, orally active inhibitor of p38 MAP kinase. The compound initially will be evaluated in dose-escalation studies in healthy volunteers for safety, exposure and inhibition of mechanism-related biomarkers. Pending positive results, it likely would be tested in patients with inflammatory diseases. Avantogen Oncology Inc., of Los Angeles, said the FDA accepted its investigational new
Adherex Technologies Inc., of Research Triangle Park, N.C., entered an agreement with the International Childhood Liver Tumor Strategy Group, a multidisciplinary group of specialists under the umbrella of the International Society of Pediatric Oncology, to conduct a Phase III trial of Adherex's sodium thiosulfate (STS) to reduce or prevent hearing loss in children associated with platinum-based chemotherapies. The randomized study, which is expected to begin early next year, will enroll about
Dendreon Corp., of Seattle, said data from an exploratory analysis of Phase III studies D9901 and D9902A showed a significant correlation between cumulative CD54 up-regulation and survival for patients treated with Provenge (sipuleucel-T), the company's cellular immunotherapy for men with advanced androgen-dependent prostate cancer. Data were presented at the International Society for Biological Therapy of Cancer annual meeting in Los Angeles. Dendreon has submitted two portions of a rolling
CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, reported encouraging preliminary results from three clinical trials of intravenous PXD101. Phase Ib data showed two partial objective responses in patients with advanced, refractory cancer and stable disease in three other patients lasting greater than 10 cycles of treatment in a study of PXD101 in combination with paclitaxel and carboplatin. Phase II results showed nine patients receiving PXD101 monotherapy achieved
Adenosine Therapeutics LLC, of Charlottesville, Va., initiated a two-part Phase Ib study in humans to evaluate apadenoson (ATL146e), a selective adenosine A2A agonist, as an anti-inflammatory agent. The study is designed to establish the drug's safety, demonstrate anti-inflammatory effectiveness in humans and determine the optimal dose. The results will serve as the foundation for multiple Phase II clinical trials involving acute inflammation. Amylin Pharmaceuticals Inc., of San Diego, said
Alfacell Corp., of Bloomfield, N.J., reported Phase IIIa data showing that patients with unresectable malignant mesothelioma treated with Onconase (ranpirnase) had greater median survival times than those treated with doxorubicin, as measured by the prognostic scoring systems of both the Cancer and Leukemia Group B and European Organization for Research and Treatment of Cancer. Findings were presented at the 8th International Mesothelioma Interest Group conference in Chicago. Onconase, which
Advanced Magnetics Inc.&, of Cambridge, Mass., said the independent Data Monitoring Committee providing oversight of the ferumoxytol Phase III intravenous iron replacement therapy program met and informed the company that no safety concerns were identified. The DMC recommended the continuation of the studies with no modifications. At that meeting, the DMC reviewed safety data from more than 1,200 subjects enrolled in the Phase III program. Algeta ASA, of Oslo, Norway, disclosed further
AM-Pharma BV, of Bunnik, the Netherlands, disclosed positive results from a pilot study in sepsis with its patented alkaline phosphatase drug. The study assessed the safety of a single treatment with 200 U alkaline phosphatase I.V./kg in patients suffering from severe sepsis. Efficacy parameters were recorded as secondary variables. Thirty-six patients admitted to intensive care units with the diagnosis of severe sepsis were included in the study, and the treatment proved well tolerated
Accentia Biopharmaceuticals Inc., of Tampa, Fla., said a new study has shown that the administration of a BiovaxID formulation given to patients with relapsed follicular non-Hodgkin's lymphoma following chemotherapy, with or without concomitant Rituxan (rituximab, Genentech Inc. and Biogen Idec Inc.), can induce complete long-lasting remissions. In the study, 80 percent of patients achieved an immune response to the BiovaxID formulation, and among those responders, the median time of complete
AVI BioPharma, of Portland, Ore., announced a multicenter, double-blind, randomized, placebo-controlled study of AVI-5126, a new generation of the Neugene antisense drug, for coronary vascular disease. AVI-5126 silences a gene known as c-myc, involved in cardiovascular restenosis. The study will evaluate the therapeutic benefit of exposing a saphenous vein to AVI-5126 before connecting it to the coronary artery circulation of patients undergoing coronary artery bypass grafts. Initial patient
Bioheart Inc., of Sunrise, Fla., said it is expanding its U.S. and European trials of MyoCell adult myogenic stem cell composition and MyoCath needle-injection catheter product candidates. In October, the company finalized its proposed protocol for a U.S. Phase II trial, which is designed to enroll up to 450 patients to confirm the safety and efficacy of adult myogenic stem cell transplantation in treating heart failure. In Europe, Bioheart expanded its Phase IIa trial from five testing centers