This regimen achieved a complete response rate of 19 percent and an overall response rate of 97 percent, with estimated progression-free survival at 24 months of 93 percent

Data from a single-arm, 333-patient Phase II trial reported at the American Society of Hematology meeting in December demonstrated quizartinib's high response rate in relapsed/refractory FLT3-ITD-positive patients, with results besting clinical outcomes reported for other kinase inhibitors...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories

Secondary endpoints include overall survival, response rate and safety...HIV-infected subjects enrolled in an ongoing SB-728-902 clinical trial (Cohorts 1-3) received a single infusion of SB-728-T, which resulted in a durable increase in total CD4 T-cells driven by increased ZFN-modified CD4 central memory T-cells

The primary endpoint is clinical benefit, which will be assessed at six months...The primary endpoint is overall survival, with secondary endpoints evaluating safety, tolerability, tumor response rates and the effect of therapy on Hsp27 levels and circulating tumor cells...RepliCel Life Sciences Inc., of Vancouver, British Columbia, said it started clinical development of an autologous cell therapy for the treatment of a variety of chronic tendon injuries, including Achilles, patellar and elbow

The primary endpoints are safety and tolerability, with secondary endpoints including the pharmacokinetic profile of the drug and an efficacy evaluation as assessed by various parameters, such as response rate as measured by bone marrow biopsy...Regentis raised $10 million last year in a Series C financing to support clinical studies and commercial launch of GelrinC in Europe. (See BioWorld Today, May 15, 2012

The post-transplant combined complete response plus near-complete response rate, was 38 percent (n = 298) compared to 24 percent (n = 182) percent, respectively (p < 0.0001...The study is being conducted by more than 60 clinical investigators worldwide, including about 11 sites in Brazil and 24 sites in India

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

The study also will assess secondary measures of clinical benefit, including progression-free survival, objective response rate and overall survival at six months and 12 months

The primary objectives include the evaluation of adverse events and the evaluation of six-month clinical response...Persistent separation in the survival curves was observed with response rates and progression-free survival also favoring the 3-mg/kg bavituximab arm

PROSTVAC and MVA-BN PRO, will be the subject of clinical presentations at the 2013 Genitourinary Cancers Symposium on Feb. 14-16, in Orlando, Fla...Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...The preliminary results from the studies supported the further clinical investigation in patients suffering from advanced prostate cancer, the company said

The company plans to use the funds to advance the clinical development programs for rindopepimut, an immunotherapy targeting epidermal growth factor variant III (EGFRvIII) that is in a registration trial in front-line glioblastoma multiforme (GBM), and CDX-011 (glembatamumab vedotin), a fully human monoclonal antibody-drug conjugate (ADC) targeting glycoprotein NMB (GPNMB) that completed a Phase IIb study in breast cancer...The company will receive proceeds of $8 million, which it expects to use to

The open-label, single-arm study will enroll about 37 patients after failure of second-line therapy, with a primary endpoint of overall response rate and secondary endpoints including progression-free survival, overall survival, median duration of response and safety...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

The primary objectives of the trial are objective response rate and progression-free survival...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

A full readout from the pivotal PACE study was presented at the American Society of Clinical Oncology meeting in June, with data showing that 54 percent of chronic-phase CML patients showed a response, besting what had been reported previously in top-line results...And Ariad execs attending the American Society of Hematology meeting in Atlanta last month said 12-month follow-up data bumped up that response rate to 56 percent. (See BioWorld Today, June 5, 2012.) As a comparison, Pfizer's Bosulif

The first trial in aggressive B-cell lymphomas showed that patients had an overall response rate of 98 percent, and one-year progression-free survival of 73 percent...The Phase I/II trial showed that patients with follicular lymphoma had an overall response rate of 83 percent and one-year progression-free survival of 67 percent...A final Phase II trial in indolent non-Hodgkin's lymphoma showed an overall response rate of 90 percent

delafloxacin showed an 88 percent clinical response rate dosed at 300 mg twice daily, compared to 82 percent for Tygacil (tigecyline, Pfizer Inc...A separate Phase II trial in community-acquired pneumonia showed an 87 percent clinical response rate at 200-mg and 400-mg doses of oral delafloxacin

regulators are happy to see a clinical response, whereas European regulators seek the more stringent outcome of remission...Proceeds will be used to advance the clinical development of EPI-743...The drug previously demonstrated efficacy in prostate, breast and ovarian cancer models, as well as in endometriosis, and the recent fundraising is expected to move VAL201 through first-in-human clinical trials.

Trial data showed clinical benefit, defined as partial response and stable disease of more than four months following up to eight cycles of treatment, at the maximum tolerated dose in 10 of 13 evaluable patients...An overall response rate of 28.5 percent, where tumor growth had stabilized or regressed, was observed in doses investigated to date

Opexa Therapeutics Inc., of The Woodlands, Texas, said Health Canada approved its clinical trial application, enabling the company to expand its ongoing trial in secondary progressive multiple sclerosis (SPMS) to include several sites in Canada...At week 34, the ACR20/50/70 response rates for patients getting 200 mg every two weeks and patients getting 400 mg every four weeks were 67.1 percent/50 percent/30 percent and 65.2 percent/52.2 percent/37.7 percent, respectively