The study, initiated in July 2012, enrolled a total of 77 patients in clinical sites in the U.S., Canada, Jamaica, Egypt and Lebanon...Sanbio Inc., of Mountain View, Calif., said the FDA has approved its investigational new drug application for the use of SB623, an allogeneic stem cell therapy product, in patients suffering from traumatic brain injuries

The following data were presented at the American Society of Clinical Oncology meeting in Chicago...Ambit Biosciences Corp., of San Diego, presented data from its Phase II ACE study of quizartinib (AC220), a FLT3 inhibitor, including data from 176 patients with either relapsed acute myeloid leukemia (AML) or AML that was refractory to second-line chemotherapy or hematopoietic stem cell transplantation (HSCT

The study was presented in an oral session at the 53rd Annual New Clinical Drug Evaluation Unit meeting in Hollywood, Fla...Bioheart Inc., of Sunrise, Fla., enrolled and treated the first patients in its ANGEL Phase I trial of adipose-derived stem cells in patients with congestive heart failure...Virttu Biologics Ltd., of Glasgow, Scotland, said an on-going clinical study in the U.S

Those results were presented at the New Clinical Drug Evaluation Unit meeting in Hollywood, Fla...Omeros Corp., of Seattle, said it filed a clinical trial application with European regulators to initiate clinical trials of OMS721, its lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2, or MASP-2, program

The study is being sponsored by the Alliance for Clinical Trials in Oncology, a cooperative group of the National Cancer Institute (NCI...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...Promedior Inc., of Lexington, Mass., presented data from a clinical study of PRM-151 at the American Thoracic Society Conference in Philadelphia

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...Neuralstem Inc., of Rockville, Md., presented updated, favorable Phase I data from its spinal cord-derived human neural stem cell (NSI-566) trial in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig 's disease) at the neuro-diabetes special medical

Advanced Cell Technology Inc., of Marlborough, Mass., said that the vision of a patient enrolled in a clinical investigation of the company's retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) has improved from 20/400 to 20/40 following treatment...Stem Cell Therapeutics Corp., of Toronto, said its wholly owned subsidiary Trillium Therapeutics has completed dosing in its Phase I study of TTI-1612 in patients with interstitial cystitis/bladder pain syndrome (IC

Bluebird's treatment approach involves the use of stem cells harvested from a patient's bone marrow...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories

Ltd., of Germantown, Md., said it filed an investigational new drug application (IND) to begin clinical trials of its adipose-derived stem cell product, RNL-JointStem, for the treatment of osteoarthritis

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...The treatment increases the harvest of stem cells and improves the cell mixture for transplantation, with previous studies suggesting the product has a superior profile compared to existing treatment

The NIH has helped fund two clinical trials – one that's testing an insulin nasal spray to treat patients with Alzheimer's and a prevention trial in people at the highest risk of the disease. (See BioWorld Today, May 16, 2012.) Other projects include whole genome sequencing to identify new genetic variants that increase or reduce the risk of the disease, new stem cell methods, tools to improve care and steps to address inappropriate use of drugs to treat behavioral symptoms, Donald Moulds

Advanced Cell Technology Inc., of Marlborough, Mass., said the first subject in the third dosage cohort was injected with 150,000 human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells in its European Phase I trial for Stargardt's macular dystrophy (SMD...Cel-Sci Corp., of Vienna, Va., entered a co-development agreement with Ergomed, a clinical research organization (CRO), to expand its Phase III study of Multikine (leukocyte interleukin) as an injectable treatment for head

The primary objectives include the evaluation of adverse events and a six-month clinical response...Cx611 is a suspension of expanded allogeneic adult stem cells derived from human adipose tissue delivered through intravenous injection

Fifty percent (eight patients) met the primary endpoint, defined as a reduction in the Mayo score between baseline and completion of treatment, while the remaining eight patients demonstrated a stable clinical condition or minor improvement...Neuralstem Inc., of Rockville, Md., said it received approval from the FDA to start a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis

The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial cells...clinical trials, for SMD and dry age-related macular degeneration (dry AMD

The primary endpoint of the study is the induction of clinical remission at week 12...The study is being conducted by more than 60 clinical investigators worldwide, including about 11 sites in Brazil and 24 sites in India...The TRIG-05 study is expected to begin enrollment this month, with a primary clinical endpoint of demonstrating efficacy, tolerability and safety of TI-001

Advanced Cell Technology Inc., of Santa Monica, Calif., treated patients in a third cohort of each of its two Phase I trials of human embryonic stem cell-(hESC) derived retinal pigment epithelial cells for macular degeneration...Tengion Inc., of Winston-Salem, N.C., said the firm's clinical trial application was accepted in Sweden to start a Phase I trial testing its Neo-Kidney Augment in up to five patients with advanced chronic kidney disease

Cellular Biomedicine Group, of Palo Alto, Calif., launched a clinical trial for TC-DC (Tumor Stem Cell-Specific Dendritic Cell) therapy for hepatocellular carcinoma...CALM is investigating the clinical efficacy and safety of Cavatak in Stage IIIc or IV melanoma

NurOwn is a technology for the propagation and differentiation of autologous mesenchymal stem cells (MSCs) into neurotrophic factor (NTF)-secreting cells...The Phase I/II trial showed a significantly slower decline in overall clinical and respiratory function, as measured by the ALS functional rating score (ALSFRS-R) and forced vital capacity (FVC) score, respectively, in the six patients who received an intrathecal injection of the cells in the six months following treatment, as compared to the