The long and hard-fought campaign against Alzheimer’s has reached a potentially significant milestone: the launch of the first clinical trials to test whether giving new drug treatments before dementia can prevent Alzheimer’s. The trial is testing two new drug treatments, donated by the drugs’ manufacturers, Roche and Eli Lilly and Co.
OncoMed Pharmaceuticals Inc. announced that it has started a Phase 1b/2 clinical trial of its anti-cancer stem cell product candidate, demcizumab (OMP-21M18) in ovarian cancer. The trial is OncoMed's fourth Phase 1b trial of demcizumab, and the second portion of this protocol would represent the first Phase 2 trial of demcizumab.
Viralytics Limited has achieved the primary endpoint in its Phase 2 clinical trial of Cavatak in the treatment of late stage melanoma patients (the CALM study). The Phase 2 trial is a single arm study being conducted at 10 U.S. sites and is designed to investigate the safety and efficacy of intratumoral Cavatak (Coxsackievirus A21) in 54 evaluable patients with late stage (IIIc and IV) malignant melanoma.
Researchers will test promising drugs aimed at preventing Alzheimer’s disease and identify and validate biological targets for novel therapies, with approximately $45 million in new funding from the National Institutes of Health (NIH).
Agenus Inc. today announced that a recent analysis from a Phase 2 trial in patients with newly diagnosed glioblastoma multiforme (GBM) treated with Prophage Series G-100 (HSPPC-96) in combination with the current standard of care (radiation and temozolomide) showed an almost 18 month median progression free survival (PFS).
Celtaxsys Inc. announced today the achievement of a significant clinical milestone for its lead clinical stage drug candidate, CTX-4430, for treatment of cystic fibrosis (CF) lung disease. Celtaxsys has successfully completed the first of two clinical trials in its Phase 1 program.
A commonly prescribed diabetes drug could reverse memory loss and the build-up of plaques on the brain linked to Alzheimer’s, according to new research. Study results show that the drug liraglutide might be able to reverse some of the damage caused by Alzheimer’s disease.
Clinical Research Management Inc. was awarded a contract by the National Institute of Allergy and Infectious Diseases (NIAID) to provide a broad spectrum of services for the design and conduct of clinical trials and clinical studies focused on the screening, diagnosis, treatment, prevention and control of sexually transmitted infections.
Bristol-Myers Squibb Co.'s skin cancer treatment Yervoy missed a main goal of achieving a significant improvement in overall survival compared to a fake drug when tested in patients with an advanced form of prostate cancer, the drugmaker said today.
Ventrus Biosciences Inc. announced positive results from two clinical dermal safety studies and one pharmacokinetic (PK) study of diltiazem hydrochloride 2% cream (VEN 307). All three studies were conducted to support the company's planned new drug application (NDA) for VEN 307 as a treatment for anal fissures (AF).
In a case report, currently available in the online edition of Beneficial Microbes, researchers describe how co-administration of NM504 eliminated the dose-limiting diarrhea caused by metformin in a patient with newly-diagnosed type 2 diabetes.
Metabolic Solutions Development Company, LLC (MSDC) will present the results of a Phase 2a study today at the 14th International Conference on Alzheimer's Drug Discovery. The study found that the mTOT-modulating insulin sensitizer (MSDC-0160) maintained glucose metabolism in key regions of the brain associated with cognitive decline due to AD.
A team of scientists, engineers and clinicians announced that they have begun a Phase 1 clinical trial of an implantable vaccine to treat melanoma. The new approach uses a disk-like sponge about the size of a fingernail that is made from FDA-approved polymers.
In a randomized trial that included about 2,000 patients with, or at high risk of, cardiovascular disease (CVD), use of a fixed-dose combination medication for blood pressure, cholesterol and platelet control compared to usual care resulted in significantly improved medication adherence after 15 months and small improvements in systolic blood pressure and low-density lipoprotein cholesterol, according to a new study.
Patients in 2010 with the deadliest form of brain cancer, glioblastoma, lived “significantly longer” than patients in 2008, reports a new population-based study in Cancer. The apparent reason: the famous tumor blood-vessel blocker Avastin, which was conditionally approved for progressive glioblastoma by the Food and Drug Administration (FDA) in 2010.
Millions more breast cancer patients should take Herceptin than do, some evidence suggests. Herceptin is history’s most successful targeted cancer drug and some studies suggest that 85 percent of breast cancer patients should receive it, not just the 20 percent getting it now.
In a study of an all-oral drug regimen, a majority of volunteers with liver damage due to hepatitis C virus (HCV) infection were cured following a six-month course of therapy that combined an experimental drug, sofosbuvir, with the licensed antiviral drug ribavirin.
In one new study, patients with diffuse large B-cell lymphoma remained disease-free up to 28 months after taking azacitidine, which made chemotherapy more effective. A second study described testing of pomalidomide, a drug approved for multiple myeloma patients, on mouse models of CNS lymphoma.
The University of California, Los Angeles' (UCLA's) Departments of Psychology, and Psychiatry and Biobehavioral Sciences Brain Research Institute, and MediciNova Inc. a biopharmaceutical company, announced that the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health, will fund a clinical trial of MN-166 (ibudilast) for alcohol dependence.
Takeda Pharmaceutical Company Limited and its partner, Zinfandel Pharmaceuticals Inc., announced the initiation of a global phase 3 clinical trial investigating a genetic-based biomarker risk assignment algorithm to predict risk of mild cognitive impairment due to Alzheimer’s disease within a five year period.
Inventors and their legal teams accepted sweeping changes in March, when longstanding U.S. laws granting patent rights to “the first-to-invent” were largely replaced by laws granting patent rights to “the first-inventor-to-file.” With ever-increasing patent filings in the United States, the shift brings the country in line with others—especially in Europe—where “first-to-file” has been in place for decades.
Cytokinetics Inc. announced the publication of two manuscripts reporting data from two clinical trials of tirasemtiv, a novel mechanism fast skeletal muscle troponin activator, in patients with amyotrophic lateral sclerosis (ALS). These manuscripts highlight results from Phase 2 clinical trials designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of two different dosing regimens of tirasemtiv.
Mallinckrodt announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-395. MNK-395 is referred to in the application as PENNSAID (diclofenac sodium topical solution) 2% w/w, studied in the treatment of the pain of osteoarthritis of the knee.
Shares of Incyte jumped Wednesday after the company said its drug Jakafi helped improve survival for patients with pancreatic cancer. The biopharmaceutical company said patients treated with Jakafi and the chemotherapy drug Xeloda lived longer than patients who received Xeloda and a placebo.
Navidea Biopharmaceuticals Inc. announced it has signed an agreement with Siemens’ PETNET Solutions that grants PETNET Solutions the right to manufacture Navidea’s Fluorine-18 labeled NAV4694, an investigational beta-amyloid PET imaging agent, which is currently being evaluated in phase 2 and 3 clinical trials evaluating subjects with signs or symptoms of cognitive impairment such as Mild Cognitive Impairment and Alzheimer’s disease.