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 company filed to go public earlier this month, aiming to raise $86.3 million to support clinical work in multiple sclerosis, inflammatory bowel disease and allergic/immune-mediated disorders...The funding allowed ReXceptor to enter a formal partnership with C2N Diagnostics, which will assist the company with the initiation and coordination of the clinical trial of an AD program licensed from Case Western's Technology Transfer Office and based on discoveries that bexarotene, a medication sold at

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

When it comes to biopharma, the development cost for one drug can be hundreds of millions of dollars, depending on the number and size of clinical trials the FDA requires...We would like to see CMS use any flexibility that exists to implement the cuts in such a way that the core mission of the agency – to provide care to beneficiaries – is retained and protected," the lawmakers said in a recent letter to CMS.

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 and neck cancer...Under the agreement, Ergomed will contribute up to $10 million toward the study, for which it will perform clinical services in exchange for a single digit percentage of milestone and royalty payments, up to an undisclosed specified amount

The primary objectives include the evaluation of adverse events and a six-month clinical response

Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the Journal of Nuclear Medicine published the results from a clinical trial of NAV4694 in healthy subjects and those with diagnosed forms of dementia

Alkermes Inc., of Dublin, Ireland, said top-line data from a Phase II study showed that ALKS 5461, a drug in development to treat patients who have an inadequate response to standard therapies for clinical depression, significantly reduced depressive symptoms across a range of standard measures, including the study's primary outcome measure, the Hamilton Depression Rating Scale (p = 0.026), the Montgomery-Asberg Depression Scale (p = 0.004) and the Clinical Global Impression-Severity Scale (p

clinical trials, for SMD and dry age-related macular degeneration (dry AMD...BHR Pharma LLC, of Herndon, Va., said the 1,000th patient has been enrolled in its SyNAPSe clinical trial, a global Phase III study evaluating the effectiveness of its intravenous progesterone infusion agent, BHR-100, to treat severe traumatic brain injury (TBI...NeuroDerm Ltd., of Ness Ziona, Israel, said enrollment of patients is ongoing in its Phase IIa clinical trial of ND0612, a treatment for Parkinson's disease

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

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

RP5063 also showed efficacy in the Clinical Global Impression Severity Scale and was well tolerated...The study, designated TRIG-05, is set to start enrollment this month, with a primary clinical endpoint of demonstrating efficacy, tolerability and safety...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

Canbex, a spinout of University College London, has said it expects to start clinical testing this year

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

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

Novavax Inc., of Rockville, Md., said top-line data from its Phase II dose-ranging study testing its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age hit its protocol-specified objectives, supporting progression to the next stage of advanced clinical testing

Eyeing Better Mousetrap with Topical Product In 2009, Revance granted worldwide aesthetic and dermatological rights to RT002, then in preclinical studies, to Medicis Pharmaceutical Corp., of Scottsdale, Ariz., in exchange for $10 million at signing and another potential $94 million, based on clinical, regulatory and commercial milestones...The latest round is expected to support ongoing clinical development of lead candidate, LiRIS (lidocaine releasing intravesical system), in development for

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

dosage form of either tedizolid or linezolid with the option to switch to the respective oral dosage forms at the discretion of the clinical investigator on or after the second day of treatment