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Astellas, AVEO announce results of tivozanib and sorafenib comparison trial on RCC

AVEO Pharmaceuticals, Inc. and Astellas Pharma Inc. today announced that tivozanib demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase 3 clinical trial evaluating the efficacy and safety of investigational drug tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma.

3 Jan 2012

Additional financing to fund Advaxis' cervical cancer trials

Advaxis, Inc.,, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has entered into a definitive Convertible Notes Purchase Agreement (Agreement) with certain accredited investors, for the purchase of the aggregate principal value of approximately $1.2 million of Convertible Promissory Notes (Notes) for an aggregate purchase price of approximately $1.0 million.

31 Dec 2011

FDA invites Amgen for ODAC meeting on XGEVA sBLA to treat castration-resistant prostate cancer

Amgen today announced the U.S. Food and Drug Administration has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

30 Dec 2011

GOG targeted therapy phase 3 clinical trial delays progression of advanced ovarian cancer

Targeted drugs, which block or disrupt particular molecules involved in the growth of tumors, have been shown to be effective treatments against many types of cancer.

29 Dec 2011

Bevacizumab delays disease progression in ovarian cancer

Treating ovarian cancer with the drug bevacizumab ("Avastin") delays the disease and may also improve survival, show the results of an international clinical trial co-led by Drs. Amit Oza of the Princess Margaret Cancer Program, University Health Network and Timothy Perren, St James's Institute of Oncology, Leeds, UK.

29 Dec 2011

Emergent commences Phase 2 combination trial of TRUw-016 with bendamustine in relapsed CLL

Emergent BioSolutions Inc. today announced the initiation of a Phase 2 study (protocol 16201) of TRU-016 in combination with bendamustine for patients with relapsed chronic lymphocytic leukemia (CLL).

29 Dec 2011

Critical considerations for adenovirus-based HIV vaccine trials

A clinical trial testing a candidate HIV vaccine known as the STEP study was halted in September 2007 after interim analysis indicated that the vaccine did not work. Moreover, subsequent analyses indicated that the vaccine made some individuals more susceptible to HIV, in particular individuals who had pre-existing immune effectors (antibodies) that recognized a component of the vaccine (adenovirus serotype 5 [Ad5]).

28 Dec 2011

IL-1 gene inactivation may reduce severe clinical complications of atherosclerosis

Atherosclerosis is a disease of the major arterial blood vessels. It is one of the major causes of heart attack and stroke. The proinflammatory molecule IL-1 has been linked to atherosclerosis and a clinical trial has been launched in which an antibody specific for IL-1-beta is being studied for its effects on the severe clinical complications of atherosclerosis.

28 Dec 2011

CEL-SCI to expand Multikine Phase III trial in head and neck cancer

CEL-SCI Corporation is in the process of expanding its Phase III clinical trial of the investigational therapy Multikine (Leukocyte Interleukin, Injection) to 4 additional European countries - Spain, Czech Republic, Slovakia and Croatia.

27 Dec 2011

Initial results from 22nd Century's X-22 Phase II-B smoking cessation trial

22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction products, today announced X-22, a prescription smoking cessation aid in development consisting of very low nicotine (VLN) cigarettes, showed a reduction of smoking from baseline over the 6-week treatment period in the company's Phase II-B clinical trial.

26 Dec 2011

Correcting anemia can preserve kidney function in many transplant recipients

Correcting anemia, a red blood cell deficiency, can preserve kidney function in many kidney transplant recipients, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology.

23 Dec 2011

Top-line results from Noven's LDMP Phase 3 clinical study on menopausal VMS

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced top-line results from the first of two planned Phase 3 clinical studies evaluating low-dose mesylate salt of paroxetine (LDMP, formerly referred to as Mesafem) for the treatment of vasomotor symptoms (VMS) associated with menopause.

23 Dec 2011

Abbott commences Esprit drug eluting BVS trial in peripheral artery disease

Abbott today announced the initiation of ESPRIT I, a first-of-its-kind clinical trial in Europe evaluating the safety and performance of the novel Esprit drug eluting bioresorbable vascular scaffold (BVS) for the treatment of blockages in the superficial femoral arteries (SFA) and iliac arteries that have resulted in claudication.

23 Dec 2011

ViroPharma to acquire Meritage

ViroPharma Incorporated today announced that it has entered into an exclusive option to acquire Meritage Pharma, Inc., a private company based in San Diego, CA focused on developing oral budesonide suspension (OBS) as a treatment for eosinophilic esophagitis (EoE), a chronic inflammatory disorder of the esophagus.

23 Dec 2011

Enrollment complete in two Anacor's tavaborole Phase 3 trials on onychomycosis

Anacor Pharmaceuticals announced today that it has completed the enrollment of approximately 600 patients in the second of its two Phase 3 trials of tavaborole, a topical anti-fungal product candidate for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.

23 Dec 2011

Science journal names UNC HIV prevention study as 2011 Breakthrough of the Year

The HIV Prevention Trials Network 052 study, led by Myron S. Cohen, MD of the University of North Carolina at Chapel Hill, has been named the 2011 Breakthrough of the Year by the journal Science.

23 Dec 2011

ThromboGenics submits ocriplasmin BLA with FDA to treat symptomatic VMA

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that it has submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ocriplasmin Intravitreal Injection, 2.5 mg/mL, for the treatment of symptomatic VMA including macular hole.

23 Dec 2011

EpiCept receives FDA approval to commence AmiKet Phase III trial for CIPN

EpiCept Corporation today announced that at a meeting earlier this week with the U.S. Food and Drug Administration (FDA), the Company was granted permission to initiate immediately the Phase III clinical development of AmiKet.

23 Dec 2011

Azithromycin shows promise against trachoma-related blindness

A UCSF study shows a popular treatment for a potentially blinding eye infection is just as effective if given every six months versus annually. This randomized study on trachoma, the leading cause of infection-caused blindness in the world, could potentially treat twice the number of patients using the same amount of medication.

22 Dec 2011

AVEO initiates enrollment in tivozanib and mFOLFOX6 Phase 2 combination trial for CRC

AVEO Pharmaceuticals, Inc. today announced the initiation of patient enrollment in an open-label, multicenter, randomized Phase 2 clinical trial, called BATON-CRC, evaluating tivozanib in combination with modified FOLFOX6 (mFOLFOX6) compared to bevacizumab in combination with mFOLFOX6 as first-line therapy in patients with advanced metastatic colorectal cancer.

22 Dec 2011