Agios expects to begin clinical trials by the middle of 2013 for its IDH2 candidate, AG-221, and in early 2014 for its IDH1 candidate, AG-120

The Burlingame, Calif.-based company raised $33 million in a Series C last year to move its monoclonal antibody pipeline toward clinical trials

LLC, a drug development advisory firm, with the goal of creating pharmacokinetic/pharmacodynamic models of Kineta's lead compound, Shk-186, and estimating optimal dose and dose frequency for humans in preparation for upcoming multidose clinical trials

Although a subcutaneous formulation of the drug is still undergoing clinical trials, expectations are low, as the intravenous version failed in a pivotal Phase III program

The €6 million (US$8 million) grant was provided to the Cardimmun consortium, consisting of Athera, Leiden University Medical Center, Turku PET Center, Clinical Trial Consultants and Smerud Medical Research

LONDON – The ongoing row over clinical trials data transparency in Europe has polarized yet further, with a threat from scientist campaigners to publish results from previously confidential documents if companies do not pledge to make results of unpublished studies available in the next year, by submitting them to peer-reviewed journals...The new regulation is intended to simplify the process of setting up clinical trials by putting in place a single portal for electronic submissions of requests to

Essentially, the product has already had a long-term, high-dose clinical trial in one patient

LONDON – South Korean biotech Kael-Gemvax is planning further investment and new clinical trials of GV1001, despite the cancer vaccine failing to meet the primary endpoint in a 1,062-patient UK Phase III trial that reported earlier this month

Incyte Corp., of Wilmington, Del., reported at the European Hematology Association meeting results from two ongoing clinical trials of Jakafi (ruxolitinib), an oral JAK1 and JAK2 inhibitor that is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF

Although a subcutaneous formulation of the drug is still undergoing clinical trials expectations are low, as the intravenous version failed in a pivotal Phase III program

Wuxi PharmaTech Inc., also of Shanghai, will provide integrated services for ARX788, including the development and manufacturing of the toxin, antibody and ADC, preclinical development and clinical trials...The €6 million (US$8 million) grant was provided to the Cardimmun consortium, consisting of Athera, Leiden University Medical Center, Turku PET Center, Clinical Trial Consultants and Smerud Medical Research

After four years of development, in 2011 Conatus terminated a Phase II trial of the compound in hepatitis C patients – and, subsequently, its development – following reports of laboratory abnormalities and adverse events in a subset of clinical trial participants

Essentially, the product has already had a long-term, high-dose clinical trial in one patient

Company (Location) Product Description Indication Status Date AUTOIMMUNE Novan Therapeutics Inc. (Durham, N.C.) SB204 Nitric oxide-releasing compound Acne Reduced colonization of skin in a Phase I trial 5/31/13 Soligenix Inc. (Princeton, N.J.) SGX203 Oral beclomethasone 17, 21-diproprionate Pediatric Crohn's disease Began its first trial 5/16/13 Xenetic Biosciences plc (London) Myeloxen Vaccine based on the Imuxen liposomal technology Multiple sclerosis Completed the Phase I safety study 5/13

Company (Location) Product Description Indication Status Date AUTOIMMUNE Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) Sarilumab Fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex Moderate to severe rheumatoid arthritis Enrolled their first patients in Phase III trials 5/16/13 Xenoport Inc. (Santa Clara, Calif.) Arbaclofen placarbil A prodrug of the R-isomer of baclofen Spasticity due to multiple sclerosis Terminated the

Company (Location) Product Description Indication Status Date AUTOIMMUNE GW Pharmaceuticals plc (Porton Down, UK) Sativex Cannabinoid product Moderate to severe spasticity in multiple sclerosis Received commercial approval for Sativex in Italy 5/8/13 CANCER Aveo Pharmaceuticals Inc. (Cambridge, Mass.) and Astellas Pharma Inc. (Tokyo) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Astellas no longer intends to submit an MAA and will not fund any

There are a lot of situations where people use only an animal model and take a shot at a clinical trial and are disappointed after spending resources that could have been spent elsewhere." – Gene Williams, executive chairman and CEO of DART Therapeutics Inc., discussing its use of Biovista Inc.'s clinical outcomes search space technology to identify potential drug candidates for in-licensing in Duchenne's muscular dystrophy "I think the biggest challenge today for selling into BRIC for global

Company (Location) Product Description Indication Status Date AUTOIMMUNE Creabilis SA (Luxembourg) CT327 Topical TrkA kinase inhibitor Chronic pruritis caused by psoriasis Phase IIb data showed a statistically significant and clinically meaningful reduction in pruritus of 60 percent compared to 20 percent for those receiving placebo 5/13/13 Idera Pharmaceuticals Inc. (Cambridge, Mass.) IMO-3100 A selective antagonist of Toll-like receptors 7 and 9 Psoriasis Phase II data showed improvements

Specifically, the partnership will focus on clinical trials to test combinations of immunotherapies, including two investigational drugs from Immune Design's pipeline