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

The company recently launched the Crohn's disease clinical trial and is actively recruiting participants with moderate to severe disease

The compound is currently undergoing early stage clinical trials for the treatment of leukemia and solid tumor cancer, with rights to all oncology applications licensed to its partner, Eisai Co...And although full terms of the Series C funding round were not disclosed, they did include the hitting of milestones on the fibrosis clinical trial, according to PRISM Pharma CFO, Dai Takehara

Schaffer said that the criteria for what constitutes a new delivery method that warrants its own safety and biodistribution data "are currently being decided at the FDA level," but that the general assumption is that in the majority of cases, vectors produced by directed evolution will need their own dataset before they are admitted into clinical trials

Significantly, the same NDA dossier was used in both submissions, a milestone in the path toward clinical trial regulatory harmonization, much sought after by both Taiwanese drugmakers and global pharmaceutical companies as an easier regulatory entryway into the enormous China market...P1101 is also undergoing clinical trials for treatment of polycythemia vera, a condition when the bone marrow makes too many red blood cells, leading to CV complications such as strokes

These efforts may have yielded valuable data from clinical trials or drug registration applications

Proceeds will be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories for marketing AAT product Glassia and for general corporate purposes

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...Agios has said it may also be possible to use metabolites as biomarkers eventually for purposes such as identifying appropriate patients for clinical trials

The difficulty comes in the fact that, generally, patients enroll in a clinical trial in the hope of getting access to a new or improved therapy...Momenta, of Cambridge, Mass., would like to avoid the recruitment competition of large clinical trials in its development of up to six biosimilars partnered with Baxter International Inc

China, for example, has a plan "definitely" moving ahead to introduce a fast-track approval process for new drugs that could exclude firms that have not conducted clinical trials in the country, Das told BioWorld Today