Company (Location) Product Description Indication Status Date AUTOIMMUNE Coronado Biosciences Inc. (Burlington, Mass.) TSO Trichuris suis ova, or CNDO-201 Psoriasis Started an open-label, multicenter study expected to enroll 20 patients 2/26/13 Xencor Inc. (Monrovia, Calif.) XmAb5871 Targets the CD32b (FcRIIb) pathway in B cells Moderate to severe rheumatoid arthritis Dosed the first patient in a Phase Ib/IIa trial 2/14/13 CANCER Gamida Cell Ltd. (Jerusalem) NiCord Umbilical cord derived stem

Janssen and partner Bayer AG, of Leverkusen, Germany, will enroll patients into five global clinical trials, which will involve a total of 28,850 patients

The great majority of vaccine clinical trials continue to fail...A clinical trial to directly compare vaccine combined with IFA or saline plus an immunostimulant is slated to start later this year

Gilead is advancing GS-1101 in Phase III trials for CLL. (See BioWorld Today, May 3, 2012.) Those two compounds eventually could be complementary, but in the period leading up to market, the two compounds could be competing for patients and investigators in clinical trials

Moving forward this year with the framework, the FDA plans to address uncertainties in how well a benefit-risk assessment based on clinical trial data translates to the postmarket setting and how to assess postmarket findings that may come from sources of varying levels of rigor, such as adverse event reports and meta-analyses

The funding allows Mesoblast to significantly broaden its clinical trial program

One CFS-afflicted activist, Robert Miller, who has been getting Ampligen by way of Philadelphia-based Hemispherx's clinical trial-related program, went on a hunger strike to call more attention to the disease and the lack of treatment for it. (See BioWorld Today, Dec. 21, 2012, and Feb. 6, 2013.) Miller told BioWorld Today this week that neither he nor Hemispherx has been invited to the workshop, but McCleary said it's likely the FDA is still putting the event together

At the conference, a clinical trial testing the addition of integrase inhibitor Isentress (raltegravir, Merck & Co Inc.) showed changes that suggested the intensification was having an effect on HIV replication, even though such an effect could not be detected by the currently used methods...Clinical trials trying to get at the reservoir would do well to make sure that they are actually using assays that will tell them what they need to know

Upon completion of the grant period, CohBar CEO Mark Rampy said CohBar will consider applying for more grants, based on the data, to support progression of lead candidates toward initial clinical trials

Now, however, there needs to be even greater coordination, drawing in pharma companies with an interest in rare diseases, to ensure potential drug candidates meet their requirements, and involving regulators to win acceptance of clinical trials with small numbers of patients...The 26 projects announced on Rare Diseases Day range from clinical trials in specific disorders, to international efforts to marshal and interrogate relevant genomic data

Addex Therapeutics SA, of Geneva, and Viva Biotech Ltd., of Shanghai, China, entered a partnership to advance oral small-molecule adenosine 2A receptor (A2AR) positive allosteric modulators. The A2AR natural ligand, extracellular adenosine, is locally produced at the sites of inflammation and has been characterized for decades as a "brake for inflammation." An oral small-molecule compound targeting A2AR activation, which selectively enhances the effect of high adenosine concentration only

Now, however, there needs to be even greater coordination, drawing in pharma companies with an interest in rare diseases, to ensure potential drug candidates meet their requirements, and involving regulators to win acceptance of clinical trials with small numbers of patients...The 26 projects announced on Rare Diseases Day range from clinical trials in specific disorders, to international efforts to marshal and interrogate relevant genomic data

The company is planning to begin clinical trials in ischemic stroke and peripheral vascular diseases this year

materials to support ongoing commercialization of Brinavess, and oral API is expected to be sufficient for clinical trials

Relmada Therapeutics Inc., of Blue Bell, Pa., said an application for a clinical trial authorization (CTA) that was submitted with the UK's Medicine and Health Regulatory Agency (MHRA) to conduct a Phase I pharmacokinetic study with the development product abuse-deterrent LevoCap extended-release (ER) capsules was approved

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, reported the first interim results in HCV/HIV co-infected patients from the company's ongoing hepatitis C (HCV) clinical trial program, HCVerso

In the trial, Abilify Maintena (n=269 adult patients) significantly delayed time to relapse compared to placebo (n = 134 adult patients; hazard ratio = 5.03, 95 percent CI = 3.15-8.02, p < 0.0001) In a key secondary endpoint, the percentage of subjects experiencing relapse (i.e., meeting clinical trial criteria for exacerbation of psychotic symptoms/relapse) was also significantly lower with Abilify Maintena compared to placebo at the end of the study (10 percent vs. 40 percent, respectively; p

PlacMalVac, a project coordinated by the University of Copenhagen, Denmark, received an FP7 European Union grant supporting the first clinical trial of a VAR2CSA-based vaccine targeting malaria parasites that infect pregnant women

It funneled those funds toward advancing RSLV-132 to clinical trials