At issue is the London-based EMA's commitment to almost complete disclosure of the clinical trial data submitted to it by drug developers seeking regulatory approval of their products...Advisory groups dealing with the protection of patient confidentiality, clinical-trial-data formats, rules of engagement, good analysis practice and legal aspects of the new regime are due to report by April 30, and the EMA is due to publish a draft policy for public comment by June 30

Inc., of Whitehouse Station, N.J., said researchers from the Clinical Trial Service Unit at Oxford University presented results from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive (extended-release niacin/laropiprant) during the late-breaking clinical trial session at the American College of Cardiology 62nd Annual Scientific Session in San Francisco...Findings were presented during the late-breaking clinical trial session

POPE was tested in a clinical trial to assure the FDA's Study Endpoints and Label Development division that verbal responses of patients to physician questions following treatment would accurately reflect their clinical response to the drug

Company (Location) Product Description Indication Status Date CANCER Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) Zaltrap Ziv-aflibercept Metastatic colorectal cancer European Commission granted marketing authorization in the European Union 2/6/13 Seattle Genetics Inc. (Bothell, Wash.) Adcetris Brentuximab vedotin Hodgkin lymphoma and systemic anaplastic large cell lymphoma Health Canada approved it for HL after failure of autologous stem cell transplant or failure of

Company (Location) Product Description Indication Status Date CANCER ArQule Inc. (Woburn, Mass.) and Daiichi Sankyo Co. Ltd. (Tokyo) ARQ197 Tivantinib Hepatocellular carcinoma Enrolled their first patient in a pivotal Phase III trial 2/1/13 AVEO Pharmaceuticals Inc. (Cambridge, Mass.) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Showed overall survival trends favoring the comparator drug Nexavar (sorafenib) at 29.3 months, compared with 28.8

Company (Location) Product Description Indication Status Date AUTOIMMUNE Ablynx NV (Ghent, Belgium) ALX-0061 Anti-IL-6R nanobody Moderately to severely active rheumatoid arthritis Phase I/II data showed ACR20, ACR50 and ACR70 scores of up to 100%, 75% and 63%, respectively 2/14/13 CANCER AbbVie (Chicago) ABT-199 A selective Bcl-2-targeting therapy Chronic lymphocytic leukemia Phase II was suspended after a patient died from tumor lysis syndrome 2/19/13 Acceleron Pharma Inc. (Cambridge, Mass

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