“Rare diseases are bad enough, but the ones that affect children are even more heartbreaking,” says Mike Snape, CEO of AMO Pharma, a virtual biotech focused on rare disease. “The medical need in these areas is greater than ever. They also present challenges for drug developers, especially with clinical trials.”
Clinical Leader news roundup for the week of April 11, 2016, with articles on pharma’s investment in patients, FitBit activity trackers in clinical trials, new Hep C combination treatment tested in Malaysia and Thailand, prostate and pancreatic cancer trials, the need for clinical trial participants, and making the most of clinical trial data.
Clinical Leader news roundup for the week of April 4, 2016, with articles on Patient recruitment via Twitter, NIH sponsors trial of anti-HIV antibody, diversity in clinical trials, INC Research partners with CISCRP, the use of apps in clinical trials, and the myth of patient centricity.
Statisticians play an important role in many phases of the clinical trial process, beginning at the design stage and progressing through the final analysis. By Justin Sjogren, MS, Clinical BioStatistician/Programmer
Oncologists and their patients have had reason recently to be encouraged by the launch of immune checkpoint inhibitors (ICIs) for the treatment of several difficult-to-treat diseases, including metastatic melanoma and non-small cell lung cancer. These novel agents activate the human immune response against antigens expressed on tumor cells, and the science has generated excitement among physicians, patients, the media and researchers.
NanoPass Technologies Ltd. ("NanoPass"), a pioneer in intradermal (into-the-skin or ID) vaccine delivery solutions, is collaborating with the US Center of Disease Control and prevention (CDC) in conducting a large phase 3 trial of polio vaccine in infants in South East Asia.
Eli Lilly and Company (NYSE: LLY) announced today Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL).
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, announced recently that it has signed an agreement with venture capital funded DecImmune Therapeutics of Cambridge, Massachusetts, USA.
Telormedix, a clinical stage biopharmaceutical company focusing on toll-like receptor 7 (TLR7) small molecules in the treatment of cancer and inflammatory diseases, recently announced that it has recruited the first patient in a Phase II trial of its lead product TMX-101, a TLR-7 agonist, in carcinoma in situ (CIS) in the bladder.
New analysis from Frost & Sullivan (http://www.healthcare.frost.com), Western European In Vitro Cancer Diagnostics Market, finds that the market earned revenues of $736.0 million in 2011 and estimates this to reach $1519.8 million in 2019. The research covers immunoassay, immunohistochemistry, nucleic acid testing (NAT), clinical chemistry and other diagnostic methods.
Researchers at The University of Texas at Austin have developed a menu of 61 new strains of genetically engineered bacteria that may improve the efficacy of vaccines for diseases such as flu, pertussis, cholera and HPV.
GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, announced it has completed enrollment in a nine-patient Phase 1/2 clinical trial testing the safety, immunogenicity and ability of its DNA/MVA vaccine to elicit protective immune responses in HIV-infected individuals.
AstraZeneca recently announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen tyrosine kinase) in development as an oral treatment for rheumatoid arthritis (RA).
Final Phase 2b data from Boehringer Ingelheim's interferon (IFN)-free Phase 2b SOUND-C2 study showed that up to 85 percent of genotype 1b (GT1b) hepatitis C (HCV) patients achieved sustained virologic response (SVR or viral cure) 12 and 24 weeks after the end of treatment with the investigational treatment regimen of faldaprevir (BI 201335) and BI 207127, in combination with ribavirin (RBV)
Janssen Pharmaceuticals, Inc. today announced that it has entered into a non-exclusive collaboration with Vertex Pharmaceuticals Incorporated to evaluate in a Phase 2 study the safety and efficacy of an all-oral regimen for the treatment of hepatitis C (HCV).
Genelux Corporation, a clinical-stage biopharmaceutical company developing vaccinia virus based oncolytic cancer therapies and companion diagnostics, announced early results of the first patient cohort treated in a Phase I/II clinical trial with GL-ONC1, its leading virotherapeutic product candidate, in patients with advanced peritoneal cavity cancers. As presented at the 8thWorld Congress on Peritoneal Surface Malignancies in Berlin, Germany, GL-ONC1 was found to be clinically well tolerated when applied directly into the peritoneal cavity.
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 1b/2a study evaluating ISIS-SMNRx in children with spinal muscular atrophy (SMA).
Novartis announced recently the construction of a new state-of-the-art biotechnology production site in Singapore with an investment valued at over USD 500 million. The new facility will focus on drug substance manufacturing based on cell culture technology.
ViaCyte, Inc., a leading regenerative medicine company developing a transformative cell therapy for treatment of diabetes, announced today that it has received a $10.1 million Strategic Partnership Award from the California Institute for Regenerative Medicine (CIRM).