Galmed Pharmaceuticals and the University of California, San Diego Enter Partnership
Galmed Pharmaceuticals reported that it has signed an Investigator-Initiated Clinical Trial Agreement with the University of California, San Diego, School of Medicine.
According to a media release, the proposed study is a Phase I/IIa trial to assess safety, tolerability, efficacy, and pharmacokinetics of Aramchol in a juvenile population with nonalcoholic fatty liver disease (NAFLD) (the ARTISAN Study). The ARTISAN Study (ARamcholTM Trial to Improve Steatosis in Adolescent NAFLD) is to be led by Dr. Jeffrey Schwimmer, Professor of Clinical Pediatrics at the University.
Fatty liver disease in children has been increasingly recognized as an important pediatric health problem. Pediatric NAFLD has some features that are similar to adults and several features that are unique to children. In the United States, there are an estimated 5 to 8 million children with NAFLD. The prevalence of NAFLD in children across the developed world is 5 to 10 percent. From a liver standpoint, the major concern is that NAFLD is a risk factor for cirrhosis and liver cancer. Beyond the risk for serious liver problems, children with NAFLD are also at increased risk for other important health problems including type 2 diabetes and atherosclerotic heart disease.
"NAFLD is the leading cause of chronic liver disease, yet there is no approved therapy in children or adults. Based upon promising data in adults, the University is developing a proof-of-concept trial for Aramchol in adolescents with NAFLD," said Jeffrey Schwimmer, MD, professor of pediatrics, University of California, San Diego, School of Medicine and Director, Fatty Liver Clinic, Rady Children's Hospital, San Diego.
The ARTISAN Study is subject to receipt of regulatory approvals and is currently expected to be initiated in the first half of 2017.
Galmed's President and Chief Executive Officer, Allen Baharaff, stated "The ARTISAN Study marks the third investigator-initiated clinical trial and continues our strategy of collaborating with leading investigators to evaluate AramcholTM's efficacy across different populations and indications. We believe addressing the unmet need for treatment of juvenile population with NAFLD should not await the clinical development for adults. Based on AramcholTM's safety profile and mechanism-of-action, we decided to approach this important indication in parallel with our ongoing adult studies."
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THE DAILY VIEW
Papyrus Joins Forces with Designer Lela Rose
Papyrus is looking to bring the “elegance and style” of fashion to its greeting cards via a new designer collaboration series.
According to a release, the collaboration marks the first time a fashion design house and greeting card brand have joined forces to develop a custom greeting card collection.
Papyrus said it is partnering with American fashion designer Lela Rose to introduce the series. Rose will feature her "sophisticated yet modern style" in the debut card and gift collection, slated to launch during New York Fashion Week. The collection will be available in New York City Papyrus stores and select retailers in September, with availability expanding to all Papyrus locations and retailers in October.
"The fashion designer collaboration series is a celebration of the commitment Papyrus has to the arts, including a focus on the fashion industry, quality craftsmanship and trend-forward design," said Christy Kaprosy, President of Papyrus-Recycled Greetings. "We are delighted to have Lela Rose's elegant line lead the first Papyrus fashion designer collaboration program, and we are excited to bring more fashion designers to our loyal customers in the future."
The company noted the collection, which draws inspiration from some of Rose's recent runway designs, consists of 16 cards and five gift accessories, including gift bags, gift tissue, roll wrap and a gift tag set. It also will be available online at papyrusonline.com
"I'm thrilled to be the first designer to collaborate with Papyrus on their exclusive new fashion series," said Lela Rose. "This is a unique way to showcase our designs, silhouettes and prints, and extend the brand into a new category."
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- Early Donation: In August, Paul G. Allen Family Foundation donated $2.8 million toward the outbreak in West Africa.
- Latest Pledge: Facebook founder Mark Zuckerberg and his wife Priscilla Chan this month pledged $25 million to the CDC.
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