6/30/2015 4:55:14 PM
We are pleased to welcome Dan Schlager, MD as the newest member of our Phase I team. He comes to us from Tiburon, California by way of Africa where he most recently served as the Expedition Physician for a National Geographic team of approximately fifty people travelling through Ethiopia, the Seychelles, Botswana, Rwanda and the Serengeti.
Born in Denver, Dr. Schlager graduated with honors from Brandeis University. He is trained in emergency medicine, and has extensive experience in business, research and innovation. As Phase I director, Dr. Schlager is committed to bringing cutting-edge research initiatives to JCCR in various therapeutic areas. Currently the Phase I unit is enrolling in a multiple sclerosis program for individuals with muscle spasticity. On the horizon, however, are programs in hypertension, cholesterol, diabetes, heart failure and plaque psoriasis.
Dr. Schlager reminds us that, “you don’t have to travel around the world to get involved in meaningful research, you can take part right here in your community and make a difference.”
Paul Hellstern, MD
6/30/2015 12:27:59 PM
I was asked to give an update in the exciting world of Gastroenterology. There are multiple areas of growth which will aid in the care of patients in the future. The two most exciting areas are in Gastroparesis and Inflammatory Bowel Disease.
Gastroparesis is a condition where the stomach no longer contracts as it should causing the motility to slow down which prevents the stomach from emptying properly. It is fairly common with between 200,000 – 3 Million patients treated per year for this disorder. The most common symptom is early satiety, or the sensation of feeling full shortly. Nausea and vomiting are also very common symptoms as are bloating, heartburn and epigastric pain. A person with gastroparesis may regurgitate or vomit undigested food many hours after eating their meal. Diabetes is the most common contributing factor to the development of gastroparesis as is the increased usage of narcotics. Additionally, there are many other reasons why a person suddenly develops gastroparesis. In some cases there is no clear cause for the condition.
Gastroparesis is a very frustrating disease as physicians only have one true drug for treatment. Metroclopramide (Reglan) has been around for years and does offer some patients some degree of relief. It does have a significant side effect profile however from tardive dyskinesia to depression to many others. It is also given orally (tablet) which in a patient who is vomiting, is not always absorbed completely. Currently there is a research program for diabetic gastroparesis using Metroclopramide in a nasal spray formulation, hoping to bypass the stomach and therefore have better absorption and greater relief for patients. Additionally, there are 3 more research trials using study medications in a variety of formulations. One of those trials is for non-diabetic gastrospareis, an area where little research has been done.
The second area of great excitement is in the world of Inflammatory Bowel Disease. It involves chronic inflammation of all or part of the digestive tract. Symptoms include severe diarrhea, abdominal pain, fatigue and weight loss. IBD can be very debilitating and sometimes leads to life threatening conditions. Ulcerative Colitis involves long lasting inflammation and sores (ulcers) in the innermost lining of the large intestine (colon) and rectum. Crohn’s involves inflammation of the lining of the entire digestive tract and often spreads deep into affected tissues.
In my twenty years of practice, treating patients with Ulcerative Colitis and Crohn’s Disease has been the most difficult conditions to treat. However in the last 5 years there have been great advances in providing relief for patients. At NCCR Research, we have been and are currently involved in many trials for both Ulcerative Colitis and Crohn’s. For UC patient’s we have seen incredible responses to the point that the patient’s colon returned to normal on exam and patient symptoms’ of diarrhea and frequent stools returned to normal. For Crohn’s patients there are also advances for treatment coming. We are currently working with a medication already approved for the treatment of acute diarrhea and this new class of drugs gives hope for Crohn’s patients. In the world of inflammatory bowel disease, there are exciting trials in the works and great optimism for the future.
6/25/2015 2:07:37 PM
Michael J. Koren, MD,FACC,CPI served as an author and investigator for two new cholesterol-lowering treatments that passed a major hurdle for FDA clearance last week. Dr. Koren is one of only two physicians world-wide who has participated in the publication of key findings for these products in seminal publications in the New England Journal of Medicine.
Jacksonville, FL -- (ReleaseWire) -- 06/17/2015 -- The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA met June 9th and 10th and recommended two products using a novel therapy for lowering the amount of low density lipoprotein (LDL) cholesterol in the blood.
These two injectable drugs, alirocumab (Praluent) and evolocumab (Repatha), are monoclonal antibodies which target a protein in the liver - PCSK9 (proprotein convertase subtilisin kexin 9). The inhibition of PCSK9 markedly reduces circulating LDL cholesterol, and is theorized to reduce cholesterol-related adverse events such as atherosclerosis, heart attack and associated negative cardiovascular outcomes. In addition to contributing to numerous peer-reviewed articles regarding PCSK9 inhibitors, Dr. Koren is CEO of Jacksonville Center for Clinical Research which has conducted over 75 clinical trials involving hundreds of participants to evaluate this new class of medication. He states, "We are at a very exciting point in the development of these products. It's fabulous new science."
JCCR's on-going participation in clinical trials with PCSK9 inhibitors will continue to provide answers to the questions of long-term safety and efficacy.