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A Mother Shares a Meaningful Story About a Genetic Cholesterol Condition

7/16/2015 7:20:14 PM
Categories: Musings

Donna didn’t think about heart disease and its potential impact on her young family until 1992 when she was rushed to the hospital at the age of 45 with 4 heart blockages. Even though her father had died of a heart attack at that same age, there just wasn’t information available at the time that would have enabled her to prevent the devastation that having genetic heart disease can bring.

Familial hypercholesterolemia is the name of an inherited condition that affects Donna and many of her family members. It causes high levels of LDL (low density lipoprotein) cholesterol levels beginning at birth, and heart attacks at an early age. A parent who carries an altered gene that causes the condition has a 1 in 2 (50 percent) chance to pass on that altered gene to each of his or her children.

Having lost her eldest son to a massive heart attack at the age of 42 and knowing that this same genetic disease affects one of her surviving two children is a source of “hurt and worry that never goes away”.

So today, Donna is thanking God that her son who carries this gene is eligible to participate in a clinical research program with a drug that has already proven to remarkably reduce LDL cholesterol. This new class of medication, called PCSK-9 inhibitors, has recently been favorably evaluated by the FDA and one of these new drugs, alirocumab, is on schedule for full FDA approval within the month.

Speaking of her son, Donna states, “I have such peace of mind knowing that he can be helped in controlling his heart disease and learn more about his condition with hands-on help.” She knows how important research participation is; she has been involved in clinical trials personally for over twenty years thanks to the dedicated efforts of her cardiologist, Michael Koren, MD. “Research programs promote awareness of disease, enable you to be watched and monitored and allow access to new therapies all while being cared for by highly skilled staff and physicians.” 

“My son and I are both relieved that he is in this program knowing that now he will receive the care and attention that is necessary to battle this genetic disease.”

This is a wonderful time to be a Rheumatologist

by Steven Mathews, MD

7/6/2015 2:07:42 PM
Categories: Breakthroughs

This is a wonderful time to be a Rheumatologist.  Our understanding of the wide scope of immune mediated inflammatory diseases has increased considerably. The intricacies of how inflammation starts, what causes it to increase in intensity and what suppresses that activity are becoming more clear.


When I began my training, the magic answer for treating Rheumatoid Arthritis was gold shots.  The problem with this approach is that it took weekly injections for 5 months to determine if there was going to be a beneficial response.  Of the 20% who did get better with this therapy, only 25 % were still on the medication after the first year due to adverse effects.


The current "gold" standard in RA therapy are the biologics.  These are a collection of medications that target the actual trigger mechanism of our body's inflammatory response.  With these new therapies, the response rate is now 75% in usually less than 12 weeks.  Due to the risk of immunosuppression, we must monitor closely for infections, but very few patients discontinue the medications for safety reasons.  What is even more significant is that approximately 30% of patients reach a point of clinical remission, the goal of any medical therapy.


We at Jacksonville Center for Clinical Research have played a role in this advancement.  We have conducted multiple pivotal studies evaluating not only the efficacy of these medications, but their safety as well.  This has given our patients the opportunity to contribute to the process of evaluating these medications, as well as the chance to benefit from these modalities years before they will be available commercially.  We are currently enrolling for a study which is evaluating the effectiveness of an oral medication, tofacitinib, with and without methotrexate versus a combination of injectable adalimumab, Humira, and methotrexate.


Our involvement in Rheumatology has not been limited to rheumatoid arthritis. We have also been involved with studies evaluating osteoporosis, gout, systemic lupus erythematosus, and osteoarthritis. We are currently looking for patients to participate in a study to evaluate the safety and clinical improvement of tanezumab in patients with osteoarthritis of the hip or knee. This is a new approach to treatment. Tanezumab binds and inhibits the action of nerve growth factor which hopefully will reduce the pain suffered by these patients.


The goal of research is always to advance our knowledge in regards to these very complicated diseases and to develop new effective and safe treatments. We have come a long way towards that goal in the past 20 years, thanks to the patients that have volunteered to participate in these studies. I see more breakthroughs in the future. 

New Clinical Study of Flublok® Influenza Vaccine Shows That Groundbreaking Flublok Is More Effective Than the Traditional Flu Shot

7/2/2015 3:06:00 PM

MERIDEN, Conn., June 25, 2015 /PRNewswire/ -- Protein Sciences Corporation announced today topline data showing that Flublok® Quadrivalent – the quadrivalent version of FDA-approved trivalent Flublok® influenza vaccine – outperformed a traditional influenza vaccine last season and was better at preventing the flu.   The company presented the results of a clinical trial comparing Flublok Quadrivalent to a traditional egg-based quadrivalent inactivated vaccine.  The data demonstrate superior performance of Flublok based on a significantly lower number of people contracting the flu after vaccination with Flublok Quadrivalent.  

In this study of approximately 9,000 subjects aged 50 and older, half received Flublok Quadrivalent influenza vaccine and half received quadrivalent inactivated influenza vaccine produced in eggs.  The results show that 31% more people were protected by Flublok than by the egg-derived vaccine.  

"This study points out the advantages of using modern technology to overcome problems with traditional influenza vaccine manufacturing," said Manon Cox, President and CEO of Protein Sciences. "Ten years ago we had the first evidence in clinical trial PSC01 that more antigen was beneficial even for healthy adults.  Today with support from the Biomedical Advanced Research and Development Authority (BARDA) we were able to show statistically significant better performance than traditional egg-produced vaccines."

Flublok is the only flu vaccine made without the use of eggs and therefore is not subject to the mutations that are sometimes introduced into the vaccine during the process of egg adaptation that can cause the traditional vaccines to be ineffective (seeSkowronski et al. (2014) PLOS ONE 9(3), e92153).  Flublok contains three times more active ingredients than traditional vaccines (3 or 4x45mcg hemagglutinin protein versus 3 or 4x15mcg hemagglutinin protein for trivalent or quadrivalent vaccine, respectively) and produced significantly higher immune responses to the A strains of influenza (especially H3N2) in the Flublok Quadrivalent study.*  Flublok is highly purified and does not contain influenza virus, antibiotics, formaldehyde, preservatives, latex, gluten or gelatin unlike other flu vaccines. 

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. HHSO100200900106C.

For more information about Flublok, please visit

About Protein Sciences

Protein Sciences specializes in vaccine development and protein production.   Our mission is our inspiration: to save lives and improve health through the creation of innovative vaccines and biopharmaceuticals.     

Flublok, the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease, was approved by FDA in January 2013.  Flublok is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing.

Healthcare professionals wishing to pre-order Flublok should contact one of the following distributors:

Learn more at and

Flublok Safety Information

Trivalent Flublok is approved for people 18 and older to prevent influenza disease.  The most common side effect from Flublok is pain at the site of injection. Headache, fatigue or muscle ache may occur.

Tell the doctor if you have ever experienced Guillain-Barre syndrome (severe muscle weakness) or have had a severe allergic reaction to any component of Flublok vaccine.

Vaccination with Flublok may not protect all individuals. Clinical effectiveness of trivalent Flublok in adults 50 and older is based on the immune response elicited by trivalent Flublok and not on demonstration of decreased influenza disease. 

Please see the complete Package Insert available at or call 203-686-0800 for more information.

*Trivalent Flublok demonstrated a higher antibody response to the A strains during 2 clinical trials in adults >50 years old.  The B strain antibody response was comparable to traditional trivalent vaccines.

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SOURCE Protein Sciences Corporation