Volume 1, 2016 | In This Issue
Taking a Giant Leap Forward: The ALR Creates It's Own Clinical Study Network >
Partners in Progress >
Exploring Delayed-Release Prednisone >
What Drives a Scientist? >
Having Our Voices Heard >
Lupus News Corner >
TAKING A GIANT LEAP FORWARD:
THE ALR CREATES ITS OWN CLINICAL STUDY NETWORK
In a bold, innovative move, the Alliance for Lupus Research (ALR) has undertaken an important new initiative — the Lupus Clinical Investigators Network (LuCIN), which will enable us to conduct our own clinical research. LuCIN promises to greatly speed scientific discovery and bring long-awaited treatment options to people with lupus.
LuCIN was created as an outcome of the collaborative effort of the ALR and the Lupus Research Institute (LRI) to "reposition" drugs already approved by the Food and Drugs Administration (FDA) for other indications.
"The initial idea of LuCIN was to bring new drugs into the lupus arena — ones that were already approved for other diseases — and test them in lupus studies. Recently we've cast a wider net to include drugs being developed for other diseases that we believe could be efficacious in lupus. In the past year, we've made great progress on this front, while charting new ground that also holds much promise," said Albert Roy, ALR Executive Director of LuCIN.
A Patient-Centered Approach
The ALR recognizes that patient involvement is crucial to the discovery process. This is why we aim to not only increase clinical trial participation — but to instill a sense of patient ownership at the 60 top-shelf academic LuCIN centers in the U.S. and Canada.
These centers have been vetted, validated, and have the potential to involve the nearly 40,000 lupus patients who are actively being treated at these sites.
Knowing that patients have a myriad of concerns regarding participation in clinical studies, the ALR has created a peer-to-peer program as a part of LuCIN called Patient Advocates for Lupus Studies (PALS).
Attracting Pharmaceutical Companies to Join LuCIN
The ALR found that pharmaceutical companies are intrigued by what LuCIN can bring to the table — access to a sizeable lupus patient base willing to participate, the world's most innovative lupus investigators, all of them with the common goal to find new answers, and an approach that can bypass much of the early cost and time needed to bring a drug to market.
The other huge benefit of LuCIN is that it will specialize in smaller studies, many of which will test drugs already approved by the FDA, to determine if they can be efficacious in treating lupus.
The ALR's First Clinical Study Will Soon Begin
The ALR's first clinical study supported by LuCIN is scheduled to begin in the summer of 2016. The study will test RAYOS® — a low dose, delayed-release form of prednisone. Widely used to treat lupus, prednisone is effective as an immunosuppressant, but it can have significant adverse side effects.
"This study presents an opportunity to explore a way to lessen the debilitating effects associated with SLE. We're hopeful that we are onto an important treatment option," said ALR President, Kenneth M. Farber. For more information on RAYOS, please read Exploring Delayed-Release Prednisone.
Moving Beyond Drug-Intervention Protocols
In addition to drug-intervention studies, LuCIN is actively looking at other modalities to alleviate lupus-related symptoms. The ALR has partnered with the University of Virginia's Contemplative Sciences Center to scientifically measure the effects of contemplative or mindfulness techniques. LuCIN will conduct this study in 2018.
The other non-drug interventional LuCIN study involves MRI technology for patients with lupus nephritis — who have the highest mortality rate of all lupus patients. This novel approach may allow doctors to look at the kidney radiographically to determine if a patient is at risk of disease progression and find ways to stop it.
"LuCIN is addressing what has to be done," Mr. Roy said with certainty. "Working directly with patients in studies is a game-changer for the ALR — allowing us to test new ways to diagnose, treat, and prevent lupus."
With LuCIN, the ALR continues to shatter barriers to lupus research by exploring pioneering solutions. Currently, LuCIN is looking at three very diverse ideas for testing in clinical studies — a new use for a currently FDA approved drug, an alternative technological approach, and mindfulness techniques. While these initiatives are well on their way to being realized, the ALR is also pursuing other promising avenues of discovery that will be tested in additional clinical studies. Stay tuned!