WHAT WE HAVE DONE
AMPEL BioSolutions launched a project in July of 2013 to re-imagine drug discovery in SLE and rapidly bring new precision therapies to patients with this chronic disabling disease.
SLE is a systemic autoimmune disease in which the immune system that normally protects against infectious diseases becomes misdirected and attacks the person’s organs and tissues. This disease predominantly affects women of childbearing age and also is more common in many minority groups. Despite intensive research on this disease, there has been only one new treatment approved in more than half a century, and that new therapy (Benlysta) has been only modestly effective. The standard process of drug development has not been effective in SLE, stimulating AMPEL BioSolutions to rethink the paradigm.
One of AMPEL’s most recent LRxLTM projects, LRxL-STATTM was launched in October of 2013 with the support of New York’s Alliance for Lupus Research & the Lupus Research Institute (LRI). Effective safe treatments for Lupus are sorely lacking, with only one drug approved for Lupus in the last 50 years. Frustrated by the slow-paced translation of basic science discoveries into new treatments for Lupus, the ALR & LRI commissioned AMPEL BioSolutions to carry out an in-depth analysis of all drugs & biologics approved for human use in the United States.
After six month of extensive research of the human & mouse literature, AMPEL has compiled the Lupus Treatment List (LRxLTM) in consultation with members of the community which were then vetted by an expert committee in April of 2014. Take a look at the LRxL-STATTM LinkedIn site to view the poster presented at the American College of Rheumatology meeting in November of 2014. The next step is conducting SLE Treatment Acceleration Trials (STAT) with our Lupus Clinical Investigators Network (LuCINTM) & Patient Partner Integrator Network (LuPPiNTM).
Through its ground-breaking LRxLTM program, AMPEL has made a significant advance on the path to advancing Lupus treatments. Under LRxLTM, AMPEL conducted extensive research to compile valuable information relating to the potential treatments and therapies for Lupus. A core component of this information is the development of what is simply referred to as LRxLTM, an actual list of all pharmaceuticals that may assist in the treatment of Lupus. Under its LRxLTM program, AMPEL will continue its research efforts and will update and revise the LRxLTM as appropriate. The LRxLTM will be utilized by LuCINTM to conduct research and trials, including LuCIN-STATTM.
AMPEL is in process of identifying highly qualified and experienced research sites to participate Lupus Drug Repositioning Initiative. This Lupus Clinical Investigators Network (LuCINTM) is composed of clinical sites throughout the United States with exceptional research capabilities and experience in Lupus.
With the administrative and technical support of AMPEL, LuCINTM sites will conduct science-rich trials on the novel and interesting agents of the Lupus Treatment List that have a high likelihood of success. We have identified over 60 sites with interest in carrying out science-rich trials of novel and interesting agents that have a high likelihood of success. In addition, we plan that all investigators will have access to all data and publication of trial results will be encouraged. The members of LuCINTM had their first meeting at the American College of Rheumatology summit in November of 2014.
An initial core initiative of LuCINTM is LuCIN STAT,TM ground-breaking research and clinical trials dedicated to testing the identified Lupus therapies. Under the LUCIN STATTM program, LuCINTM will focus on SLE treatment and acceleration trials for the Lupus therapies that are added to the LRxLTM.
LuPPiNTM, or the Lupus Patient Partner Integrator Network, is AMPEL’s patient centric program to develop a network of caregivers, patients and patient advocates dedicated to assisting and supporting Lupus patients. LuPPiNTM has its roots in Dr. Peter Lipsky’s internationally recognized program at the UT Southwestern Medical Center in Dallas for Rheumatoid Arthritis patients called Patient Partners. Patients were trained to help medical students and professionals detect early signs and symptoms of musculoskeletal conditions, thereby facilitating an early diagnosis and therapeutic intervention to improve patient outcomes. These “Patient Partners” were a milestone in patient empowerment with “Centers of Excellence” established worldwide and more than 600 Patients Partners trained over a four-year period.
Today, AMPEL BioSolutions aims to expand this program to SLE clinical research through LuPPiNTM. Because of the difficulty of diagnosis and the lack of clear communication of symptoms, AMPEL believes that developing a patient training program will facilitate better communication between patients and doctors. In addition, patient partners—whether they be Lupus patients or dedicated patient advocates—can be of great help in educating Lupus patients about available treatment options, demystifying clinical trials to other patients, and helping to explain the nature of clinical trials, the patient protections in such trials and the important contribution patients can make in the development of new treatments. Working together with Lupus advocacy organizations and individuals, AMPEL through its LuPPiNTM program is pushing the boundaries of clinical research and developing ways of improving the clinical trial experience by actively engaging patient involvement.
AMPEL BioSolutions has developed a unique and proprietary system for assessing the efficacy of Lupus treatment known as CoLTsTM. CoLTsTM enables potential Lupus therapies to be scored and ranked based on defined criteria. As part of its CoLTsTM program, AMPEL BioSolutions provides analysis of Lupus therapies to its partners who are testing existing Lupus therapies and/or hereafter-discovered Lupus therapies. Parties that are interested in utilizing CoLTsTM should contact AMPEL.
- Kadmon, KD025 ROCK2 inhibitor
- Janssen, Stelara IL-12/23 inhibitor