CHICAGO, IL – November 5, 2018 – The Loretto Hospital announced
today that it now hosts FDA-approved clinical trials. Each clinical trial
will be coordinated through the hospital’s new Clinical Research
Department in collaboration with pharmaceutical companies. Current trials
include sickle cell disease (SCD) and heart disease studies. Additional
research studies include Crohn's disease and Ulcerative Colitis. The
Loretto Hospital will be the first safety-net hospital in the State of
Illinois to host clinical trials.
“The Loretto Hospital is one of the very few safety-net hospitals
to offer clinical research. Our goal is to bring these type of programs
to the Austin Community which will help improve outcomes in our community.
Clinical Research will increase the discovery and development of better
prevention, diagnostic and treatment methods of our patient,” said
Dr. Anosh Ahmed, chief operating officer and medical officer at The Loretto Hospital.
Presently, The Loretto Hospital is collaborating with Imara, Inc, a pharmaceutical
company dedicated to researching new therapies for people living with
SCD and other blood disorders. Their first study is a new treatment for
SCD called IMR-687. Sickle cell disease is a rare, genetically inherited
condition that alters hemoglobin, the protein in red blood cells that
transports oxygen throughout the body. The altered hemoglobin distorts
red blood cells into a stiff, inflexible crescent shape, known as a “sickle.”
Painful episodes can occur when sickled red blood cells get stuck in small
blood vessels. These episodes deprive tissues and organs of oxygen-rich
blood and can lead to vaso-occlusive crisis (VOC), acute chest syndrome
(ACS), and permanent damage to organs including the liver, spleen, kidney
The new IMR-687 therapy is a highly selective, potent small molecule inhibitor
of phosphodiesterase-9 (PDE9i) that may work on both the underlying red
and white blood cell pathology of the disease. #23025495.1 IRB Approved
at the Study Level Nov 01, 2018 Although the exact number of people living
with SCD is unknown, it is estimated that 1 out of every 365 African American
is living with it, and about 1 in 13 African American babies is born with
sickle cell trait, according to the Centers for Disease Control (CDC).
“Studies such as IMR-687 can be very effective in homing in on the
right treatment with comprehensive data. But data has to be representative
of all the ethnic groups most affected by the disease. More minorities
should participate in these medical breakthroughs in order to provide
us with the correct data,” Dr. Sandeep Mellacheruvu said, director
of clinical research at The Loretto Hospital.
Historically, African Americans have had lower representation in medical
research than White Americans. In response to this lack of diversity,
the Federal Drug Administration Office of Minority Health (OMH) established
guidelines for collecting data across racial and ethnic lines. According
to a 2016 report issued by OHM, “Collection of Race and Ethnicity
Data in Clinical Trials: Guidance for Industry and Food and Drug Administration
Staff,” it is the expectation that sponsors enroll participants
who reflect demographics for clinically relevant populations with regard
to age, race, gender and ethnicity. Despite this federal mandate, according
to the National Institute on Health, African Americans still represent
less than 10 percent of all clinical research.
“Unfortunately, African Americans have not participated in studies
because of discrimination, lack of education about the effectiveness of
these studies, and the negative stigma associated with studies like the
Tuskegee Study more than 86 years ago,” Mellacheruvu said.
Low participation has been attributed to lack of education about the studies,
lack of recruitment to minorities by the issuing drug companies and partnering
health care facilities, and mistrust of previously issued government-approved
studies that have left lasting scars on minorities.
As innovation in medical research emerges and with tight regulations surrounding
these new FDA-approved studies, individuals who participate in this level
of medical research get first access to medical breakthrough treatment
before the drugs hit the market; are paid for their time throughout the
study; and receive free health care and medication for the duration of
Additional FDA-approved studies at The Loretto Hospital include heart failure,
Chrohn’s disease and ulcerative colitis, with future studies focusing
on low testosterone and pericarditis.
The Loretto Hospital is now accepting participants for Phase 2a clinical
study evaluating IMR687 as a potential treatment for Sickle Cell Disease.
The study may take up to 28-weeks to complete. Participants will receive
compensation for travel, a stipend, free medication for SCD, free health
care and monitoring throughout the study.
To learn more about the Sickle Cell Disease (IMR-687) Study, or to learn
how to participate, or to learn more about our upcoming studies, call
866-268-2175. You may also visit our website at www.lorettohospital.org #