Download ExThera Medical Presents Results of Cytomegalovirus (CMV

NEWS RELEASE
FOR IMMEDIATE RELEASE
Contact: Ronald C. Trahan, APR, President, Ronald Trahan Associates Inc., +1-508-359-4005, x108
ExThera Medical Presents Results of
Cytomegalovirus (CMV) Binding Study
Results presented on Jan. 20, 2015, at the
44th Critical Care Congress of the Society for Critical Care Medicine
“We are developing a s i m p l e b u t powerful new tool to t r e a t
bacterial and viral bloodstream infections.” Robert Ward, CEO
BERKELEY, Calif., Jan. 28, 2015—ExThera Medical Corporation, a pioneer in the development of
broad-spectrum, biomimetic devices for treating life-threatening bloodstream infections, disclosed
today that its Seraph® Microbind® Affinity Blood Filter ( Seraph) quickly removed
Cytomegalovirus from CMV-spiked whole blood. Study results were presented at the 2015 44th
Critical Care Congress of the Society for Critical Care Medicine.
Over a million new cases of sepsis are identified in the U.S. annually, with an equally large case
population in Europe and Asia. It is one of the top-ten causes of death in the U.S., killing over 225,000
Americans each year, more than lung and breast cancer combined. Severe sepsis has reported mortality
rates ranging from 30 to 60 percent, at an average treatment cost of $22,000 per case, representing
40% of all ICU costs.
In addition to early treatment of bloodstream infections to prevent sepsis, Seraph, a dialysis-like
therapy, is potentially useful in treating cytomegalovirus reactivation during severe sepsis, and in
patients with compromised immune systems from other causes. In late-stage sepsis, 24% percent of
the patients test positive for CMV viremia. Also:
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Approximately 60% of all adults are seropositive from previous (often mild) CMV infection;
CMV reactivation in sepsis is associated with increased fungal infections, expensive ICU
stays and a doubling of the 90-­‐day mortality compared to patients without CMV
reactivation;
Reactivation of CMV is a source of significant morbidity in immunocompromised patients,
including organ transplant recipients, HIV-­‐infected patients, and cancer patients;
Cytomegalovirus (CMV), like many pathogenic bacteria, fungi, and other viruses, utilizes
heparan sulfate to bind to cell surfaces in the body;
Seraph uses immobilized heparin (an analogue of heparan sulfate) in a flow-­‐through
cartridge that binds and removes CMV from blood.
CMV disease can lead to very serious complications, including pneumonia, hepatitis, encephalitis,
myelitis, colitis, retinitis and neuropathy. In HIV patients, CMV disease often leads to death. With
drug therapy, there is an average six-day lag before a sustained drop (e.g., a one log reduction) is seen
in CMV viral blood levels, but only 58% respond after 21 days. In addition, there are over 30,000
solid organ transplants conducted in the U.S. every year with recipients requiring immune-suppressing
drugs. Bloodstream infections and CMV disease in this patient group occur more often than in the
general population.
Seraph is the only device reported to remove both bacteria and viruses directly from
whole blood without adding anything to the blood being treated. It therefore has the
potential to treat so-called ‘polymicrobial’ infections seen in critically i l l and
immuno-compromised patients.
According to Dr. Keith McCrea, CTO of ExThera, “After only about 30 seconds of
total contact with our S e r a p h ‘ adsorption media’ 82% of CMV was removed from
blood samples spiked with the virus.
A typical 4-hour clinical treatment involves 300
seconds of contact, so we believe that a 99+% reduction is possible in that time. In addition,
we measured the CMV binding capacity of our Seraph device and found it to be
very high, exceeding the entire bloodstream virus load in viremic patients.”
Since 2008, privately funded ExThera (short for Extracorporeal Therapy) has been developing new
tools to treat a wide range of bloodstream infections caused by both bacteria and viruses. ExThera’s
Seraph® Microbind® Affinity Blood Filter (Seraph), now fully developed and about to enter
clinical trials, is a broad-spectrum ‘hemoperfusion’ device with demonstrated ability to bind and
remove a long list of disease-causing agents, including toxins, fungi and inflammatory cytokines.
“ExThera’ s mission is to offer simple, device-based therapies for rapid treatment
of bloodstream infections— including those caused by agents for which there are
no effective therapeutic drugs. We are pleased to report these encouraging in vitro
results against a virus that affects patients whose immune systems are compromised
by disease or cancer treatment, or chronically suppressed because of organ
transplantation,” said Bob Ward, CEO of ExThera.
In addition to the potential to treat many viral and bacterial bloodstream infections for the prevention of
septic shock, Seraph is a flexible platform that may be reconfigured with optional “ supplemental
adsorbents” to deal with future ‘weaponized,” or naturally-evolved, pathogens.
About ExThera Medical
Privately held ExThera Medical, based in Berkeley, Calif., is targeting the clinical treatment of bloodborne diseases including bacteremia and viremia, as well as the removal of harmful substances present
in banked human blood. While medical treatments of e.g., bacteremia caused by S. aureus or MRSA
(Methicillin-Resistant S. aureus) usually rely on antibiotics, ExThera Medical’s Seraph® device
capitalizes on the pathogen’s affinity to attach to immobilized heparin, a natural anticoagulant which
has many other biological attributes. Seraph® is designed to be a biomimetic adjunct or alternative to
anti-infective therapy for reducing pathogen load and the duration of bloodstream infections, thereby
preventing complications such as endocarditis, osteomyelitis, and a runaway systemic inflammatory
response. The Company introduced its Seraph device concept to clinicians last year at the 2014 annual
congress of the Society for Critical Care Medicine.
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CAUTION: ExThera Medical’s Seraph® device is not cleared by the FDA for distribution in the
United States.
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